DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
- Conditions
- Spinal InjuriesAdhesions
- Interventions
- Device: DuraGen Plus Adhesion Barrier Matrix
- Registration Number
- NCT00387829
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
- Detailed Description
For more information, please visit www.DuragenStudy.com
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 347
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 DuraGen Plus Adhesion Barrier Matrix Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
- Primary Outcome Measures
Name Time Method Radiological, Pain, and Functional Outcome Assessments 6 months Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).
Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.
Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
- Secondary Outcome Measures
Name Time Method Radiological, Pain, and Functional Outcome Assessments 12 months Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).
Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.
Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
Trial Locations
- Locations (36)
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Orthopedics Intl.
🇺🇸Seattle, Washington, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
University of Miami
🇺🇸Miami, Florida, United States
Orthopaedic Specialties Spine Center
🇺🇸Clearwater, Florida, United States
The Back Center
🇺🇸Melbourne, Florida, United States
Southern California Orthopedic Institute
🇺🇸Van Nuys, California, United States
Ronderos Neurosurgery Center, Providence Hospital
🇺🇸Mobile, Alabama, United States
Spine Institute
🇺🇸Santa Monica, California, United States
Bluegrass Orthopedics
🇺🇸Lexington, Kentucky, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Chicago Institute of Neurosurgery and Neuroresearch
🇺🇸Chicago, Illinois, United States
Montana Neuroscience Institute Foundation
🇺🇸Missoula, Montana, United States
University of Cincinnati Medical Center / Mayfield Clinic
🇺🇸Cincinnati, Ohio, United States
William S. Muir, MD, PC
🇺🇸Las Vegas, Nevada, United States
Central Ohio Neurological Surgery
🇺🇸Westerville, Ohio, United States
The Cleveland Clinic Spine Institute
🇺🇸Cleveland, Ohio, United States
Texas Back Institute
🇺🇸Plano, Texas, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of South Florida
🇺🇸Tampa, Florida, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Roger Williams Hospital
🇺🇸Providence, Rhode Island, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Columbia Orthopedic Group
🇺🇸Columbia, Missouri, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Mission Hospital
🇺🇸Mission Viejo, California, United States
Spine Source
🇺🇸Beverly Hills, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Southeastern Orthopedic Center
🇺🇸Savannah, Georgia, United States
Princeton Brain and Spine Care
🇺🇸Langhorne, Pennsylvania, United States
University of Medicine and Dentistry of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Greenwich Neurosurgery/Greenwich Hospital
🇺🇸Greenwich, Connecticut, United States
Interactive Neuroscience Center
🇺🇸Shreveport, Louisiana, United States