Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair

NCT01809002 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ANG-CP-007
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 21

Brief Summary

Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.

Conditions

Peripheral Nerve Discontinuities

Outcome Measures

Primary Outcomes (2)

• Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)

  Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.

  Month 12

• Static Two-Point Discrimination (Data As-reported)

  s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.

  Up to Month 12

Secondary Outcomes (5)

• Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)

  Month 12

• Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)

  Month 12

• Time to Recovery of s2PD (Data As-reported)

  Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op)

• Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)

  Month 12

• Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)

  Month 12

Other Outcomes (1)

• Number of Participants With Persistent and Unresolved Pain (Data As-reported)

  Operative Day+1, Month 1, Month 3, Month 6, Month 9, Month 12

Study Arms (2)

Processed Nerve Allograft

EXPERIMENTAL

Processed Nerve Allograft

Biological: Processed Nerve Allograft (human)

Collagen Nerve Cuff

ACTIVE COMPARATOR

Device: Collagen Nerve Cuff

Interventions

Processed Nerve Allograft (human) BIOLOGICAL

Processed Nerve Allograft

Collagen Nerve Cuff DEVICE

Bovine collagen based nerve cuff

Collagen Nerve Cuff

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peripheral Nerve Injury

You may not qualify if:

• Peripheral Neuropathy
• Allergic to Bovine products such as Bovine Collagen Nerve Cuff

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (21)

University California, Davis

Sacramento, California, 95817, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Florida Orthopaedic Institute

Tampa, Florida, 33609, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Curtis National Hand Center

Baltimore, Maryland, 21218, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Hand Surgery Specialists of Nevada

Las Vegas, Nevada, 89148, United States

Location

University of Rochester Medical Center

Rochester, New York, 14627, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Penn State Universtiy

Hershey, Pennsylvania, 16801, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Univeristy of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23228, United States

Location

Marshall Orthopaedics

Huntington, West Virginia, 25701, United States

Location

Related Publications (1)

• Isaacs J, Eswaran S, Ilyas A, Means KR, Levin LS. Digital Nerve Repair With Flexor Tendon Injury: Conduits are Less Effective. Hand (N Y). 2025 Dec 30:15589447251406917. doi: 10.1177/15589447251406917. Online ahead of print.

  PMID: 41472406 DERIVED

Limitations and Caveats

It is important to refer to the population being analyzed and the analysis methodology, as certain analyses include a repeated measures mixed modeling approach to address missing or incomplete data, while other analyses were conducted with as reported data. This resulted in certain populations containing extrapolated data for missing or incomplete data points and others excluded those subjects from the analysis.

Results Point of Contact

• Title: Stacy Arnold, VP of Clinical Research
• Organization: Axogen

sarnold@axogeninc.com

770-833-2570

Study Officials

• Jonathan E Isaacs, MD

  Virginia Commonwealth University Medical Center

  PRINCIPAL INVESTIGATOR

• L. Scott Levin, MD FACS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 12, 2013
• Study Start: June 1, 2015
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: July 12, 2023
• Results First Posted: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)