Clinical trial NCT00432159: Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Official title: A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Degenerative Disc Disease
Keywords: cervical
spinal
arthroplasty
disc
surgical
ACDF
DDD
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

Detailed description: This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

Eligibility criteria: Key Inclusion Criteria:

* Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
* Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
* Moderate Neck Disability Index (NDI) score
* Able to give informed consent for study participation
* Able and willing to return for all follow-up visits

Key Exclusion Criteria:

* Significant cervical degenerative disc disease
* Prior fusion procedure at any level(s) (C1-T1)
* Marked cervical instability on lateral or flexion/extension radiographs
* Presence of systemic infection or infection at the surgical site
* Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
* History of alcohol and/or drug abuse
* Any known allergy to a metal alloy or polyethylene
* Morbid obesity
* Any significant general illness (e.g., metastatic cancer, HIV)

Primary outcomes:
measure: Overall Success
timeFrame: 24 months
Secondary outcomes:
measure: NDI Success
timeFrame: 24 months
measure: Neurological Component of Success
timeFrame: 24 months
measure: Subsequent Secondary Surgery Component of Success
timeFrame: 24 months
measure: Device-Related SAE Component of Success
timeFrame: 24 months
measure: NDI - Change From Baseline
timeFrame: 24 months
measure: Neck Pain VAS Scores - Change From Baseline
timeFrame: 24 months
measure: Maximum Arm Pain VAS - Change From Baseline
timeFrame: 24 months
measure: Average Arm Pain VAS - Change From Baseline
timeFrame: 24 months
measure: Maximum Shoulder Pain VAS - Change From Baseline
timeFrame: 24 months
measure: Average Shoulder Pain VAS - Change From Baseline
timeFrame: 24 months
measure: Dysphagia Disability Index - Change From Baseline
timeFrame: 24 months
measure: SF-36 - Physical Composite Scores (PCS) - Change From Baseline
timeFrame: 24 months
measure: SF-36 - Mental Composite Scores (MCS) - Change From Baseline
timeFrame: 24 months
measure: Work Status Assessment
timeFrame: 24 months
measure: Return to Work
timeFrame: 24 months
measure: Activity
timeFrame: 24 months
measure: Subject Satisfaction
timeFrame: 24 months
measure: Global Cervical Range of Motion - Change From Baseline
timeFrame: 24 months
measure: Average Radiographic Disc Height (mm) - Change From Post-op
timeFrame: 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Olympia Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center
state: California
city: Loveland
country: United States
facility: Rocky Mountain Associates in Orthopedic Medicine, PC
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
city: Chicago
country: United States
facility: Rush University/Midwest Orthopaedics
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Overland Park
country: United States
facility: Johnson County Spine
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Newton
country: United States
facility: Boston Spine Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Twin Cities Spine
state: Minnesota
city: Springfield
country: United States
facility: St. John's Regional Medical Center
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital Neurological Associates
state: Montana
city: Omaha
country: United States
facility: Nebraska Spine Center, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Diseases and Surgery of the Spine
state: Nevada
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Johnson City
country: United States
facility: Southern NY Neurosurgical Group
state: New York
city: Syracuse
country: United States
facility: Upstate Medical College/SUNY
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates
state: North Carolina
city: Durham
country: United States
facility: Triangle Orthopaedic Associates
state: North Carolina
city: Eugene
country: United States
facility: Neurospine Institute
state: Oregon
city: Dallas
country: United States
facility: North Texas Spine Care at Baylor Health
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Queensland
country: Australia
facility: Pacific Private Clinic
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
Study officials:
References: