Multiple Doses Versus Single Dose of Cefazolin to Prevent Periprosthetic Joint Infection After Revision Arthroplasty: a Multicenter Open-label, Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- Success rate of revision arthroplasty
研究概览
简要总结
The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question[s] it aims to answer are:
- Is an extended regimen compared to a single dose of cefazolin associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee?
- What are the incidence, risk factors, treatment outcome and prognosis of surgical site infections and periprosthetic joint infection during follow-up?
- What is the safety and tolerance of the antimicrobial prophylaxis regimens used?
- What are the antimicrobial susceptibility patterns of micro-organisms causing PJI during follow-up?
- What is the patient' physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty, using patient related outcome measurements (PROMS)?
[question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].
详细描述
Periprosthetic joint infection (PJI) is an important complication of total joint arthroplasty of the hip and knee and occurs in 1-2% after primary arthroplasty and in 10-15% after revision arthroplasty. To prevent a PJI, peri-operative antibiotic prophylaxis is given. There's inadequate evidence for a recommendation about the optimal duration of prophylaxis, especially in revision arthroplasty. The aim of this multicenter open-label, randomized controlled trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. Patients will be recruited at the orthopedic departments of two Dutch hospitals, University Medical Center Radboudumc Nijmegen (Radboudumc) and Sint Maartenskliniek in Nijmegen (SMK). Patients will be included if they will undergo revision arthroplasty of the hip or knee, with exclusion of patients with a proven PJI at baseline. A total of 780 subjects will be randomized between 2 prophylactic strategies: A) Cefazolin at a single dose of 2 grams intravenously 15-60 minutes before incision; B) Cefazolin at a dose of 2 grams intravenously 15-60 minutes before incision, followed by cefazolin 1 gram intravenously t.i.d. until five days post-surgery. The primary endpoint is the difference in proportion of infectious-free implant survival between both groups within 1 year of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Planned revision arthroplasty of the hip or knee prosthesis (index revision arthroplasty), with revision of one or more fixed components.
排除标准
- •If the index revision arthroplasty has been cancelled.
- •Revision of single mobile parts only.
- •PJI on baseline, based on 'definite infection' score according to the Philadelphia consensus definition 2018
- •PJI on baseline, based on a positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacterales, Pseudomonas spp, Acinetobacter spp, Candida spp).
- •Contraindication to cefazolin:
- •a. Previous allergic reaction according to the criteria in Appendix A. b. Severe kidney disease defined as eGFR <10 ml/min. f. Antimicrobial treatment within 3 days prior to index revision arthroplasty. g. Subjects who are currently enrolled in investigational immunosuppressive drug trials.
- •h. Subjects who are unable to provide informed consent.
研究组 & 干预措施
extended cefazolin prophylaxis
5 days of cefazolin prophylaxis start dose 2000mg followed by 14 doses of 1000mg
干预措施: Cefazolin (Drug)
结局指标
主要结局
Success rate of revision arthroplasty
时间窗: 1 year after revision arthroplasty
1. Implant retention during follow-up, 2. No 'definite infection' score for PJI according to the Philadelphia consensus definition 2018 during follow-up 3. No PJI based on positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacteriaceae, Pseudomonas spp, Acinetobacter spp, Candida spp) during follow-up. 4. No more than 4 consecutive weeks of systemic antimicrobial therapy for any reason during follow-up.
次要结局
- resistance rate of causative of SSI/PJI to cefazolin(1 year after revision arthroplasty)
- incidence periprosthetic joint infection(1 year after revision arthroplasty)
- The number of repeated surgeries.(1 year after revision arthroplasty)
- Reason repeated surgery(1 year after revision arthroplasty)
- adverse drug events(1 year after revision arthroplasty)
- Risk factors associated with SSI and PJI: BMI, age, age of implant before revision,(1 year after revision arthroplasty)
- Patient related outcome measurements(1 year after revision arthroplasty)
- incidence surgical site infections(1 year after revision arthroplasty)
- Implant survival at the end of the study.(during inclusion of the study)