Pelvic Inclination Measurement by Navigated Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Brest
- Enrollment
- 33
- Locations
- 4
- Primary Endpoint
- Pelvic inclination measurement
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Pelvic inclination measurement
Time Frame: Day 0
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
Secondary Outcomes
- Variation of pelvic inclination before and after hip replacement(Month 2)