Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
NCT ID: NCT01809002
Last Updated: 2023-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2015-06-30
2021-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Processed Nerve Allograft
Processed Nerve Allograft
Processed Nerve Allograft (human)
Collagen Nerve Cuff
Collagen Nerve Cuff
Bovine collagen based nerve cuff
Interventions
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Processed Nerve Allograft (human)
Collagen Nerve Cuff
Bovine collagen based nerve cuff
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergic to Bovine products such as Bovine Collagen Nerve Cuff
18 Years
65 Years
ALL
No
Sponsors
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Axogen Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan E Isaacs, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University Medical Center
L. Scott Levin, MD FACS
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University California, Davis
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Florida Orthopaedic Institute
Tampa, Florida, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Curtis National Hand Center
Baltimore, Maryland, United States
Spectrum Health
Grand Rapids, Michigan, United States
Hennepin Healthcare
Minneapolis, Minnesota, United States
Hand Surgery Specialists of Nevada
Las Vegas, Nevada, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Penn State Universtiy
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Univeristy of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Marshall Orthopaedics
Huntington, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ANG-CP-007
Identifier Type: -
Identifier Source: org_study_id
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