Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate

Laboratoire Ceraver-Osteal

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Hip Arthroplasty Replacement

Treatments: Procedure: Total Hip Arthroplasty Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01454271

CERAVERBIO11

2011-A00597-34 (Other Identifier)

Details and patient eligibility

About

The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age less than 75 years old
• Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis

Exclusion criteria

• Previous infectious hip arthritis
• Previous surgeries on the operated hip
• Revision of THA

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Total Hip Arthroplasty CERAFIT® grafted

Experimental group

Treatment:

Procedure: Total Hip Arthroplasty Replacement