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)