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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: XL TDR; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Silicon Valley Spine Institute
    • Thousand Oaks, California, United States, 91360
      • Conejo Orthopaedic and Spine Institute
  • Colorado
    • Durango, Colorado, United States, 81301
      • Spine Colorado / Durango Orthopedic Associates
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Spine Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Miami Beach, Florida, United States, 33140
      • South Florida Spine Institute
    • Sarasota, Florida, United States, 34342
      • Southeastern Spine Center & Research Institute
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Augusta, Georgia, United States, 30909
      • West Augusta Spine Specialists
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • Missouri
    • Jefferson City, Missouri, United States, 65101
      • Spine Midwest
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Western Regional Spine Center for Brain and Spine Surgery
  • New York
    • Lockport, New York, United States, 14094
      • Buffalo Spine Surgery
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthopedics
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Southeastern Spine Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Central Texas Spine Institute
  • Washington
    • Spokane, Washington, United States, 99208
      • Northwest Orthopaedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Total disc replacement; Other: Lumbar fusion surgery; Lumbar fusion surgery
Other: Outcomes from lumbar fusion study	Other: Lumbar fusion surgery; Lumbar fusion surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in ODI	December 2012

Secondary Outcome Measures

Outcome Measure	Time Frame
Disc Height	December 2012

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Principal Investigator: William D Smith, MD, Western Regional Center for Brain and Spine Surgery

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 22, 2009
• First Submitted That Met QC Criteria: June 23, 2009
• First Posted (Estimate): June 24, 2009

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: DDD; Single Level; Lumbar Disc Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: NUVA-LTDR-0701