Clinical trial NCT01526681: Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
Official title: A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Nerve Injuries
Keywords: Sensory Nerve
Mixed Nerve
Motor Nerve
Neurotization
Nerve Injury
Peripheral Nerve Injury
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects surgically repaired with Avance Nerve Graft to reconstruct peripheral nerve discontinuities.

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: Incidence of conduit, autograft, or procedure related adverse events
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
Secondary outcomes:
measure: Pain Level
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
measure: Cost of Care
timeFrame: Through study completion or until lost to follow-up, approximately 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: RANGER & MATCH: Arizona Center for Hand Surgery
state: Arizona
city: Phoenix
country: United States
facility: RANGER: Phoenix Children's Hospital
state: Arizona
city: Orange
country: United States
facility: RANGER & MATCH: University of California - Irvine
state: California
city: San Francisco
country: United States
facility: RANGER & MATCH: The Buncke Clinic
state: California
city: Stanford
country: United States
facility: Sensation-NOW: Stanford University
state: California
city: Aurora
country: United States
facility: Sensation-NOW: University of Colorado School of Medicine
state: Colorado
city: Washington
country: United States
facility: Sensation-NOW: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: RANGER: University of Miami
state: Florida
city: Tampa
country: United States
facility: RANGER & MATCH: Florida Orthopaedic Institute
state: Florida
city: Atlanta
country: United States
facility: RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta
state: Georgia
city: Kansas City
country: United States
facility: RANGER & MATCH: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Sensation-NOW: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: RANGER: University of Kentucky
state: Kentucky
city: Metairie
country: United States
facility: Sensation-NOW: Advanced Reconstructive Care, LLC
state: Louisiana
city: Baltimore
country: United States
facility: RANGER: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Sensation-NOW: Johns Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: RANGER: Walter Reed National Military Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: MATCH: Hennepin County Medical Center
state: Minnesota
city: Columbia
country: United States
facility: RANGER & MATCH: University of Missouri - Columbia
state: Missouri
city: Omaha
country: United States
facility: Sensation-NOW: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Sensation-NOW: University of Nevada, Las Vegas
state: Nevada
city: Rutherford
country: United States
facility: RANGER: Multi-Disciplinary Specialists
state: New Jersey
city: Charlotte
country: United States
facility: RANGER & MATCH: OrthoCarolina Research Institute, Inc.
state: North Carolina
city: Durham
country: United States
facility: RANGER: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: RANGER: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Sensation-NOW: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: RANGER: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: RANGER: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Sensation-NOW: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Sensation-NOW: University of Pennsylvania
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Sensation-NOW: East Cooper Plastic Surgery
state: South Carolina
city: Germantown
country: United States
facility: RANGER & MATCH: Campbell Clinic
state: Tennessee
city: Nashville
country: United States
facility: RANGER & MATCH: Vanderbilt University
state: Tennessee
city: Nashville
country: United States
facility: Sensation-NOW: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Sensation-NOW: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: RANGER: University of North Texas/John Peter Smith Hospital
state: Texas
city: Fort Worth
country: United States
facility: Sensation-NOW: University of North Texas/John Peter Smith Hospital
state: Texas
city: Houston
country: United States
facility: Sensation-NOW: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Sensation-NOW: Houston-Methodist Central
state: Texas
city: Houston
country: United States
facility: Sensation-NOW: Houston-Methodist West/North
state: Texas
city: Lubbock
country: United States
facility: RANGER: Texas Tech University HSC
state: Texas
city: Richardson
country: United States
facility: Sensation-NOW: Joshua Lemmon, MD, PLLC
state: Texas
city: San Antonio
country: United States
facility: RANGER: San Antonio Military Medical Center
state: Texas
city: San Antonio
country: United States
facility: Sensation-NOW: PRMA Plastic Surgery
state: Texas
city: Richmond
country: United States
facility: Sensation-NOW: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: RANGER & MATCH: University of Washington
state: Washington
city: Vienna
country: Austria
facility: RANGER: University Hospital
city: Toronto
country: Canada
facility: RANGER: North York General Hospital
state: Ontario
city: Edgbaston
country: United Kingdom
facility: RANGER & MATCH: University Hospital Birmingham, England
state: Birmingham
Study officials:
References: