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

Musculoskeletal Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152538
• Other study ID #: CLF19/03
• Status: Recruiting
• Start date: July 15, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 28, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Knee Replacement
• Musculoskeletal Diseases
• Musculoskeletal Disorder

Intervention

Other:
• not intervention but investigation
possible differences in quadriceps muscular activity

Locations

Country	Name	City	State
Italy	Roberto Gatti	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quadriceps muscle activity	Surface EMG, RMS peak (mV)	day before surgery, first postoperative day, third postoperative day for TKA group
Secondary	Change in pain perception	Numeric Rating Scale (NRS) 0-10. A value of 0 represents absence of pain, whereas a value of 10 represents maximum pain	day before surgery, first postoperative day, third postoperative day for TKA group
Secondary	Change in walking ability	Timed Up and Go (TUG) evaluated in seconds,	day before surgery, thurd postoperative day for TKA group