Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Mechanical axis
研究概览
简要总结
The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
- •Age 50-80 year
- •Patients with osteoarthritis who voluntarily participated in the project
排除标准
- •Patients with osteoporosis
- •History of inflammatory arthroplathy
- •Previous fracture or open surgery on the same knee
- •Patients with bilateral total knee arthroplasty
- •Patients osteoarthritis with revision surgery
结局指标
主要结局
Mechanical axis
时间窗: Change from baseline mechanical axis at 6 weeks after surgery
Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus \<age 2 and physiologic valgus \<age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention
次要结局
- Knee Society and Knee Society function score(Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery)
- Range of motion of knee(Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery)
- Oxford knee score(Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery)
研究者
Satit Thiengwittayaporn
Associate Professor
Navamindradhiraj University