Intraosseous (IO) Vancomycin Into the Medial Malleolus vs Intravenous (IV) Administration in Revision Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Level of Vancomycin
研究概览
简要总结
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site.
- •Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
- •Age > 18 years.
排除标准
- •Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- •Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure.
- •Any hardware, condition, or anatomic status that prevents the medial malleolus from being a viable intraosseous injection site.
- •Refusal to participate
- •Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
研究组 & 干预措施
Intraosseous (IO) Vancomycin
IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the operating room after sterile preparation of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision.
干预措施: Intraosseous Vancomycin (Drug)
Intravenous (IV) Vancomycin
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for revision total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS).
结局指标
主要结局
Level of Vancomycin
时间窗: During the surgery
The study team will assess the level of vancomycin in the distal femur, proximal tibia, and systemic samples between the intravenous and intraosseous administration groups.
次要结局
未报告次要终点
研究者
Kwan Park, MD
Orthopedic Surgeon
The Methodist Hospital Research Institute