← Evidence libraryCORD I (collagenase for Dupuytren)
Injectable collagenase clostridium histolyticum for Dupuytren's contracture
Hurst LC, Badalamente MA, Hentz VR, et al. The New England journal of medicine 2009 · PMID 19726771 · doi:10.1056/nejmoa0810866
Randomised trialManagementHandCitation checked
- Question
- Is injectable collagenase effective at correcting Dupuytren's contracture compared with placebo?
- Design
- Multicentre double-blind placebo-controlled RCT in the USA.
- Patients
- Adults with Dupuytren's contracture of the MCP or PIP joint with a palpable cord.
- Intervention
- Collagenase clostridium histolyticum injection into the cord followed by finger extension manipulation (up to three injections)
- Comparison
- Placebo injection
- Primary outcome
- Reduction of contracture to within 0-5 degrees of full extension 30 days after last injection
- Key result
- Collagenase achieved the primary end point in significantly more joints than placebo, with better results at the MCP than the PIP joint; adverse events were mostly local (swelling, bruising, skin tears), with rare tendon rupture.
- Limitations
- Placebo rather than surgical comparator; short follow-up so recurrence was not addressed; industry funded.
- Impact on practice
- Led to licensing of collagenase and NICE approval (TA459) as an alternative to fasciectomy in selected patients; recurrence and availability have since limited its use in the UK.