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临床试验/NCT05391152
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

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

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

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