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ACTIVE NOT RECRUITING

NCT01526681

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

3126

Start Date

2008-11

Completion Date

2028-11

Last Updated

2026-01-26

Healthy Volunteers

Conditions

Peripheral Nerve Injuries

Interventions

OTHER

Processed Human Nerve Graft

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

OTHER

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

Historical control from established literature

OTHER

Autogenous Nerve Graft

Nerve gap reconstructions with autogenous nerve graft within the upper extremity

DEVICE

Nerve Tube Conduit

Nerve gap reconstructions with nerve tube conduit within the upper extremity

PROCEDURE

Autologous Breast Reconstruction with Neurotization

PROCEDURE

Autologous Breast Reconstruction without Neurotization

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.

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

RANGER & MATCH: University of Kansas Medical Center

Kansas City, Kansas, United States

Sensation-NOW: University of Kansas Medical Center

Kansas City, Kansas, United States

RANGER: University of Kentucky

Lexington, Kentucky, United States

Sensation-NOW: Advanced Reconstructive Care, LLC

Metairie, Louisiana, United States

RANGER: Johns Hopkins University

Baltimore, Maryland, United States

Sensation-NOW: Johns Hopkins University

Baltimore, Maryland, United States

RANGER: Walter Reed National Military Medical Center

Bethesda, Maryland, United States

MATCH: Hennepin County Medical Center

Minneapolis, Minnesota, United States

RANGER & MATCH: University of Missouri - Columbia

Columbia, Missouri, United States

Sensation-NOW: University of Nebraska Medical Center

Omaha, Nebraska, United States

Sensation-NOW: University of Nevada, Las Vegas

Las Vegas, Nevada, United States

RANGER: Multi-Disciplinary Specialists

Rutherford, New Jersey, United States

RANGER & MATCH: OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States

RANGER: Duke University

Durham, North Carolina, United States

RANGER: University of Cincinnati

Cincinnati, Ohio, United States

Sensation-NOW: University of Cincinnati

Cincinnati, Ohio, United States

RANGER: Cleveland Clinic

Cleveland, Ohio, United States

RANGER: Ohio State University Medical Center

Columbus, Ohio, United States

Sensation-NOW: Ohio State University Medical Center

Columbus, Ohio, United States

Sensation-NOW: University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sensation-NOW: East Cooper Plastic Surgery

Mt. Pleasant, South Carolina, United States

RANGER & MATCH: Campbell Clinic

Germantown, Tennessee, United States

RANGER & MATCH: Vanderbilt University

Nashville, Tennessee, United States

Sensation-NOW: Vanderbilt University

Nashville, Tennessee, United States

Sensation-NOW: University of Texas Southwestern Medical Center

Dallas, Texas, United States

RANGER: University of North Texas/John Peter Smith Hospital

Fort Worth, Texas, United States

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

Fort Worth, Texas, United States

Sensation-NOW: Baylor College of Medicine

Houston, Texas, United States

Sensation-NOW: Houston-Methodist Central

Houston, Texas, United States

Sensation-NOW: Houston-Methodist West/North

Houston, Texas, United States

RANGER: Texas Tech University HSC

Lubbock, Texas, United States

Sensation-NOW: Joshua Lemmon, MD, PLLC

Richardson, Texas, United States

RANGER: San Antonio Military Medical Center

San Antonio, Texas, United States

Sensation-NOW: PRMA Plastic Surgery

San Antonio, Texas, United States

Sensation-NOW: Virginia Commonwealth University

Richmond, Virginia, United States

RANGER & MATCH: University of Washington

Seattle, Washington, United States

RANGER: University Hospital

Vienna, Austria

RANGER: North York General Hospital

Toronto, Ontario, Canada

RANGER & MATCH: University Hospital Birmingham, England

Edgbaston, Birmingham, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)