跳至主要内容
临床试验/NCT04390607
NCT04390607Unknown不适用

A Research Study to Determine if a Leukocyte Esterase Electrochemical Assay Can be Used as a Marker for Periprosthetic Joint Infection

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
230
试验地点
1
主要终点
Receiver Operating Curve (ROC) analysis

研究概览

简要总结

The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.

研究设计

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

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

  • 1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection

排除标准

  • known active gout flare
  • existing corrosion or metallosis
  • inflammatory arthritis
  • preexisting diagnosis of infection in the same joint
  • patients undergoing second-stage procedure for infection.

结局指标

主要结局

Receiver Operating Curve (ROC) analysis

时间窗: 20 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验