Airflow and Hip Prosthesis Infections: A Registry Study Comparing Laminar vs. Turbulent Flow in the Danish Hip Arthroplasty Register.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110,000
- 主要终点
- Revisions due to periprosthetic joint infections at 365 days after surgery
研究概览
简要总结
Background: During hip replacement surgery, there is a risk that bacteria in the operating room can cause an infection. To try and reduce this risk, some operating rooms use a special system called laminar airflow (LAF), which reduces the number of bacteria in the air. However, it's not clear if LAF is better than the older system, called turbulent airflow (TAF), for preventing infections.
Aim: The aim of this study is to compare the two airflow systems and see if LAF is better at preventing infections after hip replacement surgery.
Methods: Information from a database containing all hip replacement surgeries done in Denmark between 2010 and 2020 is examined. The number of infections that occur in surgeries done with LAF, which reduces the number of bacteria in the air during surgery, is compared to the number of infections that occur in surgeries done with TAF. To make the results more credible, the data from the hip register was combined with data from the bacterial cultures taken during surgery.
Use and relevance: Infections after hip replacement surgery can be very serious and expensive to treat. Hospitals need to choose the best airflow system to help prevent these infections. This study is important because it gives more accurate information about which system is better at preventing infections and can help hospitals make better choices when they are designing or renovating operating rooms.
详细描述
Rationale and background
Prosthetic joint infection (PJI) is one of the most feared complication after total hip arthroplasty (THA), with increased mortality and morbidity, as well as a significant cost for society. Since the 1960s, in addition to systemic prophylactic antibiotics and antibiotic-laden bone cement, efforts have been made to make the air in the operating rooms (OR) as clean as possible with filtering and replacement of the air .
This has led to the official current PJI incidence of 0.57-0.80 % in the first year after surgery according to the Danish Hip Arthroplasty Register (DHR) and the Swedish Hip Arthroplasty Register (SHAR), even though the true incidence of PJI probably is about 40 % higher, due to under-registration in the registers following revision surgery .
The risk of PJI is potentially affected by contamination in the OR, patient related risk factors and prosthesis factors. The prosthesis factors include type of implant and implant fixation method. Cemented implants have a lower overall revision rate, although the results are not unanimous when it comes to revision due to PJI.
The risk of contamination in the OR is affected by the cleanliness of the air. There are two different types of ventilation systems used to achieve a clean environment in an OR. The first is turbulent airflow (TAF), where the air is continuously replaced with filtered ultra-clean air that trickles down from the ventilation shaft. The second is laminar airflow (LAF) where the ultra-clean air flows in a single direction, with the goal to prevent particles carrying bacteria, that are floating in the air, to land on the patient or sterile equipment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary Total hip arthroplasty performed in Denmark between 2010 and 2020
排除标准
- •Tumor or metastasis as indication for total hip arthroplasty
结局指标
主要结局
Revisions due to periprosthetic joint infections at 365 days after surgery
时间窗: t=365 days
PJI is defined as revision with 2 or more positive biopsies with the same bacteria in MiBa or revision reported to DHR as PJI at t=365 days.
Revisions due to periprosthetic joint infections at 90 days after surgery
时间窗: t=90 days
PJI is defined as revision with 2 or more positive biopsies with the same bacteria in MiBa or revision reported to DHR as PJI at t=90 days.
次要结局
- Revisions due to aseptic loosening at 90 days after surgery(t=90 days)
- Any revision at 90 days after surgery(t=90 days)
- Revisions due to aseptic loosening at 365 days after surgery(t=365 days)
- Any revision at 365 days after surgery(t=365 days)
研究者
Jacob Moflag Svensson, MD
MD
University Hospital Bispebjerg and Frederiksberg
