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

Condition(s) studied

Investigational drug(s) / intervention(s)

Processed Human Nerve Graft: Implantation of appropriate length of processed human nerve graft at the time of surgery

Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.: Historical control from established literature

Autogenous Nerve Graft: Nerve gap reconstructions with autogenous nerve graft within the upper extremity

Nerve Tube Conduit: Nerve gap reconstructions with nerve tube conduit within the upper extremity

Study 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.

Eligibility

Primary outcome measure(s)

• Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events — 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 — 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 — 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 — 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 assessment includes evaluation using Semmes Weinstein Monofilament kit measured in g/mm2.
• Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction — 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 — 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.

Trial sites (49)

+ 9 more sites — see the full list on the official registry below.