Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Antibiotic concentration
研究概览
简要总结
This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.
排除标准
- •Withdrawal of informed consent,
- •allergy to any of the study medications or to bone cement,
- •use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
- •high risk of infection,
- •history of peri-articular injections for multimodal pain management.
研究组 & 干预措施
Group A (Control-negative group)
include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic
干预措施: total knee arthroplasty (Procedure)
Group B (tobramycin group)
includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
干预措施: total knee arthroplasty (Procedure)
Group B (tobramycin group)
includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
干预措施: Tobramycin (Drug)
Group C (gentamicin group)
Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
干预措施: total knee arthroplasty (Procedure)
Group C (gentamicin group)
Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
干预措施: Gentamicin (Drug)
Group D (Control-positive group)
Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement
干预措施: total knee arthroplasty (Procedure)
Group D (Control-positive group)
Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement
干预措施: Antibiotic cement spacer (Device)
结局指标
主要结局
Antibiotic concentration
时间窗: 24 hours
To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid
次要结局
未报告次要终点