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Registry of Avance Nerve Graft Evaluating Utilization and Outcomes for the Reconstruction of Peripheral Nerve Discontinuities (RANGER)

This study is currently recruiting participants.
Verified March 2013 by AxoGen, Inc
Sponsor:
Information provided by (Responsible Party):
AxoGen, Inc
ClinicalTrials.gov Identifier:
NCT01526681
First received: February 1, 2012
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Nerve Injuries
 Other: Processed Human Nerve Tissue Scaffold
Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AxoGen, Inc:

Primary Outcome Measures:
  • Incidence of Avance Nerve Graft Related Adverse Events [ Time Frame: Up to 3 years or until lost to follow-up ] [ Designated as safety issue: Yes ]
    Participants will be followed through the course of their recovery, not expected to exceed 3 years or until lost to follow-up.


Secondary Outcome Measures:
  • Improvement in Function in Injured Peripheral Nerve [ Time Frame: Up to 3 years or until lost to follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants will be followed through the course of their recovery, not expected to exceed 3 years or until lost to follow-up.


Estimated Enrollment: 500
Study Start Date: November 2008
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Avance Nerve Graft
Processed Human Nerve Tissue Scaffold
 Other: Processed Human Nerve Tissue Scaffold
Implantation of appropriate length of processed human nerve tissue scaffold at the time of surgery
Historical Control for Standard Treatment
Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
 Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.
Historical Control from Established Literature

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects treated with Avance Nerve Graft to reconstuct peripheral nerve discontinuities.

Criteria

Inclusion Criteria:

  • Adult patients treated with Avance Nerve Graft

Exclusion Criteria:

  • Subjects who do not provide informed consent or decline participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526681

Contacts
Contact: Erick W DeVinney 386-462-6829 edevinney@axogeninc.com

Locations
United States, California
The Buncke Clinic Recruiting
San Francisco, California, United States, 94114
Contact: Darrell Brooks, MD            
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Brian Rinker, MD            
United States, New Jersey
Institute for Nerve, Hand and Reconstructive Surgery Not yet recruiting
Rutherford, New Jersey, United States, 07070
Contact: Renata V Weber, MD            
Sponsors and Collaborators
AxoGen, Inc
  More Information

No publications provided

Responsible Party: AxoGen, Inc
ClinicalTrials.gov Identifier: NCT01526681     History of Changes
Other Study ID Numbers: ANG-CP-005
Study First Received: February 1, 2012
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by AxoGen, Inc:
Sensory Nerve
Mixed Nerve
Motor Nerve

ClinicalTrials.gov processed this record on June 18, 2013