Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 2
- 主要终点
- Bone biopsies multisite
研究概览
简要总结
On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic.
Primary:
Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.
Hypothesis:
Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient is more than 18 years old.
- •Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection
- •Patient who do not declined to have his medical records reviewed for research
- •Patient with health insurance
排除标准
- •Patient minor (<18 years).
- •Pregnant or lactating woman.
- •Major under guardianship Patient.
- •Patient deprived of liberty or under court order
结局指标
主要结局
Bone biopsies multisite
时间窗: 4 years
Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.
次要结局
未报告次要终点