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临床试验/NCT03826108
NCT03826108Unknown不适用

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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Occurrence of the first SA-PJI after a primary joint arthroplasty

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent a primary hip or knee arthroplasty between 2013 and
  • Diagnosis of SA -PJI in the first 12 months after primary arthroplasty.

排除标准

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

结局指标

主要结局

Occurrence of the first SA-PJI after a primary joint arthroplasty

时间窗: 1 year

Occurrence of medical events after SA-PJI

时间窗: 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

次要结局

  • Clinical or microbiological failure after the SA-PJI(18 months)

研究者

研究点 (1)

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