Overview

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 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.