Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Purpose
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.
Condition
- Peripheral Nerve Discontinuities
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Peripheral Nerve Injury
Exclusion Criteria
- Peripheral Neuropathy - Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Processed Nerve Allograft |
Processed Nerve Allograft |
|
Active Comparator Collagen Nerve Cuff |
|
Recruiting Locations
More Details
- NCT ID
- NCT01809002
- Status
- Completed
- Sponsor
- Axogen Corporation