Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

• Status: Enrolling by invitation
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Skane

Criteria

Inclusion Criteria:

• Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.

• Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.

• Palpable cord in the palm and/or affected finger causing the recurrent contracture.

• No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.

Exclusion Criteria:

• Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.

• Signs of nerve or vascular injury in the affected finger.

• Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger

• Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).

• Previous trauma or other surgery involving the affected finger.

• More than 2 previous surgeries, collagenase injections or needle fasciotomies in the affected finger.

• Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.

• Patient refusal to participate