NCT04587440: DYPAMAT

Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

Status unknown NA Last updated 11 January 2022

What this trial tests

NA trial testing Pelvic inclination measurement in Coxarthrosis; Primary in 53 participants. Status unknown.

Timeline

2 February 2021

Primary endpoint
2 February 2023

2 August 2023

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	53
Start date	2 February 2021
Primary completion	2 February 2023
Estimated completion	2 August 2023
Sites	1 location across France

Drugs / interventions tested

• Pelvic inclination measurement

Conditions studied

• Coxarthrosis; Primary — all drugs for Coxarthrosis; Primary →
• Coxarthrosis; Secondary — all drugs for Coxarthrosis; Secondary →

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Coxarthrosis; Primary or Coxarthrosis; Secondary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Total hip replacement is one of the most common surgical procedure in France. In 2010, an estimated 147 513 total hip procedures were performed. This number is constantly increasing.

Although it is common, it can lead to many complications. The intra-prosthetic luxation is the second one after aseptic loosening.

The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components. This orientation is influenced by statics and dynamics parameters.

So far, the literature shows that only static parameters are considered by surgeons. Thus, in reference to Lewinneck publication, which states that the luxation risk is lower if the cup is oriented with 15° +/- 10° of anteversion and 40°+/- 10° of inclination with respect to the anterior pelvic plan (APP). Defined by the two anterosuperior iliacs spines and pubic symphysis.

However, this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life.

To consider these variations of pelvic inclination, it is possible to measure the angle between APP and the horizontal (in lying position) or the vertical (in standing position) plan.

Several devices allow the measure of pelvic inclination but they all have important limits (EOS radiography, scanner or navigation). A new device has been developed in Brest to measure this inclination in several positions of the daily life.This software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility.

The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device, and to assess the amount of variation induced by hip replacement procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.