Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand
Phase 1
Completed
- Conditions
- Adhesion of Flexor Tendon of Hand
- Interventions
- Registration Number
- NCT00261209
- Lead Sponsor
- Stony Brook University
- Brief Summary
The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.
- Detailed Description
In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.
Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- zone II flexor tendon adhesion of at least one finger
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Exclusion Criteria
- any chronic, serious or uncontrolled medical condition
- inability to conform to study visits (12-15 per year)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Collagenase Injection Collagenase injection Injection of collagenase into adhesion restricting tendon gliding Collagenase Injection Collagenase Injection of collagenase into adhesion restricting tendon gliding
- Primary Outcome Measures
Name Time Method Restoration of PIP and DIP joint motion. 6 months
- Secondary Outcome Measures
Name Time Method Hand Grip strength (kg) 6 months
Trial Locations
- Locations (1)
Dept. Orthopaedics, SUNY@Stony Brook
🇺🇸Stony Brook, New York, United States