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

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.

Study Overview

• Status: Unknown
• Conditions: Musculoskeletal Disorder; Arthroplasty, Knee Replacement
• Intervention / Treatment: Other: not intervention but investigation

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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Recruiting
      • Roberto Gatti
      • Contact: Roberto Gatti, Prof; Phone Number: 0282245610; Email: roberto.gatti@hunimed.eu
      • Principal Investigator: Roberto Gatti, Prof
      • Sub-Investigator: Federico Temporiti, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample and hospitalized patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy subjects; Healthy subjects matched with TKA patients	Other: not intervention but investigation; possible differences in quadriceps muscular activity
TKA patients; age greater than 18 years old and a recent TKA.	Other: not intervention but investigation; possible differences in quadriceps muscular activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quadriceps muscle activity	Surface EMG, RMS peak (mV)	day before surgery, first postoperative day, third postoperative day for TKA group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in walking ability	Timed Up and Go (TUG) evaluated in seconds,	day before surgery, thurd postoperative day for TKA group

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2019
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): February 28, 2020

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: CLF19/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No