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

Overview

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.

Full Title of Study: “A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 2025

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • RANGER: Avance Nerve Graft
    • Processed Human Nerve Graft
  • Historical Control for Standard Treatment
    • Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
  • MATCH Arm: Contemporary Control
    • Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
  • Sensation-NOW Arm: Breast Neurotization
    • Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization

Clinical Trial Outcome Measures

Primary Measures

  • Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • Participants will be followed through the course of their recovery based on Physician’s standard of care practice or until lost to follow-up.
  • RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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.
  • RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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.
  • Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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 assessments may include evaluation using a neurosensory testing device or Semmes Weinstein Monofilaments measured in g/mm2.
  • Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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.
  • Incidence of conduit, autograft, or procedure related adverse events
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • Participants will be followed through the course of their recovery based on Physician’s standard of care practice or until lost to follow-up.

Secondary Measures

  • Pain Level
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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.
  • RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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.
  • Cost of Care
    • Time Frame: Through study completion or until lost to follow-up, approximately 3 years
    • 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.

Participating in This Clinical Trial

Primary Study Criteria (RANGER Avance):

Inclusion Criteria

  • 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 Criteria

• 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.

Exclusion Criteria

  • Direct nerve repairs;
  • Nerve gaps greater than 70mm;
  • Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions;
  • Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.

Addendum 2 (Sensation-NOW) Criteria:

Inclusion Criteria

  • Female ≥ 18 years old;
  • Undergone post mastectomy autologous breast reconstruction within the last 18 months;
  • Able to provide informed consent and are willing to comply with post-operative care procedures and assessments.

Exclusion Criteria

  • Secondary neurotization revision surgery for partial or total flap loss;
  • Expected use of medication during the study that is known to impact nerve regeneration or to cause peripheral neuropathy;
  • Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Axogen Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Erick W DeVinney, 386-462-6800, clinicalresearch@axogeninc.com

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