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

Last updated: August 7, 2019
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Active - Recruiting

Phase

N/A

Condition

Staphylococcal Infections

Treatment

N/A

Clinical Study ID

NCT03826108
FIS-MET-2019-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who underwent a primary hip or knee arthroplasty between 2013 and 2016.

  • Diagnosis of SA -PJI in the first 12 months after primary arthroplasty.

Exclusion

Exclusion Criteria:

• Patients with a previous SA infection or prosthesis revision on the index joint (jointwhich was replaced during arthroplasty).

Study Design

Total Participants: 600
Study Start date:
April 16, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Hospital Universitario Virgen Macarena

    Sevilla, Andalucía 41009
    Spain

    Active - Recruiting

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