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Sponsored by: |
Medtronic Spine, Biologics & Navigation |
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Information provided by: | Medtronic Spine, Biologics & Navigation |
ClinicalTrials.gov Identifier: | NCT00635843 |
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.
Condition | Intervention | Phase |
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Spinal Diseases |
Device: MAVERICK™ Disc Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft (Fusion) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | "A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease" |
Enrollment: | 577 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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MAVERICK™ Disc: Experimental |
Device: MAVERICK™ Disc
The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.
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Fusion |
Device: LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft (Fusion)
The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.
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For this clinical trial, there are two treatment groups, i.e., investigational patients who receive the MAVERICK™ Total Disc Replacement and control patients who receive the anterior lumbar interbody fusion procedure with INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device. Each investigational site will enroll patients in a 2:1 investigational:control treatment randomization scheme.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Clinical Department ( Ed Hord / Sr. Manager ) |
Study ID Numbers: | G010354, P01-08 |
Study First Received: | March 7, 2008 |
Last Updated: | March 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00635843 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lumbar degenerative disc disease at one level from L4-S1 |
Spinal Diseases Musculoskeletal Diseases Benzocaine Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |