Pelvic Inclination Measurement by Navigated Ultrasound

Arthroplasty, Replacement, Hip Clinical Trial

— MIPEN  

Official title:

Pelvic Inclination Measurement by Navigated Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555812
• Other study ID #: 29BRC18.0061 MIPEN
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Other:
• Pelvic inclination measurement
Measurement of pelvic inclination per ultrasound

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Clinique de Keraudren	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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