Technology and System for Minimally Invasive TKA Surgery Robot
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Full-length radiography of both lower limbs
研究概览
简要总结
Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.
详细描述
- For the current minimally invasive total knee arthroplasty, due to the limitation of the surgical field of view and the scope of operation, and the error of the intraoperative osteotomy saw, it can cause intraoperative damage to ligaments, nerves and blood vessels, postoperative lower limb force lines and prosthesis position Poor, abnormal movement and force of the patellofemoral joint and tibiofemoral joint after surgery can easily lead to clinical symptoms such as rapid wear of the prosthesis, short service life, postoperative knee pain, and even possible problems with surgical failure and revision. Developed a robot for minimally invasive total knee replacement surgery. Minimally invasive total knee arthroplasty is performed by surgical robot and manual operation. According to intraoperative and postoperative imaging observations, the position of the prosthesis, and the evaluation of soft tissue balance during and after the operation, the two methods are compared with the surgical robot and manual operation. Kind of surgery.
- To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No surgery on the knee joint.
排除标准
- •Knee surgery history.
- •Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
- •Severe flexion contracture deformity.
- •Revision and replacement surgery for knee joints.
结局指标
主要结局
Full-length radiography of both lower limbs
时间窗: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs
Conventional anteroposterior radiograph of Both Lower Extremities
时间窗: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities
Operation time
时间窗: During the operation
The time from the start of the skin incision to the completion of the skin suture
computed tomography
时间窗: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through computed tomography
Magnetic Resonance Imaging
时间窗: Before and two days after the operation
Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging
Range of motion
时间窗: Before and two days after the operation
Knee joint range of motion. Normal flexion 150°, extension 0°
次要结局
未报告次要终点