FESSH prep Dupuytren disease CORD I efficacy, five year recurrence after needle fasciotomy versus limited fasciectomy, the DISC trial, firebreak dermofasciectomy evidence, the 2020 European withdrawal of collagenase
Contemporary treatment of Dupuytren contracture: collagenase, needle fasciotomy and fasciectomy
Regarding the evidence for contemporary treatments of Dupuytren contracture:
1.In the CORD I trial, 64 % of collagenase-injected cords, against about 7 % of placebo-injected cords, reached 0–5° of full extension 30 days after the last injection.
2.Five years after the Dutch randomised comparison, recurrence — an increase in total passive extension deficit of more than 30° — had occurred in about 85 % of hands treated by percutaneous needle fasciotomy and about 21 % of those treated by limited fasciectomy.
3.In the DISC trial, collagenase injection was not shown to be non-inferior to limited fasciectomy on the Patient Evaluation Measure at one year (the upper confidence limit of the difference, 8.8 points, crossed the 6-point margin), and re-intervention for recurrent contracture was more frequent after collagenase.
4.A randomised trial showed that a 'firebreak' full-thickness skin graft reduces recurrence compared with Z-plasty closure after fasciectomy for proximal interphalangeal joint contracture.
5.Collagenase (Xiapex) was withdrawn from the European market in 2020 because of safety concerns about flexor tendon rupture.
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Answer key and explanations — open after answering
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1. In the CORD I trial, 64 % of collagenase-injected cords, against about 7 % of placebo-injected cords, reached 0–5° of full extension 30 days after the last injection.
True
CORD I randomised 308 patients with contractures of 20° or more to up to three injections of collagenase clostridium histolyticum (0.58 mg) or placebo at 30-day intervals, with manipulation the next day. The primary end point — contracture reduced to 0–5° of full extension 30 days after the last injection — was met by 64.0 % of collagenase-treated cords and 6.8 % of placebo cords (P < 0.001); range of motion improved from 43.9° to 80.7° versus 45.3° to 49.5°. Three serious treatment-related events occurred: two tendon ruptures and one complex regional pain syndrome.
- Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, et al.. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009;361(10):968-79. PMID 19726771
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2. Five years after the Dutch randomised comparison, recurrence — an increase in total passive extension deficit of more than 30° — had occurred in about 85 % of hands treated by percutaneous needle fasciotomy and about 21 % of those treated by limited fasciectomy.
True
Van Rijssen and colleagues randomised 111 patients (115 hands) with a passive extension deficit of at least 30°. Recurrence at five years was 84.9 % after needle fasciotomy and 20.9 % after limited fasciectomy (P < 0.001) and occurred sooner after fasciotomy; older age at treatment reduced recurrence. Satisfaction was higher after fasciectomy, yet 53 % of patients said they would prefer needle fasciotomy for a recurrence, and the authors recommend fasciotomy for older patients and those who accept early recurrence in exchange for fast recovery, low complication rates and minimal invasiveness.
- van Rijssen AL, Ter Linden H, Werker PMN. Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012;129(2):469-477. PMID 21987045
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3. In the DISC trial, collagenase injection was not shown to be non-inferior to limited fasciectomy on the Patient Evaluation Measure at one year (the upper confidence limit of the difference, 8.8 points, crossed the 6-point margin), and re-intervention for recurrent contracture was more frequent after collagenase.
True
DISC was a UK multicentre pragmatic non-inferiority trial that randomised 672 people with moderate contracture. At one year the mean Patient Evaluation Measure score (0–100, higher is worse) was 17.8 after collagenase and 11.9 after fasciectomy, a difference of 5.9 points (95 % CI 3.1 to 8.8) against a 6-point margin, so non-inferiority was not shown (one-sided P = 0.49); the difference was 7.2 points at two years. Moderate or severe complications were less frequent after collagenase (1.8 % vs 5.1 %), but recurrent contracture led to re-intervention in 14.6 % versus 3.4 %.
- Dias J, Tharmanathan P, Arundel C, Welch C, Wu Q, Leighton P, et al.. Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture. N Engl J Med. 2024;391(16):1499-1510. PMID 39383454
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4. A randomised trial showed that a 'firebreak' full-thickness skin graft reduces recurrence compared with Z-plasty closure after fasciectomy for proximal interphalangeal joint contracture.
False
Ullah, Dias and Bhowal randomised 79 patients (90 fingers) with proximal interphalangeal contracture to fasciectomy closed with a Z-plasty or with a firebreak full-thickness graft. The groups were comparable for grip, motion and disability at every visit, overall recurrence was 12.2 %, and no improvement in correction or recurrence was found up to three years after surgery; the Cochrane review of Dupuytren surgery reached the same conclusion.
- Ullah AS, Dias JJ, Bhowal B. Does a 'firebreak' full-thickness skin graft prevent recurrence after surgery for Dupuytren's contracture?: a prospective, randomised trial. J Bone Joint Surg Br. 2009;91(3):374-8. PMID 19258615
- Rodrigues JN, Becker GW, Ball C, Zhang W, Giele H, Hobby J, et al.. Surgery for Dupuytren's contracture of the fingers. Cochrane Database Syst Rev. 2015;2015(12):CD010143. PMID 26648251
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5. Collagenase (Xiapex) was withdrawn from the European market in 2020 because of safety concerns about flexor tendon rupture.
False
Distribution of Xiapex in Europe ended in 2020, and collagenase was withdrawn at the same time from the Asian, Australian and Canadian markets; the European Medicines Agency records the withdrawal (effective 1 March 2020) as requested by the marketing authorisation holder for commercial reasons, and the literature cites poor demand and lack of reimbursement, not a safety measure, and the drug remains in use in the United States, where Medicare use kept rising. Tendon rupture is a recognised but rare complication (two of 308 patients in CORD I). Since the withdrawal, percutaneous needle fasciotomy has been the main minimally invasive option in Europe.
- Passiatore M, De Vitis R, Taccardo G. Xiapex™ will no longer be distributed in Europe: Our concerns and our hopes relative to collagenase. Hand Surg Rehabil. 2020;39(5):466. PMID 32376510
- Pistone ES, Majeed SW, Torres GB, Brown RE, Faillace J. Nationwide Medicare and Medicaid Trends in Management of Dupuytren's Contracture. Hand (N Y). 2025;21(9):1533-1540. PMID 41400061
- Chung D, Shiff B, Bal DS, Southall T, Blachman-Braun R, Grenier M, et al.. Insurance approval rates for collagenase clostridium histolyticum prior to discontinuation: a Canada-wide analysis. Int J Impot Res. 2023;36(6):581-587. PMID 37626201