Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection
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
- 否
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
Christian Suren
Associate Professor
Technical University of Munich
