Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in pain as assessed by VAS
研究概览
简要总结
The aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. Additionally these two surgical methods for degenerative diseases of the cercival spine are analyzed comparatively in order to see whether one procedure should be preferred.
详细描述
The study population consists of patients who are suffering from neck and cervicobrachial pain because of degenerative diseases of the cervical spine. In that population conservative treatment such as analgesia and physiotherapy is no more sufficient, so that surgery is necessary. For surgical treatment are chosen either total disc replacement with an cervical disc prostheses or anterior cervical decompression and fusion.
In the context of this work the clinical success of these surgical methods should be analasied by means of the neck disability index (NDI), the visual analogue scale (VAS) in centimeter, clinical examinations, the satisfaction of patients with the surgery and the occurrence of adverse events. The included patients are examined and seen before and after the surgery.
Furthermore the two different methods are compared to each other in order to detect a possible advantage of one type of surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have to undergo surgery such as spondylodesis or disc prosthesis of the cervical spine because of degenerative diseases and who have been operated in the University Hospital of Bonn between 2011 and 2015.
排除标准
- •Patients under the age of 18 years
- •Pregnant women
- •Patients who are not willing to participate in the study
- •Patients unable to take part in the study because of any other known restriction or incompatibility
结局指标
主要结局
Change in pain as assessed by VAS
时间窗: Preoperative (baseline day 0), Follow up (24 months)
Pain objectified by the VAS
次要结局
- Change in Neck disability Index(Preoperative (baseline day 0), Follow up (24 months))
研究者
Dr. Yorck Rommelspacher
Dr. med. Yorck Rommelspacher
University Hospital, Bonn