Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- show significant difference of degeneration of disc above and below the operated stage between the two groups
研究概览
简要总结
The aim of the study is to evaluate the impact of the cervical disk surgery on the deterioration of the adjacent levels. The investigators compare the radiological deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty. 220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and clinical follow-up is organized for a period of 3 years.
详细描述
Anterior surgery of the cervical spine is one of the most practiced procedures in spine surgery. Its immediate accuracy and safety is proved since a long time in case of degenerative disk disease or disk herniation. But the segmental arthrodesis leads to an overload of the adjacent disk. A lot of studies have shown that the increasing mobility and pressure of the adjacent segments can be responsible of new degeneration and clinical symptoms. Recently, cervical disk prosthesis have been developed to maintain the mobility at the level of the surgery. This technique is supposed to decrease the risk of adjacent disk disease but, at this time, the analysis of the results is difficult, due to the lack of randomized studies with long term follow up.
The aim of our prospective randomized study is to evaluate the aftermath of the arthroplasty compared to the fusion on the adjacent disk degeneration.
The main objective is to show a radiological difference at 3 years in term of adjacent disk degeneration.
The secondary objectives are:
- evaluate the rate of new clinical symptoms during three years
- show differences during the postoperative period, especially concerning the length of the hospital stay, the use of pain killers and return to work.
- verify the maintaining of mobility pf the prosthesis during three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical radiculopathy
- •myelopathy due to a cervical disk disease
- •lack of effect of the medical treatment
- •CT scan or MRI showing a compression of roots and/or spinal cord
排除标准
- •plurisegmenta disk disease
- •injuries happened during professional activities
- •previous cervical surgery
结局指标
主要结局
show significant difference of degeneration of disc above and below the operated stage between the two groups
时间窗: 3 years after surgery
次要结局
- show difference of neurological pain between the two groups(during the 3 years of follow-up)
- show difference of duration of hospitalization and consumption of medication(during the first month after surgery)