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临床试验/NCT03627000
NCT03627000已完成不适用

Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection

Hospices Civils de Lyon0 个研究点目标入组 114 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114
主要终点
rate of treatment failure

研究概览

简要总结

This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done.

A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation.

The aim is to determine the microbiological epidemiology in patients experiencing failure following reimplantation to establish, based on the drug susceptibilities, which cement could be the most active.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with prosthetic joint infection having had a 2-step exchange at least from the reimplantation, between 2013 and 2015.

排除标准

  • 未提供

结局指标

主要结局

rate of treatment failure

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

次要结局

  • rate of clinical failure(Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption))
  • rate of bacteria involved in microbiological failure(Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugénie MABRUT

Clinical Research Assistant

Hospices Civils de Lyon

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