Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis: a Cohort Prospective Follow-up for 5 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- JOA score
研究概览
简要总结
To evaluate the efficacy of 3 different types of cervical disc prosthesis (Prodisc-C, Mobi-C and Prestige-LP) in the treatment of cervical spondylosis.
详细描述
A cohort, retrospective analysis will be performed of 150 patients who were in implementation of artificial disc replacement in our department from 2008 to 2012 and accepted a regular postoperatively follow-up up to 5 years, the sample will be divided into 3 groups according to prosthesis and 50 people in each group. The outcome will be measured among 3 groups respectively on the operation (such as operation time, intraoperative bleeding.), postoperative complications (such as prosthesis sinking, displacement and prolapse, adjacent segments degeneration and heterotopic ossification), photographic indicators and functional efficacy analysis and then a comparison for self-contrast pre- and post-operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients was diagnosed as cervical spondylosis based on imaging and symptomology;
- •patients were purely underwent TDR within the three kinds of prosthesis;
- •the range of participants is from 20-65 years;
- •conservative treatment of 6 months is invalid;
- •never had cervical operations.
排除标准
- •Patients suffered from cervical trauma or congenital malformations;
- •non-artificial cervical disc replacement or hybrid surgery;
- •ones who refused to be followed up.
结局指标
主要结局
JOA score
时间窗: 5 years
The whole name is Japanese Orthopaedic Association Scores for Assessment of Cervical spondylosis, the range of JOA is 0-17 and the full score is 17 to represent a normal function.
次要结局
- range of motion (ROM)(5 years)
- prosthesis sinking(5 years)
研究者
Zhu Zhenqi
Clinical Professor
Peking University People's Hospital