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OpenTrials
Completed

NCT Number: NCT03555812

Pelvic Inclination Measurement by Navigated Ultrasound

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest University Hospital, Brest, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic inclination measurement

Other

Measurement of pelvic inclination per ultrasound

Primary outcomes

  1. 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

  1. Variation of pelvic inclination before and after hip replacement

    Time frame: Month 2

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: MIPEN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2018
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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