Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hip Arthroplasty Replacement
- Sponsor
- Laboratoire Ceraver-Osteal
- Locations
- 1
- Primary Endpoint
- Femoral component osseous-integration
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Femoral component osseous-integration
Time Frame: 1 year after surgery
Scoring system of Engh
Secondary Outcomes
- Infection rate(1 year after surgery)
- Quality of Life(One, three, six and twelve months after surgery)