Adhesions Clinical Trial
Official title:
Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
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.
Status | Terminated |
Enrollment | 347 |
Est. completion date | December 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria (Abstracted from clinical protocol): - Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine - Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs - Requires removal of herniated disc fragment Exclusion Criteria (Abstracted from clinical protocol): - Current or historic open traumatic injury to the spine - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Spine Source | Beverly Hills | California |
United States | University of Virginia | Charlottesville | Virginia |
United States | Chicago Institute of Neurosurgery and Neuroresearch | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
United States | University of Cincinnati Medical Center / Mayfield Clinic | Cincinnati | Ohio |
United States | Orthopaedic Specialties Spine Center | Clearwater | Florida |
United States | The Cleveland Clinic Spine Institute | Cleveland | Ohio |
United States | Columbia Orthopedic Group | Columbia | Missouri |
United States | Greenwich Neurosurgery/Greenwich Hospital | Greenwich | Connecticut |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Princeton Brain and Spine Care | Langhorne | Pennsylvania |
United States | William S. Muir, MD, PC | Las Vegas | Nevada |
United States | Bluegrass Orthopedics | Lexington | Kentucky |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | The Back Center | Melbourne | Florida |
United States | University of Miami | Miami | Florida |
United States | Mission Hospital | Mission Viejo | California |
United States | Montana Neuroscience Institute Foundation | Missoula | Montana |
United States | Ronderos Neurosurgery Center, Providence Hospital | Mobile | Alabama |
United States | University of Medicine and Dentistry of New Jersey | New Brunswick | New Jersey |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Texas Back Institute | Plano | Texas |
United States | Roger Williams Hospital | Providence | Rhode Island |
United States | Virginia Commonwealth University Health System | Richmond | Virginia |
United States | University of California, San Diego | San Diego | California |
United States | Spine Institute | Santa Monica | California |
United States | Southeastern Orthopedic Center | Savannah | Georgia |
United States | Orthopedics Intl. | Seattle | Washington |
United States | Swedish Neuroscience Institute | Seattle | Washington |
United States | Interactive Neuroscience Center | Shreveport | Louisiana |
United States | Tallahassee Neurological Clinic | Tallahassee | Florida |
United States | University of South Florida | Tampa | Florida |
United States | Southern California Orthopedic Institute | Van Nuys | California |
United States | Central Ohio Neurological Surgery | Westerville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Integra LifeSciences Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiological, Pain, and Functional Outcome Assessments | 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. |
6 months | No |
Secondary | Radiological, Pain, and Functional Outcome Assessments | 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. |
12 months | No |
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