XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)

Completed · Phase 3

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00927238

Run by

NuVasive

People needed

246

Starts

2009-07-01

Expected to finish

2015-07-01

Last updated by the study team

2015-07-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Idiopathic scoliosis
• 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
• BMI >40
• 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

Where it is running

• Silicon Valley Spine Institute — Campbell, California, United States
• Conejo Orthopaedic and Spine Institute — Thousand Oaks, California, United States
• Spine Colorado / Durango Orthopedic Associates — Durango, Colorado, United States
• Christiana Spine Center — Newark, Delaware, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• South Florida Spine Institute — Miami Beach, Florida, United States
• Southeastern Spine Center & Research Institute — Sarasota, Florida, United States
• University of South Florida — Tampa, Florida, United States
• West Augusta Spine Specialists — Augusta, Georgia, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Spine Midwest — Jefferson City, Missouri, United States
• Western Regional Spine Center for Brain and Spine Surgery — Las Vegas, Nevada, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Southern Oregon Orthopedics — Medford, Oregon, United States
• Southeastern Spine Institute — Mt. Pleasant, South Carolina, United States
• Central Texas Spine Institute — Austin, Texas, United States
• Northwest Orthopaedic Specialists — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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