Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia (ME1)

December 18, 2018 updated by: SuperSonic Imagine

Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia

Achilles tendon plays a significant role in walking and sporting activities, particularly through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line examination of choice for patients suspected of having Achilles tendon injury, which is more and more frequent. Nowadays, ultrasound elastography can be used to evaluate the viscoelasticity properties of Achilles tendon, however little is known about the reproducibility of the technique. This study aims to evaluate the reproducibility of supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in Achilles tendon and plantar fascia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100020
        • Beijing Chao-Yang Hospital
      • Beijing, China, 100191
        • The third Affiliated Hospital of Peking University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers without any Achilles tendon disease

Description

Inclusion Criteria:

  • Volunteers with normal Achilles tendon:
  • Normal adult aged over 18 years old;
  • Without lower limb malformation;
  • With no symptoms of Achilles tendon lesion and no negative results of routine ultrasound examination for a possible tendinopathy.

Exclusion Criteria:

  • Subjects who failed to meet all inclusion criteria were will be automatically excluded;
  • Subjects who did will not wish or could will not sign the informed consent in person.

  • Volunteers with abnormal Achilles tendon for any of these reasons:

    • Lower limb malformation;
    • Achilles tendon pain, Achilles tendon disease, surgical history of Achilles tendon surgery, morphologic abnormalities of Achilles tendon ( gray-scale/color Doppler/MRI/plain film);
    • Suffer from systemic, metabolic and endocrine diseases, including but not limited to, diabetes, familial hyperlipidemia (FH), systemic lupus erythematosus (SLE), gout, ankylosing spondylitis, hyperthyroidism, chronic renal failure, etc.
    • Pregnant women;
    • Apply Ongoing hormone hormonal therapy;
    • Athletes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and inter-operator reproducibility
Time Frame: Baseline
Intraclass Correlation Coefficient
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of limb dominance
Time Frame: Baseline
Variability of ICC as a function of dominant versus non-dominant leg
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperSonic Imagine

Collaborators

Peking University Third Hospital
Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ME1

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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