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

Axogen

Status: Enrolling

Conditions: Peripheral Nerve Injuries

Treatments: Procedure: Autologous Breast Reconstruction without Neurotization; Procedure: Autologous Breast Reconstruction with Neurotization; Other: Processed Human Nerve Graft; Other: Autogenous Nerve Graft; Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.; Device: Nerve Tube Conduit

Study type: Observational

Funder types: Industry

Identifiers

NCT01526681

ANG-CP-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

5,000 participants in 4 patient groups

RANGER: Avance Nerve Graft

Description:

Processed Human Nerve Graft

Treatment:

Other: Processed Human Nerve Graft

Historical Control for Standard Treatment

Description:

Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.

Treatment:

Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.

MATCH Arm: Contemporary Control

Description:

Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit

Treatment:

Device: Nerve Tube Conduit

Other: Autogenous Nerve Graft

Sensation-NOW Arm: Breast Neurotization

Description:

Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization

Treatment:

Procedure: Autologous Breast Reconstruction with Neurotization

Procedure: Autologous Breast Reconstruction without Neurotization