Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
RANGER: Avance Nerve Graft Processed Human Nerve Graft
  • Other: Processed Human Nerve Graft
    Implantation of appropriate length of processed human nerve graft at the time of surgery
Historical Control for Standard Treatment Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
  • Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.
    Historical control from established literature
MATCH Arm: Contemporary Control Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
  • 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
Sensation-NOW Arm: Breast Neurotization Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization
  • Procedure: Autologous Breast Reconstruction with Neurotization
  • Procedure: Autologous Breast Reconstruction without Neurotization

Recruiting Locations

Sensation-NOW: Vanderbilt University
Nashville, Tennessee 37232
Contact:
Galen Perdikis, MD

RANGER & MATCH: Vanderbilt University
Nashville, Tennessee 37232
Contact:
Wesley Thayer, MD PhD

More Details

Status
Recruiting
Sponsor
Axogen Corporation

Study Contact

Stacy Arnold
386-462-6800
clinicalresearch@axogeninc.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.