Randomized Multicenter Study Comparing Avance Nerve Graft and Sural Nerve Autograft for Upper Extremity Mixed and Motor Nerve Repair and Recovery

What this Trial Is About

Researchers are conducting a multicenter, randomized study to compare two nerve repair methods for people needing reconstruction of mixed or motor nerves in the upper arm or hand. The study focuses on evaluating the recovery of motor and sensory functions after nerve injury using either the Avance Nerve Graft or the patients own sural nerve autograft. This study aims to determine whether the Avance Nerve Graft is not less effective than the autograft method. Participants will be randomly assigned to receive either the Avance Nerve Graft, a sterile nerve scaffold made from human nerve tissue, or a sural nerve autograft, which uses nerve tissue harvested from the patients lower leg during surgery. The study includes a screening visit, an operative visit for the nerve repair, and nine follow-up visits spread over two years at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24 to monitor recovery. Throughout the study, participants will undergo assessments of motor and sensory function using the MRCC score at each follow-up visit. Additional measures include recovery milestones, treatment response, and functional disability scores for the upper and lower extremities. Participants are expected to comply with the study schedule for 24 months, during which safety and recovery outcomes will be closely monitored by the research team.

A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction