Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,948
- 试验地点
- 2
- 主要终点
- Infection
研究概览
简要总结
Prospective randomized study in cemented primary total knee arthroplasty. In one group the cement used was standard cement, without any antibiotics and in the other group the cement used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in all cases. The main variable was the presence of infection according to the Center of Disease Control criteria with a minimum of 12 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Primary total knee replacement. Both genders. No age limits.
排除标准
- •Allergy to erythromycin or colistin. Previous infection in the knee.
结局指标
主要结局
Infection
时间窗: The minimum follow-up is 12 months.
Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.
次要结局
未报告次要终点
研究者
Pedro Hinarejos
PhD
Parc de Salut Mar