A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method
研究概览
简要总结
30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.
详细描述
In this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. Patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. All subjects will undergo CT evaluation and clinical function evaluation. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-45 years old, with closed epiphyses;
- •For the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ II;
- •There is no history of trauma or fracture of the ipsilateral knee joint;
- •The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).
排除标准
- •BMI is less than 18.5 or greater than 35 kg/m2;
- •Patients with moderate or severe knee degeneration;
- •Those with limited flexion angle (<120 degrees);
- •Cartilage defect area is greater than 2 cm2 or Outerbridge damage score> Grade II.
结局指标
主要结局
3D-CT compares the position of the tibial canal made by the robot-assisted positioning and the traditional positioning method
时间窗: Knee CT examinations were performed on patients one week after surgery
Evaluate the position of the reconstructed tibia canal through 3D-CT using Taukada's method, t / T × 100% was used to evaluate the anteroposterior radial orientation of the tibial tract. Use l / L × 100% to evaluate the orientation of the inner and outer diameters of the tibial tract.
3D-CT compares the position of the femoral canal made by the robot-assisted positioning and the traditional positioning method
时间窗: Knee CT examinations were performed on patients one week after surgery
Evaluate the position of the reconstructed femoral canal through 3D-CT according to Bernard and Hertel (BH) quadrant method, l / L × 100% and h / H × 100% are used to evaluate the femoral bone canal positioning.
次要结局
未报告次要终点