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Sponsored by: |
Medtronic Spine, Biologics & Navigation |
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Information provided by: | Medtronic Spine, Biologics & Navigation |
ClinicalTrials.gov Identifier: | NCT00667459 |
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.
Condition | Intervention | Phase |
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Cervical Degenerative Disc Disease |
Device: PRESTIGE® LP Cervical Disc Device: ATLANTIS Anterior Cervical Plate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multicenter, Controlled Clinical Trial of an Artifical Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease |
Enrollment: | 280 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
PRESTIGE® LP Cervical Disc
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Device: PRESTIGE® LP Cervical Disc
The PRESTIGE® LP Cervical Disc is inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
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2
The study uses a group of patients who received a ACDF fusion treatment in a previous IDE trial (G010188)
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Device: ATLANTIS Anterior Cervical Plate
Anterior cervical discectomy and fusion with ATLANTIS plate from control group from IDE study G010188.
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This pivotal clinical trial is being conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc device will be implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (IDE # G010188)will be compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Documented or diagnosed cervical instability defined by radiographs showing
Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)
If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.
United States, Alabama | |
Montgomery Neurosurgical | |
Montgomery, Alabama, United States, 36106 | |
United States, Florida | |
Orlando Neurosurgery | |
Winter Park, Florida, United States, 32789 | |
United States, Georgia | |
The Hughston Clinic, P.C. | |
Columbus, Georgia, United States, 31908 | |
Atlanta Brain & Spine Care | |
Atlanta, Georgia, United States, 30309 | |
United States, Illinois | |
Loyola University Medical Center Neuro | |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
OrthoIndy | |
Indianapolis, Indiana, United States, 46260 | |
United States, Iowa | |
Cedar Neurological Surgeons, PC | |
Cedar Rapids, Iowa, United States, 52403 | |
United States, Missouri | |
Springfield Neurological Institute | |
Springfield, Missouri, United States, 65804 | |
The Orthopaedic Center of St. Louis | |
Chesterfield, Missouri, United States, 63017 | |
United States, New Hampshire | |
New Hampshire Neurospine Insititute | |
Bedford, New Hampshire, United States, 03110 | |
United States, New York | |
Buffalo Neurosurgery Group | |
West Seneca, New York, United States, 14224 | |
Beth Israel Medical Center | |
New York, New York, United States, 10003 | |
United States, Oregon | |
Oregon Neurosurgery Specialists | |
Eugene, Oregon, United States, 97401 | |
United States, South Carolina | |
Charleston Neurosurgical Associates | |
Charleston, South Carolina, United States, 29414 | |
United States, Tennessee | |
Neurological Surgeons, P.C. | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Brain and Spine Center of Texas, L.L.P. | |
Plano, Texas, United States, 75093 | |
United States, Virginia | |
University of Virginia,Neurosurgery Department | |
Charlottesville, Virginia, United States, 22908 | |
Virginia Spine Institute | |
Reston, Virginia, United States, 20190 | |
United States, Washington | |
Inland Neurosurgery & Spine Associates, P.S. | |
Spokane, Washington, United States, 99204 |
Responsible Party: | Clinical Affairs, Clinical Affairs, Reimbursement & Health Policy ( Ed Hord/Sr. Manager ) |
Study ID Numbers: | PRESTIGE® LP Protocol, #P03-03 |
Study First Received: | April 24, 2008 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00667459 |
Health Authority: | United States: Food and Drug Administration |
Cervical Disc |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |