A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DePuy Spine
- 入组人数
- 500
- 试验地点
- 64
- 主要终点
- Overall Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
1-level 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.
干预措施: Cervical TDR (Device)
1-level 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.
干预措施: ACDF with plate (Device)
2-level 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.
干预措施: Cervical TDR (Device)
2-level ACDF
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.
干预措施: ACDF with plate (Device)
Training: 1 & 2-level 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.
干预措施: Cervical TDR (Device)
结局指标
主要结局
Overall Success
时间窗: 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.
次要结局
- 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)