Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concentration of Antibiotics in Cementless Knees Post op
研究概览
简要总结
The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.
详细描述
Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Age over 18
- •Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis
排除标准
- •Diminished mental capacity
- •Vancomycin allergy
- •Tobramycin allergy
- •Chronic kidney disease stage III and stage IV
研究组 & 干预措施
Vancomycin Powder
All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.
干预措施: Vancomyscin (Device)
Tobramycin Powder
All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.
干预措施: Tobramycin Powder (Drug)
结局指标
主要结局
Concentration of Antibiotics in Cementless Knees Post op
时间窗: 1 hour, 4 hours, and 24 hours
1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.
次要结局
- Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.(1 hour, 4 hours, and 24 hours)