NCT04724915已完成不适用
Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 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
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
- Alignment(Preoperative and postoperatively at 6 weeks and 6 months.)
- Patient reported outcome measures(Preoperative)
- 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.)
- Change in patient reported outcome measures(Postoperatively at 6 weeks, 6 months, 1 year and 2 years.)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Robotic Assisted Surgery In Total Knee ReplacementKnee OsteoarthritisNCT05842538Sahlgrenska University Hospital, Sweden200
Unknown
不适用
Post-Market Study of Robotic-Arm Assisted Total Knee ArthroplastyOsteoarthritis, KneeNCT03106558Rothman Institute Orthopaedics400
已完成
不适用
MAKO Total Knee ArtroplastyOsteoarthritis, KneeNCT05744895Washington University School of Medicine123
已完成
不适用
Mako Functionally Aligned Total Knee Arthroplasty vs Mako Mechanically Aligned Total Knee ArthroplastyOsteo Arthritis KneeSurgeryOsteoarthritisNCT04092153University College, London100
已完成
不适用
Robotic Assisted TKATotal Knee ReplacementNCT06062615Rothman Institute Orthopaedics60