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Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Sponsor: Societe ACTIVBIOMAT
Summary
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
Official title: Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by Sodium Polystyrene Sulfonate -PolyNASS- (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2017-05-08
Completion Date
2039-12
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
Total Hip Arthroplasty
Implanting THA grafted with PolyNass or not
Locations (7)
CHU de Bordeaux Site Pellegrin
Bordeaux, France
Hopital Ambroise Pare
Boulogne-Billancourt, France
CH Privé Brestois et Clinique Pasteur
Brest, France
CHU Cavale Blanche
Brest, France
Hôpital Lariboisière
Paris, France
CH de Cornouaille
Quimper, France
HUS
Strasbourg, France