Original article
Outcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up

https://doi.org/10.1016/j.apmr.2014.07.009Get rights and content

Abstract

Objective

To report outcomes regarding general and specific physical health-related quality of life of treatment with percutaneous osseointegrated prostheses.

Design

Prospective 2-year case-control study.

Setting

University hospital.

Participants

Individuals (N=39; mean age, 44±12.4y) with unilateral transfemoral amputation as a result of trauma (n=23), tumor (n=11), or other cause (n=5). At baseline, 33 of the 39 participants used socket-suspended prostheses.

Intervention

Osseointegrated prosthesis.

Main Outcome Measures

Questionnaire for Persons with Transfemoral Amputation (Q-TFA), Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical functioning (PF) and physical component summary (PCS), SF-6D, and Physiological Cost Index (PCI).

Results

At 2 years postimplantation, 6 of 7 Q-TFA scores improved (P<.0001) compared with baseline (prosthetic use, mobility, problem, global, capability, walking habits). The walking aid subscore did not improve (P=.327). Of the 39 participants, increased prosthesis use was reported by 26, same amount of use by 11, and less use by 2. Improvement was reported in 16 of the 30 separate problem items (P<.05). Unchanged items included problems regarding phantom limb pain and pain from the back, shoulders, and contralateral limb. The PF, PCS, and SF-6D improved a mean of 24.1±21.4 (P<.0001), 8.5±9.7 (P<.0001), and .039±.11 (P=.007) points, respectively. Walking energy cost decreased (mean PCI at baseline, .749; mean PCI at follow-up, .61; P<.0001).

Conclusions

Two years after intervention, patients with a unilateral TFA treated with an OPRA implant showed important improvements in prosthetic function and physical quality of life. However, walking aids used and the presence of phantom limb pain and pain in other extremities were unchanged. This information is valuable when considering whether percutaneous osseointegrated prostheses are a relevant treatment option.

Section snippets

Methods

The OPRA treatment involves 2 surgeries 6 months apart, followed by a careful increase in implant loading and prosthetic activity over at least 6 months, resulting in a treatment period of about 1 year.7, 18 The OPRA study is composed of 51 patients treated with 55 implants (n=45 unilateral TFA, n=6 bilateral TFA of whom 4 were treated bilaterally) enrolled in the study from 1999 through 2007. Specific demographics have previously been described.18 The OPRA study protocol comprises assessments

Results

The results showed that 6 of 45 subjects with a unilateral TFA were not followed for 2 years for varying reasons (implant removed because of complications: n=3, deceased: n=1, lost to follow-up: n=1, withdrawn because of problems with contralateral limb: n=1).18 As a result, the data reported in this study are based on 39 subjects (17 men, 22 women) with unilateral TFA. The amputation was the result of trauma (n=23), tumor (n=11), or other cause (n=5). The mean age at amputation was 31±14.8

Discussion

This prospective study focused on individuals with a unilateral TFA treated with osseointegration and followed for 2 years. The results confirm earlier publications reporting that patients treated with the OPRA show important improvements with regard to prosthetic mobility and HRQOL.13, 14 In the evaluation of whether or not a bone-anchored prosthesis is an adequate treatment alternative, the patient should be given detailed realistic information, including possible benefits and complications.

Conclusions

This prospective study showed increased and large-scale daily prosthesis use, reduced problems, improved mobility, including more walking and decreased energy cost, and improved physical HRQOL in individuals with a unilateral TFA treated with the OPRA implants and followed over 2 years. However, there was no significant change in use of walking aids, trouble reported with regard to phantom limb pain, and pain problems from the back, shoulders, and contralateral limb compared with baseline.

Suppliers

  • a.

    Integrum AB, Krokslätts Fabriker 50, 43137 Mölndal, Sweden.

  • b.

    IBM Corp, 1 New Orchard Rd, Armonk, NY 10504-1722.

Acknowledgment

We thank Eva Häggström, CPO, Department for Prosthetics and Orthotics, Sahlgrenska University Hospital, for collection of data regarding prosthetic components.

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    • Cited by (0)

    Supported in part by an ALF grant from Sahlgrenska University Hospital (grant no. ALF-GBG-138721), Promobila Foundation, Jimmy Dahlsten Fund, and Johan Jansson Foundation, all from Sweden.

    Disclosures: Brånemark is a shareholder in the Integrum Company. No benefits in any form have been received directly or indirectly to the subject of this article. The other authors have nothing to disclose.

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