XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
XL TDR
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
1 other identifier
interventional
246
1 country
17
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 similar indications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2009
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 30, 2015
July 1, 2015
5 years
June 22, 2009
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in ODI
December 2012
Secondary Outcomes (1)
Disc Height
December 2012
Study Arms (2)
XL TDR
EXPERIMENTALThe 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.
Outcomes from lumbar fusion study
OTHERInterventions
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Eligibility Criteria
You may qualify if:
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuVasivelead
Study Sites (17)
Silicon Valley Spine Institute
Campbell, California, 95008, United States
Conejo Orthopaedic and Spine Institute
Thousand Oaks, California, 91360, United States
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, 81301, United States
Christiana Spine Center
Newark, Delaware, 19713, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
South Florida Spine Institute
Miami Beach, Florida, 33140, United States
Southeastern Spine Center & Research Institute
Sarasota, Florida, 34342, United States
University of South Florida
Tampa, Florida, 33606, United States
West Augusta Spine Specialists
Augusta, Georgia, 30909, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Spine Midwest
Jefferson City, Missouri, 65101, United States
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, 89109, United States
Buffalo Spine Surgery
Lockport, New York, 14094, United States
Southern Oregon Orthopedics
Medford, Oregon, 97504, United States
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464, United States
Central Texas Spine Institute
Austin, Texas, 78731, United States
Northwest Orthopaedic Specialists
Spokane, Washington, 99208, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William D Smith, MD
Western Regional Center for Brain and Spine Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 24, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2014
Study Completion
July 1, 2015
Last Updated
July 30, 2015
Record last verified: 2015-07