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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Nerve Injuries
• Intervention / Treatment: Other: Processed Human Nerve Graft; Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.; Other: Autogenous Nerve Graft; Device: Nerve Tube Conduit; Procedure: Autologous Breast Reconstruction with Neurotization; Procedure: Autologous Breast Reconstruction without Neurotization

Detailed Description

This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft.

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Stacy Arnold; Phone Number: 386-462-6800; Email: clinicalresearch@axogeninc.com

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • RANGER: University Hospital
    • Contact: Christine Radtke, MD
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2K 1E1
      • Recruiting
      • RANGER: North York General Hospital
      • Contact: Yasser El-Sheikh, MD
• United Kingdom
  • Birmingham
    • Edgbaston, Birmingham, United Kingdom, B15 2TH
      • Recruiting
      • RANGER & MATCH: University Hospital Birmingham, England
      • Contact: Dominic Power, MD
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • RANGER & MATCH: Arizona Center for Hand Surgery
      • Contact: Allen Liu, MD DDS
    • Phoenix, Arizona, United States, 85016
      • Completed
      • RANGER: Phoenix Children's Hospital
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • RANGER & MATCH: University of California - Irvine
      • Contact: Gregory Rafijah, MD
    • San Francisco, California, United States, 94114
      • Recruiting
      • RANGER & MATCH: The Buncke Clinic
      • Contact: Gregory Buncke, MD
      • Principal Investigator: Gregory Buncke, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Sensation-NOW: Stanford University
      • Contact: Arash Momeni, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Sensation-NOW: University of Colorado School of Medicine
      • Contact: David Mathes, MD
  • Florida
    • Miami, Florida, United States, 33176
      • Completed
      • RANGER: University of Miami
    • Tampa, Florida, United States, 33609
      • Recruiting
      • RANGER & MATCH: Florida Orthopaedic Institute
      • Contact: Jason Nydick, DO
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta
      • Contact: Bryce T Gillespie, MD
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • RANGER & MATCH: University of Kansas Medical Center
      • Contact: David Megee, MD
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • Sensation-NOW: University of Kansas Medical Center
      • Contact: David Megee, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • RANGER: University of Kentucky
      • Contact: Debra Bourne, MD
  • Louisiana
    • Metairie, Louisiana, United States, 70002
      • Recruiting
      • Sensation-NOW: Advanced Reconstructive Care, LLC
      • Contact: Ravi Tandon, MD
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Completed
      • RANGER: Johns Hopkins University
    • Baltimore, Maryland, United States, 21287
      • Suspended
      • Sensation-NOW: Johns Hopkins University
    • Bethesda, Maryland, United States, 20889
      • Recruiting
      • RANGER: Walter Reed National Military Medical Center
      • Contact: Leon Nesti, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • MATCH: Hennepin County Medical Center
      • Contact: Jacqueline Geissler, MD
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • RANGER & MATCH: University of Missouri - Columbia
      • Contact: Julia Nuelle, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Recruiting
      • Sensation-NOW: University of Nebraska Medical Center
      • Contact: Sean C Figy, MD
  • New Jersey
    • Rutherford, New Jersey, United States, 07070
      • Recruiting
      • RANGER: Multi-Disciplinary Specialists
      • Contact: Renata V Weber, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • RANGER & MATCH: OrthoCarolina Research Institute, Inc.
      • Contact: R. Glenn Gaston, MD; Phone Number: 704-323-3634
    • Durham, North Carolina, United States, 27705
      • Completed
      • RANGER: Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • RANGER: University of Cincinnati
      • Contact: Ryan Gobble, MD
    • Cincinnati, Ohio, United States, 45221
      • Recruiting
      • Sensation-NOW: University of Cincinnati
      • Contact: Ryan Gobble, MD
    • Cleveland, Ohio, United States, 44195
      • Completed
      • RANGER: Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • RANGER: Ohio State University Medical Center
      • Contact: Sonu Jain, MD
    • Columbus, Ohio, United States, 43210
      • Completed
      • Sensation-NOW: Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Completed
      • Sensation-NOW: University of Pennsylvania
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Recruiting
      • Sensation-NOW: East Cooper Plastic Surgery
      • Contact: James Craigie, MD
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • RANGER & MATCH: Campbell Clinic
      • Contact: William Weller, MD
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • RANGER & MATCH: Vanderbilt University
      • Contact: Wesley Thayer, MD PhD
      • Contact: Mihir Desai, MD
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Sensation-NOW: Vanderbilt University
      • Contact: Galen Perdikis, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • Sensation-NOW: University of Texas Southwestern Medical Center
      • Contact: Nicholas Haddock, MD
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • RANGER: University of North Texas/John Peter Smith Hospital
      • Contact: William Pientka, MD
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Sensation-NOW: University of North Texas/John Peter Smith Hospital
      • Contact: Steven Mapula, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Sensation-NOW: Houston-Methodist Central
      • Contact: Aldona Spiegel, MD
    • Houston, Texas, United States, 77094
      • Recruiting
      • Sensation-NOW: Houston-Methodist West/North
      • Contact: Warren Ellsworth, MD
      • Principal Investigator: Warren Ellsworth, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Sensation-NOW: Baylor College of Medicine
      • Contact: Marco Maricevich, MD
      • Principal Investigator: Marco Maricevich, MD
    • Lubbock, Texas, United States, 79430
      • Recruiting
      • RANGER: Texas Tech University HSC
      • Principal Investigator: Brendan MacKay, MD
      • Contact: Brendan MacKay, MD
    • Richardson, Texas, United States, 75802
      • Recruiting
      • Sensation-NOW: Joshua Lemmon, MD, PLLC
      • Contact: Joshua Lemmon, MD
    • San Antonio, Texas, United States, 78231
      • Completed
      • RANGER: San Antonio Military Medical Center
    • San Antonio, Texas, United States, 78240
      • Completed
      • Sensation-NOW: PRMA Plastic Surgery
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Not yet recruiting
      • Sensation-NOW: Virginia Commonwealth University
      • Contact: Tae Chong, MD
      • Principal Investigator: Tae Chong, MD
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • RANGER & MATCH: University of Washington
      • Contact: Erin Miller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RANGER: Avance Nerve Graft; Processed Human Nerve Graft	Other: 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.	Other: 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	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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	Participants will be followed for a change in pain level as measured by VAS, when available, through the course of their recovery using Physician's standard of care assessments for pain or until lost to follow-up.	Through study completion or until lost to follow-up, approximately 3 years
RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve	Participants will be followed for change in quality of life as measured by Disabilities of the Arm Shoulder and Hand Questionnaire (DASH), if available, 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
Cost of Care	Participants will be followed for cost of care, as converted to USD, from the surgical nerve procedure through the course of their recovery or until lost to follow-up using available data in the medical record from Physician's standard of care.	Through study completion or until lost to follow-up, approximately 3 years

Collaborators and Investigators

• Sponsor: Axogen Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimated): February 6, 2012

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Nerve Injury; Sensory Nerve; Mixed Nerve; Motor Nerve; Neurotization; Peripheral Nerve Injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nerve Injuries
• Other Study ID Numbers: ANG-CP-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No