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临床试验/NCT05060952
NCT05060952招募中不适用

Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Diagnostic accuracy of synovial fluid calprotectin

研究概览

简要总结

A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • scheduled arthroplasty exchange for any of the following reasons:
  • infection
  • loosening
  • instability
  • malalignment
  • periprosthetic fracture

排除标准

  • acute prosthetic joint infection

结局指标

主要结局

Diagnostic accuracy of synovial fluid calprotectin

时间窗: Intraoperatively

The level of synovial fluid calprotectin measured in joint fluid aspirate as a diagnostic test for prosthetic joint infection. The accuracy is calculated by comparing its results with the International Consensus Meeting (ICM) on prosthetic joint infection criteria of 2018.

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Suren

Associate Professor

Technical University of Munich

研究点 (1)

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