XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
NCT ID: NCT00927238
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2009-07-31
2015-07-31
Brief Summary
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Detailed Description
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The XL TDR is intended to be used to reconstruct the spine following the removal of part or all of the intervertebral disc on one level of the lumbar spine.
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XL TDR
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
XL TDR
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Lumbar fusion surgery
Lumbar fusion surgery
Outcomes from lumbar fusion study
Lumbar fusion surgery
Lumbar fusion surgery
Interventions
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XL TDR
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Lumbar fusion surgery
Lumbar fusion surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Principal Investigators
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William D Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Western Regional Center for Brain and Spine Surgery
Locations
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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
Countries
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Other Identifiers
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NUVA-LTDR-0701
Identifier Type: -
Identifier Source: org_study_id
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