A Phase 1/2 interventional study of Total Hip Arthroplasty Replacement in Hip Arthroplasty Replacement, sponsored by Laboratoire Ceraver-Osteal. Withdrawn at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Laboratoire Ceraver-Osteal · Phase 1/2, Interventional, and Prevention
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.
This is the only study on the registry with Laboratoire Ceraver-Osteal as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Total Hip Arthroplasty Replacement
Total Hip Arthroplasty Replacement
Femoral component osseous-integration
Scoring system of Engh
Time frame: 1 year after surgery
Infection rate
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
Time frame: 1 year after surgery
Quality of Life
SF-36 score
Time frame: One, three, six and twelve months after surgery
This study is withdrawn, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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