Clinical trial NCT04152538: Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects
Official title: Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty, Knee Replacement
Musculoskeletal Disorder
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample and hospitalized patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in quadriceps muscle activity
timeFrame: day before surgery, first postoperative day, third postoperative day for TKA group
Secondary outcomes:
measure: Change in pain perception
timeFrame: day before surgery, first postoperative day, third postoperative day for TKA group
measure: Change in walking ability
timeFrame: day before surgery, thurd postoperative day for TKA group
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Roberto Gatti
state: Milan
Study officials:
References: