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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Axogen Corporation
Study ID
NCT07657182
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 12, 2026
Status verified
Jun 2026
Primary completion
Dec 5, 2030
Completion
Dec 5, 2030

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Avance Nerve Graft
    Study Treatment: Avance Nerve Graft repairs of mixed or motor nerves (\> 25 mm gaps)
  • Active Comparator: Sural nerve autograft
    Comparator: Sural nerve autograft repairs of mixed or motor nerves (\> 25 mm gaps)

Primary Outcome Measure

Recovery of motor function [ Time Frame: Assessed at 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OrthoIndyIndianapolisIndiana46260
Melanie Glover
[email protected]
317-802-2880
Brandon Smetana, MD (PRINCIPAL_INVESTIGATOR)

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OrthoIndy· Indianapolis, IN

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