A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
Axogen Corporation
Summary
This is a multicenter, 1:1 randomized, prospective, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
Description
This is a multicenter, 1:1 randomized, prospective, evaluator blinded, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. The study will assess recovery of motor and sensory function via MRCC score for nerve repairs with Avance Nerve Graft (Study Treatment) and sural nerve autograft (Comparator) through non-inferiority analyses. Participants will be considered enrolled to the study once all screening and eligibility criteria have been met and the participant has been centrally randomized to either Avance Nerve Graft or sural nerve autog…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Study Participant Criteria 1. Be ≥ 18 years of age at the time of consent; 2. Willing and able to comply with all aspects of the treatment and evaluation schedule over a 24-month duration; 3. Provide documented Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to initiation of any study procedures; Injury/Repair Criteria for Each Nerve 4. Primary or secondary nerve injury repair with sural nerve autograft or Avance Nerve Graft for fully transected reconstruction of the following upper extremity mixed and/or motor nerve…
Interventions
- BiologicalAvance Nerve Graft
A commercially available, sterile, single-use peripheral nerve scaffold indicated for the treatment of functional deficits, manufactured from decellularized and sterilized extracellular matrix derived from human peripheral nerve tissue.
- ProcedureSural nerve autograft
A patient's own peripheral nerve tissue harvested in a secondary surgical procedure of the lower extremity where a functioning sural nerve is sacrificed for use in the reconstruction of a nerve defect.
Location
- OrthoIndyIndianapolis, Indiana