ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)
|ClinicalTrials.gov Identifier: NCT03826108|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : August 9, 2019
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.
|Condition or disease|
|Staphylococcus Aureus Prosthetic Joint Infection Arthroplasty Complications|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||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|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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 [ Time Frame: 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
- Clinical or microbiological failure after the SA-PJI [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826108
|Contact: Reinaldo Espindola, MDemail@example.com|
|Contact: Maria Dolores del Toro, MDfirstname.lastname@example.org|
|Hospital Universitario Virgen Macarena||Recruiting|
|Sevilla, Andalucía, Spain, 41009|
|Contact: Jesús Rodríguez Baño 955 00 80 00|