Clinical Trial: Registry of Avance Nerve Graft Evaluating Utilization and Outcomes for the Reconstruction of Peripheral Nerve Discontinuities

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Registry Study: A Multicenter, Retrospective Study of Avance Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair

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.

Detailed Summary:
Sponsor: AxoGen, Inc

Current Primary Outcome: Incidence of Avance Nerve Graft Related Adverse Events [ Time Frame: Up to 3 years or until lost to follow-up ]

Participants will be followed through the course of their recovery, not expected to exceed 3 years or until lost to follow-up.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in Function in Injured Peripheral Nerve [ Time Frame: Up to 3 years or until lost to follow-up ]
    Participants will be followed through the course of their recovery, not expected to exceed 3 years or until lost to follow-up.
  • Rate of Return of Meaningful Recovery Following Peripheral Nerve injury [ Time Frame: Up to 3 years or until lost to follow-up ]
    Participants will be followed through the course of their recovery, not expected to exceed 3 years or until lost to follow-up.


Original Secondary Outcome: Same as current

Information By: AxoGen, Inc

Dates:
Date Received: February 1, 2012
Date Started: November 2008
Date Completion: December 2020
Last Updated: January 24, 2016
Last Verified: January 2016