A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood
研究概览
简要总结
Periprosthetic joint infection (PJI) is a national health crisis and leads to very poor outcomes for patients undergoing elective joint replacement. Within the realm of elective total knee arthroplasty (TKA), various methods of infection prophylaxis are in place. These include sterile precautions, would/tissue handling, and antibiotic prophylaxis. With respect to the latter, various approaches have been utilized including intravenous and intraosseous administration of vancomycin, preoperatively. Intraosseous administration does require another wound and a specific device to administer. The investigators proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.
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
- 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
- •Any patient over the age of 18 years of age receiving treatment at UC San Diego Health
- •Undergoing primary unilateral TKA
- •Ability to provide consent
排除标准
- •previous surgery on the knee (with the exception of arthroscopy)
- •BMI > 35
- •contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc)
- •diabetics with A1c>7.5% (unless controlled fructosamine)
- •immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations)
- •no history of active infections
- •no history of chronic kidney disease
研究组 & 干预措施
Intraosseous (IO) Vancomycin
500mg dose Vancomycin (in 100mL saline)
干预措施: Vancomycin (Drug)
Intraarticular (IA) Vancomycin
500mg dose Vancomycin (in 30mL saline)
干预措施: Vancomycin (Drug)
结局指标
主要结局
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood
时间窗: Intraoperative
次要结局
未报告次要终点
研究者
Scott Ball, MD
Clinical Professor
University of California, San Diego
