NCT05391152尚未招募不适用
Comparison Between Robotic-Arm Assisted Modified Kinematic Alignment Total Knee Replacement And Traditional Manual Alignment Total Knee Replacement:A Prospective Multicenter, Double-Blind Study
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- KSS score
研究概览
简要总结
This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.
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
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 years and 85 years
- •primary total knee replacement
排除标准
- •obvious bone defect
- •infection
- •BMI>>35kg/m2
- •severe osteoporosis
- •mental disease
结局指标
主要结局
KSS score
时间窗: 3 months
Keen Society Score
次要结局
- HKA angle(3 months)
- mLDFA(3 months)
- mMPTA(3 months)
- SFCA(3 months)
- knee ROM(3 months)
- blood loss(intraoperative)
- surgical duration(intraoperative)
- complication(3 months)
研究者
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