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

NCT07657182 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ANG-CP-013
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Avance Nerve Graft; Sural Nerve Autograft; Processed Nerve Allograft; Peripheral Nerve Reconstruction; Mixed Nerve Repair; Motor Nerve Repair; MRCC; Nerve Gap; Nerve-RESTORE

Outcome Measures

Primary Outcomes (2)

• Recovery of motor function

  Medical Research Council Classification (MRCC) of motor recovery score. This is an ordinal scale from M0-M5, with grade M0 meaning no contraction and M5 meaning full recovery in all muscles.

  Assessed at 24 months

• Recovery of sensory function

  Medical Research Council Classification (MRCC) of sensory recovery score. This is an ordinal scale from S0-S4, with grade S0 meaning absence of sensibility in the autonomous area and S4 meaning complete recovery (2-point discrimination, 2-6 mm).

  Assessed at 24 months

Secondary Outcomes (6)

• Meaningful recovery (MR) of motor and sensory function

  Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

• Treatment response (TR) of motor and sensory function

  Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

• Time to MR of motor and sensory function

  Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

• Time to TR of motor and sensory function

  Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

• QuickDASH upper extremity disability score

  Assessed at 24 months

Study Arms (2)

Avance Nerve Graft

EXPERIMENTAL

Study Treatment: Avance Nerve Graft repairs of mixed or motor nerves (\> 25 mm gaps)

Biological: Avance Nerve Graft

Sural nerve autograft

ACTIVE COMPARATOR

Comparator: Sural nerve autograft repairs of mixed or motor nerves (\> 25 mm gaps)

Procedure: Sural nerve autograft

Interventions

Avance Nerve Graft BIOLOGICAL

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.

Also known as: Acellular nerve allograft-arwx

Avance Nerve Graft

Sural nerve autograft PROCEDURE

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.

Sural nerve autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study Participant Criteria
• Be ≥ 18 years of age at the time of consent;
• Willing and able to comply with all aspects of the treatment and evaluation schedule over a 24-month duration;
• 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
• 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(s):
• Median nerve: proximal nerve stump within 20 cm from the center point of the thenar eminence and distal to the crease of the elbow;
• Anterior interosseous nerve;
• Median nerve recurrent motor branch;
• Radial nerve: proximal nerve stump within 20 cm of the center of the forearm (midpoint between the tip of the olecranon and the styloid process) and distal to the mid-humerus;
• Posterior interosseous nerve.
• In study participants with multiple eligible nerve repairs, repair of all eligible nerves completed with the same study treatment, either Avance Nerve Graft or sural nerve autograft;
• Measured nerve gap(s) following resection \> 25 mm;
• Nerve(s) repaired ≤ 120 days post injury;
• Undergo coaptation on both the proximal and distal portion of the nerve gap(s) per the USPI for Avance Nerve Graft and per standard of care for sural nerve autograft; and

You may not qualify if:

• Study Participant Criteria
• Currently enrolled in another clinical study that may interfere with treatment, assessment of recovery, or participation in this study;
• Deformities or injuries of the limb, hand, or digits that affect both the primary and secondary assessments for eligible nerve repair(s);
• History of neuropathy of any etiology, diabetic neuropathy or any other known neuropathy including compressive/traumatic neuropathies affecting the target limb;
• History of progressive neurodegenerative or autoimmune disorder affecting peripheral nerve or motor function (e.g., amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease);
• History of chronic ischemic condition of the upper extremity;
• Expected use of medication during the study that is known to impact nerve regeneration or to cause peripheral neuropathy;
• Undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular systems;
• Participant is unlikely to comply with all study requirements and standard medical care procedures for the duration of the study schedule;
• Injury/Repair Criteria for Each Nerve
• Median nerve repairs where the ulnar nerve has been transected due to injury or repair;
• Repair(s) of a sensory-only proximal nerve stump;
• Incomplete nerve transections;
• Multilevel nerve injury pattern requiring two or more isolated reconstructions along the nerve pathway (for example, reconstruction of median nerve in forearm and recurrent motor branch resulting in repair pattern of graft to native nerve to graft to distal target);
• Inadequate soft tissue coverage or extensive soft tissue injury which will impair recovery assessment;

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (1)

OrthoIndy

Indianapolis, Indiana, 46260, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• R. Glenn Gaston, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacy Arnold

CONTACT

(386) 462-6800; clinicalresearch@axogeninc.com

Hayley Nicolosi

CONTACT

(386) 462-6800; hnicolosi@axogeninc.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the surgeon, study participant and clinical research coordinator to the treatment group is not possible, and attempts will be made to maintain the blind for the upper extremity sensory and motor function outcomes assessor. Repair of a nerve discontinuity necessarily requires the surgeon to perform one of two procedures with distinct procedural characteristics that differ in operative steps, surgical locations, and graft appearance, making surgeon blinding infeasible. The study participant will also be unblinded due to the presence or absence of a donor-site harvest wound and a newly created functional deficit at the autograft donor site. The assessments for sensory and motor function will be conducted by a qualified assessor who has been blinded to the participant's treatment group. The lower extremity assessments for participants in the sural nerve autograft group will be conducted by a separate, qualified assessor who is not blinded to the participant's treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants meeting the inclusion and exclusion criteria are centrally randomized in a 1:1 ratio intra-operatively, following stratification by longest gap length and nerve injured, and all nerve injuries qualifying for study enrollment shall be reconstructed with the same randomly assigned treatment.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): December 5, 2030
• Study Completion (Estimated): December 5, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)