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Sponsored by: |
Abbott Spine |
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Information provided by: | Abbott Spine |
ClinicalTrials.gov Identifier: | NCT00134537 |
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
Condition | Intervention | Phase |
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Low Back Pain |
Device: Interspinous process and dynamic stabilization Device: Conservative Care |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 300 |
Study Start Date: | November 2004 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Interspinous process and dynamic stabilization
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Device: Interspinous process and dynamic stabilization
Interspinous process and dynamic stabilization
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2: Active Comparator
Conservative Care
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Device: Conservative Care
Medication, exercise and spinal injections
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subjects must meet all inclusion and exclusion criteria listed below for participation in the study.
Inclusion Criteria:
Diagnosis of mild to moderate degenerative disc disease (DDD), which requires:
Exclusion Criteria:
United States, Arizona | |
Spine Specialists of Arizona | |
Phoenix, Arizona, United States, 85015 | |
Arizona Institute for Minimally Invasive Spine Care | |
Phoenix, Arizona, United States, 85020 | |
United States, California | |
UCLA Spine Center | |
Santa Monica, California, United States, 90404 | |
Spine Source | |
Beverly Hills, California, United States, 90212 | |
United States, Colorado | |
The Spine Education & Research Institute | |
Thornton, Colorado, United States, 80229 | |
Boulder Neurosurgical Associates | |
Boulder, Colorado, United States, 80304 | |
United States, Georgia | |
Emory University Medical Center | |
Atlanta, Georgia, United States, 30329 | |
United States, Illinois | |
Illinois Bone & Joint Institute | |
Morton Grove, Illinois, United States, 60053 | |
United States, Indiana | |
Fort Wayne Orthopedics | |
Fort Wayne, Indiana, United States, 46804 | |
United States, Maryland | |
Greater Baltimore Medical Center | |
Baltimore, Maryland, United States, 21204 | |
Orthopaedic Associates | |
Towson, Maryland, United States, 21204 | |
United States, Missouri | |
The Orthopedic Center of St. Louis | |
Chesterfield, Missouri, United States, 63017 | |
United States, New York | |
Orthopedic Spine Care of Long Island | |
Melville, New York, United States, 11747 | |
United States, Oregon | |
Orthopedic Spine Associates | |
Eugene, Oregon, United States, 97401 | |
United States, Pennsylvania | |
The Orthopedic Specialty Center (Abington Hospital) | |
Willow Grove, Pennsylvania, United States, 19090 | |
United States, Texas | |
TBI/ Plano Presbyterian Hospital | |
Plano, Texas, United States, 75093 | |
Central Texas Spine Institute | |
Austin, Texas, United States, 78731 |
Responsible Party: | Abbott Spine ( Roger Brown, DVP Clinical, Regulatory, and Quality ) |
Study ID Numbers: | SN002-001-05 |
Study First Received: | August 23, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00134537 |
Health Authority: | United States: Food and Drug Administration |
Degenerative Disc Disease of the lumbar spine |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Nervous System Diseases |