Study Stopped
Sponsor voluntarily terminated study
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
1 other identifier
interventional
347
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 12, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
November 20, 2013
CompletedSeptember 7, 2017
August 1, 2017
4.2 years
October 12, 2006
June 7, 2013
August 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Radiological, Pain, and Functional Outcome Assessments
12 months
Study Arms (2)
1
ACTIVE COMPARATORUse of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
2
NO INTERVENTIONControl arm is surgery alone (no adhesion barrier)
Interventions
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Ronderos Neurosurgery Center, Providence Hospital
Mobile, Alabama, 36608, United States
Spine Source
Beverly Hills, California, 90212, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Mission Hospital
Mission Viejo, California, 92691, United States
University of California, San Diego
San Diego, California, 92103, United States
Spine Institute
Santa Monica, California, 90404, United States
Southern California Orthopedic Institute
Van Nuys, California, 91405, United States
Greenwich Neurosurgery/Greenwich Hospital
Greenwich, Connecticut, 06830, United States
Orthopaedic Specialties Spine Center
Clearwater, Florida, 33756, United States
The Back Center
Melbourne, Florida, 32901, United States
University of Miami
Miami, Florida, 33136, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
University of South Florida
Tampa, Florida, 33606, United States
Southeastern Orthopedic Center
Savannah, Georgia, 31405, United States
Northwestern University
Chicago, Illinois, 60611, United States
Chicago Institute of Neurosurgery and Neuroresearch
Chicago, Illinois, 60640, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Bluegrass Orthopedics
Lexington, Kentucky, 40509, United States
Interactive Neuroscience Center
Shreveport, Louisiana, 71119, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Columbia Orthopedic Group
Columbia, Missouri, 65205, United States
Montana Neuroscience Institute Foundation
Missoula, Montana, 59802, United States
William S. Muir, MD, PC
Las Vegas, Nevada, 89169, United States
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08901, United States
University of Cincinnati Medical Center / Mayfield Clinic
Cincinnati, Ohio, 45267, United States
The Cleveland Clinic Spine Institute
Cleveland, Ohio, 44195, United States
Central Ohio Neurological Surgery
Westerville, Ohio, 43081, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Princeton Brain and Spine Care
Langhorne, Pennsylvania, 19047, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Roger Williams Hospital
Providence, Rhode Island, 02908, United States
Texas Back Institute
Plano, Texas, 75093, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
Orthopedics Intl.
Seattle, Washington, 98122, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Medical Affairs
- Organization
- Intergra LifeSciences
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Benzel, MD
The Cleveland Clinic Spine Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2006
First Posted
October 13, 2006
Study Start
October 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
September 7, 2017
Results First Posted
November 20, 2013
Record last verified: 2017-08