Pelvic Inclination Measurement by Navigated Ultrasound (MIPEN)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Arthroplasty, Replacement, Hip

Treatments: Other: Pelvic inclination measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03555812

29BRC18.0061 MIPEN

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Healthy volunteers

Experimental group

Description:

* 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.

Treatment:

Other: Pelvic inclination measurement

Patients

Experimental group

Description:

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.

Treatment:

Other: Pelvic inclination measurement