Investigation on Diagnostic Criteria for Septic Arthritis：a Multi-center Nested Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- ESR
研究概览
简要总结
Septic arthritis (SA) is a rare but highly disabling disease. The ideal diagnosis criteria is not well established. There is an urgent need to establish golden standard for diagnosis.
详细描述
Septic arthritis (SA) is a rare but highly disabling disease. Epidemiologic studies have documented an incidence of 0.9-1.3 per 100,000 [1, 2]. The treatment is challenging and the ideal diagnosis criteria is not well established. The specific tactics employed by relevant researches varied widely [3-6]. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss [2]. Therefore, there is an urgent need to establish golden standard for diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •admission to orthopaedics
- •complete data
排除标准
- •Accompanied with fracture
- •Accompanied with other infections
- •Accompanied with immune system diseases
结局指标
主要结局
ESR
时间窗: preoperatively
erythrocyte sedimentation rate (ESR)
joint swelling and redness
时间窗: preoperatively
to check whether there is joint swelling and redness by visual inspection and palpation
WBC counts
时间窗: preoperatively
white blood cell (WBC) counts
%PMN
时间窗: preoperatively
percent of polymorphonuclear leukocytes (%PMN)
positive MR findings
时间窗: preoperatively
to determine whether there are positive MR findings, such as joint effusion, cartilage damage, etc.
positive pathological findings
时间窗: intraoperatively
determined by 5 or more neutrophils per high-power field on histopathologic examination
CRP
时间窗: preoperatively
concentration of C-reactive protein (CRP)
Albumin
时间窗: preoperatively
concentration of albumin
Globulin
时间窗: preoperatively
concentration of globulin
Body temperature
时间窗: preoperatively
to check whether there has been a fever (\>37.2°C) previously or now by medical history consultation and physical examination
sinus tract
时间窗: preoperatively
to check whether there is any sinus tract by visual inspection
positive X-ray findings
时间窗: preoperatively
to determine whether there are positive X-ray findings, such as bone destruction, narrowing of the joint space, etc.
positive culture
时间窗: preoperatively
determined by a bacterial growth when culture of blood or joint fluid in agarose
次要结局
未报告次要终点