Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON)

• ClinicalTrials.gov Identifier: NCT01809002
• Recruitment Status: Active, not recruiting
• First Posted: March 12, 2013
• Last Update Posted: August 19, 2020
• Sponsor: Axogen Corporation
• Information provided by (Responsible Party): Axogen Corporation

Tracking Information

• First Submitted Date: March 4, 2013
• First Posted Date: March 12, 2013
• Last Update Posted Date: August 19, 2020
• Actual Study Start Date: June 2015
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 8, 2013): Recovery of Static Two Point Discrimination Assessed by Discriminator (in mm) [ Time Frame: 12 month ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
• Official Title: A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Peripheral Nerve Discontinuities

Intervention

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

Study Arms

• Experimental: Processed Nerve Allograft
  Processed Nerve Allograft
  Intervention: Biological: Processed Nerve Allograft (human)
• Active Comparator: Collagen Nerve Cuff
  Intervention: Device: Collagen Nerve Cuff

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 22, 2019): 220
• Original Estimated Enrollment (submitted: March 8, 2013): 150
• Estimated Study Completion Date: November 2021
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Peripheral Nerve Injury

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01809002
• Other Study ID Numbers: ANG-CP-007
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Axogen Corporation
• Study Sponsor: Axogen Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jonathan E Isaacs, MD; Virginia Commonwealth University Medical Center
• Principal Investigator: L. Scott Levin, MD FACS; University of Pennsylvania

• PRS Account: Axogen Corporation
• Verification Date: August 2020