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Study Comparing Avance Nerve Graft and Autograft for Nerve Reconstruction

This study is comparing two ways to repair damaged nerves in the arm: the Avance Nerve Graft and a sural nerve autograft. The Avance Nerve Graft is a ready-made material from human nerve tissue. A sural nerve autograft uses a piece of your own nerve taken from your lower leg. This study is for adults aged 18 and older who need reconstruction of a mixed or motor nerve in their upper arm. Researchers will look at how well motor function (movement) and sensory function (feeling) recover after 24 months. The study is currently unclear about its recruitment status.

Study design
This is a randomized, comparative study involving 178 participants across multiple centers. Participants will be randomly assigned to receive either the Avance Nerve Graft or a sural nerve autograft, and the evaluators will not know which treatment you received.
What's involved
You would have a screening visit, an operation, and then 9 follow-up visits over 24 months. These visits occur at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their operation to assess recovery of motor and sensory function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07657182

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Axogen Corporation
~178 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Avance Nerve GraftSural nerve autograft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recovery of motor function
Measured over Assessed at 24 months
+1 more outcome measured

Conditions

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

Explore related trials

Injury of nerve of upper extremityPeripheral Nerve DiscontinuityPeripheral Nerve Injury

NCT07657182

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OrthoIndy

    Indianapolis, Indianastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Stacy Arnold
[email protected]
(386) 462-6800
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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. 5. Zone of injury of eligible nerve(s) resectable to healthy nerve both distally and proximally and within the anatomical regions of Inclusion Criterion #4; 6. 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; 7. Measured nerve gap(s) following resection \> 25 mm; 8. Nerve(s) repaired ≤ 120 days post injury; 9. 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 10. Either treatment method, Avance Nerve Graft or sural nerve autograft, is a viable option for all eligible nerve repair(s) (i.e., volume of injured nerve\[s\] does not exceed availability of sural nerve autograft for reconstruction, study participants are not treated with a combination of treatment types).

What this trial measures

  • Recovery of motor functionAssessed at 24 months

    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.

  • Recovery of sensory functionAssessed at 24 months

    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).