跳至主要内容
临床试验/NCT02160977
NCT02160977已完成不适用

Prospective Randomized Comparative Study on the Proprioception of the Knee Post MIS TKA (Minimally Invasive Surgery Total Knee Arthroplasty) and MIS-QS(Quadriceps Sparing ) TKA

Jia-kuo yu1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Proprioception of the Knee Post Operation

研究概览

简要总结

If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover earlier, it will accelerate the regaining of motion control ability and motion control accuracy of the TKA patients. This study compared the proprioception difference of the post operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of proprioception recovery were analyzed following the two different TKA procedures and the advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.

详细描述

Patients were scheduled prospectively to undergo total knee arthroplasties were randomly assigned to receive either a MIS-QS TKA or a MIS TKA. Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Paired two-tailed t tests with a level of significance of p < 0.05 were used to assess the effect of the different arthroplasty procedure on the postoperative knee joint proprioception for all subjects.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of osteoarthritis
  • •Indication of TKA

排除标准

  • •Bilateral total knee replacements
  • •Rheumatoid arthritis
  • •Genu valgus over than 10 degrees and genu varum over 15 degrees
  • •ROM (Range of motion) of preoperative knee joint less than 100 degree.

研究组 & 干预措施

QS-TKA

Experimental

patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)

干预措施: total knee arthroplasty (Procedure)

MIS-TKA

Active Comparator

patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)

干预措施: total knee arthroplasty (Procedure)

结局指标

主要结局

Proprioception of the Knee Post Operation

时间窗: six months

Proprioception of the knee position sense was assessed by the knee angle reproduction test (10\~20 degree, 30\~40 degree, 80\~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Scale Name:degree scale range:0\~180 degree,and a higher values represent a worse outcome

次要结局

  • HSS(Hospital for Special Surgery) Score of the Knee Joint(6 months)
  • VAS(Visual Analogue Scale/Score) of the Knee Joint(6 months)

研究者

发起方
Jia-kuo yu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jia-kuo yu

professor

Peking University Third Hospital

研究点 (1)

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