A Multi-center Randomized Controlled Trial Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 656
- 主要终点
- the accuracy of pedicle screw
研究概览
简要总结
The purpose of this study is to investigate the difference of the accuracy and safety between traditional spine surgery and computer assisted navigation system spine surgery.
详细描述
The object of study is the patients who are going to undergo pedicle screw fixation operation. there are two clinical trial centers.one is beijing jishuitan hospital,the other is beijing shuili hospital.the study protocol will be reviewed by the Ethics Committee of Beijing Jishuitan Hospital. after the patients sign the informed consent,they will be divided into two groups randomly.the patients' basic information and medical informations including the accuracy and safety will be collected.the data above all will be compared.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need to undergo pedicle screw fixation surgery
- •Sign informed consent
- •Capacity person
排除标准
- •refused to sign the informed consent
- •the age is not between 18 and 75 years old
结局指标
主要结局
the accuracy of pedicle screw
时间窗: one week after the spine surgery
one week after the spine surgery,measure the accuracy of pedicle screw by CT examination
次要结局
- complication(three days after the spine surgery)