The CORD I trial is a phase 3, double-blind, placebo-controlled RCT testing injectable collagenase clostridium histolyticum for Dupuytren's contracture. It enrolled 308 patients with fixed-flexion contractures ≥20° across 16 U.S. centers. The core question: can a 0.58 mg injection plus next-day manipulation reduce MCP or PIP contracture to ≤5° without surgery?
Open fasciectomy carried real risks — digital nerve injury in 1.7–7.8%, infection in up to 10.6%, and recurrence in 26–80% of patients. And required extensive postoperative hand therapy. Patients with early disease, significant comorbidities, or aversion to surgery had no good alternative.
CORD I changed that calculus. When you see a patient with an MCP contracture ≥20° (and certainly at the ≥30° surgical threshold), collagenase injection is now a guideline-supported office-based option: inject into the cord, manipulate the next day, prescribe a night splint. No hand therapy required.
The data encode a decision rule worth committing to memory: MCP contractures ≤50° hit 89% success. PIP contractures ≤40° hit 81% success. The worse the contracture at the time of treatment, the lower the response rate. Don't wait.
This trial provided the pivotal phase 3 evidence for FDA approval of Xiaflex in 2010, making collagenase the first and only pharmacotherapy approved for Dupuytren's contracture and establishing the injection-plus-manipulation protocol now standard in hand surgery practice.
The CORD I trial is a phase 3, double-blind, placebo-controlled RCT testing injectable collagenase clostridium histolyticum for Dupuytren's contracture. It enrolled 308 patients with fixed-flexion contractures ≥20° across 16 U.S. centers. The core question: can a 0.58 mg injection plus next-day manipulation reduce MCP or PIP contracture to ≤5° without surgery?
Open fasciectomy carried real risks — digital nerve injury in 1.7–7.8%, infection in up to 10.6%, and recurrence in 26–80% of patients. And required extensive postoperative hand therapy. Patients with early disease, significant comorbidities, or aversion to surgery had no good alternative.
CORD I changed that calculus. When you see a patient with an MCP contracture ≥20° (and certainly at the ≥30° surgical threshold), collagenase injection is now a guideline-supported office-based option: inject into the cord, manipulate the next day, prescribe a night splint. No hand therapy required.
The data encode a decision rule worth committing to memory: MCP contractures ≤50° hit 89% success. PIP contractures ≤40° hit 81% success. The worse the contracture at the time of treatment, the lower the response rate. Don't wait.
This trial provided the pivotal phase 3 evidence for FDA approval of Xiaflex in 2010, making collagenase the first and only pharmacotherapy approved for Dupuytren's contracture and establishing the injection-plus-manipulation protocol now standard in hand surgery practice.