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

Status: Recruiting
Location: See all (49) locations...
Intervention Type: Procedure, Other, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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:

‣ 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

Locations
United States
Arizona
RANGER & MATCH: Arizona Center for Hand Surgery
COMPLETED
Phoenix
RANGER: Phoenix Children's Hospital
COMPLETED
Phoenix
California
RANGER & MATCH: University of California - Irvine
COMPLETED
Orange
RANGER & MATCH: The Buncke Clinic
COMPLETED
San Francisco
Sensation-NOW: Stanford University
RECRUITING
Stanford
Colorado
Sensation-NOW: University of Colorado School of Medicine
RECRUITING
Aurora
Washington, D.c.
Sensation-NOW: George Washington University
RECRUITING
Washington D.c.
Florida
RANGER: University of Miami
COMPLETED
Miami
RANGER & MATCH: Florida Orthopaedic Institute
COMPLETED
Tampa
Georgia
RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta
COMPLETED
Atlanta
Kansas
RANGER & MATCH: University of Kansas Medical Center
COMPLETED
Kansas City
Sensation-NOW: University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
RANGER: University of Kentucky
COMPLETED
Lexington
Louisiana
Sensation-NOW: Advanced Reconstructive Care, LLC
RECRUITING
Metairie
Maryland
RANGER: Johns Hopkins University
COMPLETED
Baltimore
Sensation-NOW: Johns Hopkins University
SUSPENDED
Baltimore
RANGER: Walter Reed National Military Medical Center
COMPLETED
Bethesda
Minnesota
MATCH: Hennepin County Medical Center
COMPLETED
Minneapolis
Missouri
RANGER & MATCH: University of Missouri - Columbia
COMPLETED
Columbia
North Carolina
RANGER & MATCH: OrthoCarolina Research Institute, Inc.
COMPLETED
Charlotte
RANGER: Duke University
COMPLETED
Durham
Nebraska
Sensation-NOW: University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
RANGER: Multi-Disciplinary Specialists
COMPLETED
Rutherford
Nevada
Sensation-NOW: University of Nevada, Las Vegas
RECRUITING
Las Vegas
Ohio
RANGER: University of Cincinnati
COMPLETED
Cincinnati
Sensation-NOW: University of Cincinnati
RECRUITING
Cincinnati
RANGER: Cleveland Clinic
COMPLETED
Cleveland
RANGER: Ohio State University Medical Center
COMPLETED
Columbus
Sensation-NOW: Ohio State University Medical Center
RECRUITING
Columbus
Pennsylvania
Sensation-NOW: University of Pennsylvania
COMPLETED
Philadelphia
South Carolina
Sensation-NOW: East Cooper Plastic Surgery
RECRUITING
Mt. Pleasant
Tennessee
RANGER & MATCH: Campbell Clinic
COMPLETED
Germantown
RANGER & MATCH: Vanderbilt University
COMPLETED
Nashville
Sensation-NOW: Vanderbilt University
RECRUITING
Nashville
Texas
Sensation-NOW: University of Texas Southwestern Medical Center
RECRUITING
Dallas
RANGER: University of North Texas/John Peter Smith Hospital
COMPLETED
Fort Worth
Sensation-NOW: University of North Texas/John Peter Smith Hospital
RECRUITING
Fort Worth
Sensation-NOW: Baylor College of Medicine
RECRUITING
Houston
Sensation-NOW: Houston-Methodist Central
RECRUITING
Houston
Sensation-NOW: Houston-Methodist West/North
RECRUITING
Houston
RANGER: Texas Tech University HSC
COMPLETED
Lubbock
Sensation-NOW: Joshua Lemmon, MD, PLLC
RECRUITING
Richardson
RANGER: San Antonio Military Medical Center
COMPLETED
San Antonio
Sensation-NOW: PRMA Plastic Surgery
COMPLETED
San Antonio
Virginia
Sensation-NOW: Virginia Commonwealth University
RECRUITING
Richmond
Washington
RANGER & MATCH: University of Washington
COMPLETED
Seattle
Other Locations
Austria
RANGER: University Hospital
COMPLETED
Vienna
Canada
RANGER: North York General Hospital
COMPLETED
Toronto
United Kingdom
RANGER & MATCH: University Hospital Birmingham, England
COMPLETED
Edgbaston
Contact Information
Primary
Stacy Arnold
clinicalresearch@axogeninc.com
386-462-6800
Time Frame
Start Date: 2008-11
Estimated Completion Date: 2025-12
Participants
Target number of participants: 5000
Treatments
RANGER: Avance Nerve Graft
Processed Human Nerve Graft
Historical Control for Standard Treatment
Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
MATCH Arm: Contemporary Control
Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
Sensation-NOW Arm: Breast Neurotization
Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization
Related Therapeutic Areas
Sponsors
Leads: Axogen Corporation

This content was sourced from clinicaltrials.gov