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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00927238
First received: June 22, 2009
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease
Device: XL TDR
Other: Lumbar fusion surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • Improvement in ODI [ Time Frame: December 2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disc Height [ Time Frame: December 2012 ] [ Designated as safety issue: Yes ]

Enrollment: 246
Study Start Date: July 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: XL TDR
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Other Name: Total disc replacement
Other: Lumbar fusion surgery
Lumbar fusion surgery
Outcomes from lumbar fusion study Other: Lumbar fusion surgery
Lumbar fusion surgery

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 made up of a ball and socket articulation and the joint is made of CoCrMo alloy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927238

Locations
United States, California
Silicon Valley Spine Institute
Campbell, California, United States, 95008
Conejo Orthopaedic and Spine Institute
Thousand Oaks, California, United States, 91360
United States, Colorado
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, United States, 81301
United States, Delaware
Christiana Spine Center
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
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
United States, Georgia
West Augusta Spine Specialists
Augusta, Georgia, United States, 30909
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Missouri
Spine Midwest
Jefferson City, Missouri, United States, 65101
United States, Nevada
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, United States, 89109
United States, New York
Buffalo Spine Surgery
Lockport, New York, United States, 14094
United States, Oregon
Southern Oregon Orthopedics
Medford, Oregon, United States, 97504
United States, South Carolina
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Central Texas Spine Institute
Austin, Texas, United States, 78731
United States, Washington
Northwest Orthopaedic Specialists
Spokane, Washington, United States, 99208
Sponsors and Collaborators
NuVasive
Investigators
Principal Investigator: William D Smith, MD Western Regional Center for Brain and Spine Surgery
  More Information

No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00927238     History of Changes
Other Study ID Numbers: NUVA-LTDR-0701
Study First Received: June 22, 2009
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NuVasive:
Single Level
Lumbar Disc Disease
DDD

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014