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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,126
Implantation of appropriate length of processed human nerve graft at the time of surgery
Historical control from established literature
Nerve gap reconstructions with autogenous nerve graft within the upper extremity
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
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Nerve gap reconstructions with nerve tube conduit within the upper extremity
RANGER & MATCH: Arizona Center for Hand Surgery
Phoenix, Arizona, United States
RANGER: Phoenix Children's Hospital
Phoenix, Arizona, United States
RANGER & MATCH: University of California - Irvine
Orange, California, United States
RANGER & MATCH: The Buncke Clinic
San Francisco, California, United States
Sensation-NOW: Stanford University
Stanford, California, United States
Sensation-NOW: University of Colorado School of Medicine
Aurora, Colorado, United States
Sensation-NOW: George Washington University
Washington D.C., District of Columbia, United States
RANGER: University of Miami
Miami, Florida, United States
RANGER & MATCH: Florida Orthopaedic Institute
Tampa, Florida, United States
RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta
Atlanta, Georgia, United States
...and 39 more locations
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years
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.
Time frame: Through study completion or until lost to follow-up, approximately 3 years