A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Degenerative Disc Disease
- Sponsor
- DePuy Spine
- Enrollment
- 500
- Locations
- 32
- Primary Endpoint
- Overall Success
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Overall Success
Time Frame: 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 Outcomes
- Global Cervical Range of Motion - Change From Baseline(24 months)
- NDI Success(24 months)
- Device-Related SAE Component of Success(24 months)
- Average Arm Pain VAS - Change From Baseline(24 months)
- Neck Pain VAS Scores - Change From Baseline(24 months)
- Neurological Component of Success(24 months)
- Subsequent Secondary Surgery Component of Success(24 months)
- NDI - Change From Baseline(24 months)
- Activity(24 months)
- Maximum Arm Pain VAS - Change From Baseline(24 months)
- SF-36 - Mental Composite Scores (MCS) - Change From Baseline(24 months)
- Return to Work(24 months)
- SF-36 - Physical Composite Scores (PCS) - Change From Baseline(24 months)
- Subject Satisfaction(24 months)
- Average Shoulder Pain VAS - Change From Baseline(24 months)
- Maximum Shoulder Pain VAS - Change From Baseline(24 months)
- Dysphagia Disability Index - Change From Baseline(24 months)
- Work Status Assessment(24 months)
- Average Radiographic Disc Height (mm) - Change From Post-op(24 months)