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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927238
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
NuVasive

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: XL TDR Other: Lumbar fusion surgery Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Improvement in ODI [ Time Frame: December 2012 ]

Secondary Outcome Measures :
  1. Disc Height [ Time Frame: December 2012 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927238


Locations
Show Show 17 study locations
Sponsors and Collaborators
NuVasive
Investigators
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Principal Investigator: William D Smith, MD Western Regional Center for Brain and Spine Surgery
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Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00927238    
Other Study ID Numbers: NUVA-LTDR-0701
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by NuVasive:
Single Level
Lumbar Disc Disease
DDD
Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases