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

NCT07657182 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-06-18

No results posted yet for this study

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.

Conditions

  • Peripheral Nerve Injury
  • Peripheral Nerve Discontinuity
  • Mixed Peripheral Nerve Injury
  • Motor Peripheral Nerve Injury
  • Upper Extremity Nerve Injury

Interventions

BIOLOGICAL

Avance 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.

PROCEDURE

Sural 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.

Sponsors & Collaborators

  • Axogen Corporation

    lead INDUSTRY

Principal Investigators

  • R. Glenn Gaston, MD · OrthoCarolina Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2030-12-05
Completion
2030-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07657182 on ClinicalTrials.gov