Status:
COMPLETED
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 si...
Detailed Description
The XL TDR® eXtreme Lateral Total Disc Replacement consists of two endplates that are provided in a number of sizes to accommodate a variety of patient anatomies and pathologies. The XL TDR device is ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Involved in active spinal litigation
- Receiving workman's compensation for spinal condition
- Mentally incompetent
- Incarcerated
- Unwilling or unable to comply with all protocol visits/assessments
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00927238
Start Date
July 1 2009
End Date
July 1 2015
Last Update
July 30 2015
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Silicon Valley Spine Institute
Campbell, California, United States, 95008
2
Conejo Orthopaedic and Spine Institute
Thousand Oaks, California, United States, 91360
3
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, United States, 81301
4
Christiana Spine Center
Newark, Delaware, United States, 19713