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

Phase 1

Withdrawn

• Conditions: Hip Arthroplasty Replacement
• Interventions: Procedure: Total Hip Arthroplasty Replacement

• Registration Number: NCT01454271
• Lead Sponsor: Laboratoire Ceraver-Osteal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-18
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Total Hip Arthroplasty CERAFIT® grafted	Total Hip Arthroplasty Replacement	-

Primary Outcome Measures

Name	Time	Method
Femoral component osseous-integration	1 year after surgery	Scoring system of Engh

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ambroise Paré Hospital. Orthopaedic surgery department; 🇫🇷 Boulogne-Billancourt, Ile De France, France