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Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults

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Abstract

Background

Hip fractures are a major healthcare problem, presenting a substantial challenge and burden to patients, healthcare systems and society. The increased proportion of older adults in the world population means that the absolute number of hip fractures is rising rapidly across the globe. Most hip fractures are treated surgically. This Cochrane Review evaluates evidence for implants used to treat extracapsular hip fractures.

Objectives

To assess the relative effects of cephalomedullary nails versus extramedullary fixation implants for treating extracapsular hip fractures in older adults.

Search methods

We searched CENTRAL, MEDLINE, Embase, Web of Science, the Cochrane Database of Systematic Reviews, Epistemonikos, ProQuest Dissertations & Theses, and the National Technical Information Service in July 2020. We also searched clinical trials databases, conference proceedings, reference lists of retrieved articles, and conducted backward‐citation searches.

Selection criteria

We included randomised controlled trials (RCTs) and quasi‐RCTs comparing cephalomedullary nails with extramedullary implants for treating fragility extracapsular hip fractures in older adults. We excluded studies in which all or most fractures were caused by a high‐energy trauma or specific pathologies other than osteoporosis.

Data collection and analysis

We used standard methodological procedures expected by Cochrane. We collected data for seven critical outcomes: performance of activities of daily living (ADL), delirium, functional status, health‐related quality of life, mobility, mortality (reported within four months of surgery as 'early mortality'; and reported from four months onwards, with priority given to data at 12 months, as '12 months since surgery'), and unplanned return to theatre for treating a complication resulting directly or indirectly from the primary procedure (such as deep infection or non‐union). We assessed the certainty of the evidence for these outcomes using GRADE. 

Main results

We included 76 studies (66 RCTs, 10 quasi‐RCTs) with a total of 10,979 participants with 10,988 extracapsular hip fractures. The mean ages of participants in the studies ranged from 54 to 85 years; 72% were women. Seventeen studies included unstable trochanteric fractures; three included stable trochanteric fractures only; one included only subtrochanteric fractures; and other studies included a mix of fracture types. More than half of the studies were conducted before 2010. Owing to limitations in the quality of reporting, we could not easily judge whether care pathways in these older studies were comparable to current standards of care.

We downgraded the certainty of the outcomes because of high or unclear risk of bias; imprecision (when data were available from insufficient numbers of participants or the confidence interval (CI) was wide); and inconsistency (when we noted substantial levels of statistical heterogeneity or differences between findings when outcomes were reported using other measurement tools).

There is probably little or no difference between cephalomedullary nails and extramedullary implants in terms of mortality within four months of surgery (risk ratio (RR) 0.96, 95% CI 0.79 to 1.18; 30 studies, 4603 participants) and at 12 months (RR 0.99, 95% CI 0.90 to 1.08; 47 studies, 7618 participants); this evidence was assessed to be of moderate certainty. We found low‐certainty evidence for differences in unplanned return to theatre but this was imprecise and included clinically relevant benefits and harms (RR 1.15, 95% CI 0.89 to 1.50; 50 studies, 8398 participants). The effect estimate for functional status at four months also included clinically relevant benefits and harms; this evidence was derived from only two small studies and was imprecise (standardised mean difference (SMD) 0.02, 95% CI ‐0.27 to 0.30; 188 participants; low‐certainty evidence). Similarly, the estimate for delirium was imprecise (RR 1.22, 95% CI 0.67 to 2.22; 5 studies, 1310 participants; low‐certainty evidence). Mobility at four months was reported using different measures (such as the number of people with independent mobility or scores on a mobility scale); findings were not consistent between these measures and we could not be certain of the evidence for this outcome. We were also uncertain of the findings for performance in ADL at four months; we did not pool the data from four studies because of substantial heterogeneity. We found no data for health‐related quality of life at four months.

Using a cephalomedullary nail in preference to an extramedullary device saves one superficial infection per 303 patients (RR 0.71, 95% CI 0.53 to 0.96; 35 studies, 5087 participants; moderate‐certainty evidence) and leads to fewer non‐unions (RR 0.55, 95% CI 0.32 to 0.96; 40 studies, 4959 participants; moderate‐certainty evidence). However, the risk of intraoperative implant‐related fractures was greater with cephalomedullary nails (RR 2.94, 95% CI 1.65 to 5.24; 35 studies, 4872 participants; moderate‐certainty evidence), as was the risk of later fractures (RR 3.62, 95% CI 2.07 to 6.33; 46 studies, 7021 participants; moderate‐certainty evidence). Cephalomedullary nails caused one additional implant‐related fracture per 67 participants. We noted no evidence of a difference in other adverse events related or unrelated to the implant, fracture or both.

Subgroup analyses provided no evidence of differences between the length of cephalomedullary nail used, the stability of the fracture, or between newer and older designs of cephalomedullary nail.

Authors' conclusions

Extramedullary devices, most commonly the sliding hip screw, yield very similar functional outcomes to cephalomedullary devices in the management of extracapsular fragility hip fractures. There is a reduced risk of infection and non‐union with cephalomedullary nails, however there is an increased risk of implant‐related fracture that is not attenuated with newer designs. Few studies considered patient‐relevant outcomes such as performance of activities of daily living, health‐related quality of life, mobility, or delirium. This emphasises the need to include the core outcome set for hip fracture in future RCTs.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Metal implants used to fix broken bones near the hip joint in older adults

Key messages

‐ Extramedullary implants produce very similar outcomes overall to cephalomedullary nails in the treatment of this type of hip fracture.

‐ There is a reduced risk of infection and non‐union (in which the bone fails to heal) with cephalomedullary nails, but an increased risk of implant‐related fracture.

Hip fractures in older people

A hip fracture is a break at the top of the thigh bone. In this review, we included people with a break near the hip joint. These types of broken hip are common in older adults whose bones may be fragile because of a condition called osteoporosis. They often happen after a fall from a standing or sitting position.

What are the treatments?

A common way of mending this type of break is to fix the broken parts of bone with metal implants. 

‐ During an operation, the surgeon may insert a metal rod (nail) through the top of the leg bone down towards the knee. This nail (called a cephalomedullary nail) is held in place with screws. 

‐ Alternatively, the surgeon may use a metal plate which sits on the outer edge of the broken bone (called an extramedullary implant) which is attached to the bone with screws.

What did we do?

We searched for studies that compared these two types of treatment. We wanted to find out the benefits and harms of these different treatments. We combined the findings from studies to see if we could find out if one treatment was better than another.

What did we find?

We found 76 studies, involving a total of 10,979 adults with 10,988 hip fractures. The average age of study participants ranged from 54 to 85 years and 72% were women; this is usual for people who have this type of fracture.

We found that there is probably little difference between treatment with a cephalomedullary nail or an extramedullary implant in the number of people who die within four months of surgery or at 12 months. There may be little or no difference in the number of people who experience confusion (also called delirium) after their surgery, and little or no difference in hip function (ability to use the hip) at four months after surgery. There may also be little or no difference in the number of people who need an additional operation on their broken hip. We are unsure whether there is a difference in how well a person can perform their daily activities, or in their health‐related quality of life at four months. We are also unsure whether cephalomedullary nails improve a person's ability to walk independently (with no more than one walking stick) at four months.

We also looked at possible side effects (or harms) from the fracture itself or from using one or other of the implants. For most types of common side effects in hip fracture surgery, there was no evidence of a difference between these two types of implants. We found that fewer people had an infection at the site of surgery, or a broken bone that failed to heal (called a non‐union), when a cephalomedullary nail was used. However, more people had a fracture during or after surgery when a cephalomedullary nail was used. 

Are we confident in what we found?

‐ We are moderately confident in the findings about how many people die after surgery. A large number of studies reported this, and the findings were often similar.

‐ We were less confident about the evidence for delirium, hip function, and additional operations. These findings included the possibility of a benefit with one of the treatments (for example, fewer operations) as well as the possibility of harm (for example, more operations).

‐ We were very unsure about the findings for how well people could perform their daily activities. This was because we could not explain the wide differences between findings in each study.

‐ We were unsure about the findings for health‐related quality of life because we could not account for the number of participants lost during study follow‐up.

‐ We were also unsure about the findings for a person's ability to walk independently four months after surgery. This was because studies measured walking ability in different ways, and they sometimes had different findings.

All the evidence that we found included at least some studies that had not clearly reported methods used to randomise participants (i.e. to allocate them by chance) to one of the two types of implants. These studies, with less rigorous study designs, might affect our findings.

How up‐to‐date is this review?

The evidence is up‐to‐date to July 2020.

Authors' conclusions

Implications for practice

Extramedullary devices, most commonly the sliding hip screw, yield very similar functional outcomes to cephalomedullary devices in the management of extracapsular fragility hip fractures. There is, however, a difference in the adverse event profile associated with these types of devices; there is a reduced risk of infection and non‐union with cephalomedullary nails, however there is also an increased risk of implant‐related fracture that is not attenuated with newer designs. Overall, using a cephalomedullary nail in the treatment of these fractures in preference to an extramedullary device saves one infection per 303 patients and causes one additional implant‐related fracture per 67 patients. There is insufficient evidence to determine whether cephalomedullary devices yield better outcomes in more unstable fracture patterns or whether long or short nail designs are preferable.

Implications for research

In common with the findings of our other reviews in this field (Lewis 2021Lewis 2022a), very considerable research resources have been and are being committed to this field; we identified two ongoing studies that may contribute data in future review updates. It is unlikely that future research will importantly alter our inferences about the relative clinical effectiveness of extramedullary and cephalomedullary implants. The estimates of any difference between these interventions for some critical outcomes are imprecise; however, the totality of the available data provide little evidence to suggest that any effect is likely to be clinically meaningful. This is consistent with the findings of the more recent, larger and better reported studies in this review (Matre 2013Parker 2017).

Commonly expressed opinions advocating the use of the more expensive cephalomedullary interventions include benefits in the treatment of unstable fracture patterns and a considerable reduction in complications with newer designs. This review demonstrates that convincing evidence for these beliefs is not available. We recommend that researchers focus on the unstable fracture subpopulation in future studies; it is likely that any clinically relevant benefit that warrants the additional implant‐related fracture risk associated with nails is likely to be most evident here. 

We encourage investigators to address the limitations in the quality of the evidence in the field through better study design and clear reporting about methods of randomisation and allocation concealment, as well as attempting to minimise attrition for participant‐reported outcomes. We raise the awareness amongst investigators of the core outcome set for hip fracture that should be included in every RCT in hip fracture (Haywood 2014). To date, few studies have considered patient‐relevant outcomes such as performance of activities of daily living, health‐related quality of life, mobility or delirium.

Given the recommendations in Haywood 2014, we recommend that future studies are large enough to detect differences in health‐related quality of life. Having reviewed the included studies we estimate that the standard deviation for EQ‐5D at four months post‐diagnosis is approximately 0.3. Assuming a minimum clinically important difference of 0.07 (Walters 2005), and an observed attrition in the included studies approaching 40%, we recommend future samples of no less than 1000 participants in order to ensure that estimates are sufficiently precise.

Summary of findings

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Summary of findings 1. Cephalomedullary nails compared to extramedullary implants for extracapsular hip fractures in adults

Cephalomedullary nails compared to extramedullary implants for extracapsular hip fractures in adults

Population: older adults with stable or unstable extracapsular hip fractures 
Setting: hospitals; included studies were conducted in: Australia, Austria, Brazil, Canada, China, Denmark, Finland, France, Greece, Hong Kong, India, Iran, Israel, Italy, Japan, Mexico, New Zealand, Norway, Pakistan, South Korea, Spain, Sweden, Switzerland, The Netherlands, Turkey, USA, UK
Intervention: cephalomedullary nails (Gamma nail, Gamma 3 nail, PFN, ultra‐short PFN, expandable PFN, PFNA, Targon PFN, TRIGEN INTERTAN nail, Holland nail, Küntscher‐Y nail)
Comparison: extramedullary implants (SHS, DHS, ABMI hip screw, compression hip screw, LISS, Medoff sliding plate, blade plates, percutaneous compression plate, dynamic Condylar screw, locking compression plate)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with extramedullary implants

Risk with cephalomedullary nails

Activities of daily living (ADL), early (≤ 4 months): using LEM (range from 0 to 100), FIM (range from 0 to 100), JOA (range from 0 to 20); higher scores indicate better performance in ADL

Follow‐up: time points in the included studies were at 4 weeks and 3 months

509
(4 studies)

Very lowa

We did not pool data because of high statistical heterogeneity. 

Delirium (at end of follow‐up)

Follow‐up: time points in the included studies were 4 months and 12 months

Study population

RR 1.22
(0.67 to 2.22)

1310
(5 studies)

Lowc

 

30 per 1,000b

37 per 1000
(20 to 67)

 

 

 

Functional status, early (≤ 4 months): using Zűckerman functional recovery score (0 to 44), and 100‐point functional recovery scale; in both scales, higher scores indicate better function

Follow‐up: time points in the included studies were at 3 months and 4 months

 

 

SMD 0.02 higher
(‐0.27 lower to 0.3 higher)

188
(2 studies)

Lowc

This effect did not indicate a clinically important difference, based on a 'rule of thumb' of: 0.2 for a small difference, 0.5 for a medium difference, and 0.8 for a large difference.

Using the Zűckerman functional recovery score, this equates to a MD of 0.22 (this is unlikely to represent a clinically important difference on this 44‐point scale)

Health‐related quality of life, early (≤ 4 months)

 

 

Inestimable

Mobility (≤ 4 months): assessed as number of participants with independent mobility

Follow‐up: time points in the included studies were at 3 months and 4 months

Study population

RR 1.12
(1.01 to 1.23)

719
(7 studies)

Very lowd

 

594 per 1,000b

665 per 1000
(600 to 730)

Mortality, early (≤ 4 months)

Follow‐up: time points in the included studies were during early postoperative period, within hospital, and at 1 month, 3 months, and 4 months

Study population

RR 0.96
(0.79 to 1.18)

4603
(30 studies)

Moderatee

 

83 per 1,000b

80 per 1000
(66 to 98)

Mortality at 12 months

Follow‐up: time points in the included studies were at 5 months, 6 months, 12 months, and 24 months

Study population

RR 0.99
(0.90 to 1.08)

7618
(47 studies)

Moderatee

 

204 per 1000b

202 per 1000
(184 to 220)

Unplanned return to theatre (at end of follow‐up)

Follow‐up: time points in the included studies were 3 months, 4 months, 5 months, 6 months, 12 months, and 24 months

Study population

RR 1.15
(0.89 to 1.50)

8398
(50 studies)

Lowf

 

43 per 1,000b

49 per 1000
(38 to 64)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AMBI: manufacturer name for implant; CI: confidence interval; DHS: dynamic hip screw; FIM: functional independence measure; JOA: Japanese Orthopaedic Association;LEM: lower extremity measure; LISS: less invasive stabilisation system; MD: mean difference; PFN: proximal femoral nail; PFNA: proximal femoral nail antirotation; RR: risk ratio; SHS: sliding hip screw; SMD: standardised mean difference

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect

aDowngraded by three levels: one level for serious risks of bias and two levels for inconsistency owing to high levels of unexplained statistical heterogeneity
bDerived from the pooled estimate of the cephalomedullary nails group
cDowngraded by two levels: one level for serious risks of bias, and one level owing to imprecision denoted by the wide CI in this estimate.
dDowngraded by two levels for serious risks of bias, and one level for inconsistency because this effect was not always apparent in other measures of early mobility (such as when measured using mobility scores)
eDowngraded by one level for serious risks of bias
fDowngraded by two levels: one level for serious risks of bias because all studies in this analysis were at high risk of detection bias, and one level for imprecision denoted by the wide CI in this estimate

Background

Description of the condition

Hip fracture is the general term for fracture of the proximal (upper) femur. These fractures can be subdivided into intracapsular fractures (those occurring within or proximal to the attachment of the hip joint capsule to the femur) and extracapsular (those occurring outside or distal to the hip joint capsule). Extracapsular hip fractures are defined as those fractures of the proximal femur within the area of bone from the attachment of the hip joint capsule to a level of five centimetres below the distal (lower) border of the lesser trochanter. Other terms used to describe these fractures include trochanteric, subtrochanteric, pertrochanteric and intertrochanteric fractures. These terms reflect the proximity of these fractures to the greater and lesser trochanters, which are two bony protuberances (bulges) at the upper end of the femur outside the joint capsule (Parker 2002).

Hip fractures occur predominantly in older people (aged over 65 years), especially women. In the UK, the mean age of a person with hip fracture is 83 years, and approximately two‐thirds occur in women (NHFD 2019). The relative proportion of extracapsular fractures also varies: 39% of hip fractures were extracapsular fractures in Bjorgul 2007, and 48% in Karagas 1996. A summary of the case‐mix for the 65,000 hip fractures occurring in 2018/19 in 175 hospitals in England, Wales and Northern Ireland was presented by an annual report of the National Hip Fracture Database (NHFD 2019). This showed that around three‐quarters of hip fractures (72.3%) occurred in women and over 91.1% of cases were aged over 70 years; around 40% of fractures were extracapsular.

Numerous subdivisions and classification methods exist for these fractures. The most practical classification, and that used for this review, is the basic division into stable trochanteric fractures (AO classification type A1) (Muller 1991) and unstable trochanteric fractures (AO classification type A2 and A3), with a separate category for subtrochanteric fractures. Stable trochanteric fractures are two‐part fractures in which the fracture line runs obliquely (at an angle) between the lesser and greater trochanter of the femur. Unstable trochanteric fractures again have an oblique fracture line running between the trochanters but in addition, there is comminution (multi‐fragmentation) of the fracture site. The comminution fragments may be the lesser trochanter, greater trochanter or both of these parts of the femur. Those fractures at the level of the lesser trochanter (AO A3, transtrochanteric) have a slightly more distally (lower) based fracture line which either runs transversely (across the bone) at the level of the lesser trochanter or in an oblique direction that is opposite (reverse) to that of stable and unstable trochanteric fractures. Transtrochanteric fractures may be two‐part or comminuted. This fracture pattern allows the femur to be displaced medially due to the pull of the abductor muscles. Subtrochanteric fractures are those fractures in which the fracture crossing the femur is predominately found within the five centimetres of bone immediately below the lesser trochanter. These fractures may be two‐part or comminuted and, in some instances, the fracture may extend proximally into the trochanteric region or distally into the shaft of the femur.

Description of the intervention

Operative treatment of extracapsular hip fractures was introduced in the 1950s using a variety of different implants. Implants may be either extramedullary or cephalomedullary in design. Worldwide, the most commonly used extramedullary implant is the sliding hip screw (SHS), which is synonymous with the term compression hip screw and equivalent models such as the Dynamic, Richards or AMBI hip screws. The SHS consists of a lag screw passed up the femoral neck to the femoral head. This lag screw is then attached to a plate on the side of the femur. These are considered 'dynamic' implants as they have the capacity for sliding at the plate/screw junction to allow for collapse at the fracture site, resulting in compression between the main fracture fragments. The Medoff plate (Medoff 1991) is a modification of the SHS. The difference is that the plate has an inner and outer sleeve, which can slide between each other. This creates additional capacity for sliding to occur at the level of the lesser trochanter as well as at the lag screw. Sliding at the lag screw can be prevented with a locking screw to create a 'one way' sliding Medoff instead of a 'two way' sliding Medoff. At a later date, the locking device on the lag screw can be removed to 'dynamise' the fracture. Another dynamic extramedullary device is the percutaneous compression plate (PCCP) (Orthofix), a minimally invasive device that is placed via two small incisions. It uses two smaller screws in the femoral head (as opposed to one large screw) to minimise damage to the lateral cortex and provide rotational stability.

Extramedullary devices may also be static devices; these do not allow collapse at the fracture site. These include pre‐contoured locking plates which allow placement of multiple screws in the femoral head that are locked into the plate, thereby preventing movement at the fracture site (e.g. the proximal femoral locking plate (PFLP)) and fixed nail plates such as the Jewett and the McLaughlin nail plates. Pre‐contoured locking plates designed for the distal (lower) femur may also be used as static fixed‐angle devices for extracapsular hip fractures by using them in a reverse position on the opposite proximal (upper) femur (e.g. reverse distal femoral less invasive stabilisation system (LISS) plates (rDF LISS) (DePuy Synthes) or the reverse distal femoral locking plate (rDFLP)). The 90‐ or 95‐degree blade plate is also a static extramedullary device. Though theoretically, the dynamic condylar screw plate has the capacity for sliding at the screw plate junction, it is more likely to act as a static device when used at the hip, with no slide occurring. Table 1 provides further details on the extramedullary devices assessed by the included trials in this review.

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Table 1. Extramedullary devices evaluated by included trials

Name

Description

Sliding hip screw (SHS)

The SHS (DePuy Synthes) consists of a lag screw passed up the femoral neck to the femoral head. This lag screw is then attached to a plate on the side of the femur typically at 135º (130º to 150º available). These are considered 'dynamic' implants as they have the capacity for sliding at the plate/screw junction to allow for controlled collapse at the fracture site, thereby facilitating fracture healing.

Medoff sliding plate

The Medoff sliding plate (Swemac Ltd) is a modification of the sliding hip screw, the difference being the plate having an inner and outer sleeve, which can slide between each other. This creates an additional capacity for sliding to occur at the level of the lesser trochanter as well as at the lag screw. Sliding at the lag screw can be prevented with a locking screw to create a 'one way' sliding Medoff instead of a 'two way' sliding Medoff. At a later date the locking device on the lag screw can be removed to 'dynamise' the fracture.

Percutaneous compression plate (PCCP)

The PCCP (Orthofix) is an extramedullary device developed by Gotfried in the late 1990s. Similar to the SHS, it utilises a telescoping mechanism in the femoral neck to facilitate collapse of the fracture. It differs in that it is minimally invasive (inserted by 2 small incisions) and uses 2 small screws in the femoral head as opposed to one large screw (SHS). This design is to provide double axis fixation to prevent femoral neck rotation and also prevent damage to the lateral femoral cortex as 2 small screws are used.

Dynamic condylar screw (DCS)

The DCS (DePuy Synthes) device is similar to the SHS device described above. It consists of a lag screw placed in the femoral head that attaches to a plate on the side of the femur via a barrel. It differs however in the angle the lag screw is attached to the plate (95º). This acute angle means that the DCS is most likely to act as a static device with little or no movement taking place at the screw/barrel junction.

Proximal femoral locking plate (PFLP)

The PFLP (DePuy Synthes) device is a pre‐contoured fixed angle device where multiple screws (7.3 mm and 5 mm) are placed in the femoral head and fixed to a pre‐contoured 4.5 mm plate with a locking mechanism. This ensures it acts as a static device that does not allow movement at the fracture site.

Reverse distal femoral less invasive stabilisation system plate (rDF LISS)

The rDF LISS plate (DePuy Synthes) is a pre‐contoured fixed angle devices used for distal femoral fractures. It is essentially a locking plate that can be applied using a minimally invasive technique. It has been used for contralateral proximal femoral fractures by reversing the plate position and placing it on the proximal femur (Zhou 2012).

Reverse distal femoral locking compression plate (rDFLP)

The rDFLP (Greens Surgical, India) is a pre‐contoured fixed angle device designed for distal femoral fractures. It has combination holes in the area of the plate placed on the femoral shaft allowing locked and non‐locked screw placement. It can be used for contralateral proximal femoral fractures by reversing the plate position and placing it on the proximal femur (Haq 2014).

Blade plate

The blade plate is a fixed‐angle device where the blade (attached to a plate) is placed in the centre of the femoral head. The angle at the blade/plate junction is typically 95% with plate lengths of 50 mm to 80 mm.

Cephalomedullary nails used for internal fixation of extracapsular fractures can either be inserted from distal to proximal (condylocephalic nails; Parker 1998) or from proximal to distal (cephalocondylic nails). Cephalocondylic nails are inserted through the greater trochanter of the femur and secured by a screw which is passed through the proximal part of the nail (or vice versa), up the femoral neck into the femoral head. Theoretical biomechanical advantages of these cephalomedullary nails over screw‐and‐plate fixation are attributed to a reduced distance between the hip joint and the implant, which diminishes the bending moment across the implant/fracture construct.

Another potential biomechanical advantage is that fixation with cephalomedullary nails results in less femoral medialisation. The reason nails reduce femoral medialisation is that the proximal part of the nail acts as a lateral buttress that sits inside the proximal femur; this reduces the potential space for fractured osteoporotic bone to collapse into (Ong 2019). More femoral medialisation has been shown to result in inferior mobility because the hip abductor muscles are detensioned and so cannot work as well (Bretherton 2016).

Examples of cephalomedullary nails are the Gamma nail (Stryker‐Howmedica), the cephalomedullary hip screw (IMHS) (Smith & Nephew), the proximal femoral nail (PFN) (Synthes), the proximal femoral nail antirotation (PFNA) (Synthes), the Targon PF (proximal femoral) nail (B. Braun), the Holland nail and the Küntscher‐Y nail (Cuthbert 1976). Condylocephalic nails are inserted into the distal femur and passed up the cephalomedullary cavity across the fracture site and up into the femoral head; these nails are not included in this review. The best‐known type of this nail is the Ender nail. Table 2 presents further information on the cephalomedullary nails assessed by the included trials in this review. A review comparing different cephalomedullary nails for these fractures is available (Queally 2014).

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Table 2. Cephalomedullary nails evaluated by the included trials

Name

Description

Gamma nail

The Gamma nail (Stryker) was introduced in the late 1980s for the treatment of extracapsular hip fractures. The implant consists of a sliding lag screw which passes through a short cephalomedullary nail. One or two screws may be passed through the nail tip to secure it to the femoral shaft (distal locking). Theoretical advantages of this implant are due to a percutaneous insertion technique and include reduced blood loss, reduced sepsis, minimal tissue trauma and reduced operating time. Modifications to the design of the Gamma nail and its instrumentation have occurred since its introduction. The long Gamma nail has a range of different lengths from 280 mm to 460 mm with two distal locking screws.

Gamma 3 nail

The Gamma 3 nail (Stryker) is the third generation of the gamma nail fixation system for proximal femoral fractures. It is a trochanteric entry nail with a reduced proximal nail diameter (15.5 mm versus 17 mm) to facilitate a shorter incision. Its length options range from 280 mm to 460 mm. Its neck‐shaft angle options include 120°, 125° and 130°. The lag screw shape has also been modified to provide superior cutting behaviour and greater resistance to cut‐out.

Intramedullary hip screw (IMHS)

The IMHS (Smith & Nephew), length 210 mm, was introduced in 1991 for the treatment of extracapsular femoral fractures. Like the Gamma nail, it consists of a nail inserted via the greater trochanter into the medullary cavity. It utilises a single screw in the femoral head that can slide through a barrel in the nail allowing fracture compression. Three different neck angles are available: 125°, 130° and 135°. Nail lengths are available from 195 mm to 440 mm.

Proximal femoral nail (PFN)

The PFN (DePuy Synthes), length 240 mm, was introduced in 1998 for the treatment of extracapsular fractures. Like the Gamma and IMHS, it consists of a nail inserted via the greater trochanter into the medullary cavity. Three lengths are available: 240 mm, 200 mm and an ultra‐short 180 mm. Two proximal lag screws are passed up the femoral neck to the head. Distal locking can performed in static or dynamic mode via two distal locking screws.

Proximal femoral nail antirotation (PFNA)

The PFNA (DePuy Synthes), length 170 mm, 200 mm or 240 mm, is a modification of the PFN. It is similar to the PFN apart from not having two proximal lag screws but instead a single helically‐shaped blade which is designed to provide increased angular and rotational stability. The helical blade is designed to avoid bone loss that occurs during drilling and insertion of a standard hip screw. It has 2 distal locking screw options for either dynamic or static locking. Blade‐shaft angle options include 125°, 130° and 135°.

Targon proximal femoral nail (PF)

The Targon PF (B. Braun), length 220 mm, is inserted into the intramedullary cavity via a trochanteric entry point. Proximally, this nail has a sliding lag screw and an antirotation pin. The Targon PF facilitates fracture dynamisation via a gliding screw that glides through a sleeve that is attached to the nail, thereby avoiding protrusion of the screw into peritrochanteric tissues.

Holland nail

The Holland nail (Zimmer Biomet) is like the Gamma and IMHS; it consists of a nail inserted via the greater trochanter in to the medullary cavity. Two proximal lag screws are passed up the femoral neck to the head.

Experimental nail (reported in Dujardin 2001)

An experimental mini‐invasive static intramedullary nail, which is not commercially available, is reported in Dujardin 2001. This consists of an intramedullary nail which is 170 mm long with a distal diameter of 12 mm and a proximal diameter of 13 mm. There are two five‐mm distal locking holes. The proximal hold of the femur is with two 7‐mm cannulated screws which diverge at a 30‐degree angle. Unlike the other proximal femoral nails, there is no sliding mechanism within the nail construct.

Kuntscher‐Y nail

The Kuntscher‐Y nail (Cuthbert 1976) is an early design of an intramedullary nail. It consists of a side arm and a separate slotted Kuntscher nail. The side arm is passed up the femoral neck, and then attached to an alignment jig to enable a slotted Kuntscher nail to be passed via the greater trochanter through a hole in the side arm and distally within the medullary cavity. The assembled implant construct has no capacity for sliding at the side arm and neither has it the capacity for distal locking.

Endovis nail

The Endovis nail (Citieffe) is available in 3 sizes (195 mm to 400 mm) and has a neck shaft angle of 130°. It has two cephalic screws for the femoral head to facilitate fracture compression. The distal section is slotted to produce a graduated variation of stiffness.

TRIGEN INTERTAN nail

The INTERTAN nail (Smith & Nephew) uses 2 cephalocervical screws in an integrated mechanism allowing intraoperative compression and rotational stability of the head‐neck fragments. It has a cannulated set screw mechanism that allows for the device to be used in fixed angle mode or in sliding/compression mode. Its length ranges from 18 cm to 46 cm (long nail option).

Russell‐Taylor Recon nail

The Russel‐Taylor Recon nail (Smith & Nephew) is an intramedullary nail that utilises a piriformis entry point. Two screws are available for fixation in the femoral head. It is a full length femoral nail with no short versions available for proximal femoral fixation only.

Trochanteric Fixation Nail (TFN)

The TFN nail (DePuy Synthes) is a titanium nail that utilises a helical blade for fixation in the femoral head instead of a lag screw. This design is intended to improve resistance to various collapse and improved rotational control of the medial fracture segment theoretically reducing the rate of cut‐out.

Why it is important to do this review

There is controversy over the choice of implant, especially the use of cephalomedullary nails versus sliding hip screws, for extracapsular hip fractures. Indeed, studies reporting a rapid increase in the use of cephalomedullary nails in the USA have pointed out, citing an earlier version of this review, that this phenomenon is not supported by the available evidence (Anglen 2008Forte 2008Forte 2010). The availability of new evidence — often on new implants that are aimed at avoiding the complications of cephalomedullary fixation (specifically, operative and later femoral fracture) — indicate a need to update this Cochrane Review (Parker 2010), which continues to compare different types of cephalomedullary nails with extramedullary implants.

The need for this review update was endorsed by a prioritisation process conducted as part of a National Institute for Health Research (NIHR)‐funded Cochrane Programme Grant on the management of hip fracture. This additionally provided the rationale for modifications to the review's protocol, together with the collection of additional context data and provision of additional results that might better inform current practice. 

Objectives

To assess the relative effects of cephalomedullary nails versus extramedullary fixation implants for treating extracapsular proximal femoral (hip) fractures in older adults.

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials (RCTs) and quasi‐RCTs comparing cephalocondylic intramedullary (cephalomedullary) nails with extramedullary implants in extracapsular hip fracture. Quasi‐RCTs are defined as trials in which the methods of allocating participants to an intervention are not random, but are intended to produce groups with similar future outcomes (Cochrane 2018). We included published papers and conference abstracts if they provided sufficient data relating to the methods and outcomes of interest.

Types of participants

We included older adults (at least 60 years of age) undergoing surgery in a hospital setting for an extracapsular proximal femoral fracture. We included trochanteric (stable or unstable) or subtrochanteric fractures which we expected to be caused by low‐energy trauma.

We expected trial populations to have a mean age of between 80 and 85 years, to include 70% women, 30% with chronic cognitive impairment, and 50% with an American Society of Anesthesiologists (ASA) score greater than two to indicate that a patient has no more than mild systemic disease without significant functional limitation (NHFD 2019NICE 2011). This would be representative of the general hip‐fracture population.

We excluded studies that focused exclusively on the treatment of participants younger than 60 years of age, of participants with fractures caused by specific pathologies other than osteoporosis, and of participants with high‐energy fractures. However, we took a pragmatic approach to study inclusion criteria and included studies with mixed populations (fragility and other mechanisms, ages, or pathologies). We expected that the proportion of participants with standard fragility fractures was most likely to outnumber those with high‐energy or local pathological fractures; therefore, the results would be generalisable to the fragility‐fracture population. If the data were reported separately for fragility fractures, we planned to use these subgroup data for our main analyses. We considered it unlikely that participants under 60 years of age would have experienced a fragility hip fracture caused by low‐energy trauma.

Types of interventions

We included surgical fixation of the fracture with a cephalomedullary nail or with an extramedullary implant. In our categorisation of implants we noted the key design characteristics of the type of implant, as well as assessing their current use worldwide. For cephalomedullary nails, we considered short and long nails, and dynamic versus static implants. For extramedullary implants, we considered dynamic versus static devices. For descriptions of the cephalomedullary nails and extramedullary implants evaluated in the included trials, see Table 1 and Table 2.

Types of outcome measures

Depending on the length of follow‐up reported, we categorised the end points for outcomes into early (up to and including four months) or 12 months (prioritising 12‐month data, but in their absence including any data after four months). We selected four months as the definition of early because most of early recovery has been achieved at this time point (Griffin 2015). This is also in accordance with the core outcome set for hip fracture, which prioritises early outcome over late recovery (Haywood 2014). Although priority was given to early outcomes in the presentation of our data, we also included outcome data at late time points, and we therefore included all outcomes without a time limit.

Critical outcomes

We extracted information on the following seven 'critical' outcomes.

  • Activities of daily living (e.g. Barthel Index (BI), Functional Independence Measure (FIM)).

  • Delirium, using recognised assessment scores such as Mini‐mental state examination (MMSE) or the 4 'A's Tests (4AT) and the Abbreviated Mental Test Score (AMTS).

  • Functional status (region‐specific) (e.g. hip rating questionnaire, Harris Hip Score, Oxford Hip Score).

  • Health‐related quality of life (e.g. Short Form Health Survey (SF‐36), EuroQol‐ 5 Dimension (EQ‐5D)).

  • Mobility (e.g. indoor/outdoor walking status, Cumulated Ambulation Score, Elderly Mobility Scale score, Timed Up and Go test, Short Physical Performance Battery, Parker mobility score (Parker 1993), self‐reported walking scores (e.g. Mobility Assessment Tool — short form)).

  • Mortality.

  • Unplanned return to theatre: secondary procedure required for a complication resulting directly or indirectly from the index operation/primary procedure measured at the end of study follow‐up.

Other important clinical outcomes

We also reported the following 'important' outcomes. Where relevant, we categorised these into early (up to and including four months) and late (after four months).

  • Pain (verbal rating or visual analogue scale (VAS)).

  • Length of in‐hospital stay.

  • Discharge destination. We used study authors' definitions, which were variably defined in the included studies.

  • Adverse events.

We also grouped adverse events by relatedness to the implant or fracture, or both. We reported each adverse event type separately for maximum clarity. We anticipated that events may have included the following.

Related adverse events

  • Damage to a nerve, tendon or blood vessel

  • Intraoperative periprosthetic fracture

  • Postoperative periprosthetic fracture

  • Loosening of prosthesis

  • Screw cut‐out

  • Implant failure

  • Wound infection (we used study authors' definitions, which were often described as deep infection or superficial infection)

Unrelated adverse events

  • Acute kidney injury

  • Blood transfusion

  • Cerebrovascular accident

  • Chest infection/pneumonia

  • Decreased cognitive ability

  • Myocardial infarction/acute coronary syndrome

  • Sepsis

  • Urinary tract infection

  • Venous thromboembolic phenomena (deep vein thrombosis and pulmonary embolism)

Search methods for identification of studies

As well as developing a strategy for this review, we developed general search strategies for the large bibliographic databases to find records to feed into a number of Cochrane Reviews and review updates on hip fracture surgery (Lewis 2021; Lewis 2022a; Lewis 2022b; Lewis 2022c). We searched the main databases up to July 2020.

Electronic searches

We identified RCTs and quasi‐RCTs through literature searching with systematic and sensitive search strategies, as outlined in Chapter 4 of the Cochrane Handbook of Systematic Reviews of Interventions (Lefebvre 2019). We applied no restrictions on language, date, or publication status. We searched the following databases for relevant trials.

  • Cochrane Central Register of Controlled Trials (CENTRAL; CRS Web; 8 July 2020).

  • MEDLINE (Ovid; 1946 to 6 July 2020).

  • Embase (Ovid; 1980 to 7 July 2020).

  • Web of Science (SCI EXPANDED; 1900 to 8 July 2020).

  • Cochrane Database of Systematic Reviews (CDSR; the Cochrane Library; 7 July 2020).

  • Database of Abstracts of Reviews of Effects (DARE; www.crd.york.ac.uk/CRDWeb/; 17 December 2018).

  • Health Technology Assessment (HTA) database (www.crd.york.ac.uk/CRDWeb/; 17 December 2018).

  • Epistemonikos (www.epistemonikos.org/; 9 July 2020).

  • Proquest Dissertations and Theses (ProQuest; 1743 to 8 July 2020).

  • National Technical Information Service (NTIS, for technical reports; www.ntis.gov/; 10 July 2020).

We developed a subject‐specific search strategy in MEDLINE and other listed databases; we adapted strategies with consideration of differences between database interfaces as well as different indexing languages. In MEDLINE, we used the sensitivity‐maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2019). In Embase, we used the Cochrane Embase filter (www.cochranelibrary.com/central/central-creation) to focus on RCTs. The initial search was run in November 2018 and December 2018, and a top‐up search was run in July 2020 in all databases except for DARE and HTA, in which no new records have been added since the initial search. At the time of the search, CENTRAL was fully up‐to‐date with all records from the Cochrane Bone, Joint, and Muscle Trauma (BJMT) Group's Specialised Register, and so it was not necessary to search this separately. We developed the search strategy in consultation with Information Specialists (see Acknowledgements) and the Information Specialist for Cochrane BJMT. Search strategies can be found in Appendix 1.

We scanned ClinicalTrials.gov (www.clinicaltrials.gov/) for ongoing and unpublished trials on 10 July 2020. Details of the search strategies used for previous versions of the review are given in Parker 2010.

Searching other resources

We handsearched the following conference abstracts from 2016 to November 2018.

  • Fragility Fractures Network Congress.

  • British Orthopaedic Association Congress.

  • Orthopaedic World Congress (SICOT).

  • Orthopaedic Trauma Association Annual Meeting.

  • The Bone & Joint Journal Orthopaedic Proceedings.

  • American Academy of Orthopaedic Surgeons Annual Meeting.

In addition, one review author (MJP) kept updated records of all related publications which we used during interim work on this update.

Data collection and analysis

In order to reduce bias, we ensured that any review author who is also a study author, co‐applicant on the Cochrane Programme Grant on the management of hip fracture, or has had an advisory role on any potentially relevant study, remained independent of study selection decisions, risk of bias assessment and data extraction for their study.

Selection of studies

Two review authors screened titles and abstracts of all the retrieved bibliographic records in a web‐based systematic reviewing platform, Rayyan (Ouzzani 2016), and in the top‐up search using Covidence. Full texts of all potentially eligible records passing the title and abstract screening level were retrieved and examined independently by two review authors, using the eligibility criteria outlined in Criteria for considering studies for this review. Full‐text screening was conducted using Covidence. Disagreements were resolved by discussion or adjudication by a third review author. Duplicates were excluded and multiple reports of the same study collated so that each study, rather than each report, was the unit of interest in the review. We prepared a PRISMA flow diagram to outline the study selection process, numbers of records at each stage of selection, and reasons for exclusions of full‐text articles (Moher 2009). We reported in the review details of key excluded studies, rather than all studies that were excluded from consideration of full‐text articles.

Since publication of the previous review (Parker 2010), some additional review authors conducted interim searches for the review. Results were incorporated in a non‐published review file (see Acknowledgements).

Data extraction and management

All review authors conferred on the essential data for extraction, and a form was structured to align with default headings in the Characteristics of included studies (see Appendix 2). Two review authors piloted the form on five studies and compared results. We then made changes to the template following additional discussion with the author team. For the remaining data extraction, one review author independently extracted data and a second review author checked all the data for accuracy. We extracted the following data.

  • Study methodology: publication type; sponsorship/funding/notable conflicts of interest of trial authors; study design; number of centres and locations; size and type of setting; study inclusion and exclusion criteria; randomisation method; number of randomised participants, losses (and reasons for losses), and number analysed for each outcome. (Collecting information relating to the participant flow helped with the assessment of risk of attrition bias.)

  • Population: baseline characteristics of the participants by group and overall (age, gender, smoking history, medication, body mass index (BMI), comorbidities, functional status such as previous mobility, place of residence before fracture, cognitive status, American Society of Anesthesiologists (ASA) status, fracture type and stability).

  • Interventions: details of each intervention (number and type, manufacturer details); general surgical details (number of clinicians and their skills and experience, perioperative care such as use of prophylactic antibiotics or antithromboembolics, mobilisation or weight‐bearing protocols).

  • Outcomes: all outcomes measured or reported by study authors; outcomes relevant to the review (including measurement tools and time points of measure); extraction of outcome data into data and analysis tables or additional tables in Review Manager 2020.

As above, a previous review author team conducted interim data extraction, and we supplemented this with additional data extraction using these criteria (see Acknowledgements).

Assessment of risk of bias in included studies

We assessed risk of bias in the included studies using the Cochrane risk of bias tool (Higgins 2011). We assessed the following domains.

  • Random sequence generation (selection bias).

  • Allocation concealment (selection bias).

  • Blinding of participants and personnel (performance bias).

  • Blinding of outcome assessors (detection bias).

  • Incomplete outcome data (attrition bias).

  • Selective reporting (reporting bias).

  • Other risks of bias.

In addition, we also considered performance bias related to the experience of the clinicians (whether clinicians were equally experienced with the implants used in the study). We considered risk of detection bias separately for: subjective outcomes measured by clinicians, objective outcomes measured by clinicians, and participant‐reported outcomes (e.g. pain and health‐related quality of life). For each domain, two review authors judged whether study authors made sufficient attempts to minimise bias in their design. For each domain, we made judgements using three measures  — high, low, or unclear risk of bias — and we recorded these judgements in risk of bias tables.

Measures of treatment effect

We calculated risk ratios (RRs) for dichotomous data outcomes with 95% confidence intervals (CIs); it was not appropriate to use Peto odds ratio (OR) to calculate effects because no outcomes had very low numbers of observed events. We expressed treatment effects for continuous data outcomes as mean differences (MDs) with 95% CIs; if the outcomes were measured using different scales, we planned to use standardised mean differences (SMDs) with 95% CIs.

In the event that studies reported dichotomous data using more than one category, we selected the following cut‐off points in the distribution of categories.

  • For functional status: we reported data for those with a score of excellent or good (using Harris Hip Score (HHS)) versus those with a score of moderate or poor.

  • For mobility: we reported data for those who were able to walk independently out of doors with no more than the use of one stick (NICE 2011), versus those who were more dependent.

  • For pain: we reported data for participants who reported no pain versus those who reported any category of pain.

  • For discharge destination: we reported data for participants who were discharged home versus those who were discharged to a care environment.

Unit of analysis issues

In preparation of the review, we encountered potential unit of analysis issues. We found that some studies reported the number of hip fractures (or cases) as well as the number of participants, with a very small number of participants having two fractured hips. Often, differentiating the denominators within a report was challenging. In such studies, depending on the outcome, the unit of analysis was either the participant (for example, for outcomes such as mortality, discharge destination, or some adverse events) or the hip (for example, for outcomes such as unplanned return to theatre). We noted this differentiation where applicable and used the unit of analysis (participants or case) that was appropriate for the outcome within these studies. One study included more than two interventions (Papasimos 2005); in the analysis, we combined data from the two cephalomedullary groups (trochanteric Gamma nails and proximal femoral nails) and compared these to the extramedullary intervention arm (AMBI hip screw).

Dealing with missing data

For each included study, we recorded the number of participant losses for each outcome. Unless reported otherwise, we assumed complete case data for mortality, unplanned return to theatre and adverse events. For outcomes that required participant assessment at end of follow‐up (such as health‐related quality of life), we prioritised intention‐to‐treat (ITT) data where these data were available. If ITT data were unavailable for these outcomes, and if study authors did not clearly report denominator figures for each group for the outcome, we reduced the denominator figure in each group to account for reported mortality. We did not impute missing data. We used the risk of bias tool to judge attrition bias. We judged studies to be at high risk of attrition bias if we noted large amounts of unexplained missing data, losses that could not be easily justified in the study population, or losses that were not sufficiently balanced between intervention groups. If we included a study with high attrition bias, we explored the effect during sensitivity analysis. We completed sensitivity analysis only for critical review outcomes and only considered attrition for outcomes that may be affected by these losses.

We attempted contact with study authors of more recently published trials when we noted that data for critical outcomes appeared to have been measured but not reported. For older studies, we used data collected by previous author teams; this included data from direct communication with study authors. Where standard deviations were not reported, we attempted to determine these from other reported data (such as standard errors, CIs, or exact P values). We noted in the Characteristics of included studies tables when we could not use outcome data because they were insufficiently reported or because numbers of losses in each group were not clearly specified.

Assessment of heterogeneity

We used the I2 statistic, automatically calculated in Review Manager 2020, to quantify the possible degree of heterogeneity of treatment effects between trials. We assumed there to be moderate heterogeneity when the I2 was between 30% and 60%; substantial heterogeneity when it was between 50% and 90%; and considerable heterogeneity when it was between 75% and 100%. We noted the importance of I2 depending on: 1) magnitude and direction of effects; and 2) strength of evidence for heterogeneity.  We investigated statistical heterogeneity using subgroup analysis in the event of at least 10 studies (Deeks 2021).

We assessed clinical and methodological diversity in terms of participants, interventions, outcomes, effect modifiers, and study characteristics for the included studies to determine whether a meta‐analysis was appropriate; we used the information collected during data extraction (Data extraction and management).

Assessment of reporting biases

We planned to investigate the potential for publication bias and explore possible small‐study biases using funnel plots. However, there were insufficient studies (fewer than 10) for most outcomes. For outcomes with 10 or more studies, we constructed a funnel plot and interpreted the plot using a visual inspection and the Harbord modified test in Stata; for the critical review outcomes we reported P values for the Harbord modified test or Egger's test. We incorporated this judgement into the assessment of publication bias within the GRADE assessment.

To assess outcome reporting bias, we screened clinical trials registers for protocols and registration documents of included studies that were prospectively published, and we sourced all clinical trials register documents that were reported in the study reports of included studies. We used evidence of prospective registration to judge whether studies were at risk of selective reporting bias.

Data synthesis

We conducted meta‐analyses only when meaningful, that is, when the treatments, participants, and the underlying clinical question were similar enough for pooling to make sense. We pooled results of comparable groups of trials using random‐effects models. This model was chosen after careful consideration of the extent to which any underlying effect could truly be thought to be fixed, given the complexity of the interventions included in this review. We presented 95% CIs throughout.

We found that some studies reported outcome data at more than one time point, and where possible, we reported data within two time point windows. Early data included data up to four months (with priority given to data closest to four months for studies that reported multiple time points within this window); 12‐month data included a window from later than four months and up to 24 months, but with priority being given to data at 12 months.

For studies that reported outcome data using more than one measurement tool, we selected the tool that was used most commonly by other studies in the comparison group, or which reported data for the most number of participants. For mobility, we prioritised data from mobility scores, followed by dichotomous data for independent mobility. 

We considered the appropriateness or otherwise of pooling data where there was considerable heterogeneity (I2 statistic value of greater than 75%) that could not be explained by the diversity of methodological or clinical features among trials. We presented data from these studies in the analyses and clearly reported these observations in the text for the critical outcomes in the review.

Subgroup analysis and investigation of heterogeneity

Although we aimed to explore possible sources of heterogeneity between studies (key effect modifiers such as age, gender, cognitive impairment, and functional status), we found insufficient studies reporting these data in a manner to allow for meaningful analysis. In addition, we noted that few studies sufficiently reported some of these possible effect modifiers.

We completed subgroup analysis on length of cephalomedullary nails (long and short nails). We found that some studies included both long and short nails; in other studies, the length of nail was not reported, and we included these in a subgroup for mixed or unknown nail lengths.

We also conducted subgroup analysis on fracture type (stable and unstable trochanteric fractures). We based the subclassification for fracture instability on either the trial authors' classification of unstable or stable fractures. However, if the study authors reported these data according to the AO classification system, we used this in preference to other classification systems: we considered that A1 were stable fractures and A2 (A2.1, 2.2 and 2.3) and A3 were unstable trochanteric fractures. We found several studies that included a mixed population of stable and unstable fractures or did not report the fracture subtypes, and we therefore included a third subgroup for 'mixed/unknown' fracture type. We did not include studies exclusively including subtrochanteric fractures in this subgroup analysis.

We conducted a post hoc subgroup analysis for intraoperative and postoperative periprosthetic fractures. We noted that other reviews indicated that there may be fewer periprosthetic fractures in more recent studies because of improved implant designs (Bhandari 2009Noris 2012). We therefore subgrouped these outcome data according to studies published before 2010 and from 2010 onwards.

We investigated whether the results of subgroups were significantly different by inspecting the overlap of CIs and performing the test for subgroup differences available in Review Manager 5 (Review Manager 2020).

Sensitivity analysis

We used sensitivity analysis to explore the effects of risks of bias on the review for critical outcomes. We performed analyses in which we excluded studies that met the following criteria.

  • Studies at high or unclear risk of selection bias for random sequence generation (this included studies that were described as quasi‐randomised, or that did not adequately describe methods used to randomise participants to intervention groups).

  • Studies at high risk of attrition bias (because studies reported a large number of losses that were unexplained or not justified for this population, or that were unbalanced between groups, and that we expected could influence outcome data).

  • Studies at high risk of performance bias (because the surgeons did not have comparable experience with both types of study implants).

  • Studies that used an extramedullary implant with static design.

Summary of findings and assessment of the certainty of the evidence

Two review authors used the GRADE system to assess the certainty of the body of evidence associated with the following seven critical outcomes in the review (Guyatt 2008).

  • Activities of daily living.

  • Delirium.

  • Functional status.

  • Health‐related quality of life.

  • Mobility.

  • Early mortality (measured within four months of surgery, and at 12 months).

  • Unplanned return to theatre.

For outcomes that were reported using more than one measurement tool, and that could not be combined in analysis, we assessed the certainty of the evidence for the outcome that used a measurement tool with the most participants. We only assessed the certainty of evidence when the evidence was supported by data with effect estimates. The GRADE approach assesses the certainty of a body of evidence based on the extent to which we can be confident that an estimate of effect or association reflects the item being assessed. Evaluation of the certainty of a body of evidence considers within‐study risk of bias, directness of the evidence (indirectness), heterogeneity of the data (inconsistency), precision of the effect estimates (imprecision), and risk of publication bias. The certainty of the evidence could be high, moderate, low or very low, being downgraded by one or two levels depending on the presence and extent of concerns in each of the five GRADE domains. We used footnotes to describe reasons for downgrading the certainty of the evidence for each outcome, and we used these judgements when drawing conclusions in the review.

We constructed a summary of findings table for the comparison of cephalomedullary nails versus extramedullary implants, using GRADE profiler software, to present the certainty of the evidence for these seven critical outcomes (GRADEpro GDT). We also assessed the certainty of the evidence for adverse event data related to the implant, fracture, or both, in which effect estimates clearly indicated an improvement or risk with one treatment over another.

Results

Description of studies

See Characteristics of included studiesCharacteristics of excluded studies, and Characteristics of ongoing studies.

Results of the search

After the removal of duplicates from the search results, we screened 28,510 titles and abstracts, which included backward citation searches and searches of clinical trials registers. We excluded 27,426 irrelevant records. We reviewed the full text of 1171 records, and because of minor changes to the review criteria, this included studies in Parker 2010. We excluded 1029 records, and report the details of 10 key studies from these records. We included 76 studies (with 134 records) and identified two ongoing studies; we incorporated 34 new studies in the review. Four studies are awaiting classification. See Figure 1.


Flow diagram. Search conducted in November 2018 and December 2018, with a top‐up search in July 2020.

Flow diagram. Search conducted in November 2018 and December 2018, with a top‐up search in July 2020.

Included studies

Types of studies and setting

We included 76 studies (see Characteristics of included studies). Five studies were reported only as abstracts in which only limited study characteristics were reported (Benum 1994Mehdi 2000Michos 2001Mott 1993Raimondo 2012). Ten studies used methods to allocate participants to interventions which we assessed to be quasi‐randomised (Butt 1995Goldhagen 1994Guyer 1991Hardy 1998Leung 1992Lopez 2002Park 1998Sharma 2018Verettas 2010Yamauchi 2014). The earliest study was reported in 1988 and the latest in 2020; 47% of the studies were completed from 2010 onwards.

Eleven studies were conducted across multiple centres (Ahrengart 1994Andalib 2020Baumgaertner 1998Benum 1994Davis 1988Ekstrom 2007Matre 2013Mott 1993Rahme 2007Reindl 2015Sanders 2017). Twelve studies were completed in the UK (Adams 2001Barton 2010Bridle 1991Butt 1995Davis 1988Harrington 2002Haynes 1996Little 2008Mehdi 2000Parker 2012Parker 2017Radford 1993); twelve in China (Cai 2016Chen 2018Gou 2013Han 2012Li 2018Song 2011Tao 2013Wang 2019Xu 2010Xu 2018Zhou 2012Zou 2009); five in Greece (Aktselis 2014Kouvidis 2012Michos 2001Papasimos 2005Verettas 2010); four in Switzerland (Guyer 1991Pelet 2001Sadowski 2002Saudan 2002); three each in Canada (O'Brien 1995Reindl 2015Sanders 2017), India (Haq 2014Singh 2017Singh 2019), Spain (Lopez 2002Utrilla 2005Varela‐Egocheaga 2009), Sweden (Ahrengart 1994Ekstrom 2007Mehdi 2000) and the USA (Baumgaertner 1998Goldhagen 1994Mott 1993); and two each in Brazil (Guerra 2014Sharma 2018), France (Dujardin 2001Giraud 2005), Italy (Carulli 2017Raimondo 2012), Japan (Kuwabara 1998Yamauchi 2014), Norway (Benum 1994Matre 2013), Pakistan (Adeel 2020Akhtar 2016), South Korea (Hong 2011Park 1998) and Turkey (Eceviz 2020Zehir 2015). The remainder took place in European countries (Hardy 1998Hoffmann 1999Kukla 1997Ovesen 2006Pahlpatz 1993Pajarinen 2005) or Australia (Rahme 2007), Hong Kong (Leung 1992), Iran (Andalib 2020), Israel (Chechik 2014), Mexico (Calderon 2013) or New Zealand (Hoffman 1996).

Types of participants

In total 10,979 participants with 10,998 hip fractures were recruited across the 76 studies. Of the included studies, 43 specified a lower age limit for participant inclusion; one only accepted participants older than 70 years (Verettas 2010); 13 used 65 years as the lower limit (Aktselis 2014Cai 2016Eceviz 2020Guerra 2014Harrington 2002Kouvidis 2012Kuwabara 1998Leung 1992Tao 2013Utrilla 2005Xu 2010Xu 2018Zehir 2015); 17 used 60 years (Bridle 1991Calderon 2013Chechik 2014Chen 2018Dujardin 2001Gou 2013Han 2012Hardy 1998Hong 2011Kukla 1997Li 2018Matre 2013Papasimos 2005Radford 1993Singh 2019Song 2011Varela‐Egocheaga 2009); four used 55 years (Reindl 2015Sadowski 2002Sanders 2017Saudan 2002); two used 50 years (Davis 1988Hoffman 1996) and 40 years (Adeel 2020Akhtar 2016); four used 18 years (Barton 2010Haq 2014Sharma 2018Singh 2017) and one used 16 years (Pelet 2001). The studies with 18 and 16 years as a lower cut‐off reported a mean age which reassured us that the study population was representative of the age group under investigation in this review. Three studies reported an upper age limit for participants; these were 70 years (Akhtar 2016), 75 years (Adeel 2020) and 90 years (Calderon 2013). The mean age for all participants was greater than 70 years of age in 82% of included studies. Three studies had a mean age less than 60 years of age (Akhtar 2016Haq 2014Singh 2017). Five studies did not report the age of participants (Ahrengart 1994Goldhagen 1994Han 2012Pahlpatz 1993Reindl 2015).

Gender was reported in 70 studies; overall, 72% of participants were female. Twelve studies specified in their inclusion criteria that participants should have been able to walk prior to surgery (Akhtar 2016Andalib 2020Cai 2016Eceviz 2020Guerra 2014Kukla 1997Papasimos 2005Reindl 2015Sanders 2017Xu 2010Yamauchi 2014Zehir 2015). Nine studies excluded participants with cognitive impairment (Chechik 2014Chen 2018Eceviz 2020Harrington 2002Li 2018Parker 2012Reindl 2015Wang 2019Yamauchi 2014) and 55% of the studies excluded pathological fractures.

Most studies included participants with trochanteric fractures; 12 studies also included subtrochanteric fractures (Benum 1994Butt 1995Ekstrom 2007Goldhagen 1994Guyer 1991Haynes 1996Leung 1992Matre 2013Michos 2001Miedel 2005Mott 1993Pahlpatz 1993). Rahme 2007 included only subtrochanteric fractures, and Eceviz 2020 included only basicervical fractures. Three studies included only stable fractures (Cai 2016Eceviz 2020Sharma 2018) and 17 studies investigated unstable fractures (Adeel 2020Akhtar 2016Aktselis 2014Andalib 2020Barton 2010Calderon 2013Ekstrom 2007Haq 2014Harrington 2002Miedel 2005Papasimos 2005Reindl 2015Sadowski 2002Singh 2017Verettas 2010Xu 2010Zehir 2015). Two studies did not report fracture subtypes (Michos 2001Raimondo 2012), and the remaining studies included both stable and unstable fractures. 

Three studies included participants with a preoperative waiting in excess of two weeks (Haq 2014Zehir 2015Zhou 2012), two studies included patients with a wait of up to two weeks (Hong 2011Reindl 2015), two studies reported a wait of seven days (Akhtar 2016Tao 2013), four studies reported a mean waiting time of five days (Eceviz 2020Singh 2017Wang 2019Yamauchi 2014), four studies had a mean of three days (Cai 2016Kouvidis 2012Rahme 2007Song 2011) and 12 studies reported a waiting time of less than 48 hours (Adams 2001Calderon 2013Chechik 2014Dujardin 2001Goldhagen 1994Haynes 1996Hoffman 1996Kukla 1997O'Brien 1995Pajarinen 2005Sanders 2017Verettas 2010). The remaining 49 studies did not report the preoperative waiting time.

Types of interventions

All studies used two‐arm designs, except for Papasimos 2005 which compared two cephalomedullary nails and an extramedullary implant.

Cephalomedullary implants

We included a number of different cephalomedullary nails in this review. Twenty‐nine studies reported outcomes of the Gamma nail (Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Benum 1994Bridle 1991Butt 1995Goldhagen 1994Guyer 1991Han 2012Haynes 1996Hoffman 1996Kukla 1997Kuwabara 1998Leung 1992Lopez 2002Michos 2001Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pahlpatz 1993Park 1998Pelet 2001Radford 1993Reindl 2015Song 2011Utrilla 2005Verettas 2010). One study specified a Gamma 3 nail (Varela‐Egocheaga 2009). A proximal femoral nail (PFN) was used in 12 studies (Adeel 2020Calderon 2013Ekstrom 2007Guerra 2014Haq 2014Hong 2011Pajarinen 2005Rahme 2007Sadowski 2002Saudan 2002Singh 2017Singh 2019) and a further 13 used the proximal femoral nail antirotation (PFNA) (Akhtar 2016Carulli 2017Chen 2018Gou 2013Li 2018Tao 2013Wang 2019Xu 2010Xu 2018Yamauchi 2014Zehir 2015Zhou 2012Zou 2009). One study used an ultra‐short PFN (Sharma 2018) and one described using an expandable PFN (Chechik 2014). Three studies specifically used a Targon PFN (Giraud 2005Parker 2012Parker 2017) and two studies used the TRIGEN INTERTAN nail (Matre 2013Sanders 2017). Five used an intramedullary hip screw (IMHS) (Baumgaertner 1998Hardy 1998Harrington 2002Hoffmann 1999Mehdi 2000). One study used a mixture of Gamma nails and PFNs (Papasimos 2005). Holland nails and Küntscher‐Y nails were used in one study each (Little 2008 and Davis 1988, respectively). Six studies reported a nonspecific intervention, describing the implant used as a cephalomedullary or intramedullary nail (Andalib 2020Cai 2016Dujardin 2001Eceviz 2020Kouvidis 2012Raimondo 2012). In Dujardin 2001, the nail was described as an experimental device that is not commercially available.

Two studies used long cephalomedullary nails (Barton 2010Little 2008), and 20 studies used mixed nail lengths or the length of the nail was unknown (Adeel 2020Akhtar 2016Calderon 2013Chechik 2014Davis 1988Hong 2011Kuwabara 1998Li 2018Lopez 2002Matre 2013Michos 2001Mott 1993O'Brien 1995Pahlpatz 1993Pelet 2001Rahme 2007Raimondo 2012Sanders 2017Singh 2017Singh 2019). The remaining studies used short nails. Twelve studies reported using double femoral head screws (Dujardin 2001Eceviz 2020Ekstrom 2007Giraud 2005Haq 2014Kouvidis 2012Little 2008Pajarinen 2005Parker 2012Parker 2017Saudan 2002Sharma 2018); three used a mixture of single and double femoral head screws (Andalib 2020Papasimos 2005Verettas 2010); one study used dual integrated screws (Sanders 2017); seven studies did not report the number of femoral head screws (Adeel 2020Baumgaertner 1998Calderon 2013Guerra 2014Rahme 2007Sadowski 2002Singh 2017); and the remaining studies used a single femoral head screw. Fourteen studies used blades rather than screws (Akhtar 2016Carulli 2017Gou 2013Hong 2011Li 2018Singh 2019Tao 2013Wang 2019Xu 2010Xu 2018Yamauchi 2014Zehir 2015Zhou 2012Zou 2009) and two studies used a mixture of blades and screws (Andalib 2020Reindl 2015). Distal locking was reported in 32% of studies, using one to two screws.

Nine studies reported using dynamic femoral head fixation (Bridle 1991Eceviz 2020Goldhagen 1994Kouvidis 2012Little 2008Parker 2012Parker 2017Reindl 2015Varela‐Egocheaga 2009) and six reported static fixation (Chechik 2014Davis 1988Dujardin 2001Singh 2019Tao 2013Wang 2019). The remaining studies did not report whether femoral head screw fixation was static or dynamic. One study described the implant as an experimental nail (Dujardin 2001).

Extramedullary implants

Seven studies reported using static extramedullary plates (Han 2012Haq 2014Pelet 2001Rahme 2007Singh 2017Tao 2013Zhou 2012); the remainder all used dynamic plates. The implants were described as either dynamic hip screws (Adeel 2020Bridle 1991Butt 1995Calderon 2013Carulli 2017Giraud 2005Guerra 2014Guyer 1991Haynes 1996Hoffmann 1999Hong 2011Kukla 1997Leung 1992O'Brien 1995Ovesen 2006Pahlpatz 1993Pajarinen 2005Radford 1993Reindl 2015Saudan 2002Sharma 2018Singh 2019Song 2011Verettas 2010Wang 2019Xu 2010Xu 2018Yamauchi 2014Zehir 2015Zou 2009), sliding hip screws (Barton 2010Baumgaertner 1998Davis 1988Dujardin 2001Eceviz 2020Lopez 2002Mehdi 2000Michos 2001Mott 1993Parker 2012Parker 2017Sanders 2017), AMBI hip screws (Hoffman 1996Kouvidis 2012Papasimos 2005), compression hip screws (Adams 2001Ahrengart 1994Aktselis 2014Benum 1994Chechik 2014Goldhagen 1994Hardy 1998Harrington 2002Kuwabara 1998Little 2008Park 1998Utrilla 2005), Less Invasive Stabilization System plate (LISS) (Tao 2013Zhou 2012), Medoff sliding plate (Ekstrom 2007Mehdi 2000), blade plates (Li 2018Pelet 2001Rahme 2007), percutaneous compression plates (Gou 2013Singh 2017), dynamic condylar screws (Akhtar 2016Sadowski 2002) or locking compression plates (Han 2012Singh 2017). One study used a mixture of dynamic hip screws and dynamic condylar screws (Andalib 2020). In another study, the type of extramedullary device was not explicitly stated but from information within the report we assume that a dynamic hip screw was used (Cai 2016).

Types of outcome measures

Three studies reported no review outcomes (Akhtar 2016Song 2011Wang 2019). All other studies reported data contributing to the critical outcomes in the review, except Hong 2011 and Mehdi 2000; these two studies reported adverse events related to the implant, index fracture, or both.

Sources of funding and declarations of interest

Study authors reported no conflicts of interest in 45% of studies. Five studies received industry funding (Hardy 1998Haynes 1996Matre 2013Miedel 2005Sanders 2017). The remaining studies did not report sources of funding or any potential conflicts of interest.

Excluded studies

Studies previously excluded are reported in Parker 2010. Here, we report the details of 10 key excluded studies (see Characteristics of excluded studies). Lee 2007 included only participants younger than 55 years of age. This study was included in a previous version of the review (Parker 2010); we have since changed the review criteria to include adults older than 60 years, and therefore Lee 2007 is no longer eligible (see Differences between protocol and review). We excluded Stern 2011 because this study was designed to compare screws and helical blades and the cephalomedullary nails and extramedullary implants were used in both intervention groups. We excluded two studies because they were reported only as abstracts with insufficient detail to allow inclusion (Ahmad 2011Gupta 2012). We excluded six clinical trial reports. Two of these were terminated early and have not published findings (ACTRN12608000162314NCT03065101). Four were completed in 2011/2012, according to the clinical trials register; we excluded these because we expect publication of findings is now unlikely (NCT00686023NCT00736684NCT01173744NCT01238068). 

Studies awaiting classification

We received confirmation that three studies have been completed but have not yet published and data were not currently available; these have been categorised as awaiting classification (NCT02788994NCT01380444NCT03849014). We also identified a fourth study which appears to be the pilot study of NCT01380444 (REGAIN 2008). It is anticipated that these studies will have an estimated number of participants totalling 856. They are investigating the Endovis intermedullary nail, PFN and Gamma 3 nail, in comparison to SHS. See Characteristics of studies awaiting classification.

Ongoing studies

We found two ongoing studies (IRCT20141209020258N80NCT03906032). Both studies compare a PFN and dynamic hip screw (DHS). These studies have an estimated enrolment of 388 participants. See Characteristics of ongoing studies.

Risk of bias in included studies

We only completed risk of bias assessments for studies that reported outcome data of interest to this review. We assessed detection bias separately for subjective and objective measures. Blank spaces in the risk of bias figure indicate that risk of bias assessment was not completed for the study or for the particular domain. See Figure 2.


'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study. Blank spaces in the figure indicate that 'Risk of bias' judgements were not made because study authors did not report data for these outcomes.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study. Blank spaces in the figure indicate that 'Risk of bias' judgements were not made because study authors did not report data for these outcomes.

Allocation

Twenty‐nine studies described adequate methods to randomise participants to treatment groups, and we judged these studies to be at low risk of selection bias for sequence generation (Andalib 2020Barton 2010Cai 2016Chechik 2014Davis 1988Eceviz 2020Ekstrom 2007Giraud 2005Guerra 2014Haq 2014Hoffman 1996Hong 2011Li 2018Little 2008Matre 2013Mott 1993Ovesen 2006Pajarinen 2005Parker 2012Pelet 2001Reindl 2015Sadowski 2002Sanders 2017Saudan 2002Singh 2019;  Varela‐Egocheaga 2009Xu 2010Zehir 2015Zhou 2012). Of these, 11 studies also reported an adequate method of concealment, and we judged these to also have a low risk of selection bias for allocation concealment (Chechik 2014Davis 1988Eceviz 2020Ekstrom 2007Hoffman 1996Matre 2013Ovesen 2006Pajarinen 2005Parker 2012Sanders 2017Singh 2019). Five studies reported an adequate method of allocation concealment but did not report methods for randomisation (Aktselis 2014Adams 2001Ahrengart 1994Baumgaertner 1998Parker 2017).

We judged 10 quasi‐randomised studies to be at high risk of selection bias (sequence generation) owing to the methods used to allocate participants to treatment groups (Butt 1995Goldhagen 1994Guyer 1991Hardy 1998Leung 1992Lopez 2002Park 1998Sharma 2018Verettas 2010Yamauchi 2014). Similarly, we also judged allocation concealment to be at high risk of bias in these studies. Although Haynes 1996 reported an appropriate method of sequence generation (described as using "randomisation cards"), which could be adequately concealed, we judged the risk of selection bias for sequence generation to be high; the study reports that some surgeons may have omitted participants from the study if a card was drawn for 'Gamma nails', due to unfamiliarity with intramedullary nailing technique.

The remaining studies did not report methods for randomisation or methods used to conceal allocation. We therefore judged the risk of bias as unclear in both domains.

Blinding

It is not possible to blind clinicians to the types of surgical interventions reported in this review. However, we did not expect that surgeons' performance would be influenced by the lack of blinding, and we judged all studies to be at low risk of performance bias related to blinding.

We expected, however, that surgeons' experience in using the implants could influence their performance. We extracted descriptions in the study report that either directly described that surgeons did not have comparable experience with both types of implants in their study (Baumgaertner 1998Guyer 1991Harrington 2002Haynes 1996Leung 1992Pelet 2001Tao 2013), or that indirectly inferred evidence of a learning curve or similar (Benum 1994Goldhagen 1994Hardy 1998Hoffman 1996Little 2008Mott 1993O'Brien 1995Papasimos 2005Zhou 2012); we judged these 16 studies to be at high risk of performance bias related to surgeon experience. We judged 24 studies to be at low risk of performance bias related to surgeon experience because surgeons were equally experienced with each type of implant under investigation (Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Bridle 1991Cai 2016Dujardin 2001Eceviz 2020Gou 2013Haq 2014Kouvidis 2012Kukla 1997Matre 2013Mehdi 2000Pajarinen 2005Parker 2012Parker 2017;  Radford 1993Sadowski 2002Saudan 2002Singh 2019Utrilla 2005Varela‐Egocheaga 2009Xu 2010). The remaining studies reported insufficient detail and the risk of performance bias related to surgeon experience was unclear. 

For detection bias, we considered whether outcomes were assessed by clinicians or participants, and whether assessment of these measures was likely to involve a subjective decision. We judged mortality to be an objective measure, and judged risk of detection bias to be low for all studies that measured this outcome. Although studies mostly did not describe whether participants were aware of treatment allocation, we judged the risk of detection bias to be low for subjective outcomes that were participant‐reported. However, we expected that all other clinically‐assessed outcomes were at high risk of detection bias because clinicians or other outcome assessors were likely to be aware of the type of treatment used. 

Incomplete outcome data

For attrition bias, we considered whether study authors clearly reported participant losses, whether losses were balanced between study groups, and whether the reasons for losses seemed acceptable. We noted that most losses were caused by death and, because of the typical age of participants in these studies, we were not concerned by these losses. 

In nine studies, we noted that a high number of losses were not clearly explained or were explained for reasons other than death, for example, because of loss to follow‐up (Ahrengart 1994Benum 1994Ekstrom 2007Guyer 1991Matre 2013Pahlpatz 1993Pajarinen 2005Papasimos 2005Sanders 2017). We judged these studies to be at high risk of attrition bias. Risk of attrition bias was unclear in three studies, and this was because of limited information reported in the abstract (Mehdi 2000Raimondo 2012), and because the number of participants randomised to each group was not reported (Tao 2013).

Selective reporting

We assessed only one study to be at low risk of selective reporting bias (Sanders 2017); this study was prospectively registered with a clinical trials register and the outcomes reported in the study report were consistent with those listed in the register. Five studies were retrospectively registered with a clinical trials register, and it was not possible to use these register documents to effectively assess risk of selective reporting bias (Barton 2010Cai 2016Eceviz 2020Parker 2017Reindl 2015). We identified one clinical trials register report and could not be certain whether the report was linked to one of our included studies because of some discrepancies in the report, and we judged risk of selective reporting bias for this study to be also unclear (Chechik 2014).

Because the remaining studies did not report clinical trials registration or a prepublished protocol, it was not possible to assess risk of selective reporting bias, and we therefore judged risk of selective reporting bias in these studies to also be unclear.

Other potential sources of bias

We judged three studies to be at high risk of bias because they were reported only as abstracts which we expected were not peer‐reviewed; in addition, we could not be certain of other potential sources of bias because of the limited detail in the reports (Benum 1994Mehdi 2000Raimondo 2012). We noted differences in patient management between study groups in Tao 2013 and Park 1998, in particular related to the time before weight‐bearing was allowed; because this could influence the data we judged the risk of other bias to be high in these studies. We identified no other potential sources of bias in the remaining studies.

Effects of interventions

See: Summary of findings 1 Cephalomedullary nails compared to extramedullary implants for extracapsular hip fractures in adults

We summarise which studies are included in each analysis in Appendix 3. For outcomes measured with scales, we present the range of scores and direction of effect for each scale in Appendix 4.

We used GRADE to assess the certainty of the evidence for the critical outcomes measured within four months of surgery (activities of daily living (ADL), functional status, health‐related quality of life, and mobility), within four months and at 12 months for mortality, and at the end of follow‐up for delirium and unplanned return to theatre). For outcomes assessed using more than one measurement, we graded the evidence for the outcome with most studies or participants. See summary of findings Table 1.

We summarise the effects of other important review outcomes in a table and report the results here only when there was evidence of a difference between the interventions. No subgroup or sensitivity analyses are reported for these outcomes. We have presented GRADE assessments for adverse events that clearly favoured one treatment; we did not complete GRADE assessments for other important outcomes.

Critical outcomes

Activities of daily living

Within four months of surgery, we found the following.

  • We did not pool studies for the performance of ADL within four months because statistical heterogeneity was substantial (I2 = 91%); see Analysis 1.1 for data from these individual studies. This outcome was measured using the Lower Extremity Measure (LEM), the Functional Independence Measure (FIM), and the Japanese Orthopaedic Association (JOA) score; higher scores in all scales indicate better performance of ADL. The studies reported these data at four weeks (Yamauchi 2014), and three months (Andalib 2020Reindl 2015Sanders 2017). The certainty of this evidence was very low; we downgraded by one level for serious risks of bias and by two levels for inconsistency owing to substantial levels of statistical heterogeneity.

  • Miedel 2005 reported the number of participants who were independent in the performance of ADL; the estimate was imprecise but suggested little evidence of a difference between interventions (RR 0.82, 95% CI 0.62 to 1.08, favours extramedullary implants; 1 study, 168 participants; Analysis 1.2).

  • Pahlpatz 1993 reported change in levels of independence using the Broos scale at three months. These data are reported in Appendix 5.

  • In addition, Aktselis 2014 reported early performance in ADL using the Barthel Index. We did not calculate an effect estimate because the number of analysed participants was unclear. See Appendix 6 for mean scores as reported by study authors.

At 12 months after surgery, we found the following.

  • The effect estimate for the performance of ADL was imprecise but provided evidence of little difference between interventions (SMD 0.01, 95% CI ‐0.26 to 0.27, favours cephalomedullary implants; 8 studies, 835 participants; I2 = 70%; Analysis 1.4). The outcome was measured using the Barthel Index, FIM, LEM, and Jensen's scoring system; we inverted the data for the Jensen's score so that higher scores in all scales in the analysis indicate better performance in ADL. All data were reported at 12 months.

  • Miedel 2005 also reported the number of participants who were independent in the performance of ADL at 12 months. Again, the estimate was imprecise but suggested little evidence of a difference between interventions (RR 0.90, 95% CI 0.70 to 1.16, favours extramedullary implants; 1 study, 156 participants; Analysis 1.5).

  • Pahlpatz 1993 reported change in levels of independence using the Broos scale at six months and we reported these data in Appendix 5.

Delirium

The data for delirium indicated little evidence of a difference between implants, but this estimate was imprecise (RR 1.22, 95% CI 0.67 to 2.22, favours extramedullary implants; 5 studies, 1310 participants; I2 = 0%; low‐certainty evidence; Analysis 1.7). Delirium was described in the studies as acute psychosis (Hoffmann 1999), mental disturbances (Papasimos 2005), confusion/delirium (Parker 2012Parker 2017) and disorientation (Varela‐Egocheaga 2009). Time points were not clearly specified in studies; overall study follow‐up ranged from four months to 12 months. We downgraded the GRADE assessment by one level for serious risks of bias, and one level owing to imprecision denoted by the wide CI in this estimate. 

Functional status

Within four months of surgery, we found the following.

  • We found little evidence of a difference in functional status, although the estimate was imprecise (SMD 0.02, 95% CI ‐0.27 to 0.30; 2 studies, 188 participants, favours cephalomedullary implants; I2 = 0%; low‐certainty evidence; Analysis 1.8). This outcome was measured using Zűckerman functional recovery scores and a 100‐point functional recovery score; for both scales, higher scores indicate better functional status. Using the Zűckerman functional recovery, this effect estimate equates to a MD of 0.22, which is unlikely to be a clinically important difference. The studies reported these data at three months (Guerra 2014) and four months (Kouvidis 2012). We downgraded the certainty of the evidence by one level for serious risks of bias and one level for imprecision as the CI included both clinically relevant benefits and harms.

  • We noted similar findings when this outcome was measured as the proportion of participants with excellent or good functional status (RR 1.04, 95% CI 0.96 to 1.13, favours cephalomedullary implants; 2 studies, 188 participants; I2 = 0%; Analysis 1.9). This was measured using the Harris Hip Score (HHS) and the scoring system by D'Aubigne 1954; see Appendix 5 for all categories of these scoring systems in these two studies. This was reported at three months (Xu 2018), and three to four months (Hoffmann 1999).

  • In addition, Raimondo 2012 reported early functional status using the HHS. We did not calculate an effect estimate because the number of analysed participants was unclear. See Appendix 6 for mean scores as reported by study authors.

At 12 months after surgery, we found the following.

  • We did not pool studies for functional status at 12 months because statistical heterogeneity was substantial (I2 = 94%); see Analysis 1.10 for data from these individual studies. This outcome was measured using the Zűckerman functional recovery score, HHS and modified HHS, Oxford Hip Score (OHS), and a 100‐point functional recovery score which is not defined. For all scales, higher scores indicate better function. Data were reported at 16 months (Gou 2013), 18 months (Li 2018), 24 months (Singh 2017), and at 12 months in all the other studies.

  • This outcome was also measured as the number of participants with excellent or good functional status using the HHS score, the Sanders scoring system and the Salvati and Wilson scoring system. We found little evidence of a difference between intervention groups and the estimate was imprecise, including clinically relevant benefits and harms (RR 1.06, 95% CI 0.89 to 1.27, favours cephalomedullary implants; 3 studies, 257 participants; I2 = 67%; Analysis 1.11). The data for other categories of these scoring systems in these studies is in Appendix 5.

  • In addition, Raimondo 2012 reported functional status at 12 months using the HHS. We did not calculate an effect estimate because the number of analysed participants was unclear. See Appendix 6 for mean scores as reported by study authors.

Health‐related quality of life

Within four months of surgery, we found the following.

  • Aktselis 2014 reported health‐related quality of life using EQ‐5D at three months, but we did not calculate an effect estimate because the number of analysed participants was unclear. See Appendix 6 for mean scores as reported by study authors; study authors reported a P value of 0.483 for their data.

At 12 months after surgery, we found the following.

  • We found little evidence of a difference in health‐related quality of life measured at 12 months in all studies using the physical component score (PCS) of SF‐12 and using EQ‐5D. The effect estimate included clinically relevant benefits and harms (SMD 0.28, 95% CI ‐0.15 to 0.71, favours cephalomedullary implants; 4 studies, 279 participants; I2 = 65%; Analysis 1.12).

Mobility

Within four months of surgery, we found the following.

  • We found that more people had independent mobility when a cephalomedullary implant was used (RR 1.12, 95% CI 1.01 to 1.23, favours cephalomedullary implants; 7 studies, 719 participants; I2 = 0%; Analysis 1.13). This was measured at three months in three studies (Carulli 2017Guyer 1991Park 1998), and at four months in the remaining studies. The certainty of this evidence was deemed to be very low (for reasons, see below).

  • We found little evidence of a difference in mobility scores when measured using the Parker 1993 mobility scale at three months (Parker 2012Parker 2017) (MD 0.16, 95% CI ‐0.15 to 0.48, favours cephalomedullary implants; 2 studies, 695 participants; I2 = 0%; Analysis 1.14); in this scale, higher scores indicate better mobility. In addition, two studies reported Parker mobility scores at six weeks (Eceviz 2020) and three months (Aktselis 2014). We did not calculate an effect estimate for these studies because the number of analysed participants was unclear and distribution values were not available. See Appendix 6 for mean scores as reported by study authors.

  • We also found that performance in a 10‐metre walking speed test, 14 days postoperatively, was improved for participants with a cephalomedullary implant in Li 2018 (MD 0.70, 95% CI 0.63 to 0.77, favours cephalomedullary implants; 1 study, 80 participants; Analysis 1.15).

  • Sanders 2017 reported this outcome as the proportion of participants who had sufficient ambulation to perform a Timed Up and Go test (TUG) at three months, and found little or no difference between interventions (RR 1.15, 95% CI 0.95 to 1.38, favours cephalomedullary implants; 1 study, 249 participants; Analysis 1.16).

  • Reindl 2015 reported the time to complete a TUG at three months, with no evidence of a difference in number of seconds to complete this test (MD 0.00, 95% CI ‐5.93 to 5.93, favours cephalomedullary implants; 1 study, 167 participants; Analysis 1.17).

  • For Analysis 1.13, we downgraded the evidence by three levels to very low certainty. We downgraded by two levels for serious risks of bias because all studies were at unclear risk of bias in at least domain, and in Park 1998 risk of other bias was high because of patient management differences between groups which could influence this outcome. We also downgraded by one level for inconsistency because we noted that effects were not consistent across the different measures of mobility at this time point; we therefore could not confidently draw conclusions about early mobility from these data.

At 12 months after surgery, we found the following.

  • We found that participants with cephalomedullary implants had more improvement in mobility when measured using the Parker 1993 mobility scale (MD 0.48, 95% CI 0.10 to 0.87, favours cephalomedullary implants; 14 studies, 1746 participants; I2 = 63%; Analysis 1.18). This outcome was measured at 10 months (Han 2012), 16 months (Gou 2013), 24 months (Singh 2017), and at 12 months in the remaining studies. We generated a funnel plot (Figure 3), and we found no statistical evidence of small‐study effects (using Egger's test, P = 0.718).

  • Barton 2010 measured this outcome using a five‐point mobility scale according to the number of walking aids used, and reported as a change‐from‐baseline score. We found some evidence of a difference between intervention groups at 12 months, but the estimate was imprecise and included the possibility of little or no clinically relevant difference (MD 0.34, 95% CI ‐0.25 to 0.93, favours extramedullary implants; 1 study, 151 participants; Analysis 1.19).

  • We found little evidence of a difference in the proportion of people who had independent mobility (RR 1.07, 95% CI 0.94 to 1.22, favours cephalomedullary implants; 12 studies, 1524 participants; I2 = 33%; Analysis 1.20). Data were reported at six months in Goldhagen 1994Haynes 1996Kuwabara 1998 and Zehir 2015, and at 12 months in the remaining studies. We generated a funnel plot (Figure 4), and we found no statistical evidence of small‐study effects (using the Harbord modified test, P = 0.656).

  • Two studies reported the proportion of people who failed to regain their pre‐fracture mobility, with little evidence of a difference between groups (RR 1.12, 95% CI 0.85 to 1.46, favours extramedullary implants; 2 studies, 246 participants; Analysis 1.23).

  • Matre 2013 and Sanders 2017 reported this outcome as the proportion of participants who had sufficient ambulation to perform a TUG at 12 months. However, we did not pool this data because we noted substantial statistical heterogeneity (I2 = 90%); see Analysis 1.21 for data from these individual studies.

  • Reindl 2015 reported the time to complete a TUG at 12 months, with little evidence of a difference in the number of seconds to complete this test (MD ‐1.00, 95% CI ‐6.91 to 4.91, favours cephalomedullary implants; 1 study, 167 participants; Analysis 1.22).

  • Kouvidis 2012 reported the number of participants who remained in bed, or in a wheelchair, with little evidence of a difference between interventions (RR 1.61, 95% CI 0.40 to 6.45, favours extramedullary implants; 1 study, 122 participants; Analysis 1.24).

Mortality

Within four months of surgery, we found the following.

  • We found little evidence of a difference in early mortality between the interventions, although the estimate was imprecise, including clinically relevant benefits and harms (RR 0.96, 95% CI 0.79 to 1.18, favours cephalomedullary implants; 30 studies, 4603 participants; I2 = 0%; moderate‐certainty evidence; Analysis 1.25). This outcome includes data reported during the early postoperative period, within hospital, and at one month, three months, and four months after surgery. We generated a funnel plot (Figure 5), and we found no statistical evidence of small‐study effects (using the Harbord modified test, P = 0.390).

  • We downgraded the evidence by one level because the evidence included studies with unclear and high risks of bias. We recognise that any benefit in this outcome is clinically meaningful for individuals who gain that benefit, such that a minimal clinically important difference for mortality is nonsensical. We also recognise that the estimate is based on data from 30 studies and 4603 participants; therefore we did not downgrade for imprecision.

At 12 months after surgery, we found the following.

Unplanned return to theatre

We found little evidence of a difference in unplanned return to theatre at the end of study follow‐up according to the type of implant. The estimate was imprecise and included large clinically relevant benefits and harms (RR 1.15, 95% CI 0.89 to 1.50, favours extramedullary implants; 50 studies, 8398 participants; I2 = 20%; low‐certainty evidence; Analysis 1.27). Most studies reported this outcome at 12 months, but this analysis also included data reported at three months (Giraud 2005Guyer 1991), four months (Hoffmann 1999Pajarinen 2005), five months (Butt 1995), six months (Ahrengart 1994Benum 1994Goldhagen 1994Haynes 1996Hoffman 1996Kukla 1997Leung 1992), and approximately 24 months (Sharma 2018Singh 2017Zhou 2012). We generated a funnel plot (Figure 7), and found no statistical evidence of small‐study effects (using the Harbord modified test, P = 0.372).

We downgraded the certainty of the evidence by one level for serious risks of bias (all studies in this analysis were at high risk of detection bias) and one level for imprecision. The absolute risk of return to theatre was low in both groups (approximately 5%) and so despite a large sample of 8398 participants, the CI was wide.

Other important outcomes

We report the summary effects of important outcomes in Table 3. We found little or no difference in measures of pain scores or those experiencing pain within four months of surgery, and little or no difference in the number of people experiencing pain at 12 months. We did not pool data for measures of pain at 12 months because of substantial statistical heterogeneity which we could not explain. We also noted little or no difference in length of hospital stay or in discharge destination to own home or previous residence.

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Table 3. Effects of other important outcomes

Outcome

Number of studies

Studies

Participants

Effect estimate

Pain, early (≤ 4 months)

Mean scores, using VAS, Salvati and Wilson scores, JOA scores;  we inverted data in analysis where appropriate so that lower scores indicating less pain

Follow‐up: at 4 weeks, 6 weeks, and 3 months

Dujardin 2001Matre 2013Parker 2017Yamauchi 2014 

832

SMD ‐0.13, 95% CI ‐0.43 to 0.17, favours cephalomedullary implants; I2 = 67%; Analysis 1.28 

Pain, early (≤ 4 months)

Number of people experiencing pain

Follow‐up: during postoperative period, and at 3 and 4 months

4

Aktselis 2014Guyer 1991Hoffmann 1999Zehir 2015

417

RR 0.79, 95% CI 0.42 to 1.46, favours cephalomedullary implants; I2 = 63%; Analysis 1.29

Pain at 12 months

Mean scores, using VAS, HHS subscore; we inverted data in analysis where appropriate so that lower scores indicate less pain

Follow‐up: at 12 months and 18 months

6

Chechik 2014Li 2018Matre 2013Parker 2017Sadowski 2002Saudan 2002

1025

We did not pool these data because of substantial statistical heterogeneity (I2 = 96%)

Pain at 12 months

Number of people experiencing pain

Follow‐up: at 6 months and 12 months

 10

Ahrengart 1994Aktselis 2014Baumgaertner 1998Calderon 2013Carulli 2017Hardy 1998Leung 1992Parker 2012Pelet 2001Utrilla 2005 

 952

RR 1.00, 95% CI 0.75 to 1.36, favours extramedullary implants; I2 = 26%; Analysis 1.31

Length of hospital stay

26

Aktselis 2014Barton 2010Baumgaertner 1998Carulli 2017Chechik 2014Chen 2018Dujardin 2001Gou 2013Harrington 2002Hoffman 1996Kouvidis 2012Kukla 1997Leung 1992O'Brien 1995Ovesen 2006Pajarinen 2005Parker 2012Parker 2017Sadowski 2002Saudan 2002Singh 2017Tao 2013Varela‐Egocheaga 2009Xu 2010Xu 2018Zehir 2015

3647

MD ‐0.52 days, 95% CI ‐1.23 to 0.18, favours cephalomedullary; I2 = 79%; Analysis 1.32

Discharge destination

Number of people discharged to own home or to previous residence

14

Baumgaertner 1998Carulli 2017Haynes 1996Hoffmann 1999Miedel 2005Pajarinen 2005Parker 2012Parker 2017Pelet 2001Sadowski 2002Sanders 2017Saudan 2002Varela‐Egocheaga 2009Zehir 2015

2451

RR 1.00, 95% CI 0.96 to 1.04, favours extramedullary implants; I2 = 0%; Analysis 1.32

CI: confidence interval; HHS: Harris Hip Score; JOA: Japanese Orthopaedic Association; MD: mean difference; RR: risk ratio: SMD: standardised mean difference: VAS: visual analogue scale

We report the summary effects of adverse effects related to the implant, index fracture, or both, in Table 4. We found fewer intraoperative periprosthetic fractures when extramedullary implants were used (RR 2.94, 95% CI 1.65 to 5.24; 35 studies, 4872 participants; I2 = 0; moderate‐certainty evidence), as well as fewer postoperative periprosthetic fractures (RR 3.62, 95% CI 2.07 to 6.33; 46 studies, 7021 participants; I2 = 0%; moderate‐certainty evidence). We noted that participants had fewer superficial infections with cephalomedullary implants (RR 0.71, 95% CI 0.53 to 0.96; 35 studies, 5087 participants; I2 = 0%; moderate‐certainty evidence), and there were fewer non‐unions (RR 0.55, 95% CI 0.32 to 0.96; 40 studies, 4959 participants; I2 = 0%; moderate‐certainty evidence). For other adverse events related to the implant, fracture or both (loosening, cut‐out, implant failure, and deep infection), we found little or no difference between interventions. See Table 4 and Analysis 1.34.

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Table 4. Adverse events related to implant, fracture, or both

Outcome

Number of studies

Studies

Participants

Effect estimate; Analysis 1.34

Intraoperative periprosthetic fracture

35

Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Baumgaertner 1998Benum 1994Bridle 1991Ekstrom 2007Goldhagen 1994Guyer 1991Hardy 1998Harrington 2002Hoffman 1996Hoffmann 1999Hong 2011Kouvidis 2012Kukla 1997Kuwabara 1998Leung 1992Lopez 2002Mehdi 2000Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Papasimos 2005Park 1998Pelet 2001Radford 1993Saudan 2002Sharma 2018Utrilla 2005Verettas 2010Xu 2010Zhou 2012

4872

RR 2.94, 95% CI 1.65 to 5.24, favours extramedullary implants; I2 = 0%

Postoperative periprosthetic fracture

 46

Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Baumgaertner 1998Benum 1994Bridle 1991Butt 1995Calderon 2013Chechik 2014Ekstrom 2007Giraud 2005Goldhagen 1994Gou 2013Guyer 1991Hardy 1998Harrington 2002Hoffman 1996Hoffmann 1999Hong 2011Kouvidis 2012Kukla 1997Kuwabara 1998Leung 1992Little 2008Lopez 2002Matre 2013Michos 2001Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pajarinen 2005Papasimos 2005Park 1998Parker 2012Parker 2017Radford 1993Sanders 2017Sharma 2018Singh 2019Utrilla 2005Xu 2010Xu 2018Zhou 2012Zou 2009

7021

RR 3.62, 95% CI 2.07 to 6.33, favours extramedullary implants; I2 = 0%

Loosening of prosthesis

 3

Li 2018Raimondo 2012Singh 2017

195

RR 0.57, 95% CI 0.12 to 2.76, favours cephalomedullary implants; I2 = 0%

Cut‐out

 49

Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Baumgaertner 1998Benum 1994Bridle 1991Chechik 2014Davis 1988Ekstrom 2007Giraud 2005Goldhagen 1994Guyer 1991Hardy 1998Harrington 2002Haynes 1996Hoffman 1996Hong 2011Kouvidis 2012Kukla 1997Kuwabara 1998Leung 1992Little 2008Lopez 2002Matre 2013Mehdi 2000Michos 2001Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pajarinen 2005Papasimos 2005Park 1998Parker 2012Parker 2017Pelet 2001Radford 1993Reindl 2015Sadowski 2002Saudan 2002Singh 2019Utrilla 2005Varela‐Egocheaga 2009Xu 2010Xu 2018Zehir 2015Zhou 2012Zou 2009

 7843

RR 0.93, 95% CI 0.71 to 1.22, favours cephalomedullary implants; I2 = 0%

Implant failure

24

Adams 2001Adeel 2020Aktselis 2014Andalib 2020Barton 2010Butt 1995Cai 2016Carulli 2017Chechik 2014Davis 1988Kukla 1997Little 2008O'Brien 1995Pelet 2001Radford 1993Sadowski 2002Sanders 2017Saudan 2002Sharma 2018Utrilla 2005Xu 2010Xu 2018Zhou 2012Zou 2009

 3190

RR 0.81, 95% CI 0.55 to 1.20, favours cephalomedullary implants; I2 = 0%

Deep infection

 35

Adams 2001Ahrengart 1994Aktselis 2014Andalib 2020Barton 2010Cai 2016Davis 1988Giraud 2005Guyer 1991Hardy 1998Hoffman 1996Hoffmann 1999Kukla 1997Leung 1992Little 2008Matre 2013Mehdi 2000Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pajarinen 2005Park 1998Parker 2012Parker 2017Pelet 2001Radford 1993Reindl 2015Sadowski 2002Saudan 2002Singh 2017Utrilla 2005Zehir 2015Zhou 2012Zou 2009

 6184

RR 0.76, 95% CI 0.41 to 1.38. favours cephalomedullary implants; I2 = 0%

Superficial infection

35

Adams 2001Adeel 2020Andalib 2020Bridle 1991Butt 1995Cai 2016Carulli 2017Chechik 2014Davis 1988Eceviz 2020Ekstrom 2007Gou 2013Kouvidis 2012Kuwabara 1998Lopez 2002Little 2008Miedel 2005O'Brien 1995Pajarinen 2005Papasimos 2005Parker 2012Parker 2017Radford 1993Rahme 2007Raimondo 2012Sharma 2018Singh 2017Singh 2019Utrilla 2005Verettas 2010Xu 2010Xu 2018Zehir 2015Zhou 2012Zou 2009 

 5087

RR 0.71, 95% CI 0.53 to 0.96, favours cephalomedullary implants; I2 = 0%

Non‐union

 40

Adeel 2020Ahrengart 1994Aktselis 2014Andalib 2020Barton 2010Baumgaertner 1998Cai 2016Calderon 2013Dujardin 2001Ekstrom 2007Giraud 2005Goldhagen 1994Gou 2013Haq 2014Hardy 1998Harrington 2002Hong 2011Kouvidis 2012Kukla 1997Leung 1992Li 2018Little 2008Michos 2001Ovesen 2006Papasimos 2005Park 1998Parker 2012Parker 2017Pelet 2001Radford 1993Rahme 2007Sadowski 2002Saudan 2002Sharma 2018Singh 2017Singh 2019Tao 2013Xu 2010Zhou 2012Zou 2009

 4959

RR 0.55, 95% CI 0.32 to 0.96, favours cephalomedullary implants ; I2 = 0%

CI: confidence interval; RR: risk ratio

For adverse events unrelated to the implant, fracture, or both (acute kidney injury, blood transfusion, cerebrovascular accident, pneumonia, myocardial infarction, urinary tract infection, deep vein thrombosis, and pulmonary embolism), we found little or no difference between types of implants. See Table 5 and Analysis 1.35.

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Table 5. Adverse events unrelated to implant, fracture, or both

Outcome

Number of studies

Studies

Number of participants

Effect estimate; Analysis 1.35

Acute kidney injury 

 2

Parker 2012Parker 2017 

 1000

RR 1.19, 95% CI 0.34 to 4.19, favours extramedullary implants; I2 = 0%

Blood transfusion

 17

Adams 2001Barton 2010Harrington 2002Little 2008Matre 2013Ovesen 2006Parker 2012Parker 2017Raimondo 2012Sadowski 2002Saudan 2002Sharma 2018Utrilla 2005Verettas 2010Xu 2010Yamauchi 2014

3726

RR 0.87, 95% CI 0.74 to 1.03, favours cephalomedullary implants; I2 = 76%

Cerebrovascular accident

11

Bridle 1991Butt 1995Chechik 2014Gou 2013Hoffman 1996Parker 2012Parker 2017Sadowski 2002Varela‐Egocheaga 2009Xu 2010Zhou 2012

2000

RR 1.41, 95% CI 0.61 to 3.24, favours cephalomedullary implants; I2 = 0%

Chest infection/pneumonia

25

Bridle 1991Butt 1995Cai 2016Carulli 2017Davis 1988Giraud 2005Gou 2013Hardy 1998Hoffman 1996Hoffmann 1999Kukla 1997Little 2008Lopez 2002Mott 1993O'Brien 1995Papasimos 2005Parker 2012Parker 2017Sadowski 2002Saudan 2002Singh 2019Tao 2013Varela‐Egocheaga 2009Xu 2010Zehir 2015

3657

RR 1.05, 95% CI 0.80 to 1.39, favours extramedullary implants; I2 = 0%

Myocardial infarction/acute coronary syndrome

11

Butt 1995Chechik 2014Gou 2013Hardy 1998Hoffman 1996Parker 2012Parker 2017Sadowski 2002Saudan 2002Varela‐Egocheaga 2009Zhou 2012

1800

RR 0.77, 95% CI 0.44 to 1.35, favours cephalomedullary implants; I2 = 0%

Urinary tract infection

16

Butt 1995Cai 2016Carulli 2017Davis 1988Hardy 1998Hoffman 1996Lopez 2002O'Brien 1995Papasimos 2005Sadowski 2002Saudan 2002Tao 2013Varela‐Egocheaga 2009Xu 2010Zehir 2015

1943

RR 1.06, 95% CI 0.79 to 1.41, favours extramedullary implants; I2 = 11%

Deep vein thrombosis

30

Adams 2001Ahrengart 1994Butt 1995Carulli 2017Davis 1988Giraud 2005Gou 2013Hardy 1998Hoffman 1996Hoffmann 1999Kukla 1997Li 2018Little 2008Lopez 2002Mott 1993Pajarinen 2005Papasimos 2005Parker 2012Parker 2017Radford 1993Sadowski 2002Saudan 2002Sharma 2018Singh 2019Tao 2013Utrilla 2005Verettas 2010Zehir 2015Zhou 2012Zou 2009

4589

RR 1.07, 95% CI 0.76 to 1.49, favours extramedullary implants; I2 = 0%

Pulmonary embolism

14

Bridle 1991Carulli 2017Hardy 1998Kukla 1997Little 2008O'Brien 1995Papasimos 2005Parker 2012Parker 2017Pelet 2001Sadowski 2002Saudan 2002Xu 2010Zehir 2015

2434

RR 1.27, 95% CI 0.54 to 3.03, favours extramedullary implants; I2 = 0%

CI: confidence interval; RR: risk ratio

Subgroup analyses

We only conducted relevant subgroup analyses for outcomes with at least 10 studies. Overall, our analyses provided no evidence of subgroup effects between the length of cephalomedullary nail used, the stability of the fracture, or between newer and older designs of cephalomedullary nail. For a summary of the subgroup analyses, see Appendix 7. Subgroup analysis according to fracture stability for unplanned return to theatre is presented in Figure 8, and subgroup analysis according to the date of study publication for postoperative periprosthetic fractures is presented in Figure 9.


Postoperative periprosthetic fractures: subgrouped according to date of publication

Postoperative periprosthetic fractures: subgrouped according to date of publication

Sensitivity analysis 

We excluded studies from the primary analyses of our critical outcomes that had high or unclear risks of selection bias for random sequence generation; high risk of attrition bias; high risk of performance bias because surgeons were not equally experienced with both implants; or in which the extramedullary implant had a static design. Overall, these analyses provided no evidence that decisions regarding the approach in the primary analysis influenced the inferences made. See Appendix 8.

Discussion

Summary of main results

We included 76 studies (66 randomised controlled trials (RCTs), 10 quasi‐RCTs) with a total of 10,979 participants with 10,988 extracapsular hip fractures. The majority of the studies included trochanteric fractures; 12 of these also included subtrochanteric fractures, one included only basicervical fractures and one included only subtrochanteric fractures. Three studies included only stable fractures, 17 included only unstable fractures and the remaining studies reported a mixed or unknown sample. We also identified two ongoing studies with an estimated recruitment of 388 participants.

We found little evidence to suggest that there was any difference between the interventions across the totality of our critical outcomes; see summary of findings Table 1. We collected data at two time points: within four months of surgery; and after four months of surgery, prioritising data at the 12 month time point whenever possible. We found little evidence of a difference between cephalomedullary nails and extramedullary implants in mortality within four months and 12 months of surgery; we judged this evidence to be of moderate certainty. Similarly, we found little evidence indicating any difference in unplanned return to theatre; we judged this evidence to be low‐certainty (despite a large sample size, the absolute risk of reoperation was low and the effect estimate was imprecise). The evidence for functional status at four months, and delirium, was derived from few studies and was imprecise including clinically relevant benefits and harms. We judged the certainty of the evidence for mobility at four months to be very low. Studies reported mobility using different measures (such as the number of people with independent mobility and scores on different mobility scales) and the findings from these measures were not consistent. Evidence for independent mobility was presented in most studies reporting this outcome, but these included studies at unclear risks of bias; this potential bias, alongside the inconsistency between different measures, meant that we could not be confident in the findings for early mobility. We were also very uncertain of the findings for performance of activities of daily living (ADL) at four months; we did not pool the data from the four studies because of substantial heterogeneity. Only one small study reported health‐related quality of life at four months, from which we were unable to calculate an effect estimate.

For these same outcomes but reported at 12 months, we found little evidence of any difference in the performance of ADL, in measures of health‐related quality of life, or functional status. Whilst with some instruments we found little or no difference in mobility, we noted that for one commonly used instrument, the Parker Mobility Scale, there was evidence of a benefit in mobility at 12 months with cephalomedullary nails.

In terms of other important outcomes, we identified no evidence of differences in pain, length of hospital stay or the number of people discharged to their own home or previous residence. For adverse events related to the implant or fracture, we found fewer superficial infections and non‐union when a cephalomedullary nail was used, but an increased risk of intraoperative and postoperative implant‐related fractures. The absolute risk of these events was low, and the certainty of the evidence was moderate; the difference between event risks equates to a number needed to treat for an additional harmful outcome of 67 for fracture risk, and a number needed to treat for an additional beneficial outcome of 303 for superficial infection risk when using a cephalomedullary nail. In the previous version of this review, it was noted that an evolution in nail design may reduce the implant‐related fracture risk; a subgroup analysis exploring this demonstrated no evidence to support such a hypothesis.

We performed further subgroup analyses which showed little evidence of a difference according to whether a short or long cephalomedullary nail was used, or amongst patients with stable or unstable fractures. However, many of the studies included a mix of nail lengths and fracture stabilities, thus limiting the certainty that there was no true difference between subgroups.

Overall completeness and applicability of evidence

The evidence is applicable to older adults with extracapsular fragility hip fractures sustained following low‐energy trauma. Where reported, we noted a range of mean ages from 54 to 85 years, and 72% of participants were female. We expected that most studies would include some participants with cognitive impairment; although this was often not reported, only nine studies excluded people with cognitive impairment. Studies did not consistently report American Society of Anesthesiologists (ASA) status scores to indicate participants' fitness for surgery. In general, we assess that the review includes participants that are largely representative of the general hip fracture population.

The included studies were conducted between 1988 and 2020, and more than half were conducted before 2010. Owing to limitations in the quality of reporting, we could not easily judge whether patient care pathways in these older studies were comparable to current standards of care. It is certainly possible that important developments have been made in cointerventions, such as the introduction of orthogeriatric care in some parts of the world, that have yielded improved outcomes for patients. We are unable to comment about whether such cointerventions may have changed the estimates of the relative benefits and harms between treatments reported here, or the absolute risks following treatment for extracapsular hip fractures.

The studies reported interventions that are generally available for worldwide use; only one study used a cephalomedullary implant described as an experimental design (Dujardin 2001). An evolution in nail design has occurred across the period of time that these studies have been conducted, which raises the possibility that some of the earliest data are no longer applicable to practice. However, our subgroup analysis showed no statistical evidence of a difference between studies published before and after 2010. Overall adverse events were infrequent, and a larger sample would be required to properly evaluate any temporal trends that may reflect improvement in design.

We found that few studies reported outcomes such as ADL or health‐related quality of life. These are key components of the core outcome set for hip fracture and yet our ability to draw inferences on the effect of interventions on these outcomes was limited. However, mortality and unplanned return to theatre were generally well‐reported, and these outcomes are valued by patients and clinicians in determining the effectiveness of the interventions. We note that this review does not include four studies that were completed in 2011 and 2012 which have not published their findings.

Quality of the evidence

We used GRADE to formally assess the certainty of the evidence for the critical outcomes in this review, with a particular focus on early patient‐reported outcome measures (PROMS). We judged several studies to have an unclear risk of selection bias because they did not provide information about randomisation methods; several other studies were deemed to be at high risk of selection bias because they used quasi‐randomised methods to allocate participants to groups. We used sensitivity analysis to explore this and found that re‐analysing the data without these studies sometimes influenced the direction of the effect, but this rarely changed our inferences. For most outcomes, we downgraded the certainty of the evidence for risk of selection bias. We downgraded the evidence for unplanned return to theatre because all studies for this outcome were at high risk of detection bias.

As with other hip fracture‐related Cochrane Reviews (Lewis 2021Lewis 2022a), PROMS were reported less frequently; approximately two‐thirds of the studies predated the publication of the core outcome set which guided the selection of the critical outcomes in this review (Haywood 2014). Where estimates were imprecise, as demonstrated by a wide confidence interval or few study participants, we downgraded for imprecision.

We also downgraded for inconsistency because we were unable to pool data for performance of ADL, owing to substantial statistical heterogeneity. Although we attempted to explore this in the sensitivity analysis, we had insufficient studies to confidently ascertain the reason for this heterogeneity. We did not downgrade the evidence for indirectness as the study populations and types of interventions were consistent with our protocol. We evaluated the risk of publication bias in only six analyses (in which we had more than 10 studies) and found no reason to downgrade the evidence for this potential limitation.

Potential biases in the review process

The review authors conducted a thorough search and independently assessed study eligibility, extracted data, and assessed risk of bias in the included studies before reaching consensus together or with one other review author. This is an update of a previous Cochrane Review from 2010 (Parker 2010), and we have made minor changes to the review in order to meet current methodological expectations in Cochrane intervention reviews (MECIR). The review forms part of a series of Cochrane Reviews of surgery for hip fractures (Lewis 2021Lewis 2022aLewis 2022bLewis 2022c). In addition to methodological changes, we made changes to the review in response to guidance resulting from the prioritisation process underpinning this project.

We included only older adults in this review update, in order to better reflect the general population with low‐energy fragility hip fractures. This resulted in the exclusion of just one study. We captured outcome data at an additional earlier time point (within four months of surgery); previously, the review included data only at 12 months. There is increasing loss to follow‐up over the first year after surgery and some evidence of consistency between quality of life and 'poor outcome' (dead or deterioration in residential status) at four months and 12 months (Griffin 2015). We judged that the earlier time point would provide valuable data. We also restructured the outcomes, bringing them in line with those identified during the prioritisation process and introducing seven critical outcomes consistent with the recommendations from the core outcome set for hip fracture (Haywood 2014). This restructuring resulted in the loss of a small number of outcomes from the review, however the data are still available in Parker 2010. We note that the data for most of the removed outcomes were sparse and typically heterogenous. 

The review includes cephalomedullary nails and extramedullary implants from different manufacturers, and there is inevitable variation in the precise detail of their design. We made the assumption that this variation was unlikely to be clinically relevant and chose to group implants from different manufacturers in the analyses. Following consensus discussions with clinicians, we subgrouped the data according to the length of cephalomedullary nails, fracture stability, and (in order to explore newer and older designs of cephalomedullary nals) also by date of reporting; we used sensitivity analysis to remove static designs from the evidence set. These approaches were, however, very limited in explaining variation between the studies because most studies reported using mixed types of implants or only short nails, or included a mixed population of fractures. 

We used GRADE only to assess the certainty of the evidence for the critical outcomes in this review that were included in our summary of findings table, as well as for adverse events that indicated a clear improvement or risk with one treatment. We did not report any judgements of certainty for the remaining review outcomes. 

Agreements and disagreements with other studies or reviews

The previous version of this review indicated that the sliding hip screw (SHS) appeared to be superior to cephalomedullary nails (Parker 2010); the evidence indicated a lower complication rate for the SHS and an absence of outcome data to support the use of the cephalomedullary nail. Bhandari 2009, which only included studies published up to 2005, also reported findings suggesting that previous concerns about the risk of increased femoral shaft fracture with Gamma nails may have been resolved with improved implant design and improved learning curves with the devices. Another review that specifically focused on the impact of different generations of Gamma nails included studies up to and including 2010, however not all studies were randomised or had a comparator (Noris 2012). The findings of the review by Noris and colleagues also suggested a reduced risk of postoperative fracture but did not address functional and mobility outcomes.

The findings of a more recent review and meta‐analysis reported the effectiveness of different implants for trochanteric fractures (Arirachakaran 2017); these included the dynamic hip screw, Medoff sliding plate, percutaneous compression plating, proximal femoral nails, Gamma nails, and Less Invasive Stabilisation System. However, the key outcomes in the work by Ariachakaran and colleagues were operative time, blood loss and hospital stay, which differ from our critical outcomes.

Other reviews in this area focused on specific types of implants such as short or long nails (Bovbjerg 2019), single or double screws (Cipollaro 2019), whether to use distal locking (Li 2020), or whether reaming was necessary (Clark 2021). Although we explored the length of cephalomedullary nails in subgroup analysis, our analyses included few studies of only long nails and we could not confidently report differences between the two lengths.

Our review included two large multicentre studies (of over 500 participants) published within the last ten years, the findings of which are consistent with our review (Matre 2013Parker 2012). A further large, multicentre study is due to be published soon (NCT01380444); this may influence the results of our review and will be included in future updates.

Flow diagram. Search conducted in November 2018 and December 2018, with a top‐up search in July 2020.

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Figure 1

Flow diagram. Search conducted in November 2018 and December 2018, with a top‐up search in July 2020.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study. Blank spaces in the figure indicate that 'Risk of bias' judgements were not made because study authors did not report data for these outcomes.

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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study. Blank spaces in the figure indicate that 'Risk of bias' judgements were not made because study authors did not report data for these outcomes.

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Figure 3

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Figure 4

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Figure 5

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Figure 6

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Figure 7

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Figure 8

Postoperative periprosthetic fractures: subgrouped according to date of publication

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Figure 9

Postoperative periprosthetic fractures: subgrouped according to date of publication

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 1: ADL, early (≤ 4 months)

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Analysis 1.1

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 1: ADL, early (≤ 4 months)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 2: ADL (≤ 4 months; independent in performance of ADL)

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Analysis 1.2

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 2: ADL (≤ 4 months; independent in performance of ADL)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 3: ADL, early (≤ 4 months; change in social dependency scale)

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Analysis 1.3

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 3: ADL, early (≤ 4 months; change in social dependency scale)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 4: ADL at 12 months

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Analysis 1.4

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 4: ADL at 12 months

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 5: ADL (12 months; independent in performance of ADL)

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Analysis 1.5

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 5: ADL (12 months; independent in performance of ADL)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 6: ADL at 12 months (change scores in social dependency scale

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Analysis 1.6

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 6: ADL at 12 months (change scores in social dependency scale

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 7: Delirium

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Analysis 1.7

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 7: Delirium

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 8: Functional status, early (≤ 4 months)

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Analysis 1.8

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 8: Functional status, early (≤ 4 months)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 9: Functional status, early (≤ 4 months; excellent or good)

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Analysis 1.9

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 9: Functional status, early (≤ 4 months; excellent or good)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 10: Functional status at 12 months (mean scores)

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Analysis 1.10

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 10: Functional status at 12 months (mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 11: Functional status (12 months; excellent or good using HHS)

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Analysis 1.11

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 11: Functional status (12 months; excellent or good using HHS)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 12: HRQoL at 12 months

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Analysis 1.12

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 12: HRQoL at 12 months

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 13: Mobility (≤ 4 months; independent mobility)

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Analysis 1.13

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 13: Mobility (≤ 4 months; independent mobility)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 14: Mobility, early (≤ 4 months; mobility scales, mean scores)

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Analysis 1.14

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 14: Mobility, early (≤ 4 months; mobility scales, mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 15: Mobility (≤ 4 months; 10 metre walking speed test)

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Analysis 1.15

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 15: Mobility (≤ 4 months; 10 metre walking speed test)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 16: Mobility (≤ 4 months; able to complete TUG)

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Analysis 1.16

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 16: Mobility (≤ 4 months; able to complete TUG)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 17: Mobility, early (≤ 4 months; TUG, mean scores)

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Analysis 1.17

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 17: Mobility, early (≤ 4 months; TUG, mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 18: Mobility at 12 months (mobility scales, mean scores)

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Analysis 1.18

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 18: Mobility at 12 months (mobility scales, mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 19: Mobility (at 12 months; change from baseline)

Figures and Tables -
Analysis 1.19

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 19: Mobility (at 12 months; change from baseline)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 20: Mobility (12 months; independent mobility)

Figures and Tables -
Analysis 1.20

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 20: Mobility (12 months; independent mobility)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 21: Mobility (12 months; able to complete TUG)

Figures and Tables -
Analysis 1.21

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 21: Mobility (12 months; able to complete TUG)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 22: Mobility at 12 months (TUG, mean scores)

Figures and Tables -
Analysis 1.22

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 22: Mobility at 12 months (TUG, mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 23: Failure to regain pre‐fracture mobility (at 12 months)

Figures and Tables -
Analysis 1.23

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 23: Failure to regain pre‐fracture mobility (at 12 months)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 24: Mobility at 12 months (remained in bed or wheelchair)

Figures and Tables -
Analysis 1.24

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 24: Mobility at 12 months (remained in bed or wheelchair)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 25: Mortality, early (≤ 4 months)

Figures and Tables -
Analysis 1.25

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 25: Mortality, early (≤ 4 months)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 26: Mortality at 12 months

Figures and Tables -
Analysis 1.26

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 26: Mortality at 12 months

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 27: Unplanned return to theatre

Figures and Tables -
Analysis 1.27

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 27: Unplanned return to theatre

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 28: Pain, early (≤ 4 months; pain scales, mean scores)

Figures and Tables -
Analysis 1.28

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 28: Pain, early (≤ 4 months; pain scales, mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 29: Experiencing pain (≤ 4 months)

Figures and Tables -
Analysis 1.29

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 29: Experiencing pain (≤ 4 months)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 30: Pain at 12 months (pain scales, mean scores)

Figures and Tables -
Analysis 1.30

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 30: Pain at 12 months (pain scales, mean scores)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 31: Experiencing pain (at 12 months)

Figures and Tables -
Analysis 1.31

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 31: Experiencing pain (at 12 months)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 32: Length of hospital stay (days)

Figures and Tables -
Analysis 1.32

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 32: Length of hospital stay (days)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 33: Discharge destination (to own home/previous residence)

Figures and Tables -
Analysis 1.33

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 33: Discharge destination (to own home/previous residence)

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 34: Adverse event related to implant, fracture, or both

Figures and Tables -
Analysis 1.34

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 34: Adverse event related to implant, fracture, or both

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 35: Adverse events unrelated to implant, fracture, or both

Figures and Tables -
Analysis 1.35

Comparison 1: Cephalomedullary nails versus extramedullary implants, Outcome 35: Adverse events unrelated to implant, fracture, or both

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 1: Functional status at 12 months (mean scores)

Figures and Tables -
Analysis 2.1

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 1: Functional status at 12 months (mean scores)

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 2: Mobility at 12 months (mobility scales, mean scores)

Figures and Tables -
Analysis 2.2

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 2: Mobility at 12 months (mobility scales, mean scores)

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 3: Mobility (12 months; independent mobility)

Figures and Tables -
Analysis 2.3

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 3: Mobility (12 months; independent mobility)

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 4: Early mortality

Figures and Tables -
Analysis 2.4

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 4: Early mortality

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 5: Mortality at 12 months

Figures and Tables -
Analysis 2.5

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 5: Mortality at 12 months

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 6: Unplanned return to theatre

Figures and Tables -
Analysis 2.6

Comparison 2: Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails, Outcome 6: Unplanned return to theatre

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 1: Functional status at 12 months (mean scores)

Figures and Tables -
Analysis 3.1

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 1: Functional status at 12 months (mean scores)

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 2: Mobility at 12 months (mobility scales, mean scores)

Figures and Tables -
Analysis 3.2

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 2: Mobility at 12 months (mobility scales, mean scores)

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 3: Mobility (12 months; independent mobility)

Figures and Tables -
Analysis 3.3

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 3: Mobility (12 months; independent mobility)

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 4: Early mortality

Figures and Tables -
Analysis 3.4

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 4: Early mortality

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 5: Mortality at 12 months

Figures and Tables -
Analysis 3.5

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 5: Mortality at 12 months

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 6: Unplanned return to theatre

Figures and Tables -
Analysis 3.6

Comparison 3: Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures, Outcome 6: Unplanned return to theatre

Comparison 4: Intraoperative and postoperative periprosthetic fractures: subgrouped by year of publication, Outcome 1: Intraoperative periprosthetic fracture

Figures and Tables -
Analysis 4.1

Comparison 4: Intraoperative and postoperative periprosthetic fractures: subgrouped by year of publication, Outcome 1: Intraoperative periprosthetic fracture

Comparison 4: Intraoperative and postoperative periprosthetic fractures: subgrouped by year of publication, Outcome 2: Postoperative periprosthetic fracture

Figures and Tables -
Analysis 4.2

Comparison 4: Intraoperative and postoperative periprosthetic fractures: subgrouped by year of publication, Outcome 2: Postoperative periprosthetic fracture

Summary of findings 1. Cephalomedullary nails compared to extramedullary implants for extracapsular hip fractures in adults

Cephalomedullary nails compared to extramedullary implants for extracapsular hip fractures in adults

Population: older adults with stable or unstable extracapsular hip fractures 
Setting: hospitals; included studies were conducted in: Australia, Austria, Brazil, Canada, China, Denmark, Finland, France, Greece, Hong Kong, India, Iran, Israel, Italy, Japan, Mexico, New Zealand, Norway, Pakistan, South Korea, Spain, Sweden, Switzerland, The Netherlands, Turkey, USA, UK
Intervention: cephalomedullary nails (Gamma nail, Gamma 3 nail, PFN, ultra‐short PFN, expandable PFN, PFNA, Targon PFN, TRIGEN INTERTAN nail, Holland nail, Küntscher‐Y nail)
Comparison: extramedullary implants (SHS, DHS, ABMI hip screw, compression hip screw, LISS, Medoff sliding plate, blade plates, percutaneous compression plate, dynamic Condylar screw, locking compression plate)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with extramedullary implants

Risk with cephalomedullary nails

Activities of daily living (ADL), early (≤ 4 months): using LEM (range from 0 to 100), FIM (range from 0 to 100), JOA (range from 0 to 20); higher scores indicate better performance in ADL

Follow‐up: time points in the included studies were at 4 weeks and 3 months

509
(4 studies)

Very lowa

We did not pool data because of high statistical heterogeneity. 

Delirium (at end of follow‐up)

Follow‐up: time points in the included studies were 4 months and 12 months

Study population

RR 1.22
(0.67 to 2.22)

1310
(5 studies)

Lowc

 

30 per 1,000b

37 per 1000
(20 to 67)

 

 

 

Functional status, early (≤ 4 months): using Zűckerman functional recovery score (0 to 44), and 100‐point functional recovery scale; in both scales, higher scores indicate better function

Follow‐up: time points in the included studies were at 3 months and 4 months

 

 

SMD 0.02 higher
(‐0.27 lower to 0.3 higher)

188
(2 studies)

Lowc

This effect did not indicate a clinically important difference, based on a 'rule of thumb' of: 0.2 for a small difference, 0.5 for a medium difference, and 0.8 for a large difference.

Using the Zűckerman functional recovery score, this equates to a MD of 0.22 (this is unlikely to represent a clinically important difference on this 44‐point scale)

Health‐related quality of life, early (≤ 4 months)

 

 

Inestimable

Mobility (≤ 4 months): assessed as number of participants with independent mobility

Follow‐up: time points in the included studies were at 3 months and 4 months

Study population

RR 1.12
(1.01 to 1.23)

719
(7 studies)

Very lowd

 

594 per 1,000b

665 per 1000
(600 to 730)

Mortality, early (≤ 4 months)

Follow‐up: time points in the included studies were during early postoperative period, within hospital, and at 1 month, 3 months, and 4 months

Study population

RR 0.96
(0.79 to 1.18)

4603
(30 studies)

Moderatee

 

83 per 1,000b

80 per 1000
(66 to 98)

Mortality at 12 months

Follow‐up: time points in the included studies were at 5 months, 6 months, 12 months, and 24 months

Study population

RR 0.99
(0.90 to 1.08)

7618
(47 studies)

Moderatee

 

204 per 1000b

202 per 1000
(184 to 220)

Unplanned return to theatre (at end of follow‐up)

Follow‐up: time points in the included studies were 3 months, 4 months, 5 months, 6 months, 12 months, and 24 months

Study population

RR 1.15
(0.89 to 1.50)

8398
(50 studies)

Lowf

 

43 per 1,000b

49 per 1000
(38 to 64)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AMBI: manufacturer name for implant; CI: confidence interval; DHS: dynamic hip screw; FIM: functional independence measure; JOA: Japanese Orthopaedic Association;LEM: lower extremity measure; LISS: less invasive stabilisation system; MD: mean difference; PFN: proximal femoral nail; PFNA: proximal femoral nail antirotation; RR: risk ratio; SHS: sliding hip screw; SMD: standardised mean difference

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect

aDowngraded by three levels: one level for serious risks of bias and two levels for inconsistency owing to high levels of unexplained statistical heterogeneity
bDerived from the pooled estimate of the cephalomedullary nails group
cDowngraded by two levels: one level for serious risks of bias, and one level owing to imprecision denoted by the wide CI in this estimate.
dDowngraded by two levels for serious risks of bias, and one level for inconsistency because this effect was not always apparent in other measures of early mobility (such as when measured using mobility scores)
eDowngraded by one level for serious risks of bias
fDowngraded by two levels: one level for serious risks of bias because all studies in this analysis were at high risk of detection bias, and one level for imprecision denoted by the wide CI in this estimate

Figures and Tables -
Summary of findings 1. Cephalomedullary nails compared to extramedullary implants for extracapsular hip fractures in adults
Table 1. Extramedullary devices evaluated by included trials

Name

Description

Sliding hip screw (SHS)

The SHS (DePuy Synthes) consists of a lag screw passed up the femoral neck to the femoral head. This lag screw is then attached to a plate on the side of the femur typically at 135º (130º to 150º available). These are considered 'dynamic' implants as they have the capacity for sliding at the plate/screw junction to allow for controlled collapse at the fracture site, thereby facilitating fracture healing.

Medoff sliding plate

The Medoff sliding plate (Swemac Ltd) is a modification of the sliding hip screw, the difference being the plate having an inner and outer sleeve, which can slide between each other. This creates an additional capacity for sliding to occur at the level of the lesser trochanter as well as at the lag screw. Sliding at the lag screw can be prevented with a locking screw to create a 'one way' sliding Medoff instead of a 'two way' sliding Medoff. At a later date the locking device on the lag screw can be removed to 'dynamise' the fracture.

Percutaneous compression plate (PCCP)

The PCCP (Orthofix) is an extramedullary device developed by Gotfried in the late 1990s. Similar to the SHS, it utilises a telescoping mechanism in the femoral neck to facilitate collapse of the fracture. It differs in that it is minimally invasive (inserted by 2 small incisions) and uses 2 small screws in the femoral head as opposed to one large screw (SHS). This design is to provide double axis fixation to prevent femoral neck rotation and also prevent damage to the lateral femoral cortex as 2 small screws are used.

Dynamic condylar screw (DCS)

The DCS (DePuy Synthes) device is similar to the SHS device described above. It consists of a lag screw placed in the femoral head that attaches to a plate on the side of the femur via a barrel. It differs however in the angle the lag screw is attached to the plate (95º). This acute angle means that the DCS is most likely to act as a static device with little or no movement taking place at the screw/barrel junction.

Proximal femoral locking plate (PFLP)

The PFLP (DePuy Synthes) device is a pre‐contoured fixed angle device where multiple screws (7.3 mm and 5 mm) are placed in the femoral head and fixed to a pre‐contoured 4.5 mm plate with a locking mechanism. This ensures it acts as a static device that does not allow movement at the fracture site.

Reverse distal femoral less invasive stabilisation system plate (rDF LISS)

The rDF LISS plate (DePuy Synthes) is a pre‐contoured fixed angle devices used for distal femoral fractures. It is essentially a locking plate that can be applied using a minimally invasive technique. It has been used for contralateral proximal femoral fractures by reversing the plate position and placing it on the proximal femur (Zhou 2012).

Reverse distal femoral locking compression plate (rDFLP)

The rDFLP (Greens Surgical, India) is a pre‐contoured fixed angle device designed for distal femoral fractures. It has combination holes in the area of the plate placed on the femoral shaft allowing locked and non‐locked screw placement. It can be used for contralateral proximal femoral fractures by reversing the plate position and placing it on the proximal femur (Haq 2014).

Blade plate

The blade plate is a fixed‐angle device where the blade (attached to a plate) is placed in the centre of the femoral head. The angle at the blade/plate junction is typically 95% with plate lengths of 50 mm to 80 mm.

Figures and Tables -
Table 1. Extramedullary devices evaluated by included trials
Table 2. Cephalomedullary nails evaluated by the included trials

Name

Description

Gamma nail

The Gamma nail (Stryker) was introduced in the late 1980s for the treatment of extracapsular hip fractures. The implant consists of a sliding lag screw which passes through a short cephalomedullary nail. One or two screws may be passed through the nail tip to secure it to the femoral shaft (distal locking). Theoretical advantages of this implant are due to a percutaneous insertion technique and include reduced blood loss, reduced sepsis, minimal tissue trauma and reduced operating time. Modifications to the design of the Gamma nail and its instrumentation have occurred since its introduction. The long Gamma nail has a range of different lengths from 280 mm to 460 mm with two distal locking screws.

Gamma 3 nail

The Gamma 3 nail (Stryker) is the third generation of the gamma nail fixation system for proximal femoral fractures. It is a trochanteric entry nail with a reduced proximal nail diameter (15.5 mm versus 17 mm) to facilitate a shorter incision. Its length options range from 280 mm to 460 mm. Its neck‐shaft angle options include 120°, 125° and 130°. The lag screw shape has also been modified to provide superior cutting behaviour and greater resistance to cut‐out.

Intramedullary hip screw (IMHS)

The IMHS (Smith & Nephew), length 210 mm, was introduced in 1991 for the treatment of extracapsular femoral fractures. Like the Gamma nail, it consists of a nail inserted via the greater trochanter into the medullary cavity. It utilises a single screw in the femoral head that can slide through a barrel in the nail allowing fracture compression. Three different neck angles are available: 125°, 130° and 135°. Nail lengths are available from 195 mm to 440 mm.

Proximal femoral nail (PFN)

The PFN (DePuy Synthes), length 240 mm, was introduced in 1998 for the treatment of extracapsular fractures. Like the Gamma and IMHS, it consists of a nail inserted via the greater trochanter into the medullary cavity. Three lengths are available: 240 mm, 200 mm and an ultra‐short 180 mm. Two proximal lag screws are passed up the femoral neck to the head. Distal locking can performed in static or dynamic mode via two distal locking screws.

Proximal femoral nail antirotation (PFNA)

The PFNA (DePuy Synthes), length 170 mm, 200 mm or 240 mm, is a modification of the PFN. It is similar to the PFN apart from not having two proximal lag screws but instead a single helically‐shaped blade which is designed to provide increased angular and rotational stability. The helical blade is designed to avoid bone loss that occurs during drilling and insertion of a standard hip screw. It has 2 distal locking screw options for either dynamic or static locking. Blade‐shaft angle options include 125°, 130° and 135°.

Targon proximal femoral nail (PF)

The Targon PF (B. Braun), length 220 mm, is inserted into the intramedullary cavity via a trochanteric entry point. Proximally, this nail has a sliding lag screw and an antirotation pin. The Targon PF facilitates fracture dynamisation via a gliding screw that glides through a sleeve that is attached to the nail, thereby avoiding protrusion of the screw into peritrochanteric tissues.

Holland nail

The Holland nail (Zimmer Biomet) is like the Gamma and IMHS; it consists of a nail inserted via the greater trochanter in to the medullary cavity. Two proximal lag screws are passed up the femoral neck to the head.

Experimental nail (reported in Dujardin 2001)

An experimental mini‐invasive static intramedullary nail, which is not commercially available, is reported in Dujardin 2001. This consists of an intramedullary nail which is 170 mm long with a distal diameter of 12 mm and a proximal diameter of 13 mm. There are two five‐mm distal locking holes. The proximal hold of the femur is with two 7‐mm cannulated screws which diverge at a 30‐degree angle. Unlike the other proximal femoral nails, there is no sliding mechanism within the nail construct.

Kuntscher‐Y nail

The Kuntscher‐Y nail (Cuthbert 1976) is an early design of an intramedullary nail. It consists of a side arm and a separate slotted Kuntscher nail. The side arm is passed up the femoral neck, and then attached to an alignment jig to enable a slotted Kuntscher nail to be passed via the greater trochanter through a hole in the side arm and distally within the medullary cavity. The assembled implant construct has no capacity for sliding at the side arm and neither has it the capacity for distal locking.

Endovis nail

The Endovis nail (Citieffe) is available in 3 sizes (195 mm to 400 mm) and has a neck shaft angle of 130°. It has two cephalic screws for the femoral head to facilitate fracture compression. The distal section is slotted to produce a graduated variation of stiffness.

TRIGEN INTERTAN nail

The INTERTAN nail (Smith & Nephew) uses 2 cephalocervical screws in an integrated mechanism allowing intraoperative compression and rotational stability of the head‐neck fragments. It has a cannulated set screw mechanism that allows for the device to be used in fixed angle mode or in sliding/compression mode. Its length ranges from 18 cm to 46 cm (long nail option).

Russell‐Taylor Recon nail

The Russel‐Taylor Recon nail (Smith & Nephew) is an intramedullary nail that utilises a piriformis entry point. Two screws are available for fixation in the femoral head. It is a full length femoral nail with no short versions available for proximal femoral fixation only.

Trochanteric Fixation Nail (TFN)

The TFN nail (DePuy Synthes) is a titanium nail that utilises a helical blade for fixation in the femoral head instead of a lag screw. This design is intended to improve resistance to various collapse and improved rotational control of the medial fracture segment theoretically reducing the rate of cut‐out.

Figures and Tables -
Table 2. Cephalomedullary nails evaluated by the included trials
Table 3. Effects of other important outcomes

Outcome

Number of studies

Studies

Participants

Effect estimate

Pain, early (≤ 4 months)

Mean scores, using VAS, Salvati and Wilson scores, JOA scores;  we inverted data in analysis where appropriate so that lower scores indicating less pain

Follow‐up: at 4 weeks, 6 weeks, and 3 months

Dujardin 2001Matre 2013Parker 2017Yamauchi 2014 

832

SMD ‐0.13, 95% CI ‐0.43 to 0.17, favours cephalomedullary implants; I2 = 67%; Analysis 1.28 

Pain, early (≤ 4 months)

Number of people experiencing pain

Follow‐up: during postoperative period, and at 3 and 4 months

4

Aktselis 2014Guyer 1991Hoffmann 1999Zehir 2015

417

RR 0.79, 95% CI 0.42 to 1.46, favours cephalomedullary implants; I2 = 63%; Analysis 1.29

Pain at 12 months

Mean scores, using VAS, HHS subscore; we inverted data in analysis where appropriate so that lower scores indicate less pain

Follow‐up: at 12 months and 18 months

6

Chechik 2014Li 2018Matre 2013Parker 2017Sadowski 2002Saudan 2002

1025

We did not pool these data because of substantial statistical heterogeneity (I2 = 96%)

Pain at 12 months

Number of people experiencing pain

Follow‐up: at 6 months and 12 months

 10

Ahrengart 1994Aktselis 2014Baumgaertner 1998Calderon 2013Carulli 2017Hardy 1998Leung 1992Parker 2012Pelet 2001Utrilla 2005 

 952

RR 1.00, 95% CI 0.75 to 1.36, favours extramedullary implants; I2 = 26%; Analysis 1.31

Length of hospital stay

26

Aktselis 2014Barton 2010Baumgaertner 1998Carulli 2017Chechik 2014Chen 2018Dujardin 2001Gou 2013Harrington 2002Hoffman 1996Kouvidis 2012Kukla 1997Leung 1992O'Brien 1995Ovesen 2006Pajarinen 2005Parker 2012Parker 2017Sadowski 2002Saudan 2002Singh 2017Tao 2013Varela‐Egocheaga 2009Xu 2010Xu 2018Zehir 2015

3647

MD ‐0.52 days, 95% CI ‐1.23 to 0.18, favours cephalomedullary; I2 = 79%; Analysis 1.32

Discharge destination

Number of people discharged to own home or to previous residence

14

Baumgaertner 1998Carulli 2017Haynes 1996Hoffmann 1999Miedel 2005Pajarinen 2005Parker 2012Parker 2017Pelet 2001Sadowski 2002Sanders 2017Saudan 2002Varela‐Egocheaga 2009Zehir 2015

2451

RR 1.00, 95% CI 0.96 to 1.04, favours extramedullary implants; I2 = 0%; Analysis 1.32

CI: confidence interval; HHS: Harris Hip Score; JOA: Japanese Orthopaedic Association; MD: mean difference; RR: risk ratio: SMD: standardised mean difference: VAS: visual analogue scale

Figures and Tables -
Table 3. Effects of other important outcomes
Table 4. Adverse events related to implant, fracture, or both

Outcome

Number of studies

Studies

Participants

Effect estimate; Analysis 1.34

Intraoperative periprosthetic fracture

35

Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Baumgaertner 1998Benum 1994Bridle 1991Ekstrom 2007Goldhagen 1994Guyer 1991Hardy 1998Harrington 2002Hoffman 1996Hoffmann 1999Hong 2011Kouvidis 2012Kukla 1997Kuwabara 1998Leung 1992Lopez 2002Mehdi 2000Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Papasimos 2005Park 1998Pelet 2001Radford 1993Saudan 2002Sharma 2018Utrilla 2005Verettas 2010Xu 2010Zhou 2012

4872

RR 2.94, 95% CI 1.65 to 5.24, favours extramedullary implants; I2 = 0%

Postoperative periprosthetic fracture

 46

Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Baumgaertner 1998Benum 1994Bridle 1991Butt 1995Calderon 2013Chechik 2014Ekstrom 2007Giraud 2005Goldhagen 1994Gou 2013Guyer 1991Hardy 1998Harrington 2002Hoffman 1996Hoffmann 1999Hong 2011Kouvidis 2012Kukla 1997Kuwabara 1998Leung 1992Little 2008Lopez 2002Matre 2013Michos 2001Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pajarinen 2005Papasimos 2005Park 1998Parker 2012Parker 2017Radford 1993Sanders 2017Sharma 2018Singh 2019Utrilla 2005Xu 2010Xu 2018Zhou 2012Zou 2009

7021

RR 3.62, 95% CI 2.07 to 6.33, favours extramedullary implants; I2 = 0%

Loosening of prosthesis

 3

Li 2018Raimondo 2012Singh 2017

195

RR 0.57, 95% CI 0.12 to 2.76, favours cephalomedullary implants; I2 = 0%

Cut‐out

 49

Adams 2001Ahrengart 1994Aktselis 2014Barton 2010Baumgaertner 1998Benum 1994Bridle 1991Chechik 2014Davis 1988Ekstrom 2007Giraud 2005Goldhagen 1994Guyer 1991Hardy 1998Harrington 2002Haynes 1996Hoffman 1996Hong 2011Kouvidis 2012Kukla 1997Kuwabara 1998Leung 1992Little 2008Lopez 2002Matre 2013Mehdi 2000Michos 2001Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pajarinen 2005Papasimos 2005Park 1998Parker 2012Parker 2017Pelet 2001Radford 1993Reindl 2015Sadowski 2002Saudan 2002Singh 2019Utrilla 2005Varela‐Egocheaga 2009Xu 2010Xu 2018Zehir 2015Zhou 2012Zou 2009

 7843

RR 0.93, 95% CI 0.71 to 1.22, favours cephalomedullary implants; I2 = 0%

Implant failure

24

Adams 2001Adeel 2020Aktselis 2014Andalib 2020Barton 2010Butt 1995Cai 2016Carulli 2017Chechik 2014Davis 1988Kukla 1997Little 2008O'Brien 1995Pelet 2001Radford 1993Sadowski 2002Sanders 2017Saudan 2002Sharma 2018Utrilla 2005Xu 2010Xu 2018Zhou 2012Zou 2009

 3190

RR 0.81, 95% CI 0.55 to 1.20, favours cephalomedullary implants; I2 = 0%

Deep infection

 35

Adams 2001Ahrengart 1994Aktselis 2014Andalib 2020Barton 2010Cai 2016Davis 1988Giraud 2005Guyer 1991Hardy 1998Hoffman 1996Hoffmann 1999Kukla 1997Leung 1992Little 2008Matre 2013Mehdi 2000Miedel 2005Mott 1993O'Brien 1995Ovesen 2006Pajarinen 2005Park 1998Parker 2012Parker 2017Pelet 2001Radford 1993Reindl 2015Sadowski 2002Saudan 2002Singh 2017Utrilla 2005Zehir 2015Zhou 2012Zou 2009

 6184

RR 0.76, 95% CI 0.41 to 1.38. favours cephalomedullary implants; I2 = 0%

Superficial infection

35

Adams 2001Adeel 2020Andalib 2020Bridle 1991Butt 1995Cai 2016Carulli 2017Chechik 2014Davis 1988Eceviz 2020Ekstrom 2007Gou 2013Kouvidis 2012Kuwabara 1998Lopez 2002Little 2008Miedel 2005O'Brien 1995Pajarinen 2005Papasimos 2005Parker 2012Parker 2017Radford 1993Rahme 2007Raimondo 2012Sharma 2018Singh 2017Singh 2019Utrilla 2005Verettas 2010Xu 2010Xu 2018Zehir 2015Zhou 2012Zou 2009 

 5087

RR 0.71, 95% CI 0.53 to 0.96, favours cephalomedullary implants; I2 = 0%

Non‐union

 40

Adeel 2020Ahrengart 1994Aktselis 2014Andalib 2020Barton 2010Baumgaertner 1998Cai 2016Calderon 2013Dujardin 2001Ekstrom 2007Giraud 2005Goldhagen 1994Gou 2013Haq 2014Hardy 1998Harrington 2002Hong 2011Kouvidis 2012Kukla 1997Leung 1992Li 2018Little 2008Michos 2001Ovesen 2006Papasimos 2005Park 1998Parker 2012Parker 2017Pelet 2001Radford 1993Rahme 2007Sadowski 2002Saudan 2002Sharma 2018Singh 2017Singh 2019Tao 2013Xu 2010Zhou 2012Zou 2009

 4959

RR 0.55, 95% CI 0.32 to 0.96, favours cephalomedullary implants ; I2 = 0%

CI: confidence interval; RR: risk ratio

Figures and Tables -
Table 4. Adverse events related to implant, fracture, or both
Table 5. Adverse events unrelated to implant, fracture, or both

Outcome

Number of studies

Studies

Number of participants

Effect estimate; Analysis 1.35

Acute kidney injury 

 2

Parker 2012Parker 2017 

 1000

RR 1.19, 95% CI 0.34 to 4.19, favours extramedullary implants; I2 = 0%

Blood transfusion

 17

Adams 2001Barton 2010Harrington 2002Little 2008Matre 2013Ovesen 2006Parker 2012Parker 2017Raimondo 2012Sadowski 2002Saudan 2002Sharma 2018Utrilla 2005Verettas 2010Xu 2010Yamauchi 2014

3726

RR 0.87, 95% CI 0.74 to 1.03, favours cephalomedullary implants; I2 = 76%

Cerebrovascular accident

11

Bridle 1991Butt 1995Chechik 2014Gou 2013Hoffman 1996Parker 2012Parker 2017Sadowski 2002Varela‐Egocheaga 2009Xu 2010Zhou 2012

2000

RR 1.41, 95% CI 0.61 to 3.24, favours cephalomedullary implants; I2 = 0%

Chest infection/pneumonia

25

Bridle 1991Butt 1995Cai 2016Carulli 2017Davis 1988Giraud 2005Gou 2013Hardy 1998Hoffman 1996Hoffmann 1999Kukla 1997Little 2008Lopez 2002Mott 1993O'Brien 1995Papasimos 2005Parker 2012Parker 2017Sadowski 2002Saudan 2002Singh 2019Tao 2013Varela‐Egocheaga 2009Xu 2010Zehir 2015

3657

RR 1.05, 95% CI 0.80 to 1.39, favours extramedullary implants; I2 = 0%

Myocardial infarction/acute coronary syndrome

11

Butt 1995Chechik 2014Gou 2013Hardy 1998Hoffman 1996Parker 2012Parker 2017Sadowski 2002Saudan 2002Varela‐Egocheaga 2009Zhou 2012

1800

RR 0.77, 95% CI 0.44 to 1.35, favours cephalomedullary implants; I2 = 0%

Urinary tract infection

16

Butt 1995Cai 2016Carulli 2017Davis 1988Hardy 1998Hoffman 1996Lopez 2002O'Brien 1995Papasimos 2005Sadowski 2002Saudan 2002Tao 2013Varela‐Egocheaga 2009Xu 2010Zehir 2015

1943

RR 1.06, 95% CI 0.79 to 1.41, favours extramedullary implants; I2 = 11%

Deep vein thrombosis

30

Adams 2001Ahrengart 1994Butt 1995Carulli 2017Davis 1988Giraud 2005Gou 2013Hardy 1998Hoffman 1996Hoffmann 1999Kukla 1997Li 2018Little 2008Lopez 2002Mott 1993Pajarinen 2005Papasimos 2005Parker 2012Parker 2017Radford 1993Sadowski 2002Saudan 2002Sharma 2018Singh 2019Tao 2013Utrilla 2005Verettas 2010Zehir 2015Zhou 2012Zou 2009

4589

RR 1.07, 95% CI 0.76 to 1.49, favours extramedullary implants; I2 = 0%

Pulmonary embolism

14

Bridle 1991Carulli 2017Hardy 1998Kukla 1997Little 2008O'Brien 1995Papasimos 2005Parker 2012Parker 2017Pelet 2001Sadowski 2002Saudan 2002Xu 2010Zehir 2015

2434

RR 1.27, 95% CI 0.54 to 3.03, favours extramedullary implants; I2 = 0%

CI: confidence interval; RR: risk ratio

Figures and Tables -
Table 5. Adverse events unrelated to implant, fracture, or both
Comparison 1. Cephalomedullary nails versus extramedullary implants

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 ADL, early (≤ 4 months) Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.2 ADL (≤ 4 months; independent in performance of ADL) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.3 ADL, early (≤ 4 months; change in social dependency scale) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.4 ADL at 12 months Show forest plot

8

835

Std. Mean Difference (IV, Random, 95% CI)

0.01 [‐0.26, 0.27]

1.5 ADL (12 months; independent in performance of ADL) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.6 ADL at 12 months (change scores in social dependency scale Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.7 Delirium Show forest plot

5

1310

Risk Ratio (M‐H, Random, 95% CI)

1.22 [0.67, 2.22]

1.8 Functional status, early (≤ 4 months) Show forest plot

2

188

Std. Mean Difference (IV, Random, 95% CI)

0.02 [‐0.27, 0.30]

1.9 Functional status, early (≤ 4 months; excellent or good) Show forest plot

2

188

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.96, 1.13]

1.10 Functional status at 12 months (mean scores) Show forest plot

12

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.11 Functional status (12 months; excellent or good using HHS) Show forest plot

3

257

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.89, 1.27]

1.12 HRQoL at 12 months Show forest plot

4

279

Std. Mean Difference (IV, Random, 95% CI)

0.28 [‐0.15, 0.71]

1.13 Mobility (≤ 4 months; independent mobility) Show forest plot

7

719

Risk Ratio (M‐H, Random, 95% CI)

1.12 [1.01, 1.23]

1.14 Mobility, early (≤ 4 months; mobility scales, mean scores) Show forest plot

2

695

Mean Difference (IV, Random, 95% CI)

0.16 [‐0.15, 0.48]

1.15 Mobility (≤ 4 months; 10 metre walking speed test) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.16 Mobility (≤ 4 months; able to complete TUG) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.17 Mobility, early (≤ 4 months; TUG, mean scores) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.18 Mobility at 12 months (mobility scales, mean scores) Show forest plot

14

1746

Mean Difference (IV, Random, 95% CI)

0.48 [0.10, 0.87]

1.19 Mobility (at 12 months; change from baseline) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.20 Mobility (12 months; independent mobility) Show forest plot

12

1524

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.94, 1.22]

1.21 Mobility (12 months; able to complete TUG) Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.22 Mobility at 12 months (TUG, mean scores) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.23 Failure to regain pre‐fracture mobility (at 12 months) Show forest plot

2

246

Risk Ratio (M‐H, Random, 95% CI)

1.12 [0.85, 1.46]

1.24 Mobility at 12 months (remained in bed or wheelchair) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.25 Mortality, early (≤ 4 months) Show forest plot

30

4603

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.79, 1.18]

1.26 Mortality at 12 months Show forest plot

47

7618

Risk Ratio (M‐H, Random, 95% CI)

0.99 [0.90, 1.08]

1.27 Unplanned return to theatre Show forest plot

50

8398

Risk Ratio (M‐H, Random, 95% CI)

1.15 [0.89, 1.50]

1.28 Pain, early (≤ 4 months; pain scales, mean scores) Show forest plot

4

832

Std. Mean Difference (IV, Random, 95% CI)

‐0.13 [‐0.43, 0.17]

1.29 Experiencing pain (≤ 4 months) Show forest plot

4

417

Risk Ratio (M‐H, Random, 95% CI)

0.79 [0.42, 1.46]

1.30 Pain at 12 months (pain scales, mean scores) Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.31 Experiencing pain (at 12 months) Show forest plot

10

1552

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.75, 1.32]

1.32 Length of hospital stay (days) Show forest plot

26

3647

Mean Difference (IV, Random, 95% CI)

‐0.52 [‐1.23, 0.18]

1.33 Discharge destination (to own home/previous residence) Show forest plot

14

2451

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.96, 1.04]

1.34 Adverse event related to implant, fracture, or both Show forest plot

68

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.1 Intra‐operative periprosthetic fracture

35

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.2 Postoperative periprosthetic fracture

46

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.3 Loosening of prosthesis

3

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.4 Screw cut out

49

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.5 Implant failure

24

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.6 Deep infection

35

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.7 Superficial infection

35

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.34.8 Non‐union

40

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35 Adverse events unrelated to implant, fracture, or both Show forest plot

44

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.1 Acute kidney injury

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.2 Blood transfusion

17

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.3 Cerebrovascular accident

11

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.4 Chest infection/pneumonia

25

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.5 Myocardial infarction/acute coronary syndrome

11

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.6 Urinary tract infection

16

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.7 Venous thromboembolic phenomena (DVT)

30

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.35.8 Venous thromboembolic phenomena (PE)

14

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Figures and Tables -
Comparison 1. Cephalomedullary nails versus extramedullary implants
Comparison 2. Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

2.1 Functional status at 12 months (mean scores) Show forest plot

10

775

Std. Mean Difference (IV, Random, 95% CI)

0.31 [‐0.44, 1.05]

2.1.1 Short nail

5

351

Std. Mean Difference (IV, Random, 95% CI)

0.07 [‐0.22, 0.36]

2.1.2 Unknown nail lengths

5

424

Std. Mean Difference (IV, Random, 95% CI)

0.53 [‐1.25, 2.31]

2.2 Mobility at 12 months (mobility scales, mean scores) Show forest plot

14

1746

Mean Difference (IV, Random, 95% CI)

0.48 [0.10, 0.87]

2.2.1 Short nail

11

1493

Mean Difference (IV, Random, 95% CI)

0.34 [0.02, 0.65]

2.2.2 Long nail

1

156

Mean Difference (IV, Random, 95% CI)

2.10 [1.32, 2.88]

2.2.3 Unknown nail length

2

97

Mean Difference (IV, Random, 95% CI)

0.26 [‐0.67, 1.20]

2.3 Mobility (12 months; independent mobility) Show forest plot

12

1524

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.94, 1.22]

2.3.1 Short nail

10

1455

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.94, 1.21]

2.3.2 Mixed or unknown nail length

2

69

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.33, 4.16]

2.4 Early mortality Show forest plot

30

4603

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.79, 1.18]

2.4.1 Short nail

22

2953

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.76, 1.20]

2.4.2 Long nail

2

400

Risk Ratio (M‐H, Random, 95% CI)

1.80 [1.02, 3.18]

2.4.3 Mixed or unknown nail lengths

6

1250

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.36, 1.14]

2.5 Mortality at 12 months Show forest plot

47

7618

Risk Ratio (M‐H, Random, 95% CI)

0.99 [0.90, 1.08]

2.5.1 Short nail

34

5374

Risk Ratio (M‐H, Random, 95% CI)

0.97 [0.87, 1.08]

2.5.2 Long nail

2

400

Risk Ratio (M‐H, Random, 95% CI)

1.28 [0.89, 1.85]

2.5.3 Mixed or unknown nail lengths

11

1844

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.82, 1.16]

2.6 Unplanned return to theatre Show forest plot

50

8398

Risk Ratio (M‐H, Random, 95% CI)

1.15 [0.89, 1.50]

2.6.1 Short nail

36

6266

Risk Ratio (M‐H, Random, 95% CI)

1.12 [0.79, 1.57]

2.6.2 Long nail

2

400

Risk Ratio (M‐H, Random, 95% CI)

1.15 [0.24, 5.40]

2.6.3 Mixed and unknown nail lengths

12

1732

Risk Ratio (M‐H, Random, 95% CI)

1.16 [0.81, 1.67]

Figures and Tables -
Comparison 2. Cephalomedullary nails versus extramedullary implants: subgrouped by short or long intramedullary nails
Comparison 3. Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

3.1 Functional status at 12 months (mean scores) Show forest plot

12

899

Std. Mean Difference (IV, Random, 95% CI)

0.27 [‐0.35, 0.88]

3.1.1 Stable fractures

2

254

Std. Mean Difference (IV, Random, 95% CI)

0.04 [‐0.21, 0.29]

3.1.2 Unstable fractures

3

144

Std. Mean Difference (IV, Random, 95% CI)

0.38 [‐0.04, 0.79]

3.1.3 Mixed stable and unstable

7

501

Std. Mean Difference (IV, Random, 95% CI)

0.30 [‐0.87, 1.47]

3.2 Mobility at 12 months (mobility scales, mean scores) Show forest plot

14

1746

Mean Difference (IV, Random, 95% CI)

0.48 [0.10, 0.87]

3.2.1 Unstable fractures

5

265

Mean Difference (IV, Random, 95% CI)

0.73 [0.19, 1.26]

3.2.2 Mixed stable and unstable fractures

9

1481

Mean Difference (IV, Random, 95% CI)

0.42 [‐0.06, 0.90]

3.3 Mobility (12 months; independent mobility) Show forest plot

12

1524

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.94, 1.22]

3.3.1 Unstable fractures

2

318

Risk Ratio (M‐H, Random, 95% CI)

1.34 [0.64, 2.82]

3.3.2 Mixed stable and unstable fractures

10

1206

Risk Ratio (M‐H, Random, 95% CI)

1.02 [0.92, 1.14]

3.4 Early mortality Show forest plot

30

4603

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.79, 1.18]

3.4.1 Unstable fractures

8

1112

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.54, 2.07]

3.4.2 Mixed stable and unstable fractures

22

3491

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.76, 1.19]

3.5 Mortality at 12 months Show forest plot

46

7558

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.90, 1.07]

3.5.1 Stable fractures

3

322

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.29, 2.23]

3.5.2 Unstable fractures

10

1464

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.82, 1.24]

3.5.3 Mixed stable and unstable fractures

33

5772

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.89, 1.08]

3.6 Unplanned return to theatre Show forest plot

49

8338

Risk Ratio (M‐H, Random, 95% CI)

1.19 [0.93, 1.53]

3.6.1 Stable fractures

2

116

Risk Ratio (M‐H, Random, 95% CI)

2.81 [0.31, 25.48]

3.6.2 Unstable fractures

12

1549

Risk Ratio (M‐H, Random, 95% CI)

0.78 [0.38, 1.61]

3.6.3 Mixed stable and unstable fractures

35

6673

Risk Ratio (M‐H, Random, 95% CI)

1.30 [1.03, 1.65]

Figures and Tables -
Comparison 3. Cephalomedullary nails versus extramedullary implants: subgrouped by stable and unstable fractures
Comparison 4. Intraoperative and postoperative periprosthetic fractures: subgrouped by year of publication

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

4.1 Intraoperative periprosthetic fracture Show forest plot

35

4872

Risk Ratio (M‐H, Random, 95% CI)

2.94 [1.65, 5.24]

4.1.1 Published before 2010

27

4049

Risk Ratio (M‐H, Random, 95% CI)

3.19 [1.72, 5.93]

4.1.2 Published from 2010 onwards

8

823

Risk Ratio (M‐H, Random, 95% CI)

1.67 [0.34, 8.35]

4.2 Postoperative periprosthetic fracture Show forest plot

46

7021

Risk Ratio (M‐H, Random, 95% CI)

3.62 [2.07, 6.33]

4.2.1 Published before 2010

30

4059

Risk Ratio (M‐H, Random, 95% CI)

4.43 [2.12, 9.26]

4.2.2 Published from 2010 onwards

16

2962

Risk Ratio (M‐H, Random, 95% CI)

2.77 [1.18, 6.51]

Figures and Tables -
Comparison 4. Intraoperative and postoperative periprosthetic fractures: subgrouped by year of publication