Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- change in Neck Disability Index (NDI)
研究概览
简要总结
The study will compare cervical arthroplasty with cervical discectomy and fusion, in the treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between the two methods, when comparing primary and secondary outcome variables.
详细描述
Anterior discectomy and fusion (ACDF) is in Norway currently the most common operative method against cervical radiculopathy, caused by disc herniation and/or spondylosis. In the last decade cervical arthroplasty has emerged as a new alternative operative method. Arthroplasty is claimed to preserve the natural motion of the spine, thereby preventing adjacent level disc disease and providing better clinical results. However, this hypothesis has not yet been adequately proven. In our study, we will prove if there is any real difference in terms of clinical effect between cervical arthroplasty and ACDF.We will also compare the overall costs of the two methods, including cost-utility analyses. Moreover, we will study the development of adjacent level disease by use of MRI scans, and analyze cervical spine motion and disc height by use of Distortion Compensated Roentgen Analysis (DCRA).
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)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25 - 60 years
- •Clinical C6 or C7 root radiculopathy with corresponding radiologic findings with or without neurological symptoms
- •Mechanical provoked pain which aggravate with physical activity or positive Spurling test
- •Radiological nerve root compression on the basis of disc herniation or spondylosis
- •NDI =/> 30 percent
- •The patient has not responded to non-operative treatment and shown no sign of improvement during the last 6 weeks
排除标准
- •Significant spondylosis involving more than one level
- •Intramedullary changes on MRI
- •Ankylosis at adjacent level
- •Clinical suspicion of myelopathy
- •Chronic generalised pain syndrome
- •Infection
- •Active cancer
- •Rheumatoid arthritis involving the cervical spine
- •Previous trauma involving the cervical spine
- •Pregnancy
- •Allergy against contents in cage/artificial disc
- •Previous neck surgery
- •Psychological or somatic illness that causes the patient not to be suitable for the study
- •The patient does not understand Norwegian orally or in writing.
- •Abuse of medication/narcotics
研究组 & 干预措施
Artificial Cervical Disc
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
干预措施: Cervical arthroplasty (Procedure)
ACDF
Anterior cervical discectomy and fusion (ACDF)
干预措施: Anterior cervical discectomy and fusion (ACDF) (Procedure)
结局指标
主要结局
change in Neck Disability Index (NDI)
时间窗: up to 5 years
次要结局
- Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity(Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
- Health economical aspects, measuring hospital costs, patient costs, primary health service costs, and performing cost-utility analyses.(Postoperatively: 3 months, 6 months, 1 year, 2 years)
- Adjacent level disc disease, measured by use of MRI scans.(Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years)
- Preservation of cervical translational and rotational segmental motion, disc height and dorsoventral displacement, by use of functional X-rays with Distortion Compensated Roentgen Analysis (DCRA)(Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years)