Hip Arthroplasty Replacement
Conditions
Keywords
Total Hip arthroplasty, Hip Osteoarthritis, Infection after Total Hip Arthroplasty
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.
Interventions
PROCEDURETotal Hip Arthroplasty Replacement
Total Hip Arthroplasty Replacement
Sponsors
Societe ACTIVBIOMAT
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral component osseous-integration | 1 year after surgery | Scoring system of Engh |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection rate | 1 year after surgery | Infection (yes/no) : Clinical, biological or radiological THA infection signs. In the case of infection suspicion, hip aspiration will be performed with joint fluid culture |
| Quality of Life | One, three, six and twelve months after surgery | SF-36 score |
Countries
France
Outcome results
None listed