Clinical trial NCT00927238: XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Degenerative Disc Disease
Keywords: Single Level
Lumbar Disc Disease
DDD
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in ODI
timeFrame: December 2012
Secondary outcomes:
measure: Disc Height
timeFrame: December 2012
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Silicon Valley Spine Institute
state: California
city: Thousand Oaks
country: United States
facility: Conejo Orthopaedic and Spine Institute
state: California
city: Durango
country: United States
facility: Spine Colorado / Durango Orthopedic Associates
state: Colorado
city: Newark
country: United States
facility: Christiana Spine Center
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami Beach
country: United States
facility: South Florida Spine Institute
state: Florida
city: Sarasota
country: United States
facility: Southeastern Spine Center & Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Augusta
country: United States
facility: West Augusta Spine Specialists
state: Georgia
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Jefferson City
country: United States
facility: Spine Midwest
state: Missouri
city: Las Vegas
country: United States
facility: Western Regional Spine Center for Brain and Spine Surgery
state: Nevada
city: Lockport
country: United States
facility: Buffalo Spine Surgery
state: New York
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
city: Mt. Pleasant
country: United States
facility: Southeastern Spine Institute
state: South Carolina
city: Austin
country: United States
facility: Central Texas Spine Institute
state: Texas
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists
state: Washington
Study officials:
affiliation: Western Regional Center for Brain and Spine Surgery
name: William D Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: