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Pelvic Inclination Measurement by Navigated Ultrasound

Pelvic Inclination Measurement by Navigated Ultrasound

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03555812
Acronym
MIPEN
Enrollment
33
Registered
2018-06-14
Start date
2018-07-18
Completion date
2019-07-17
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Hip

Keywords

Hip, Arthroplasty, pelvic inclination, ultrasound

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.

Interventions

Measurement of pelvic inclination per ultrasound

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

measurements of pelvic inclination

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic inclination measurementDay 0The 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

MeasureTime frameDescription
Variation of pelvic inclination before and after hip replacementMonth 2The 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026