NCT01526681

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,126 (actual)
• Sponsor: Axogen Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Peripheral Nerve Injuries

Interventions

Type	Name	Description
OTHER	Processed Human Nerve Graft	Implantation of appropriate length of processed human nerve graft at the time of surgery
OTHER	Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.	Historical control from established literature
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
PROCEDURE	Autologous Breast Reconstruction with Neurotization
PROCEDURE	Autologous Breast Reconstruction without Neurotization

Timeline

• Start date: 2008-11-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2012-02-06
• Last updated: 2026-01-26

Locations

49 sites across 4 countries: United States, Austria, Canada, United Kingdom