Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,832
- 试验地点
- 2
- 主要终点
- Acute Infection rate
研究概览
简要总结
The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.
详细描述
Group A: patients receiving single dose of IV cefazolin 10-60 minutes before incision.
Group B: patients receiving a single dose of IV cefazolin 10-60 minutes before incision + a single dose of intra-articular vancomycin powder before articulation (hip or knee) closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Because of the nature of the intervention, it is impossible for the surgeon to be blinded. However, postoperative infection will be diagnosed by an independent co-worker, not involved in the surgery. Patients will be blind as they will not be aware if they had intra-articular vancomycin powder or not
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
- •Standard criteria for the implantation of primary total hip or knee replacement
- •Revision of an aseptic THA or TKA.
- •Adults >18 years of age
- •Diagnosis of Osteoarthrosis (OA), Osteonecrosis (ON), Arthritis; or aseptic loosening of THA/TKA.
- •Subject is willing to consent to participate in the study
- •Subject is available for follow-up through at least 2 years
- •Subject has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk.
- •Subject who are fluent in English and / or French and able to understand their role in the study
排除标准
- •Active, local infection or systemic infection.
- •Participation in any other pharmaceutical, biologic or medical device clinical investigation
- •Subjects with known allergy to vancomycin
- •Subjects unable to consent
- •Patient with skin pathology
结局指标
主要结局
Acute Infection rate
时间窗: 3 months
Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given
次要结局
- Long-term infection rate(2 years)
- Primary vs revision(2 years)
- Surgery time(2 years)
- Risk factor(2 years)
研究者
Benoit Benoit
Orthopaedic surgeon, principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal