Avance Nerve Graft for Peripheral Nerve Injury
(Nerve-RESTORE℠ Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
R. Glenn Gaston, MD
Principal Investigator
OrthoCarolina Research Institute, Inc.
Are You a Good Fit for This Trial?
This trial is for people who need surgery to repair a mixed or motor nerve injury in their arm. Participants must be able to attend regular follow-up visits after surgery. People with certain health conditions or factors that could affect healing may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Avance Nerve Graft
- Sural nerve autograft
Trial Overview
The study compares two ways of repairing damaged nerves in the arm: using an Avance Nerve Graft (a processed donor nerve) versus a sural nerve autograft (using the patient's own nerve). Patients are randomly assigned to one group and followed for up to 2 years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Study Treatment: Avance Nerve Graft repairs of mixed or motor nerves (\> 25 mm gaps)
Comparator: Sural nerve autograft repairs of mixed or motor nerves (\> 25 mm gaps)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axogen Corporation
Lead Sponsor
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