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

Running, not enrolling

Conditions studied: Peripheral Nerve Injuries

In brief

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.

Key facts

Study ID

NCT01526681

Run by

Axogen Corporation

People needed

3126

Starts

2008-11-01

Expected to finish

2028-11-01

Last updated by the study team

2026-01-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• 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

Full record on ClinicalTrials.gov

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