A Prospective, Multicenter, Non Inferiority, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Pedicle Screw Fixation Assisted by Orthopedic Surgical Navigation System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 主要终点
- Deviation of the position of Kirschner needle
研究概览
简要总结
This clinical trial is a prospective, multicenter, non inferiority, randomized controlled trial. We plan to include 112 subjects in China and randomly assign them to the experimental group and the control group according to the ratio of 1:1. The experimental group used the orthopedic surgery navigation and positioning system produced by Nanjing Tuodao Medical Technology Co., Ltd., while the control group used the orthopedic surgery navigation and positioning system produced by Beijing tianzhihang Medical Technology Co., Ltd. Taking the position deviation of Kirschner wire as the main evaluation index, it was proved that the test instrument was not inferior to the control instrument. The test data shall be submitted to the State Drug Administration for approval of the marketing license of the test device
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
- None
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
- •They were 18-75 years old;
- •From thoracic vertebrae to lumbar vertebrae, pedicle screw fixation is needed;
- •Signed informed consent, willing to receive treatment and follow-up according to the requirements of the trial protocol.
排除标准
- •Patients with pedicle deformity.
- •Patients with severe osteoporosis.
- •Patients with spinal tumor or tuberculosis.
- •Patients with abnormal liver function (alanine aminotransferase, aspartate aminotransferase values > 3 times of the upper limit of the normal range) and abnormal renal function (creatinine values > 3 times of the upper limit of the normal range).
- •Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time > 1.5 times of the upper limit of normal range).
- •Pregnant or lactating women.
- •Patients with mental disorders.
- •The investigators evaluated patients who were not suitable for pedicle screw fixation.
- •Patients who are participating in clinical trials of any other device or drug.
- •Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.
结局指标
主要结局
Deviation of the position of Kirschner needle
时间窗: Immediately after operation
Comparing the actual placement position of Kirschner wire with the planned position of C-arm 3D scanning, the average deviation of the entry point and the insertion point was the position deviation of Kirschner wire
次要结局
- Entry point deviation(Immediately after operation)
- Dead center deviation(Immediately after operation)
- Operation time(Immediately after operation)
- apparatus Success rate(Immediately after operation)
- Incidence of device defects(Immediately after operation)
- Angle deviation of axial plane(Immediately after operation)
- Technical success rate(Immediately after operation)
- Excellent and good rate of pedicle screw placement(Discharge or 7 days after surgery, whichever comes first)
- Angular deviation of sagittal plane(Immediately after operation)
- Incidence of re nailing(Immediately after operation)
- Incidence of severe surgical complications(Discharge or 7 days after surgery, whichever comes first)
- Incidence of adverse events and serious adverse events(Discharge or 7 days after surgery, whichever comes first)
- Spatial angle deviation(Immediately after operation)
- Incidence of conversion to manual nail placement(Immediately after operation)
- Success rate of operation(Immediately after operation)