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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04152538
Other study ID # CLF19/03
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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