Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
研究概览
简要总结
The purpose of the study is to characterize and quantify the level of antibiotics eluted from antibiotic laden cement after primary cemented total knee arthroplasty.
Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria.
Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.
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 be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.
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
- Single (Participant)
盲法说明
patient will not know which antibiotic cement group they are in
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
- •Age over 18
- •Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.
- •Primary diagnosis of knee osteoarthritis
排除标准
- •Diminished mental capacity
- •Vancomycin allergy
- •Tobramycin allergy
- •Patient history requiring IV administration of vancomycin or tobramycin perioperatively
- •Chronic kidney disease stage III and stage IV
研究组 & 干预措施
Pre-mixed tobramycin
patients will receive pre-mixed tobramycin cement
干预措施: pre-mixed tobramycin (Device)
hand mixed tobramycin
patients will receive hand mixed tobramycin cement
干预措施: hand mixed tobramycin (Drug)
hand mixed vancomycin
patients will receive hand mixed vancomycin cement
干预措施: hand mixed vancomycin (Drug)
hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
干预措施: hand mixed vancomycin (Drug)
hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
干预措施: hand mixed tobramycin (Drug)
结局指标
主要结局
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
时间窗: 24 hours
We wanted to measure the effect of elution level of vancomycin and tobramycin together
次要结局
未报告次要终点