Enzyme injection as nonsurgical treatment of Dupuytren's disease.

Surgical fasciectomy is the currently accepted treatment of Dupuytren's disease. The goal of this study was to test the clinical safety and efficacy of clostridial collagenase injection as a nonsurgical treatment of Dupuytren's disease in a phase II open-label trial. Thirty-five Dupuytren's disease patients entered the study (32 men and 3 women). The mean age was 65 years. The first 6 patients were treated following a dose escalation protocol and received 300, 600, 1,200, 2,400, 4,800, and 9,600 U collagenase injected into the cord that was causing contracture of the metacarpophalangeal (MCP) joint. There were no beneficial clinical effects of these injections. The remaining 29 patients had collagenase injections at a dose level of 10,000 U, causing contractures of 34 MCP joints, 9 proximal interphalangeal (PIP) joints, and 1 thumb. Twenty-eight of the 34 MCP joint contractures corrected to normal extension (0 degrees ) and 2 of the 34 MCP joint contractures corrected to 5 degrees of normal extension, with full range of motion, within 1 to 14 days of injection. In the patients with PIP joint contractures, 4 of the 9 joints corrected to normal (0 degrees ). One PIP joint corrected to within 10 degrees of normal and 2 corrected to within 15 degrees of normal. There were 2 failures; these patients will require surgery. The mean follow-up period was 20.0 +/- 5.6 months for the MCP joints and 14.1 +/- 6.6 months for the PIP joints. Clostridial collagenase injection of Dupuytren's cords causing MCP and PIP joint contractures appears to have merit as nonsurgical treatment of this disorder. Pending further placebo, double-blind studies, collagenase injection to treat Dupuytren's disease may be a safe and effective alternative to surgical fasciectomy.

RCT Entities:   Population Interventions Outcomes