MedTrace Logo

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

NCT01454271 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-14

No results posted yet for this study

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.

Conditions

  • Hip Arthroplasty Replacement

Interventions

PROCEDURE

Total Hip Arthroplasty Replacement

Total Hip Arthroplasty Replacement

Sponsors & Collaborators

  • Societe ACTIVBIOMAT

    lead INDUSTRY

Principal Investigators

  • Philippe Hardy, Ph.D. · Ambroise Paré Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454271 on ClinicalTrials.gov