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

Peripheral Nerve Injuries Clinical Trial

— RANGER®  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01526681
• Other study ID #: ANG-CP-005
• Status: Recruiting
• Start date: November 2008
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Axogen Corporation
• Contact: Stacy Arnold
• Phone: 386-462-6800
• Email: clinicalresearch[@]axogeninc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Wounds and Injuries

Intervention

Other:
• 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

Device:
• Nerve Tube Conduit
Nerve gap reconstructions with nerve tube conduit within the upper extremity

Procedure:
• Autologous Breast Reconstruction with Neurotization

• Autologous Breast Reconstruction without Neurotization

Locations

Country	Name	City	State
Austria	RANGER: University Hospital	Vienna
Canada	RANGER: North York General Hospital	Toronto	Ontario
United Kingdom	RANGER & MATCH: University Hospital Birmingham, England	Edgbaston	Birmingham
United States	RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta	Atlanta	Georgia
United States	Sensation-NOW: University of Colorado School of Medicine	Aurora	Colorado
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	RANGER & MATCH: OrthoCarolina Research Institute, Inc.	Charlotte	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 & MATCH: University of Missouri - Columbia	Columbia	Missouri
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 Texas Southwestern Medical Center	Dallas	Texas
United States	RANGER: Duke University	Durham	North Carolina
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	RANGER & MATCH: Campbell Clinic	Germantown	Tennessee
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 & 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	RANGER: Texas Tech University HSC	Lubbock	Texas
United States	Sensation-NOW: Advanced Reconstructive Care, LLC	Metairie	Louisiana
United States	RANGER: University of Miami	Miami	Florida
United States	MATCH: Hennepin County Medical Center	Minneapolis	Minnesota
United States	Sensation-NOW: East Cooper Plastic Surgery	Mount Pleasant	South Carolina
United States	RANGER & MATCH: Vanderbilt University	Nashville	Tennessee
United States	Sensation-NOW: Vanderbilt University	Nashville	Tennessee
United States	Sensation-NOW: University of Nebraska Medical Center	Omaha	Nebraska
United States	RANGER & MATCH: University of California - Irvine	Orange	California
United States	Sensation-NOW: University of Pennsylvania	Philadelphia	Pennsylvania
United States	RANGER & MATCH: Arizona Center for Hand Surgery	Phoenix	Arizona
United States	RANGER: Phoenix Children's Hospital	Phoenix	Arizona
United States	Sensation-NOW: Joshua Lemmon, MD, PLLC	Richardson	Texas
United States	Sensation-NOW: Virginia Commonwealth University	Richmond	Virginia
United States	RANGER: Multi-Disciplinary Specialists	Rutherford	New Jersey
United States	RANGER: San Antonio Military Medical Center	San Antonio	Texas
United States	Sensation-NOW: PRMA Plastic Surgery	San Antonio	Texas
United States	RANGER & MATCH: The Buncke Clinic	San Francisco	California
United States	RANGER & MATCH: University of Washington	Seattle	Washington
United States	Sensation-NOW: Stanford University	Stanford	California
United States	RANGER & MATCH: Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Axogen Corporation

Countries where clinical trial is conducted

United States,  Austria,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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