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Registry of Avance Nerve Graft's use and recovery outcomes after nerve reconstruction

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

Observational Axogen Corporation · NCT01526681

This study looks at how well the Avance® Nerve Graft works for people recovering from nerve reconstruction surgery compared to other methods.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
SexAll
SponsorAxogen Corporation Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations49 sites (Phoenix, Arizona and 48 other locations)
Trial IDNCT01526681 on ClinicalTrials.gov

What this trial studies

This observational registry collects data on the utilization, safety, and outcomes of the Avance® Nerve Graft in patients who have undergone nerve reconstruction procedures. The study includes optional addendums to create comparative groups, such as those repaired with nerve autografts and nerve tube conduits. It aims to evaluate real-life clinical responses and recovery rates following nerve injuries across multiple centers. Data will be gathered through medical record chart reviews and follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates include males and females who have undergone nerve repair using the Avance® Nerve Graft and have returned for at least one post-operative follow-up visit.

Not a fit: Patients who are unlikely to complete the recommended follow-up or have not undergone nerve repair with the Avance® Nerve Graft may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of nerve repair outcomes and enhance treatment strategies for patients with peripheral nerve injuries.

How similar studies have performed: Other studies have shown success with similar nerve grafting approaches, indicating potential for meaningful insights from this registry.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Phoenix, Arizona and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peripheral Nerve InjuriesSensory NerveMixed NerveMotor NerveNeurotizationNerve InjuryPeripheral Nerve Injury
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.