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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
XL TDR
Lumbar fusion surgery
Sponsored by
NuVasive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Single Level, Lumbar Disc Disease, DDD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Silicon Valley Spine Institute
  • Conejo Orthopaedic and Spine Institute
  • Spine Colorado / Durango Orthopedic Associates
  • Christiana Spine Center
  • Georgetown University Medical Center
  • South Florida Spine Institute
  • Southeastern Spine Center & Research Institute
  • University of South Florida
  • West Augusta Spine Specialists
  • Spine Institute of Louisiana
  • Spine Midwest
  • Western Regional Spine Center for Brain and Spine Surgery
  • Buffalo Spine Surgery
  • Southern Oregon Orthopedics
  • Southeastern Spine Institute
  • Central Texas Spine Institute
  • Northwest Orthopaedic Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

XL TDR

Outcomes from lumbar fusion study

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement in ODI

Secondary Outcome Measures

Disc Height

Full Information

First Posted
June 22, 2009
Last Updated
July 28, 2015
Sponsor
NuVasive
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1. Study Identification

Unique Protocol Identification Number
NCT00927238
Brief Title
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
Acronym
XL TDR
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuVasive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Single Level, Lumbar Disc Disease, DDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XL TDR
Arm Type
Experimental
Arm Description
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.
Arm Title
Outcomes from lumbar fusion study
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
XL TDR
Other Intervention Name(s)
Total disc replacement
Intervention Description
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Intervention Type
Other
Intervention Name(s)
Lumbar fusion surgery
Intervention Description
Lumbar fusion surgery
Primary Outcome Measure Information:
Title
Improvement in ODI
Time Frame
December 2012
Secondary Outcome Measure Information:
Title
Disc Height
Time Frame
December 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Smith, MD
Organizational Affiliation
Western Regional Center for Brain and Spine Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silicon Valley Spine Institute
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Conejo Orthopaedic and Spine Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Spine Colorado / Durango Orthopedic Associates
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Christiana Spine Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
South Florida Spine Institute
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Southeastern Spine Center & Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34342
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
West Augusta Spine Specialists
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Spine Midwest
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Western Regional Spine Center for Brain and Spine Surgery
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Buffalo Spine Surgery
City
Lockport
State/Province
New York
ZIP/Postal Code
14094
Country
United States
Facility Name
Southern Oregon Orthopedics
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Southeastern Spine Institute
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Central Texas Spine Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Northwest Orthopaedic Specialists
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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