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Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction | Clinical Trials | Clareo Health

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Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair

NCT01526681•Axogen Corporation

View on ClinicalTrials.gov

Summary

This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.

Detailed Description

This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft. Addendum 1 (MATCH) establishes a comparative arm to collect data on nerve injuries repaired with nerve autografts and nerve tube conduits at select RANGER® participating sites. Addendum 2 (Sensation-NOW) establishes a focused arm to collect data on autologous breast reconstructive procedures where neurotization was completed. Post-mastectomy autologous breast reconstruction procedures without neurotization will serve as an internal control group to allow for comparisons.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Primary Study Criteria (RANGER Avance):
•Males and Females who have undergone nerve repair using the Avance® Nerve Graft for the repair of a nerve injury
•Returned for at least one post-operative follow-up visit
•Have nerve transection injuries to the upper extremity;
•Have undergone tension free end to end nerve coaptation on both the proximal and distal portion of the nerve gap with nerve autograft or nerve entubulation with nerve tube conduit at a participating ANG-CP-005 registry site after 2004 and;
•Have completed sufficient follow-up assessments at a regeneration rate of 2mm/day to determine the outcomes of the repair or is willing to comply with site specific post-operative care procedures and assessments to determine the outcome of the repair.
•Female ≥ 18 years old
•Undergo post mastectomy autologous breast reconstruction with one type of autologous flap (no stacked reconstructions or use of implant with autologous flap)
•Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest
•Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction:
+7 more criteria

Exclusion Criteria

•Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up.
•Addendum 1 (MATCH) Criteria:
•Direct nerve repairs;
•Nerve gaps greater than 70mm;
•Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions;
•Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
•Addendum 2 (Sensation-NOW) Criteria:
•Surgical history of secondary revision surgery for partial or total flap loss
•Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
•Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
+9 more criteria

Locations (49)

RANGER & MATCH: Arizona Center for Hand Surgery

Phoenix, Arizona, United States

RANGER: Phoenix Children's Hospital

Phoenix, Arizona, United States

RANGER & MATCH: University of California - Irvine

Orange, California, United States

RANGER & MATCH: The Buncke Clinic

San Francisco, California, United States

Sensation-NOW: Stanford University

Stanford, California, United States

Sensation-NOW: University of Colorado School of Medicine

Aurora, Colorado, United States

Sensation-NOW: George Washington University

Washington D.C., District of Columbia, United States

RANGER: University of Miami

Miami, Florida, United States

RANGER & MATCH: Florida Orthopaedic Institute

Tampa, Florida, United States

RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta

Atlanta, Georgia, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

November 1, 2028

Completion Date

November 1, 2028

Last Updated

January 26, 2026

Enrollment

3,126

ACTUAL participants

Conditions

Peripheral Nerve Injuries

Interventions

Processed Human Nerve Graft

OTHER

Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.

OTHER

Autogenous Nerve Graft

OTHER

Nerve Tube Conduit

DEVICE

Autologous Breast Reconstruction with Neurotization

PROCEDURE

Autologous Breast Reconstruction without Neurotization

PROCEDURE

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Peripheral Nerve Injuries

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RECRUITINGNA

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Peripheral Nerve InjuriesNeuroma of Nerve Repair+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry

Autologous Human Schwann Cells in Peripheral Nerve Repair

StimRouter Registry Clinical Protocol

Prospective Comparison of Adductor Canal Block Performed With a Multiport Versus Single Bevel Needle

Early Sensory Re-education of the Hand With a Sensor Glove Model