Pelvic Inclination Measurement by Navigated Ultrasound (MIPEN)

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 Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Other: Pelvic inclination measurement

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Brest University Hospital
  • Brest, France, 29200
    • Clinique de Keraudren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; 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; Measurement of pelvic inclination per ultrasound
Experimental: Patients; 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; Measurement of pelvic inclination per ultrasound

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Hip, Arthroplasty, pelvic inclination, ultrasound
• Other Study ID Numbers: 29BRC18.0061 MIPEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No