An observational study in Staphylococcus Aureus, Prosthetic Joint Infection and Arthroplasty Complications, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 600 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Recruitment of cases: the cases will be detected by chart review of all patients who underwent a primary arthroplasty and matching the list with microbiological records for SA-PJI infections or discharged records of patients admitted for PJI or any joint procedure.
Recruitment of controls: for each case, the list of patients who underwent a primary arthroplasty in the following week and in the same joint as the case will be reviewed, the first three patients without evidence of PJI during one year will be selected.
Exclusion Criteria:
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.
Patient who underwent a primary hip or knee arthroplasty and did not develop any type of PJI during the first year after the procedure.
Occurrence of the first SA-PJI after a primary joint arthroplasty
Time frame: 1 year
Occurrence of medical events after SA-PJI
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
Time frame: 18 months
Clinical or microbiological failure after the SA-PJI
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.
Time frame: 18 months
Plan to share: Undecided
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla