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

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Unknown status
CT.gov ID
NCT04152538
Collaborator
(none)
15
1
7.5
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects
Actual Study Start Date :
Jul 15, 2019
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change in quadriceps muscle activity [day before surgery, first postoperative day, third postoperative day for TKA group]

    Surface EMG, RMS peak (mV)

Secondary Outcome Measures

  1. Change in pain perception [day before surgery, first postoperative day, third postoperative day for TKA group]

    Numeric Rating Scale (NRS) 0-10. A value of 0 represents absence of pain, whereas a value of 10 represents maximum pain

  2. Change in walking ability [day before surgery, thurd postoperative day for TKA group]

    Timed Up and Go (TUG) evaluated in seconds,

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Roberto Gatti Rozzano Milan Italy 20089

Sponsors and Collaborators

  • Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Michele Tedeschi, clinical research menager, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT04152538
Other Study ID Numbers:
  • CLF19/03
First Posted:
Nov 5, 2019
Last Update Posted:
Nov 5, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2019