Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Knee Laxity
研究概览
简要总结
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.
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)
盲法说明
Masked investigators will be responsible for the data processing and analysis. Reporting will be done together with non-masked authors.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage osteoarthritis of the knee joint with failed conservative treatment
排除标准
- •Previous ligament trauma of the MCL/LCL
- •Previous fracture of femur or tibia
- •Fixed flexion contracture > 10°
- •Flexion < 110°
- •Coronal deformity > 15°
- •Previous infection of the knee joint
- •Ligament insufficiency
- •Neurologic conditions
研究组 & 干预措施
Robot-assisted TKA
Patients undergoing TKA with the assistance of robot technology.
干预措施: Robot-Assisted Total Knee Arthroplasty (Procedure)
Conventional TKA
Patients undergoing TKA with manual instrumentarium
干预措施: Conventional Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Knee Laxity
时间窗: Preoperative and postoperatively at 1 year.
Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.
次要结局
- Patient reported outcome measures(Preoperative)
- Change in patient reported outcome measures(Postoperatively at 6 weeks, 6 months, 1 year and 2 years.)
- Alignment(Preoperative and postoperatively at 6 weeks and 6 months.)
- Knee laxity anteroposterior(Preoperative and postoperatively at 1 year.)
- Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.(Postoperatively at 1 year.)