A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair
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.
• 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
• 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.
• 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