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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 :
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Experimental |
|
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| Patients | Experimental | a consultation the day before surgery, and a consultation 2 months after surgery, each including:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic inclination measurement | Other | Measurement of pelvic inclination per ultrasound |
|
| 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 |
| 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 |
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Inclusion Criteria:
For primary endpoint
No medical or surgical history
Major healthy voluntary topic with
Subject having signed an informed consent
For the secondary endpoint
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de Keraudren | Brest | 29200 | France | |||
| Brest University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31665548 | Result | 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. |
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measurements of pelvic inclination
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| Brest |
| 29609 |
| France |