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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01809002
Recruitment Status : Active, not recruiting
First Posted : March 12, 2013
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Axogen Corporation

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.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Discontinuities Biological: Processed Nerve Allograft (human) Device: Collagen Nerve Cuff Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Processed Nerve Allograft
Processed Nerve Allograft
Biological: Processed Nerve Allograft (human)
Active Comparator: Collagen Nerve Cuff Device: Collagen Nerve Cuff
Bovine collagen based nerve cuff




Primary Outcome Measures :
  1. Recovery of Static Two Point Discrimination Assessed by Discriminator (in mm) [ Time Frame: 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripheral Nerve Injury

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809002


Locations
Show Show 20 study locations
Sponsors and Collaborators
Axogen Corporation
Investigators
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Principal Investigator: Jonathan E Isaacs, MD Virginia Commonwealth University Medical Center
Principal Investigator: L. Scott Levin, MD FACS University of Pennsylvania
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Responsible Party: Axogen Corporation
ClinicalTrials.gov Identifier: NCT01809002    
Other Study ID Numbers: ANG-CP-007
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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