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

NCT ID: NCT04152538

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2020-02-28

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.

Conditions

Arthroplasty, Knee Replacement; Musculoskeletal Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy subjects

Healthy subjects matched with TKA patients

not intervention but investigation

Intervention Type: OTHER

possible differences in quadriceps muscular activity

TKA patients

age greater than 18 years old and a recent TKA.

not intervention but investigation

Intervention Type: OTHER

possible differences in quadriceps muscular activity

Interventions

not intervention but investigation

possible differences in quadriceps muscular activity

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

clinical research menager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Roberto Gatti

Rozzano, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Roberto Gatti, Prof

Role: primary

roberto.gatti@hunimed.eu

0282245610

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLF19/03

Identifier Type: -

Identifier Source: org_study_id