DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
NCT ID: NCT00387829
Last Updated: 2017-09-07
Study Results
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View full resultsBasic Information
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TERMINATED
NA
347 participants
INTERVENTIONAL
2006-10-31
2011-12-31
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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1
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
DuraGen Plus Adhesion Barrier Matrix
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
2
Control arm is surgery alone (no adhesion barrier)
No interventions assigned to this group
Interventions
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DuraGen Plus Adhesion Barrier Matrix
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
Eligibility Criteria
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Inclusion Criteria
* Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs
* Requires removal of herniated disc fragment
Exclusion Criteria
* Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures
* Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study
* Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial
* Clinically significant structural disorders
* Known positive for HIV
* Insulin-dependent Diabetes Mellitus patients
* Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2)
* History of alcohol or drug abuse within 2 years prior to randomization
18 Years
70 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Benzel, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic Spine Institute
Locations
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Ronderos Neurosurgery Center, Providence Hospital
Mobile, Alabama, United States
Spine Source
Beverly Hills, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mission Hospital
Mission Viejo, California, United States
University of California, San Diego
San Diego, California, United States
Spine Institute
Santa Monica, California, United States
Southern California Orthopedic Institute
Van Nuys, California, United States
Greenwich Neurosurgery/Greenwich Hospital
Greenwich, Connecticut, United States
Orthopaedic Specialties Spine Center
Clearwater, Florida, United States
The Back Center
Melbourne, Florida, United States
University of Miami
Miami, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
Southeastern Orthopedic Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Chicago Institute of Neurosurgery and Neuroresearch
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Bluegrass Orthopedics
Lexington, Kentucky, United States
Interactive Neuroscience Center
Shreveport, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Columbia Orthopedic Group
Columbia, Missouri, United States
Montana Neuroscience Institute Foundation
Missoula, Montana, United States
William S. Muir, MD, PC
Las Vegas, Nevada, United States
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States
University of Cincinnati Medical Center / Mayfield Clinic
Cincinnati, Ohio, United States
The Cleveland Clinic Spine Institute
Cleveland, Ohio, United States
Central Ohio Neurological Surgery
Westerville, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Princeton Brain and Spine Care
Langhorne, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Roger Williams Hospital
Providence, Rhode Island, United States
Texas Back Institute
Plano, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Orthopedics Intl.
Seattle, Washington, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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DURA-US-2006-1
Identifier Type: -
Identifier Source: org_study_id
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