The Diagnosis Dilemma: Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in the Diagnosis of Chronic Infection in Total Joint Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- serum ESR level
研究概览
简要总结
aim of this study was to determine accuracy of using leucocyte esterase (LE),Erythroscyte sedimentation rates (ESR) and C- Reactive protein (CRP) for diagnosing periprosthetic joint infections (PJI)
详细描述
This study is a Prospective cohort study done on 80 patients and the ICM scoring system was used to assess the status of the patient as regards infection diagnosis as regards the use of Major criteria for infection (Sinus communicating with the joint, 2 positive cultures of the same organism) and minor criteria.
Patients included in the study presented with symptoms and signs and were suspected to have PJI. They had either one of the major criteria for PJI (definite diagnosis) or one or two of the minor criteria. All patients underwent aspiration for synovial LE, cytology, cultures and synovial fluid analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Infected and query infected TJR patients Time of presentation >=4 weeks post op.
排除标准
- •presentation before 4 weeks post op Hematogenous infections Patients with infection elsewhere in the body Patients with inflammatory arthritis as gouty arthritis, SLE and RA.
结局指标
主要结局
serum ESR level
时间窗: at day 0
(mm/hr)(more than or equal 30mm/hr is considered positive/infected{PJI})
serum CRP level
时间窗: at day 0
(mg/L)(more than or equal 10 mg/L is considered positive/infected{PJI})
Synovial Leukocyte esterase dipstick test
时间窗: at day 0
(Plus 1 or more is considered positive/infected{PJI})
次要结局
未报告次要终点