NCT06323577招募中不适用
Comparison of Functional Outcomes in Restricted Kinematic Alignment and Mechanical Alignment in Robotic Assisted Simultaneous Bilateral Total Knee Arthroplasty. A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Forgotten joint score
研究概览
简要总结
The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.
The main question[s] it aims to answer are:
- Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
- Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years
- •Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty
- •ASA classification I-II
排除标准
- •Valgus deformity
- •BMI > 40kg/m2
- •History of previous knee surgery
- •Active infection of the knee joint
研究组 & 干预措施
Restricted kinematic alignment
Experimental
干预措施: Restricted kinematic alignment (Procedure)
Mechanical alignment
Active Comparator
干预措施: Mechanical alignment (Procedure)
结局指标
主要结局
Forgotten joint score
时间窗: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Point 0-100 (0 mean worst, 100 mean best)
次要结局
- Modified WOMAC score(6 weeks, 3months, 6 months, 1 year and 2 years after surgery)
- Pain score(every 6 hours for 2 days after surgery then once a day for 2 weeks after surgery then once a week until 3 months after surgery)
- Range of motion(6 weeks, 3months, 6 months, 1 year and 2 years after surgery)
- Hip knee ankle angle(6 weeks, 3months, 6 months, 1 year and 2 years after surgery)
- Complications(Until 2 years after surgery)
- Incidence of soft tissue releasing(During surgery)
研究者
Yot Tanariyakul
Principle investigator
Thammasat University Hospital
研究点 (2)
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