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

NCT01526681 | Active Not Recruiting

• 1 other identifier: ANG-CP-005
• Study Type: observational
• Target: 3,126
• Locations: 4 countries
• Sites: 49

Brief 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.

Conditions

Peripheral Nerve Injuries

Keywords

Sensory Nerve; Mixed Nerve; Motor Nerve; Neurotization; Nerve Injury; Peripheral Nerve Injury

Outcome Measures

Primary Outcomes (6)

• Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events

  Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.

  Through study completion or until lost to follow-up, approximately 3 years

• RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery

  Participants will be followed for a change in sensory function, if applicable, of the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care sensory assessments or until lost to follow-up.

  Through study completion or until lost to follow-up, approximately 3 years

• RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery

  Participants will be followed for a change in motor function, if applicable, to the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care motor assessments or until lost to follow-up.

  Through study completion or until lost to follow-up, approximately 3 years

• Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction

  Participants will be followed for change in sensation through the course of their recovery using Physician's standard of care assessments or until lost to follow-up. Standard of care sensory assessment includes evaluation using Semmes Weinstein Monofilament kit measured in g/mm2.

  Through study completion or until lost to follow-up, approximately 3 years

• Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction

  Participants will be followed for change in quality of life as measured by Breast Q through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented.

  Through study completion or until lost to follow-up, approximately 3 years

• Incidence of conduit, autograft, or procedure related adverse events

  Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.

  Through study completion or until lost to follow-up, approximately 3 years

Secondary Outcomes (3)

• Pain Level

  Through study completion or until lost to follow-up, approximately 3 years

• RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve

  Through study completion or until lost to follow-up, approximately 3 years

• Cost of Care

  Through study completion or until lost to follow-up, approximately 3 years

Study Arms (4)

RANGER: Avance Nerve Graft

Processed Human Nerve Graft

Other: Processed Human Nerve Graft

Historical Control for Standard Treatment

Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.

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

MATCH Arm: Contemporary Control

Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit

Other: Autogenous Nerve Graft; Device: Nerve Tube Conduit

Sensation-NOW Arm: Breast Neurotization

Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization

Procedure: Autologous Breast Reconstruction with Neurotization; Procedure: Autologous Breast Reconstruction without Neurotization

Interventions

Processed Human Nerve Graft OTHER

Implantation of appropriate length of processed human nerve graft at the time of surgery

RANGER: Avance Nerve Graft

Autogenous Nerve Graft OTHER

Nerve gap reconstructions with autogenous nerve graft within the upper extremity

MATCH Arm: Contemporary Control

Nerve Tube Conduit DEVICE

Nerve gap reconstructions with nerve tube conduit within the upper extremity

MATCH Arm: Contemporary Control

Autologous Breast Reconstruction with Neurotization PROCEDURE

Sensation-NOW Arm: Breast Neurotization

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

Historical control from established literature

Historical Control for Standard Treatment

Autologous Breast Reconstruction without Neurotization PROCEDURE

Sensation-NOW Arm: Breast Neurotization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.
• 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;
• Addendum 2 (Sensation-NOW) 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

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (49)

RANGER & MATCH: Arizona Center for Hand Surgery

Phoenix, Arizona, 85004, United States

Location

RANGER: Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

RANGER & MATCH: University of California - Irvine

Orange, California, 92868, United States

Location

RANGER & MATCH: The Buncke Clinic

San Francisco, California, 94114, United States

Location

Sensation-NOW: Stanford University

Stanford, California, 94305, United States

Location

Sensation-NOW: University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Sensation-NOW: George Washington University

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

Location

RANGER: University of Miami

Miami, Florida, 33176, United States

Location

RANGER & MATCH: Florida Orthopaedic Institute

Tampa, Florida, 33609, United States

Location

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

Atlanta, Georgia, 30342, United States

Location

RANGER & MATCH: University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Sensation-NOW: University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

RANGER: University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Sensation-NOW: Advanced Reconstructive Care, LLC

Metairie, Louisiana, 70002, United States

Location

RANGER: Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Sensation-NOW: Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

RANGER: Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MATCH: Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

RANGER & MATCH: University of Missouri - Columbia

Columbia, Missouri, 65212, United States

Location

Sensation-NOW: University of Nebraska Medical Center

Omaha, Nebraska, 68118, United States

Location

Sensation-NOW: University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

RANGER: Multi-Disciplinary Specialists

Rutherford, New Jersey, 07070, United States

Location

RANGER & MATCH: OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

Location

RANGER: Duke University

Durham, North Carolina, 27705, United States

Location

RANGER: University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Sensation-NOW: University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

RANGER: Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

RANGER: Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Sensation-NOW: Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Sensation-NOW: University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Sensation-NOW: East Cooper Plastic Surgery

Mt. Pleasant, South Carolina, 29464, United States

Location

RANGER & MATCH: Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

RANGER & MATCH: Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Sensation-NOW: Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Sensation-NOW: University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

RANGER: University of North Texas/John Peter Smith Hospital

Fort Worth, Texas, 76104, United States

Location

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

Fort Worth, Texas, 76104, United States

Location

Sensation-NOW: Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Sensation-NOW: Houston-Methodist Central

Houston, Texas, 77030, United States

Location

Sensation-NOW: Houston-Methodist West/North

Houston, Texas, 77094, United States

Location

RANGER: Texas Tech University HSC

Lubbock, Texas, 79430, United States

Location

Sensation-NOW: Joshua Lemmon, MD, PLLC

Richardson, Texas, 75802, United States

Location

RANGER: San Antonio Military Medical Center

San Antonio, Texas, 78231, United States

Location

Sensation-NOW: PRMA Plastic Surgery

San Antonio, Texas, 78240, United States

Location

Sensation-NOW: Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

RANGER & MATCH: University of Washington

Seattle, Washington, 98195, United States

Location

RANGER: University Hospital

Vienna, Austria

Location

RANGER: North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

RANGER & MATCH: University Hospital Birmingham, England

Edgbaston, Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 6, 2012
• Study Start: November 1, 2008
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (1); AU (1); US (46)