Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice? - a Multicentric Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,554
- 试验地点
- 2
- 主要终点
- Prosthetic Joint Infections (with or without the need for further surgery)
研究概览
简要总结
This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).
详细描述
Periprosthetic joint infection (PJI) is a major burden for healthcare systems. The European Bone and Joint Infection Society (EBJIS) proposed a new set of criteria introducing a three level 'traffic light' distinction: Infection Unlikely, Infection Confirmed but also an intermediate group called Infection Likely (but nor confirmed). This retrospective multi-center, multi-national cohort study is to validate the EBJIS Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018
排除标准
- •less than two years follow up
- •less than four intraoperative microbiology samples (synovial fluid, tissue samples, implant sonication)
- •no preoperative/intraoperative synovial fluid differential leukocyte count
结局指标
主要结局
Prosthetic Joint Infections (with or without the need for further surgery)
时间窗: since 01.01.2013 with a minimum of two years follow up
Number of Prosthetic Joint Infections (with or without the need for further surgery) according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).
Need for Revision Surgery
时间窗: since 01.01.2013 with a minimum of two years follow up
Number of Revision Surgeries (for all causes, PJI and aseptic failure) according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).
Survival rates of different subgroups among each PJI definition
时间窗: since 01.01.2013 with a minimum of two years follow up
Survival rates of different subgroups among each PJI definition ("Infection Unlikely", "Infection Confirmed", "Infection Likely (but nor confirmed)"
Survival rates between different definitions
时间窗: since 01.01.2013 with a minimum of two years follow up
Survival rates between different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).
次要结局
未报告次要终点