Peripheral Nerve Injuries
Conditions
Keywords
Sensory Nerve, Mixed Nerve, Motor Nerve, Neurotization, Nerve Injury, Peripheral Nerve Injury
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. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.
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
OTHERProcessed Human Nerve Graft
Implantation of appropriate length of processed human nerve graft at the time of surgery
OTHERStandard Treatment, Autogenous Nerve Graft, Direct Suture, etc.
Historical control from established literature
OTHERAutogenous Nerve Graft
Nerve gap reconstructions with autogenous nerve graft within the upper extremity
DEVICENerve Tube Conduit
Nerve gap reconstructions with nerve tube conduit within the upper extremity
PROCEDUREAutologous Breast Reconstruction with Neurotization
Sponsors
Axogen Corporation
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | 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 | 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 | 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. |
Countries
Austria, Canada, United Kingdom, United States
Outcome results
None listed