Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- leukocyte esterase level using a leukocyte esterase test strip
研究概览
简要总结
Pediatric joint infections are a common diagnostic dilemma encountered by treating orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in determining the presence of joint infection.
The purpose of this study is to test the usefulness of a chemical test strip to detect infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric patients. The test strip measures an enzyme called leukocyte esterase, which has been shown to be useful in detecting the presence of infection in fluids from other parts of the body. This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for evaluating pediatric joint infections. The hypothesis of the study is that a positive leukocyte esterase test identifies a septic joint in pediatric patients undergoing intraoperative joint aspiration.
详细描述
Pediatric patients requiring an intra-articular joint aspiration for suspected infection or for other reasons will have a leukocyte esterase test performed on fluid removed from the joint. A convenience sample of consecutive patients will be screened according to inclusion/exclusion criteria and enrolled in the study by informed consent. All patients who will be screened for the study will have already been identified as needing an intra-articular joint aspiration in accordance with standard of care. All patients who are enrolled in the study will have the leukocyte esterase test performed on the fluid that is aspirated. Results of the test strip will be recorded.
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
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients at this facility over the age of 3 months and below the age of 18 years who receive an intra-articular aspiration
排除标准
- •Immunocompromised patients
- •Renal failure patients
- •Patients younger than 3 months old
- •Patients 18 years of age or older
- •Volume of aspirate is less than 1.5 mL
结局指标
主要结局
leukocyte esterase level using a leukocyte esterase test strip
时间窗: at the time of an intraoperative joint aspiration
A positive leukocyte esterase test strip will be considered an indicator of a septic joint
次要结局
- baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip(at the time of intraoperative joint aspiration)