Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Cefazolin Concentration
研究概览
简要总结
The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. The main question it aims to answer is:
• Does intraosseous cefazolin increase antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone? Researchers will compare patients receiving intraosseous cefazolin plus standard intravenous cefazolin to those receiving placebo injection plus standard intravenous cefazolin to see if local antibiotic delivery improves outcomes.
Participants will:
- Receive standard intravenous cefazolin before surgery and either intraosseous cefazolin or placebo
- Provide blood samples before and after antibiotic administration
- Have small tissue samples collected during surgery
- Complete routine postoperative follow-up and outcome assessment for 90 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The subject population will include all patients over the age of 18 scheduled to undergo primary total hip replacement receiving antibiotic prophylaxis for prosthetic joint infection with the institution standards i.v. bolus dose of cefazolin just prior to surgery.
排除标准
- •Patients with reduced renal function (GFR < 30), reduced liver function (AST/ALT >3x upper limit of normal) and weight greater than 120kg will be excluded since these variables may impact cephalosporin pharmacokinetics and pharmacodynamics and confound our results. We will also exclude patients undergoing bilateral total hip arthroplasty. We will also exclude patients with documented cefazolin anaphylaxis, active documented joint infection, history of diabetes, inflammatory arthropathies, patients unable to understand written and/or spoken English and those undergoing revision total hip replacement.
研究组 & 干预措施
Intraosseous Ancef
50cc mixture of sterile injectable normal saline and one gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter prior to incision
干预措施: CeFAZolin 1000 MG (Drug)
Intraosseous Ancef
50cc mixture of sterile injectable normal saline and one gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter prior to incision
干预措施: Saline (0.9%, sterile, for infusion) (Drug)
Intraosseous Saline
50cc sterile injectable normal saline will be administered intra-osseously into the patient's operative side greater trochanter prior to incision
干预措施: Saline (0.9%, sterile, for infusion) (Drug)
结局指标
主要结局
Cefazolin Concentration
时间窗: From administration of intra-osseous ancef to 4 hours post-operatively
Cefazolin concentration in local tissues and serum
次要结局
- Post-operative complications(time of surgery to 90 days from surgery)
研究者
Andrezj Brzezinski, MD
Clinical Assistant Professor
Rutgers, The State University of New Jersey