PURPOSE: Collagenase has been investigated in phase II and phase III clinical trials for the treatment of Dupuytren's disease. The purpose of this study is to report 8-year follow-up results in a subset of patients who had collagenase injection for the treatment of Dupuytren's contracture. METHODS:Twenty-three patients who participated in the phase II clinical trial of injectable collagenase were contacted by letter and phone. Eight patients were enrolled, completed a Dupuytren's disease questionnaire, and had independent examination of joint motion by a single examiner. RESULTS:Eight patients completed the 8-year follow-up study: 6 had been treated for isolated metacarpophalangeal (MCP) joint contracture, and 2 had been treated for isolated proximal interphalangeal (PIP) joint contracture. Average preinjection contracture was 57 degrees in the MCP group. Average contracture was 9 degrees at 1 week, 11 degrees at 1 year, and 23 degrees at 8-year follow-up. Four of 6 patients experienced recurrence, and 2 of 6 had no evidence of disease recurrence at 8-year follow-up. Average preinjection contracture was 45 degrees in the PIP group. Average contracture was 8 degrees at 1 weeks, 15 degrees at 1 year, and 60 degrees at 8-year follow-up. Both patients experienced recurrence at 8-year follow-up. No patients had had further intervention on the treated finger in either the MCP or the PIP group. Patients subjectively rated the overall clinical success at 60%, and 88% of patients stated that they would pursue further injection for the treatment of their recurrent or progressive Dupuytren's disease. CONCLUSIONS:Enzymatic fasciotomy is safe and efficacious, with initial response to injection resulting in reduction of joint contracture to within 0 degrees -5 degrees of normal in 72 out of 80 patients. Initial evaluation of long-term recurrence rates suggests disease recurrence or progression in 4 out of 6 patients with MCP contractures and 2 patients with PIP contractures; however, recurrence was generally less severe than the initial contracture in the MCP group. In addition, patient satisfaction was high.
RCT Entities:
PURPOSE: Collagenase has been investigated in phase II and phase III clinical trials for the treatment of Dupuytren's disease. The purpose of this study is to report 8-year follow-up results in a subset of patients who had collagenase injection for the treatment of Dupuytren's contracture. METHODS: Twenty-three patients who participated in the phase II clinical trial of injectable collagenase were contacted by letter and phone. Eight patients were enrolled, completed a Dupuytren's disease questionnaire, and had independent examination of joint motion by a single examiner. RESULTS: Eight patients completed the 8-year follow-up study: 6 had been treated for isolated metacarpophalangeal (MCP) joint contracture, and 2 had been treated for isolated proximal interphalangeal (PIP) joint contracture. Average preinjection contracture was 57 degrees in the MCP group. Average contracture was 9 degrees at 1 week, 11 degrees at 1 year, and 23 degrees at 8-year follow-up. Four of 6 patients experienced recurrence, and 2 of 6 had no evidence of disease recurrence at 8-year follow-up. Average preinjection contracture was 45 degrees in the PIP group. Average contracture was 8 degrees at 1 weeks, 15 degrees at 1 year, and 60 degrees at 8-year follow-up. Both patients experienced recurrence at 8-year follow-up. No patients had had further intervention on the treated finger in either the MCP or the PIP group. Patients subjectively rated the overall clinical success at 60%, and 88% of patients stated that they would pursue further injection for the treatment of their recurrent or progressive Dupuytren's disease. CONCLUSIONS: Enzymatic fasciotomy is safe and efficacious, with initial response to injection resulting in reduction of joint contracture to within 0 degrees -5 degrees of normal in 72 out of 80 patients. Initial evaluation of long-term recurrence rates suggests disease recurrence or progression in 4 out of 6 patients with MCP contractures and 2 patients with PIP contractures; however, recurrence was generally less severe than the initial contracture in the MCP group. In addition, patient satisfaction was high.