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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 : Recruiting
First Posted : March 12, 2013
Last Update Posted : July 24, 2019
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)
Estimated 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
Study Start Date : June 2015
Estimated Primary Completion Date : August 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


Contacts
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Contact: Erick DeVinney 386-362-6829 edevinney@axogeninc.com

Locations
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United States, California
University California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Christopher Bayne, MD         
Principal Investigator: Christopher Bayne, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Robert Matthias, MD         
Principal Investigator: Robert Matthias, MD         
University of Miami Active, not recruiting
Miami, Florida, United States, 33146
Florida Orthopaedic Institute Recruiting
Tampa, Florida, United States, 33609
Contact: Jason Nydick, DO         
Principal Investigator: Jason Nydick, DO         
United States, Indiana
Indiana Hand to Shoulder Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Greg Merrell, MD         
Sub-Investigator: Jeffrey Greenberg, MD         
Principal Investigator: Greg Merrell, MD         
United States, Kentucky
University of Kentucky Active, not recruiting
Lexington, Kentucky, United States, 40506
United States, Maryland
Curtis National Hand Center Recruiting
Baltimore, Maryland, United States, 21218
Contact: Kenneth Means, MD         
Principal Investigator: Kenneth Means, MD         
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kevin Chan, MD         
Principal Investigator: Kevin Chan, MD         
United States, Minnesota
Hennepin Healthcare Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Jacqueline Geissler, MD         
Principal Investigator: Jacqueline Geissler, MD         
United States, Nevada
Hand Surgery Specialists of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Colby Young, MD         
Principal Investigator: Colby Young, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14627
Contact: Warren Hammert, MD         
Principal Investigator: Warren Hammert, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Fraser Leversedge, MD         
Principal Investigator: Fraser Leversedge, MD         
Wake Forest Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Zhongyu Li, MD         
Principal Investigator: Zhongyu Li, MD PhD         
United States, Pennsylvania
Penn State Universtiy Recruiting
Hershey, Pennsylvania, United States, 16801
Contact: Kenneth Taylor, MD         
Principal Investigator: Kenneth Taylor, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: L. Scott Levin, MD FACS         
Principal Investigator: L. Scott Levin, MD FACS         
Principal Investigator: David Bozentka, MD         
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Asif Ilyas, MD         
Principal Investigator: Asif Ilyas, MD         
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Virginia
Univeristy of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Nicole Deal, MD         
Principal Investigator: Nicole Deal, MD         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23228
Contact: Jonathan E Isaacs, MD         
Principal Investigator: Jonathan E Isaacs, MD         
United States, West Virginia
Marshall Orthopaedics Active, not recruiting
Huntington, West Virginia, United States, 25701
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     History of Changes
Other Study ID Numbers: ANG-CP-007
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: June 2019
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