Status:
ACTIVE_NOT_RECRUITING
Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease
Lead Sponsor:
Region Skane
Conditions:
Dupuytren Disease of Finger
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 contract...
Detailed Description
No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03406338
Start Date
March 20 2018
End Date
September 1 2027
Last Update
April 16 2025
Active Locations (1)
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1
Department of Orthopedics Hässleholm-Kristianstad
Hässleholm, Sweden, SE 28125