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ACTIVE NOT RECRUITING
NCT03113981
NA

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

Sponsor: Societe ACTIVBIOMAT

View on ClinicalTrials.gov

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

Interventions

DEVICE

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