Pelvic Inclination Measurement by Navigated Ultrasound

Study Overview
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Brief Summary
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Prospective, multicenter, non-randomized study. 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.

Official Title
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Pelvic Inclination Measurement by Navigated Ultrasound

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Other: Pelvic inclination measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For primary endpoint 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: Minor subject Resumption of total hip prosthesis Subject who can not express their consent to research Presence of medical or surgical history for healthy volunteers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: measurements of pelvic inclination
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>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. | Other: Pelvic inclination measurement<br>* Measurement of pelvic inclination per ultrasound<br>|
| Experimental: Patients<br>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. | Other: Pelvic inclination measurement<br>* Measurement of pelvic inclination per ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic inclination measurement | The pelvic inclination measurement corresponds to the anterior pelvic plane also known as the Lewinnek's plane; defined by the plane between both anterior superior iliac spine and the pubic symphysis. A Portable Ultrasound based Device is used for the Measurement of the Pelvic Tilt | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of pelvic inclination before and after hip replacement | The pelvic inclination measurement corresponds to the anterior pelvic plane also known as the Lewinnek's plane; defined by the plane between both anterior superior iliac spine and the pubic symphysis. A Portable Ultrasound based Device is used for the Measurement of the Pelvic Tilt | Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Arthroplasty, pelvic inclination, ultrasound