The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients
with single-level degenerative disc disease compared to other devices approved by the FDA for
the same or similar indications.
Device: XL TDR
Other: Lumbar fusion surgery
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00927238
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
18-70 years of age (inclusive and skeletally mature) at the time of surgery
Diagnosis of image-confirmed symptomatic DDD at one of the following levels: L1/L2, L2/L3, L3/L4, or L4/L5
DDD diagnosed using patient history and image-confirmation such as (but not limited to), MRI, CT, or CT Myelogram with one or more of the following factors: contained herniated nucleus pulposus, facet joint degeneration/changes, decreased disc height
>2mm, and/or scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
Preoperative ODI ≥ 30 points
Unresponsive to conservative treatment for ≥ 6 months
Symptomatic multilevel lumbar degeneration
Chronic back or leg pain of unknown etiology
Non-contained or extruded herniated nucleus pulpous
Previous or other lumbar surgery at any level except prior discectomy, laminotomy, or nucleolysis at the same level
Involved vertebral endplates dimensionally smaller than 45mm in the medial-lateral and/or 20mm in the anterior/posterior directions
Defect in the pars interarticularis
Radiographic signs of significant instability at operative level
Lytic spondylolisthesis or degenerative spondylolisthesis > than grade 1
Bony lumbar spinal stenosis
Radiographic confirmation of significant facet joint disease or degeneration
Another lumbar device implanted
Clinically compromised vertebral bodies at the affected level due to trauma
Presence of metastases or active spinal tumor malignancy
Osteopenia, osteoporosis, or metabolic bone disease
Active local or systemic infection, including AIDS and hepatitis
Rheumatoid arthritis or other autoimmune disease
Taking any medications or supplements which potentially interfere with bone/soft tissue healing
Progressive neuromuscular disease
Allergy to device materials, specifically: cobalt-chromium-molybdenum alloy, titanium, and hydroxyapatite
Pregnant, or may become pregnant within follow-up period of study
Enrolled in another investigational study within the last 90 days
Waddell signs of inorganic behavior ≥3
History of substance abuse
Involved in active spinal litigation
Receiving workman's compensation for spinal condition
Unwilling or unable to comply with all protocol visits/assessments
All locations for NCT00927238
United States (17)
Silicon Valley Spine Institute
Campbell, California, United States, 95008
Conejo Orthopaedic and Spine Institute
Thousand Oaks, California, United States, 91360
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, United States, 81301
Christiana Spine Center
Newark, Delaware, United States, 19713
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
South Florida Spine Institute
Miami Beach, Florida, United States, 33140
Southeastern Spine Center & Research Institute
Sarasota, Florida, United States, 34342
University of South Florida
Tampa, Florida, United States, 33606
West Augusta Spine Specialists
Augusta, Georgia, United States, 30909
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Jefferson City, Missouri, United States, 65101
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, United States, 89109
Buffalo Spine Surgery
Lockport, New York, United States, 14094
Southern Oregon Orthopedics
Medford, Oregon, United States, 97504
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States, 29464
Central Texas Spine Institute
Austin, Texas, United States, 78731
Northwest Orthopaedic Specialists
Spokane, Washington, United States, 99208
View full eligibility
Tris trial is registered with FDA with number: NCT00927238. The sponsor of the trial is NuVasive and it is looking for 246 volunteers for the current phase.
Official trial title: A Pivotal, Multi-Center, Clinical Trial Evaluating The Safety And Effectiveness of The Lumbar TDR Device In Patients With Single-Level Lumbar Degenerative Disc Disease
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