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Trial record 1 of 1 for:    AxoGen | West Virginia, United States
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Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON)

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

Tracking Information
First Submitted Date  ICMJE March 4, 2013
First Posted Date  ICMJE March 12, 2013
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
Recovery of Static Two Point Discrimination Assessed by Discriminator (in mm) [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Nerve Discontinuities
Intervention  ICMJE
  • Biological: Processed Nerve Allograft (human)
  • Device: Collagen Nerve Cuff
    Bovine collagen based nerve cuff
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
220
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2013)
150
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Peripheral Nerve Injury

Exclusion Criteria:

  • Peripheral Neuropathy
  • Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809002
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Axogen Corporation
Study Sponsor  ICMJE Axogen Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP