Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
NCT ID: NCT01526681
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
3126 participants
OBSERVATIONAL
2008-11-30
2028-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
NCT03135392
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
NCT05368428
Autologous Nerve Graft Breast Reconstruction Neurotization
NCT06629012
Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components
NCT07308275
Reduction of Arm Volume and Improvement in Lymphedema Via Surgery
NCT06606145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RANGER: Avance Nerve Graft
Processed Human Nerve Graft
Processed Human Nerve Graft
Implantation of appropriate length of processed human nerve graft at the time of surgery
Historical Control for Standard Treatment
Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.
Historical control from established literature
MATCH Arm: Contemporary Control
Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
Autogenous Nerve Graft
Nerve gap reconstructions with autogenous nerve graft within the upper extremity
Nerve Tube Conduit
Nerve gap reconstructions with nerve tube conduit within the upper extremity
Sensation-NOW Arm: Breast Neurotization
Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization
Autologous Breast Reconstruction with Neurotization
Autologous Breast Reconstruction without Neurotization
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Processed Human Nerve Graft
Implantation of appropriate length of processed human nerve graft at the time of surgery
Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.
Historical control from established literature
Autogenous Nerve Graft
Nerve gap reconstructions with autogenous nerve graft within the upper extremity
Nerve Tube Conduit
Nerve gap reconstructions with nerve tube conduit within the upper extremity
Autologous Breast Reconstruction with Neurotization
Autologous Breast Reconstruction without Neurotization
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
* 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
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
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Axogen Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANG-CP-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.