Clinical Trials Directory

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UnknownNCT03826108

ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)

Retrospective Study to Identify the Incidence, Risk Factors and Outcomes of Prosthetic Joint Infection Due to Staphylococcus Aureus After Primary Knee or Hip Joint Replacement

Status
Unknown
Phase
Study type
Observational
Enrollment
600 (estimated)
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This microorganism is frequently associated with treatment failure, hospitalizations and need of prosthesis removal, leading to an important morbidity and an increase in healthcare costs. ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the costs, the number of hospitalizations and the surgical procedures needed to treat and control the infection and finally the factors influencing therapeutic failure. Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries in order to include 150 cases and 450 controls. The results of this study will provide critical information to develop strategies to prevent and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will help in the design of future clinical trials in prosthesis infections by providing reliable estimates on the incidence of SA-PJI and the subsequent burden on health care services.

Conditions

Timeline

Start date
2019-04-16
Primary completion
2020-05-01
Completion
2020-12-31
First posted
2019-02-01
Last updated
2019-08-09

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03826108. Inclusion in this directory is not an endorsement.