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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00387829
Other study ID # DURA-US-2006-1
Secondary ID
Status Terminated
Phase N/A
First received October 12, 2006
Last updated September 17, 2013
Start date October 2006
Est. completion date December 2011

Study information

Verified date September 2013
Source Integra LifeSciences Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

For more information, please visit www.DuragenStudy.com


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
DuraGen Plus Adhesion Barrier Matrix
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

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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