Pelvic Inclination Measurement by Navigated Ultrasound

NCT03555812 | Completed

• 1 other identifier: 29BRC18.0061 MIPEN
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Hip, Arthroplasty, pelvic inclination, ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Variation of pelvic inclination before and after hip replacement

  Month 2

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

* 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

Patients

EXPERIMENTAL

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

Interventions

Pelvic inclination measurement OTHER

Measurement of pelvic inclination per ultrasound

Healthy volunteers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For primary endpoint
• No medical or surgical history
• Major healthy voluntary topic with
• Body Mass Index (BMI) \<20 for a subject
• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Clinique de Keraudren

Brest, 29200, France

Location

Brest University Hospital

Brest, 29609, France

Location

Related Publications (1)

• 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.

  PMID: 31665548 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: measurements of pelvic inclination

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 14, 2018
• Study Start: July 18, 2018
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: December 3, 2025

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)