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

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ClinicalTrials.gov Identifier: NCT03014739
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : December 20, 2018
Sponsor:
Collaborators:
Beijing Chao Yang Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
SuperSonic Imagine

Brief Summary:
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.

Condition or disease Intervention/treatment
Achilles Tendon Plantar Fascia Other: Supersonic ShearWave Elastography

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Study Type : Observational
Actual Enrollment : 1165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Intervention Details:
  • Other: Supersonic ShearWave Elastography
    ShearWave Elastography (SWE) is part of routine ultrasound examination


Primary Outcome Measures :
  1. Intra- and inter-operator reproducibility [ Time Frame: Baseline ]
    Intraclass Correlation Coefficient


Other Outcome Measures:
  1. Effect of limb dominance [ Time Frame: Baseline ]
    Variability of ICC as a function of dominant versus non-dominant leg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers without any Achilles tendon disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014739


Locations
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China
Beijing Chao-Yang Hospital
Beijing, China, 100020
The third Affiliated Hospital of Peking University
Beijing, China, 100191
Sponsors and Collaborators
SuperSonic Imagine
Beijing Chao Yang Hospital
Peking University Third Hospital
Publications of Results:
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Responsible Party: SuperSonic Imagine
ClinicalTrials.gov Identifier: NCT03014739    
Other Study ID Numbers: ME1
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SuperSonic Imagine:
Elastography
Musculoskeletal System