Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial

doi:10.1016/j.jhsa.2017.03.003

The Journal of Hand Surgery

Volume 42, Issue 5, May 2017, Pages 321-328.e3

https://doi.org/10.1016/j.jhsa.2017.03.003 Get rights and content

Purpose

Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use.

Method

In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score.

Results

Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed.

Conclusions

This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF.

Type of study/level of evidence

Therapeutic I.

Section snippets

Study oversight

The study was performed as a prospective, single-center, independent, open-label, randomized controlled trial. The study complied with the principles of the Declaration of Helsinki. Oral and written informed patient consent was obtained prior to inclusion.

All patients in the study received fully financed treatment within the national public health care system, providing universal coverage and free and equal access to public health care services. No reimbursement was made for participation. None

Patient flow and characteristics

The allocated groups were similar at baseline, except for affected digit, because index and middle finger rays were by chance only allocated to PNF. Baseline patient demographics are shown in Table 1. Baseline clinical data are shown in Table A1 (available on the Journal’s Web site at www.jhandsurg.org). All included patients were ethnic Scandinavian. All the CCH patients had manipulation within 25 ± 4 hours, except for 1 patient who postponed the appointment and was manipulated 44 hours after

Discussion

This randomized controlled trial, directly compared CCH to PNF in isolated PIP joint DC. We found that CCH had inferior outcomes after 2 years compared with PNF, in terms of clinical improvement (8% vs 32%) and complications (93% vs 24%). The groups were similar in all the other secondary outcome parameters evaluated. The safety profile of the treatments performed in our study corresponded to those previously reported.7, 10

In 2009, the CORD-I study,² a phase-3 randomized placebo-controlled

Acknowledgments

We appreciate the time and effort put into this project by the patients participating in this study and our 2 dedicated project nurses, Birgit Toft Schultz and Gitte Basse; Morten Søndergaard for participation in the initial phase of the project planning and screening of patients for inclusion; and Søren S. Mikkelsen for willing support of the project as head of the department.

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Cited by (72)

Quality and Reliability Analysis of YouTube as a Source for Patient Education on Dupuytren's Contracture
2024, Journal of Hand Surgery Global Online
This study seeks to assess the quality and reliability of YouTube videos on Dupuytren’s contracture.
The first 50 unique videos on Dupuytren’s contracture were evaluated by searching YouTube for Dupuytren’s contracture. Video metrics, source, and content type were recorded. Video reliability was assessed using the Journal of American Medical Association (JAMA) Benchmark criteria. Video educational quality was assessed using the Global Quality Score (GQS) and a Dupuytren’s Contracture-Specific Score (DC-SS).
The total number of views for all 50 videos evaluated was 1,908,608 (mean, 38,172.16 ± 5,502.45 views). The mean reliability (JAMA) score was 2.21 ± 0.69 (range 0–4), the mean educational quality (GQS) score was 2.80 ± 1.28 (range 1–5), and the mean disease-specific (DC-SS) score was 6.05 ± 2.17 (range 0–15). Nonphysician health care professionals had the most popular videos, but the lowest DC-SS. GQS varied based on the video source, with physician-uploaded videos having the highest average quality scores. Physician source was an independent positive predictor of higher quality (GQS) (β = 0.477).
Videos on Dupuytren’s contracture were frequently viewed on YouTube but had overall low educational quality and reliability. Of the videos that discussed collagenase as a treatment option, 40% failed to mention percutaneous needle aponeurotomy. Patients may be exposed to an incomplete set of treatment options. Educational content on YouTube should be interpreted cautiously and proper in-office education and high-quality resources for Dupuytren’s contracture should be provided by physicians.
Therapeutic IV.
Collagenase Treatment Versus Needle Fasciotomy for Single-Digit Dupuytren Contractures: A Meta-Analysis of Randomized Controlled Trials
2023, Journal of Hand Surgery
The objective of this systematic review and meta-analysis was to synthesize the available randomized controlled trial data comparing needle fasciotomy and collagenase treatment for single-digit Dupuytren contractures with a minimum of 3-year follow-up and determine whether one treatment is superior regarding contracture correction and functional outcomes.
A systematic review and meta-analysis was conducted by searching four databases for randomized controlled trials investigating the single-digit treatment outcomes for Dupuytren contracture comparing collagenase treatment and needle fasciotomy with a minimum of 3-year follow-up. The risk of bias of included studies was assessed using the Cochrane risk-of-bias tool. A meta-analysis was performed using a random effects model in anticipation of unobserved heterogeneity. The primary outcome measure was contracture recurrence. Secondary outcome measures included final fixed flexion contracture (FFC), Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores, and Unité Rhumatologique des Affections de la Main (URAM) scores.
After screening 264 articles, 4 randomized clinical trials were eligible for final inclusion. One trial had a high risk of bias, and two trials had some concern for bias. The final meta-analysis included 347 patients, 169 who underwent collagenase treatment and 178 who underwent needle fasciotomy. No significant differences were noted between the groups in contracture recurrence, FFC, and URAM scores. The pooled data showed a higher QuickDASH score in the collagenase treatment group compared with the needle fasciotomy group, but the observed difference was less than what would be expected to be clinically relevant.
Needle fasciotomy and collagenase treatment have similar outcomes with regards to contracture recurrence, final FFC, QuickDASH scores, and URAM scores for the single-digit treatment for Dupuytren contracture at a minimum of 3-year follow-up. Relevant factors that may be considered during the shared decision-making process for treatment selection include surgeon and patient preferences, costs of treatment, and the disparate complication profiles of these two treatments.
Therapeutic II.
Advanced Dupuytren Contracture: Approach to Management
2023, Hand Clinics
Pharmacotherapies in Dupuytren Disease: Current and Novel Strategies
2023, Journal of Hand Surgery
Dupuytren disease is a benign, progressive fibroproliferative disorder of the hands. To date, only one pharmacotherapy (clostridial collagenase) has been approved for use in Dupuytren disease. There is a great need for additional nonsurgical methods that can be used to either avoid the risks of invasive treatments or help minimize recurrence rates following treatment. A number of nonsurgical modalities have been discussed in the past and continue to appear in discussions among hand surgeons, despite highly variable and often poor or no long-term clinical data. This article reviews many of the pharmacotherapies discussed in the treatment of Dupuytren disease and novel therapies used in inflammation and fibrosis that offer potential treatment options.
Dutch Multidisciplinary Guideline on Dupuytren Disease
2023, Journal of Hand Surgery Global Online
To provide a comprehensive, evidence-based overview of the treatment for Dupuytren disease, specifically needle techniques, radiotherapy, primary conservative therapy, surgery, lipofilling, operative arthrolysis, salvage techniques, and the postoperative protocol and to make clinical recommendations for health care practitioners and patients.
Comprehensive multidisciplinary guideline process funded by the Quality Foundation of the Dutch Federation of Medical Specialists. This process included a development, commentary, and authorization phase. Patients participated in every phase. Multiple databases and existing guidelines up to August 2020 were searched. Studies on Dupuytren disease were considered eligible. Specific eligibility criteria were described per module. To appraise the certainty of the evidence, reviewers extracted data, assessed the risk of bias, and used the Grading of Recommendations Assessment, Development and Evaluation method, where applicable. Important considerations were as follows: patient values and preferences, costs, acceptability of other stakeholders, and feasibility of implementation. Recommendations were made based on the evidence from the literature and the considerations. The primary and secondary outcome measures were defined per module based on the input of patients obtained in collaboration with the Netherlands Patient Federation and health care providers from different professions.
The following 8 specific modules were completed for Dupuytren disease: (1) needle techniques, (2) radiotherapy, (3) primary conservative therapy, (4) surgery, (5) lipofilling, (6) operative arthrolysis, (7) salvage techniques, and (8) the postoperative protocol.
Our Dutch multidisciplinary guideline on Dupuytren disease provides 8 modules developed according to the standards of the Dutch Federation of Medical Specialists. Evidence-based recommendations for clinical practice are provided for needle techniques, radiotherapy, primary conservative therapy, surgery, lipofilling, operative arthrolysis, salvage techniques, and the postoperative protocol. This guideline can assist health care providers and patients in clinical practice.
Systematic review/I-II.
New protocol in the treatment of Peyronie's disease by combining platelet-rich plasma, percutaneous needle tunneling, and penile modeling: Preliminary results
2023, Progres en Urologie
Intra-lesional injections of collagenase (Xiapex®) were the only non-invasive treatment option for Peyronie's disease (PD), until their withdrawal from the European market.
To evaluate the feasibility, efficacy, and safety of a combined treatment of percutaneous needle tunnelling (PNT) with penile modelling (PM) and the injection of platelet-rich plasma (PRP) under general anesthesia in the treatment of PD.
A prospective case series study included patients with PD in a stable phase who underwent this procedure between March 2020 and January 2023. The main outcome was an improvement in curvature.
Thirty-six patients underwent this novel approach for the treatment of PD. The pretreatment mean ± standard deviation (SD) curvature degree was 57.5 ± 20.61° (range 20–90°). After the protocol, the mean curvature degree was 40.86 ± 25.13° (range 0–90°). The curvature angle improved significantly (P = 0.0001), with a mean improvement difference of 16.85 ± 14.81° (range 0–50°) and a mean improvement percentage of 47.7 ± 40.29% (range 0–100%).
Our preliminary experience suggests that PNT and PRP injections with PM are effective and safe for the treatment of penile deformity of PD.
4: case series study
Les injections intra lésionnelles de collagénase (Xiapex®) ont été la seule option de traitement non invasif de la maladie de Lapeyronie (MP), jusqu’à leur retrait du marché européen.
Évaluer la faisabilité, l’efficacité et l’innocuité d’un traitement par injection de tunnelisation percutanée à l’aiguille (TPA), plasma riche en plaquettes (PRP) avec modelage de pénis sous anesthésie générale dans le traitement de la MP.
Une étude prospective des séries de case a inclus des patients atteints de MP en phase stable, traites entre mars 2020 et janvier 2023. Le critère principal était une amélioration de la courbure.
Trente-six patients ont subi ce traitement de la MP. Le degré de courbure moyen ± écart-type avant traitement était de 57,5 ± 20,61° (intervalle 20–90°). Après le protocole, le degré de courbure moyen était de 40,86 ± 25,13° (intervalle 0–90°). L’angle de courbure s’est significativement amélioré (p = 0,0001), avec une différence d’amélioration moyenne de 16,85 ± 14,81° (intervalle 0–50°) et un pourcentage d’amélioration moyen de 47,7 ± 40,29 % (intervalle 0–100 %).
Notre expérience préliminaire suggère que les injections de PRP par TPA, suivies de modelage de pénis pourraient être efficaces et sûres pour le traitement de la courbure de verge liée à la MP.
4: séries de cas

View all citing articles on Scopus

: S.T.S., T.B., and P.S. attended the International 2013 Dupuytren Summit meeting in Vienna, Austria; invited by Pfizer Denmark (transportation and accommodation included). No personal fees or other disclosures for the authors.

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Editor's choiceInjectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial

Purpose

Method

Results

Conclusions

Type of study/level of evidence

Section snippets

Study oversight

Patient flow and characteristics

Discussion

Acknowledgments

J Hand Surg Am

J Hand Surg Am

J Hand Surg Am

J Hand Surg Am

J Hand Surg Eur Vol

J Hand Surg Br

J Hand Ther

J Hand Surg Am

J Hand Surg Am

J Hand Surg Am

J Hand Surg Am

J Hand Surg Am

Scientific understanding and clinical management of Dupuytren disease

Nat Rev Rheumatol

Editor's choice
Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial