Clinical Research Directory

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

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.

Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment. The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis. Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis. A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting. No previous clinical trial