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临床试验/NCT04152538
NCT04152538Unknown不适用

Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Change in quadriceps muscle activity

研究概览

简要总结

During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle.The aim of the study is to investigate differences in quadriceps neuromuscular activity in the acute phase after surgery.

详细描述

During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle. The current phenomenon depends on a complex mechanism called Arthrogenic Muscle Inhibition (AMI). AMI has been studied only in sub-acute and chronic phase after TKA due to the invasive procedures employed in order to evaluate it; However, clinical observation and experimental studies suggest presence of this phenomenon also in the first postoperative days. The aim of the study is to investigate differences in quadriceps neuromuscular activity, in acute phase.

The study is a prospective observational study.15 healthy subjects and 15 patients scheduled for TKA will be recruited. Patients will be asked to perform three isokinetic taks in the same standardized biomechanical context in order to evaluate changes in quadriceps neuromuscular activity after surgery as primary outcome. Secondly, correlation between primary aim and pain perceived by the patient will be investigated. Moreover, patient's functional ability will be assessed using the Timed Up and Go Test (TUG). Data will be recorded the day before TKA, at one and three days after surgery.

At the end of data acquisition, normality and homogeneity of demographic variables will be assessed. Differences in the outcome measures will be investigated with the t student test (or with the related non-parametric tests) and by means of the mixed models repeated measures ANOVA test. Linear regression will be applied to evaluate any correlation between outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • age: over 18 years.
  • subjects eligible for TKA.

排除标准

  • QAB (quadriceps activation battery) < 6 the day before the operation
  • neurological or musculoskeletal diseases (different from the causes that which led the patient to the TKA), which may interfere with the quadriceps muscle activation or with motor performance of the subject.
  • Uncooperative subjects.

结局指标

主要结局

Change in quadriceps muscle activity

时间窗: day before surgery, first postoperative day, third postoperative day for TKA group

Surface EMG, RMS peak (mV)

次要结局

  • Change in pain perception(day before surgery, first postoperative day, third postoperative day for TKA group)
  • Change in walking ability(day before surgery, thurd postoperative day for TKA group)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Tedeschi

clinical research menager

Istituto Clinico Humanitas

研究点 (1)

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