Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
- Conditions
- Cervical Degenerative Disc Disease
- Interventions
- Device: Cervical TDRDevice: ACDF with plate
- Registration Number
- NCT00432159
- Lead Sponsor
- DePuy Spine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1-level Cervical TDR Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. 2-level Cervical TDR Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Training: 1 & 2-level Cervical TDR Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. 1-level ACDF with plate ACDF with plate Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. 2-level ACDF ACDF with plate Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
- Primary Outcome Measures
Name Time Method Overall Success 24 months Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
- Secondary Outcome Measures
Name Time Method NDI Success 24 months 15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Device-Related SAE Component of Success 24 months no device related serious adverse events
Average Arm Pain VAS - Change From Baseline 24 months Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Neurological Component of Success 24 months no new clinically significant permanent abnormalities in neurological function
Subsequent Secondary Surgery Component of Success 24 months no subsequent secondary surgical intervention at the index level
NDI - Change From Baseline 24 months Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Neck Pain VAS Scores - Change From Baseline 24 months Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Global Cervical Range of Motion - Change From Baseline 24 months Activity 24 months Clinical Assessment of Activity
Maximum Arm Pain VAS - Change From Baseline 24 months Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
SF-36 - Mental Composite Scores (MCS) - Change From Baseline 24 months Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Return to Work 24 months Estimated Proportion of Subjects Returning to Work
Average Shoulder Pain VAS - Change From Baseline 24 months Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
SF-36 - Physical Composite Scores (PCS) - Change From Baseline 24 months Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Maximum Shoulder Pain VAS - Change From Baseline 24 months Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Dysphagia Disability Index - Change From Baseline 24 months Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
Work Status Assessment 24 months Subject Satisfaction 24 months Subject Satisfaction (Would you have this procedure again?)
Average Radiographic Disc Height (mm) - Change From Post-op 24 months
Trial Locations
- Locations (32)
Upstate Medical College/SUNY
🇺🇸Syracuse, New York, United States
Sutter Medical Center
🇺🇸Sacramento, California, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Johnson County Spine
🇺🇸Overland Park, Kansas, United States
St. John's Regional Medical Center
🇺🇸Springfield, Missouri, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Rush University/Midwest Orthopaedics
🇺🇸Chicago, Illinois, United States
Carolina Neurosurgery & Spine Associates
🇺🇸Charlotte, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States
Pacific Private Clinic
🇦🇺Queensland, Australia
St. Patrick Hospital Neurological Associates
🇺🇸Missoula, Montana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Center for Diseases and Surgery of the Spine
🇺🇸Las Vegas, Nevada, United States
Rocky Mountain Associates in Orthopedic Medicine, PC
🇺🇸Loveland, Colorado, United States
Florida Orthopaedic Institute
🇺🇸Tampa, Florida, United States
Triangle Orthopaedic Associates
🇺🇸Durham, North Carolina, United States
North Texas Spine Care at Baylor Health
🇺🇸Dallas, Texas, United States
Olympia Medical Center
🇺🇸Beverly Hills, California, United States
Emory Orthopaedics and Spine Center
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Twin Cities Spine
🇺🇸Minneapolis, Minnesota, United States
Nebraska Spine Center, LLC
🇺🇸Omaha, Nebraska, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Southern NY Neurosurgical Group
🇺🇸Johnson City, New York, United States
Neurospine Institute
🇺🇸Eugene, Oregon, United States
Texas Back Institute
🇺🇸Plano, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Boston Spine Group
🇺🇸Newton, Massachusetts, United States