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

Degenerative Disc Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927238
• Other study ID #: NUVA-LTDR-0701
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2009
• Last updated: July 28, 2015
• Start date: July 2009
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Device:
• XL TDR
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.

Other:
• Lumbar fusion surgery
Lumbar fusion surgery

Locations

Country	Name	City	State
United States	West Augusta Spine Specialists	Augusta	Georgia
United States	Central Texas Spine Institute	Austin	Texas
United States	Silicon Valley Spine Institute	Campbell	California
United States	Spine Colorado / Durango Orthopedic Associates	Durango	Colorado
United States	Spine Midwest	Jefferson City	Missouri
United States	Western Regional Spine Center for Brain and Spine Surgery	Las Vegas	Nevada
United States	Buffalo Spine Surgery	Lockport	New York
United States	Southern Oregon Orthopedics	Medford	Oregon
United States	South Florida Spine Institute	Miami Beach	Florida
United States	Southeastern Spine Institute	Mt. Pleasant	South Carolina
United States	Christiana Spine Center	Newark	Delaware
United States	Southeastern Spine Center & Research Institute	Sarasota	Florida
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Northwest Orthopaedic Specialists	Spokane	Washington
United States	University of South Florida	Tampa	Florida
United States	Conejo Orthopaedic and Spine Institute	Thousand Oaks	California
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in ODI		December 2012
Secondary	Disc Height		December 2012