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

• Conditions: Arthroplasty, Knee Replacement; Musculoskeletal Disorder
• Interventions: Other: not intervention but investigation

• Registration Number: NCT04152538
• Lead Sponsor: Istituto Clinico Humanitas

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 Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-07-30
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-03
• Last Update Submitted: 2019-11-03
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy subjects	not intervention but investigation	Healthy subjects matched with TKA patients
TKA patients	not intervention but investigation	age greater than 18 years old and a recent TKA.

Primary Outcome Measures

Name	Time	Method
Change in quadriceps muscle activity	day before surgery, first postoperative day, third postoperative day for TKA group	Surface EMG, RMS peak (mV)

Secondary Outcome Measures

Name	Time	Method
Change in pain perception	day before surgery, first postoperative day, third postoperative day for TKA group	Numeric Rating Scale (NRS) 0-10. A value of 0 represents absence of pain, whereas a value of 10 represents maximum pain
Change in walking ability	day before surgery, thurd postoperative day for TKA group	Timed Up and Go (TUG) evaluated in seconds,

Trial Locations

Locations (1)

Roberto Gatti; 🇮🇹 Rozzano, Milan, Italy