Status:
RECRUITING
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
Lead Sponsor:
Axogen Corporation
Conditions:
Peripheral Nerve Injuries
Eligibility:
All Genders
Brief 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 addendu...
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....
Eligibility Criteria
Inclusion
- Primary Study Criteria (RANGER Avance):
- 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
- • 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT01526681
Start Date
November 1 2008
End Date
December 1 2025
Last Update
July 29 2025
Active Locations (49)
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1
RANGER & MATCH: Arizona Center for Hand Surgery
Phoenix, Arizona, United States, 85004
2
RANGER: Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
RANGER & MATCH: University of California - Irvine
Orange, California, United States, 92868
4
RANGER & MATCH: The Buncke Clinic
San Francisco, California, United States, 94114