A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Axogen Corporation
- Enrollment
- 3,126
- Locations
- 49
- Primary Endpoint
- Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts 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.
- •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
- •Undergo post mastectomy autologous breast reconstruction with one type of autologous flap (no stacked reconstructions or use of implant with autologous flap)
- •Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest
- •Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction:
- •Breast-Q Physical Well Being of the Chest
- •Breast-Q Satisfaction with Breast
- •Breast-Q Physical Well Being of the Abdomen
- •Breast-Q Abnormal Breast Sensations
- •Breast-Q Impact of Breast Sensation on Quality of Life
- •Breast-Q Return of Breast Sensation
- •Able to provide informed consent and are willing to comply with post-operative care procedures and assessments
- •Exclusion Criteria:
- •Surgical history of secondary revision surgery for partial or total flap loss
- •Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
- •Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
- •Currently undergoing IV chemotherapy or radiation
- •Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
- •Additional Eligibility criteria to Modules
- •Module 1: Native Skin Reconstructions with and without neurotization.
- •Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region.
- •Sensory assessments must be completed on ≥ 8 Zones of Native Skin.
- •Center zone measurement may be on either Native Skin or Flap Skin.
- •All Inner and Outer zone measurements must be on Native Skin.
- •De-identified photo of the breast reconstruction with 9 zones identified.
Arms & Interventions
RANGER: Avance Nerve Graft
Processed Human Nerve Graft
Intervention: Processed Human Nerve Graft (Other)
Historical Control for Standard Treatment
Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
Intervention: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc. (Other)
MATCH Arm: Contemporary Control
Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
Intervention: Autogenous Nerve Graft (Other)
MATCH Arm: Contemporary Control
Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
Intervention: Nerve Tube Conduit (Device)
Sensation-NOW Arm: Breast Neurotization
Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization
Intervention: Autologous Breast Reconstruction with Neurotization (Procedure)
Sensation-NOW Arm: Breast Neurotization
Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization
Intervention: Autologous Breast Reconstruction without Neurotization (Procedure)
Outcomes
Primary Outcomes
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: 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 assessment includes evaluation using Semmes Weinstein Monofilament kit 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.
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.
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 Outcomes
- Pain Level(Through study completion or until lost to follow-up, approximately 3 years)
- RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve(Through study completion or until lost to follow-up, approximately 3 years)
- Cost of Care(Through study completion or until lost to follow-up, approximately 3 years)