NCT05438628

Brief Summary

In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 22, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

July 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

June 22, 2022

Last Update Submit

February 21, 2023

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

  • Prediction accuracy of the thickness of rectus abdominis, biceps brachii muscles measured with point of care ultrasound

    Preoperative evaluation

Secondary Outcomes (13)

  • Thickness of quadratus femoris muscle measured with point-of care ultrasound

    Preoperative evaluation

  • Circumference of thigh

    Preoperative evaluation

  • Difference between thickness of left and right rectus abdominis muscles

    Preoperative evaluation

  • Difference between thickness of left and right biceps brachii muscles

    Preoperative evaluation

  • Difference between thickness of left and right quadriceps femoris muscles

    Preoperative evaluation

  • +8 more secondary outcomes

Study Arms (1)

Patients scheduled for total knee arthroplasty surgery

Diagnostic Test: Point of care ultrasound

Interventions

Point of care ultrasoundDIAGNOSTIC_TEST

Measurement of thickness of rectus abdominis, biceps brachii muscles

Patients scheduled for total knee arthroplasty surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 60 years old or older scheduled for total knee arthroplasty

You may qualify if:

  • Patients 60 years old or older scheduled for total knee arthroplasty

You may not qualify if:

  • Unable to communicate with the patient or the patient's guardian
  • Myopathy
  • History of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle.
  • History of total knee arthroplasty in the recent 3 months prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 30, 2022

Study Start

July 4, 2022

Primary Completion

December 13, 2022

Study Completion

December 30, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

KR(1)