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临床试验/NCT05265598
NCT05265598已完成不适用

Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
试验地点
1
主要终点
number of bacteria

研究概览

简要总结

This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

详细描述

Implant associated infections in orthopaedics and trauma surgery are a well-known and feared complication. Prosthetic-joint infection (PJI) is caused by a biofilm which is located atop the surface of the implant which as growing with the duration of the PJI. This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

研究设计

研究类型
Observational
观察模型
Cohort
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 revision surgery of hip, knee and shoulder arthroplasties operated at the university hospital of Basel between 2011 and 2021,
  • patients who had a PJI as a suspected diagnosis and
  • have microbiological cultures from sonication fluid from removed prosthesis.

排除标准

  • patients in the database who
  • have non-bacterial microbiological positive cultures (e.g. fungal infection) and
  • have not received a sonication of the removed prosthesis during the diagnostic process

结局指标

主要结局

number of bacteria

时间窗: one time assessment at baseline

number of bacteria detected during revision surgery will be taken from the sonication fluid and the quantitative analysis of the microbiological samples

duration of the infection

时间窗: one time assessment at baseline

duration of the infection

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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