Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

Primary Study Criteria (RANGER Avance):

Inclusion Criteria:

• Males and Females who have undergone nerve repair using the Avance® Nerve Graft forthe 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 anddistal portion of the nerve gap with nerve autograft or nerve entubulation withnerve 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 todetermine the outcomes of the repair or is willing to comply with site specificpost-operative care procedures and assessments to determine the outcome of therepair.

Exclusion Criteria:

• Direct nerve repairs;

• Nerve gaps greater than 70mm;

• Subjects who, in the opinion of the investigator, were non-compliant to theinvestigator's post-operative treatment or rehabilitation instructions;

• Any subject who at the discretion of the Investigator is not suitable for inclusionin the study.

Addendum 2 (Sensation-NOW) Criteria:

Inclusion Criteria:

• Female ≥ 18 years old

• Undergo post mastectomy autologous breast reconstruction with one type of autologousflap (no stacked reconstructions or use of implant with autologous flap)

• Neurotization must be completed using a donor nerve from the flap and a recipientnerve from the chest

• Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) andthe 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 careprocedures 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 isnon-neurotized, 1 reconstructed breast is neurotized)

• Currently prescribed medication known to impact nerve regeneration or to causeperipheral neuropathy

• Currently undergoing IV chemotherapy or radiation

• Any subject who at the discretion of the Investigator is not suitable for inclusionin 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 sparingmastectomy OR a breast reconstruction from a skin sparing mastectomy with exposedflap 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.