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Sponsored by: |
SpinalMotion |
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Information provided by: | SpinalMotion |
ClinicalTrials.gov Identifier: | NCT00292292 |
The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.
Condition | Intervention |
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Degenerative Disc Disease |
Device: Artificial Disc |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage |
Estimated Enrollment: | 850 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Kineflex: Experimental |
Device: Artificial Disc
Insertion of Kineflex Disc
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Charite: Active Comparator |
Device: Artificial Disc
Insertion of Kineflex Disc
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The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria Summary:
Exclusion Criteria Summary:
United States, California | |
Tower Orthopedics and Sports Medicine | |
Beverly Hills, California, United States, 90211 | |
University of California San Diego | |
San Diego, California, United States, 92103 | |
CORE Orthopaedic Medical Center | |
Encinitas, California, United States, 92024 | |
Loma Linda University | |
San Bernardino, California, United States, 92408 | |
UCSF Dept. of Orthopaedic Surgery | |
San Francisco, California, United States, 94122 | |
Kaiser Oakland Regional Spine Surgery | |
Oakland, California, United States, 94611 | |
United States, Colorado | |
Rocky Mountain Associates in Orthopedic Medicine, P.C. | |
Loveland, Colorado, United States, 80538 | |
United States, Illinois | |
Illinois Neuro-Spine Center | |
Aurora, Illinois, United States, 60504 | |
United States, Louisiana | |
Spine Institute of Louisiana | |
Shreveport, Louisiana, United States, 71101 | |
United States, Maryland | |
Orthopaedic Associates, P.A | |
Towson, Maryland, United States, 21204 | |
Maryland Brain and Spine Center | |
Annapolis, Maryland, United States, 21401 | |
United States, Nevada | |
Sierra Regional Spine Institute | |
Reno, Nevada, United States, 89509 | |
United States, New York | |
Buffalo Spine Surgery | |
Lockport, New York, United States, 14094 | |
Slocum Dickson Medical Group | |
New Hartford, New York, United States, 13413 | |
Manhattan Orthopaedics, P.C. | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Triangle Orthopaedic Associates, P.A. | |
Durham, North Carolina, United States, 27704 | |
Carolina Neurosurgery and Spine Associates | |
Charlotte, North Carolina, United States, 28207 | |
United States, Pennsylvania | |
Univ. of Pittsburgh Medical Center | |
Pittsburg, Pennsylvania, United States, 15213 | |
United States, Texas | |
Texas Back Institute Clinical Research Organization | |
Plano, Texas, United States, 75093 | |
Gordon Spine Associates | |
Tyler, Texas, United States, 75701 | |
United States, Washington | |
Orthopedics International Spine | |
Kirkland, Washington, United States, 98034 |
Principal Investigator: | David Bradford, MD | Medical Monitor |
Responsible Party: | SpinalMotion ( VP Regulatory & Clinical Affairs ) |
Study ID Numbers: | Kineflex |
Study First Received: | February 13, 2006 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00292292 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |