Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Screw guide wire adjustment times
研究概览
简要总结
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
详细描述
Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal disease required for screw fixation；signed the inform consent
排除标准
- •Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.
研究组 & 干预措施
Robot assisted surgery group
Spinal surgery using TIANJI Robot system.
干预措施: TIANJI Robot (Device)
Free hand surgery group
Spinal surgery using fluoroscopy-based free hand technique
干预措施: Fluoroscopy (Device)
Navigation-assisted surgery group
Spinal surgery using Navigation-assisted technique
干预措施: Navigation (Device)
结局指标
主要结局
Screw guide wire adjustment times
时间窗: During surgery
The adjustment times of screw guide wire during surgery
Perforation rate of screw
时间窗: Up to 12 weeks
Rate of screws breaching out pedicles on postoperative CT image
Screw adjustment times
时间窗: During surgery
The adjustment times of screw during surgery
Deviation of screw
时间窗: Up to 12 weeks
The deviation between the actual position of screw and the preoperative designed position
次要结局
- Operation time(During surgery)
- Blood loss(During surgery)
- Complications(Up to 4 weeks)
- Hospital stay after surgery(Up to 4 weeks)
- Hospitalization costs(Up to 4 weeks)
- Visual Analogue Scale(3 days after surgery)
- Neck Disability Index(3 days after surgery)
- Oswestry Disability Index(3 days after surgery)
- modified Japanese orthopaedic association score(3 days after surgery)
研究者
Wei Tian
Professor
Beijing Jishuitan Hospital