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Ultrasound for Rectus Femoris Measurement

NCT04105816 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-21

No results posted yet for this study

Summary

Postoperative protocols for orthopedic procedures on the lower limb often require a period of immobilization to protect the surgical site. The consequence of this immobilization is muscle atrophy which can be severe, delaying a patient's return to activity and predisposing them to recovery complications or subsequent injury (1)(2).

The current standard methods to assess lower limb muscle atrophy all have their respective limitations. Thigh circumference or isokinetic strength values are indirect measures of atrophy and can be inaccurate. Magnetic resonance imaging (MRI) of muscle cross-sectional area (CSA) is time-consuming and expensive. Computed tomography imaging of muscle CSA is expensive and exposes the patient to radiation (3). For these reasons, none of the current methods are ideal for regular use in the clinic.

Musculoskeletal ultrasound is a promising measurement tool to assess muscle atrophy in postoperative patients. Ultrasound is non-invasive, cost-effective, does not involve radiation, and can give direct images of muscle size (4). Musculoskeletal ultrasound requires further research on its potential as an evaluation tool for postoperative lower limb orthopedic patients-specifically, whether ultrasound is a reliable and valid tool for quadriceps size measurements.

Conditions

  • Muscle Atrophy, Proximal
  • Muscle Atrophy
  • ACL Tear
  • Quadriceps Muscle Atrophy

Interventions

DEVICE

892.1550 Ultrasonic pulsed doppler imaging system

Use of the ultrasound to measure quadriceps volume

DIAGNOSTIC_TEST

Thigh circumference measurement

Tape measure used to measure thigh circumference of all participating patients in the study at the same visit in which they receive ultrasound measurements of thigh muscles.

Sponsors & Collaborators

  • Robert Westermann

    lead OTHER

Principal Investigators

  • Robert Westermann, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-03-01
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04105816 on ClinicalTrials.gov