NCT02890043已完成3 期
Clinical Trial for the Application of Tirobot System
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- perforation rate of pedicle screws
研究概览
简要总结
The object of this study was to evaluate the accuracy and safety of the Tirobot system.
详细描述
Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery
排除标准
- •severe osteoporosis
- •old thoracolumbar fracture
- •deformity of pedicle
- •combined with coagulation disorders
- •combined with other systematic disease
结局指标
主要结局
perforation rate of pedicle screws
时间窗: up to postoperative 3 days
number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number
次要结局
- operation time(through the operation complete, an average of 2 hours)
- complications(up to postoperative 3 months)
研究者
Wei Tian
Director
Beijing Jishuitan Hospital
研究点 (1)
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