Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2018-07-18
2019-07-17
Brief Summary
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Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.
Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty
After signing the inform consent form:
For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :
* a medical examination
* 10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.
For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :
* a medical examination
* 3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Healthy volunteers
* a medical examination
* 10 measurements of pelvic tilt in sitting position, 10 measurements of pelvic tilt in supine position and 10 measurements of pelvic tilt in standing position, each performed by three different operators. These measurements will be done by ultrasound.
Pelvic inclination measurement
Measurement of pelvic inclination per ultrasound
Patients
a consultation the day before surgery, and a consultation 2 months after surgery, each including:
* a medical examination
* 3 pelvic tilt measurements (1 standing, 1 sitting and 1 lying down). These measurements will be done by ultrasound.
Pelvic inclination measurement
Measurement of pelvic inclination per ultrasound
Interventions
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Pelvic inclination measurement
Measurement of pelvic inclination per ultrasound
Eligibility Criteria
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Inclusion Criteria
* No medical or surgical history
* Major healthy voluntary topic with
* Body Mass Index (BMI) \<20 for a subject
* 24 \<BMI \<26 for a subject
* BMI\> 30 for a subject
* Subject having signed an informed consent
For the secondary endpoint
* Adult patient requiring total hip arthroplasty for severe hip osteoarthritis
* Patient having signed an informed consent
Exclusion Criteria
* Resumption of total hip prosthesis
* Subject who can not express their consent to research
* Presence of medical or surgical history for healthy volunteers
18 Years
ALL
Yes
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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Clinique de Keraudren
Brest, , France
Brest University Hospital
Brest, , France
Countries
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References
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Dardenne G, Pluchon JP, Letissier H, Guezou-Philippe A, Gerard R, Lefevre C, Stindel E. Accuracy and Precision of an Ultrasound-Based Device to Measure the Pelvic Tilt in Several Positions. J Ultrasound Med. 2020 Apr;39(4):667-674. doi: 10.1002/jum.15141. Epub 2019 Oct 30.
Other Identifiers
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29BRC18.0061 MIPEN
Identifier Type: -
Identifier Source: org_study_id
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