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

• Conditions: Arthroplasty Complications; Staphylococcus Aureus; Prosthetic Joint Infection

• Registration Number: NCT03826108
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-04-16
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09
• Primary Completion: 2020-05-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of the first SA-PJI after a primary joint arthroplasty	1 year
Occurrence of medical events after SA-PJI	18 months	Events to be traced after the SA-PJI infection are: * Hospital readmission; * Total hospitalization days; * Joint surgical procedures (debridement, removal and replacement of joint prosthesis); * All cause and SA-PJI related mortality

Secondary Outcome Measures

Name	Time	Method
Clinical or microbiological failure after the SA-PJI	18 months	Clinical failure will be considered to be present if the patient died due to complications related to SA-PJI or if any of the following will be present by the end of the 18 months follow up period after the diagnosis of the first SA-PJI: joint pain or swelling causing an impaired functionality; persistent sinus tract; need for antibiotic treatment for PJI, arthrodesis or amputation. Microbiological failure is defined as any isolation of SA from the joint, periarticular tissues or the blood that was not resolved by the end of the 18th month after the diagnosis of the first SA-PJI.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Andalucía, Spain