Status:
COMPLETED
Effectiveness of Splinting After Collagenase Injection
Lead Sponsor:
Foundation for Orthopaedic Research and Education
Collaborating Sponsors:
Endo, Inc.
Conditions:
Dupuytren Contracture
Dupuytren's Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Dupuytren disease is a fibroproliferative condition of the palmar and digital fascia. A collagen containing cord forms which can lead to fixed flexion contracture of one or more fingers. While there i...
Detailed Description
Patients with Dupuytren disease that meet inclusion criteria will be consented to participate. All patients will be randomized to splint or no splint group prior to treatment. Baseline data will be co...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Contracture of 1 or more digits caused by palpable cord
- PIP joint flexion contracture of 20 degrees or more or;
- MCP joint flexion contracture of 20 degrees or more
Exclusion
- Age less than 18 years
- Prior CCH injection for contracture less than 1 year before start of study
- Prior surgical intervention for contracture less than 1 year before start of study
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04874870
Start Date
July 12 2021
End Date
December 1 2023
Last Update
February 26 2025
Active Locations (1)
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1
Florida Orthopaedic Institute
Tampa, Florida, United States, 33637