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Clinical Trials/NCT04152538
NCT04152538UnknownNot Applicable

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

Istituto Clinico Humanitas1 site in 1 country15 target enrollmentStarted: July 15, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
Change in quadriceps muscle activity

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change in quadriceps muscle activity

Time Frame: day before surgery, first postoperative day, third postoperative day for TKA group

Surface EMG, RMS peak (mV)

Secondary Outcomes

  • 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)

Investigators

Sponsor
Istituto Clinico Humanitas
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michele Tedeschi

clinical research menager

Istituto Clinico Humanitas

Study Sites (1)

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