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

ArmDescriptionAssigned Intervention
Experimental
Processed Nerve Allograft
Processed Nerve Allograft
  • Biological: Processed Nerve Allograft (human)
Active Comparator
Collagen Nerve Cuff
  • Device: Collagen Nerve Cuff
    Bovine collagen based nerve cuff

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Debra Bourne, MD

More Details

NCT ID
NCT01809002
Status
Recruiting
Sponsor
Axogen Corporation

Study Contact

Erick DeVinney
386-362-6829
edevinney@axogeninc.com