NL-OMON22317尚未招募不适用
Multiple doses versus single dose of cefazolin to prevent periprosthetic joint infection after revision arthroplasty: a multicenter open-label, randomized clinical trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Radboudumc
- 入组人数
- 780
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a.Aged 18 years or older.
- •b.Planned revision arthroplasty of the hip or knee prosthesis (index revision arthroplasty), with revision of one or more fixed components.
排除标准
- •a.If the index revision arthroplasty has been cancelled.
- •b.Revision of single mobile parts only.
- •c.PJI on baseline, based on ’definite infection’ score according to the Philadelphia consensus definition 2018
- •d.PJI on baseline, based on a positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacterales, Pseudomonas spp, Acinetobacter spp, Candida spp).
- •e.Contraindication to cefazolin: previous allergic reaction, severe kidney disease defined as eGFR <10 ml/min.
- •f.Antimicrobial treatment within 3 days prior to index revision arthroplasty.
- •g.Subjects who are currently enrolled in investigational immunosuppressive drug trials.
- •h.Subjects who are unable to provide informed consent.
研究者
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