NCT05461651招募中不适用
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
Centre of Postgraduate Medical Education2 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Incidence of surgical site infection
研究概览
简要总结
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.
详细描述
Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gosnartrosis
排除标准
- •no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score > II
结局指标
主要结局
Incidence of surgical site infection
时间窗: up to 24 months
The incidence of deep and superficial SSI after knee arthroplasty
次要结局
- Blood test - CRP(12 weeks,)
- Blood test - IL 6(12 weeks,)
- Functional tests(24 months)
- Knee injury and Osteoarthritis Outcome Score(24 months)
- 36-Item Short Form Survey(24 months)
- Visual analog Scale(24 months)
- Tegner Lysholm Knee Scoring Scale(24 months)
研究者
Rafał Kamiński
Professor
Centre of Postgraduate Medical Education
研究点 (2)
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