Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial

Abstract

IntroductionThere is no definitive cure for Dupuytren disease (DD), and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for recurrence, although associated with a high incidence of complications. Collagenase injection, a non-surgical treatment option, has been shown to be a safe and effective method; however, most studies regarding collagenase have involved first-time treatment. Collagenase efficacy in patients with recurrent DD beyond the immediate effect has not yet been determined. The aim of our study is to compare surgical fasciectomy and collagenase injection in treating recurrent DD.Methods and analysisThe study is a single-centre randomised controlled trial. Inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, and a palpable cord causing the recurrent contracture. A total of 56 patients will be randomised to either surgical fasciectomy or collagenase injection. A hand therapist blinded to patients’ group allocation will measure range of motion at baseline, 3 months, 12 months, 24 months and 60 months. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20° in the treated finger joint at 2 years compared with 3 months. The secondary outcomes include changes in total active motion, active and passive extension deficit from baseline up to 5 years, scores on patient-reported outcome measures, adverse events and costs of treatment.Ethics and disseminationEthical approval has been obtained from the Regional Ethical Review Board, Lund University, Sweden(2017/623). The trial will be conducted according to the Helsinki Declaration of 1975, revised in 2000. The results of the trial will be disseminated as published articles in peer-reviewed journals.Trial registrationNCT03406338; Pre-results.

Risk Factors for Long-Term Contracture Recurrence after Collagenase Injection for Dupuytren Disease: A Prospective Cohort Study

“…Collagenase can also be used for treating recurrent disease, with good results shown at 1 year [ 27 ]. With regard to treatment of recurrent Dupuytren disease, evidence from RCTs is needed [ 28 ].…”

Cost-effectiveness of Recurrent Dupuytren Contracture Treatment

“…Balancing these trade-offs can make treatment selection challenging, especially when no formal treatment guidelines exist. Consequently, both nonsurgical and surgical treatments are applied in various combinations to the same joint when Dupuytren contracture recurs . Furthermore, as treatment costs for LF, PNA, and CCH differ substantially, identifying the most cost-effective treatment regimen has the potential to considerably reduce health care expenditure.…”