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
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
- 否
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
研究点 (1)
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