Effectiveness of Splinting After Collagenase Injection

• Status: Enrolling by invitation
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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 is no cure, many treatment options are available to manage symptoms. One of these options is injectable collagenase clostridium histolyticum (CCH). CCH is a combination of two highly selective microbial collagenases that can disrupt collagen types I and III usually found in cords. Current standard of care after receiving a CCH injection is daily hand exercises and use of a static night brace for four months. However, there is limited evidence that use of a night splint after CCH injection has any benefit post-treatment. The goal of our randomized, controlled trial, is to determine the clinical effectiveness of splinting after CCH injection. Study subjects will be adults 18 years of age or older with Dupuytren disease and contracture of one or more digits. Treatment includes collagenase clostridium histolyticum injection for Dupuytren flexion contraction, with randomization to static night splint or no splint.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: Endo Pharmceuticals; EndoPharmceuticals

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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