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

Overview

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.

Full Title of Study: “A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and AvanceĀ® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2021

Interventions

  • Biological: Processed Nerve Allograft (human)
  • Device: Collagen Nerve Cuff
    • Bovine collagen based nerve cuff

Arms, Groups and Cohorts

  • Experimental: Processed Nerve Allograft
    • Processed Nerve Allograft
  • Active Comparator: Collagen Nerve Cuff

Clinical Trial Outcome Measures

Primary Measures

  • Recovery of Static Two Point Discrimination Assessed by Discriminator (in mm)
    • Time Frame: 12 month

Participating in This Clinical Trial

Inclusion Criteria

  • Peripheral Nerve Injury

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Axogen Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jonathan E Isaacs, MD, Principal Investigator, Virginia Commonwealth University Medical Center
    • L. Scott Levin, MD FACS, Principal Investigator, University of Pennsylvania
  • Overall Contact(s)
    • Erick DeVinney, 386-362-6829, edevinney@axogeninc.com

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