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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Prosthetic Joint Infection; Arthroplasty Complications; Staphylococcus Aureus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03826108

FIS-MET-2019-01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

600 participants in 2 patient groups

Cases

Description:

Patient who underwent a primary hip (total or partial) or knee arthroplasty and developed a PJI that was culture-confirmed for SA during the first year after the procedure.

Controls

Description:

Patient who underwent a primary hip or knee arthroplasty and did not develop any type of PJI during the first year after the procedure.