NCT04152538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

July 30, 2019

Last Update Submit

November 3, 2019

Conditions

Arthroplasty, Knee ReplacementMusculoskeletal Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in quadriceps muscle activity

    Surface EMG, RMS peak (mV)

    day before surgery, first postoperative day, third postoperative day for TKA group

Secondary Outcomes (2)

  • Change in pain perception

    day before surgery, first postoperative day, third postoperative day for TKA group

  • Change in walking ability

    day before surgery, thurd postoperative day for TKA group

Study Arms (2)

healthy subjects

Healthy subjects matched with TKA patients

Other: not intervention but investigation

TKA patients

age greater than 18 years old and a recent TKA.

Other: not intervention but investigation

Interventions

not intervention but investigationOTHER

possible differences in quadriceps muscular activity

TKA patientshealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample and hospitalized patients

You may qualify if:

  • age: over 18 years.
  • subjects eligible for TKA.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberto Gatti

Rozzano, Milan, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical research menager

Study Record Dates

First Submitted

July 30, 2019

First Posted

November 5, 2019

Study Start

July 15, 2019

Primary Completion

December 30, 2019

Study Completion

February 28, 2020

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)