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NCT01526681 Clinical Trial

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

Peripheral Nerve Injuries Clinical Trial

— RANGER®  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01526681
Other study ID # ANG-CP-005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2008
Est. completion date December 2025

Study information
Verified date July 2023
Source Axogen Corporation
Contact Stacy Arnold
Phone 386-462-6800
Email clinicalresearch@axogeninc.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

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Sponsors (1)
Lead Sponsor Collaborator
Axogen Corporation

Countries where clinical trial is conducted

United States,  Austria,  Canada,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up. Through study completion or until lost to follow-up, approximately 3 years
Primary RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery Participants will be followed for a change in sensory function, if applicable, of the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care sensory assessments or until lost to follow-up. Through study completion or until lost to follow-up, approximately 3 years
Primary RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery Participants will be followed for a change in motor function, if applicable, to the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care motor assessments or until lost to follow-up. Through study completion or until lost to follow-up, approximately 3 years
Primary Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction Participants will be followed for change in sensation through the course of their recovery using Physician's standard of care assessments or until lost to follow-up. Standard of care sensory assessment includes evaluation using Semmes Weinstein Monofilament kit measured in g/mm2. Through study completion or until lost to follow-up, approximately 3 years
Primary Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction Participants will be followed for change in quality of life as measured by Breast Q through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented. Through study completion or until lost to follow-up, approximately 3 years
Primary Incidence of conduit, autograft, or procedure related adverse events Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up. Through study completion or until lost to follow-up, approximately 3 years
Secondary Pain Level Participants will be followed for a change in pain level as measured by VAS, when available, through the course of their recovery using Physician's standard of care assessments for pain or until lost to follow-up. Through study completion or until lost to follow-up, approximately 3 years
Secondary RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve Participants will be followed for change in quality of life as measured by Disabilities of the Arm Shoulder and Hand Questionnaire (DASH), if available, through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented. Through study completion or until lost to follow-up, approximately 3 years
Secondary Cost of Care Participants will be followed for cost of care, as converted to USD, from the surgical nerve procedure through the course of their recovery or until lost to follow-up using available data in the medical record from Physician's standard of care. Through study completion or until lost to follow-up, approximately 3 years
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