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Nerve graft registry tracks recovery in thousands of patients

NCT ID NCT01526681

Disease control Sponsor: Axogen Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows over 3,000 people who received the Avance Nerve Graft to repair damaged peripheral nerves. Researchers are tracking safety, sensory and motor function recovery, and quality of life in real-world settings. The goal is to understand how well this processed human nerve graft works compared to standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Processed human nerve graft
What this could lead to
If successful, this could confirm that Avance Nerve Graft is a safe and effective option for repairing damaged nerves, potentially restoring feeling and movement.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. Nerve recovery varies widely and may not be complete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

3,126 people

The number who actually took part.

Start date

Nov 2008

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects surgically repaired with Avance Nerve Graft to reconstruct peripheral nerve discontinuities.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Primary Study Criteria (RANGER Avance): Inclusion Criteria: * 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 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: Inclusion Criteria: * 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. Exclusion 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: Inclusion Criteria: * 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: * Breast-Q Physical Well Being of the Chest * Breast-Q Satisfaction with Breast * Breast-Q Physical Well Being of the Abdomen * Breast-Q Abnormal Breast Sensations * Breast-Q Impact of Breast Sensation on Quality of Life * Breast-Q Return of Breast Sensation * Able to provide informed consent and are willing to comply with post-operative care procedures and assessments Exclusion 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 * Currently undergoing IV chemotherapy or radiation * Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule Additional Eligibility criteria to Modules Module 1: Native Skin Reconstructions with and without neurotization. * Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region. * Sensory assessments must be completed on ≥ 8 Zones of Native Skin. * Center zone measurement may be on either Native Skin or Flap Skin. * All Inner and Outer zone measurements must be on Native Skin. * De-identified photo of the breast reconstruction with 9 zones identified.

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Conditions

The condition(s) this trial relates to.

Peripheral Nerve Injuries traumatic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral nerve injuries

Contacts and locations

Locations

  • MATCH: Hennepin County Medical Center

    Minneapolis, Minnesota, 55415, United States

  • RANGER & MATCH: Arizona Center for Hand Surgery

    Phoenix, Arizona, 85004, United States

  • RANGER & MATCH: Campbell Clinic

    Germantown, Tennessee, 38138, United States

  • RANGER & MATCH: Florida Orthopaedic Institute

    Tampa, Florida, 33609, United States

  • RANGER & MATCH: OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolina, 28207, United States

  • RANGER & MATCH: The Buncke Clinic

    San Francisco, California, 94114, United States

  • RANGER & MATCH: University Hospital Birmingham, England

    Edgbaston, Birmingham, B15 2TH, United Kingdom

  • RANGER & MATCH: University of California - Irvine

    Orange, California, 92868, United States

  • RANGER & MATCH: University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • RANGER & MATCH: University of Missouri - Columbia

    Columbia, Missouri, 65212, United States

  • RANGER & MATCH: University of Washington

    Seattle, Washington, 98195, United States

  • RANGER & MATCH: Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • RANGER: Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • RANGER: Duke University

    Durham, North Carolina, 27705, United States

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

    Atlanta, Georgia, 30342, United States

  • RANGER: Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • RANGER: Multi-Disciplinary Specialists

    Rutherford, New Jersey, 07070, United States

  • RANGER: North York General Hospital

    Toronto, Ontario, M2K 1E1, Canada

  • RANGER: Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • RANGER: Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • RANGER: San Antonio Military Medical Center

    San Antonio, Texas, 78231, United States

  • RANGER: Texas Tech University HSC

    Lubbock, Texas, 79430, United States

  • RANGER: University Hospital

    Vienna, Austria

  • RANGER: University of Cincinnati

    Cincinnati, Ohio, 45220, United States

  • RANGER: University of Kentucky

    Lexington, Kentucky, 40506, United States

  • RANGER: University of Miami

    Miami, Florida, 33176, United States

  • RANGER: University of North Texas/John Peter Smith Hospital

    Fort Worth, Texas, 76104, United States

  • RANGER: Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

  • Sensation-NOW: Advanced Reconstructive Care, LLC

    Metairie, Louisiana, 70002, United States

  • Sensation-NOW: Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Sensation-NOW: East Cooper Plastic Surgery

    Mt. Pleasant, South Carolina, 29464, United States

  • Sensation-NOW: George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Sensation-NOW: Houston-Methodist Central

    Houston, Texas, 77030, United States

  • Sensation-NOW: Houston-Methodist West/North

    Houston, Texas, 77094, United States

  • Sensation-NOW: Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Sensation-NOW: Joshua Lemmon, MD, PLLC

    Richardson, Texas, 75802, United States

  • Sensation-NOW: Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Sensation-NOW: PRMA Plastic Surgery

    San Antonio, Texas, 78240, United States

  • Sensation-NOW: Stanford University

    Stanford, California, 94305, United States

  • Sensation-NOW: University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • Sensation-NOW: University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

  • Sensation-NOW: University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Sensation-NOW: University of Nebraska Medical Center

    Omaha, Nebraska, 68118, United States

  • Sensation-NOW: University of Nevada, Las Vegas

    Las Vegas, Nevada, 89154, United States

  • Sensation-NOW: University of North Texas/John Peter Smith Hospital

    Fort Worth, Texas, 76104, United States

  • Sensation-NOW: University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Sensation-NOW: University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Sensation-NOW: Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Sensation-NOW: Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

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