Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systemic Vancomycin Concentrations
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 tourniquetless total knee arthroplasty.
详细描述
Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups.
Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups
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
- Double (Participant, Outcomes Assessor)
盲法说明
- Participant will be blinded to their mode of vancomycin administration.
- Lab will be blinded to which group subject samples come from when doing concentration level testing.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing a primary total knee arthroplasty.
- •Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.
- •Age >18 years.
- •Total knee arthroplasty performed without the use of a tourniquet.
排除标准
- •Previous surgery on the knee (including arthroscopic knee surgery)
- •BMI above 35
- •Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- •Inability to locate the tibial tubercle or administer the IO infusion
- •Refusal to participate
- •Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.
- •Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
研究组 & 干预措施
Intravenous Vancomycin Administration
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary 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).
干预措施: Intravenous Vancomycin (Drug)
Intraosseous Vancomycin Administration
- IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group.
- IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
- Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.
干预措施: Intraosseous Vancomycin Injection (Drug)
结局指标
主要结局
Systemic Vancomycin Concentrations
时间窗: will be recorded day of surgery
Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.
Vancomycin Bone/Tissue Concentrations
时间窗: immediate post-op
Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,
次要结局
- 30 day & 90 day post-operative complication rates(30 days post-op, 90 days post-op)
研究者
Timothy S. Brown
Principal Investigator
The Methodist Hospital Research Institute