Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture

Background Treatments for Dupuytren’s contracture include limited fasciectomy and collagenase injection. Evidence comparing these treatments is limited. Methods We performed an unblinded, multicenter, pragmatic, two-arm, randomized controlled non-inferiority trial comparing collagenase injection to limited fasciectomy in persons with moderate Dupuytren’s contracture. The primary outcome was the score on the Patient Evaluation Measure Hand Health Questionnaire (range 0 to 100, higher scores indicating worse outcome) 1-year post-treatment. The pre-specified non-inferiority margin was 6 points. Results 672 participants were randomized (n=336 per group). Primary analysis included 599 (314 collagenase; 285 limited fasciectomy). At 1-year, the mean score on the Hand Health questionnaire was 17.8 in the collagenase group (n = 284) and 11.9 in the limited fasciectomy group (n = 250); between group difference = 5.9 (95%CI: 3.1 to 8.8, one sided p value for non-inferiority 0.49). At 2 years (n = 229 and n = 197 in collagenase and limited fasciectomy groups, respectively), the between group difference was 7.2 (95%CI: 4.2 to 10.9). The percentage of persons with moderate to severe complications was 2% in the collagenase group and 5% in the limited fasciectomy group. Recurrent contracture requiring re-intervention occurred in 8% after collagenase versus 1.7% after limited fasciectomy. Conclusions Collagenase was not non-inferior to limited fasciectomy with respect to the Patient Evaluation Measure hand health questionnaire score at 1-year post-treatment. (Supported by NIHR Health Technology Assessment programme; Trial registration: ISRCTN18254597)