NCT03113981

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

Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by Sodium Polystyrene Sulfonate -PolyNASS- (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Societe ACTIVBIOMAT · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis, Hip
• Coxarthrosis; Primary
• Coxarthrosis; Secondary
• Osteonecrosis; Aseptic, Idiopathic
• Hip Arthroplasty Replacement
• Hip Arthroplasty, Total
• Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Total Hip Arthroplasty	Implanting THA grafted with PolyNass or not

Timeline

• Start date: 2017-05-08
• Primary completion: 2024-12-31
• Completion: 2039-12-01
• First posted: 2017-04-14
• Last updated: 2025-12-22

Locations

7 sites across 1 country: France