Incidence of Modifiable Risk Factors and Their Association With Infections in Primary Elective Arthroplastic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,484
- 试验地点
- 2
- 主要终点
- Number of Participants with Surgical site infection
研究概览
简要总结
Hip and knee total joint arthroplasty are one of the most frequently performed surgery worldwide. However, prosthetic joint infection remains a devastating complication of them, associated with severe morbidity, increased mortality and huge costs. Several underlying medical conditions that have been identified as independent risk factors for development of prosthetic joint infection.
The hypothesis of the study is that by utilizing the waiting time for operation (6 -12 months) to improve the state of known modifiable risk factors the frequency of prosthetic joint infection may be decreased. This optimization was established with co-operation between hospital and primary care.
Therefore a prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty of either hip or knee was planned.
The control arm was included one week prior to surgery at the anesthesia preoperative assessment outpatient clinic and were operated on between 27/8 2018 and 7/9 2020 and consists of 738 patients.
Inclusion of the interventional arm happened at the orthopedic outpatient clinic from 2/1 2019 - 30/1 2021, 6 -12 months prior to surgery and an appointment with their general physician ensured within 3 weeks for further evaluation. Enlisted have been 1010 patients, operation of them started 25/3 2019 and to date 710 patients have been operated on, but due to delays caused by Covid-19 (SARS-CoV-2) surgery of them is still ongoing.
The effect of the intervention will be evaluated with by comparison of patient characteristics and frequency of surgical site and prosthetic joint infections before and after.
详细描述
Hip and knee total joint arthroplasty allow effective treatment of disability and pain due to joint destruction, and are one of the most frequently performed surgery worldwide. Surgical-site infections remain a serious complication of total joint arthroplasty, occurring in 1-7% of cases. The most severe form of surgical site infection, prosthetic joint infection is a devastating complication associated with severe morbidity, increased mortality and huge costs. There are several underlying medical conditions that have been identified as independent risk factors for development of prosthetic joint infection that might be improved before operation, called modifiable risk factors, namely pre-operative anemia, obesity, diabetes, poor nutritional status, smoking and physical activity.
The hypothesis of the study is that by utilizing the waiting time for operation (6 -12 months) to improve the state of known modifiable risk factors the frequency of prosthetic joint infection may be decreased. This optimization was established with co-operation between hospital and primary care.
Therefore a prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty of either hip or knee, comparing patient characteristics and outcome was planned.
Control Arm: Inclusion of 'usual care' patients started 20/8 2018 one week prior to surgery at the anesthesia preoperative assessment outpatient clinic. At that point in time there were 561 patients already on a waiting list for either hip or knee arthroplastic surgery. The next four months to 31/12 2018 66 more patients were added to the study. After 1/1 2019 (when collection to the interventional part had started) further 111 patients were added (15% of the 'usual care' group). These were patients where it had been missed to offer or had declined participation in the interventional arm of the study at the orthopedic outpatient clinic and when discovered at the preoperative clinic one week prior to surgery were offered participation in the 'usual care' arm as they had received traditional preoperative preparation. Operation of these patients started at 27/8 2018 and lasted to 7/9 2020 and consists of total of 738 individuals.
Interventional arm: Inclusion into the interventional arm of the study occurred between 2/1 2019 to 30/1 2021, 6 -12 months prior to surgery at the orthopedic outpatient clinic, ensuring an appointment with the patient general physician within 3 weeks afterwards to further analyze results of blood test and assess if further tests, treatments or consultation of other specialists would be preferred to optimize their condition. Patients at extremes of BMI also had a nutritional advice at the hospital. Enlisted have been 1010 patients, operation of them started 25/3 2019 and to date 710 patients have been operated on, but due to delays caused by COVID-19 (SARS-CoV-2) surgery of them is still ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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 adult patients undergoing elective primary arthroplasty of either hip or knee at Landspitali University Hospital
排除标准
- •Contraindications for operation detected after inclusion. Patients having an operation on another joint within the inclusion period were not re-included.
结局指标
主要结局
Number of Participants with Surgical site infection
时间窗: 2 years postoperatively
Evaluated according to CDC's National Healthcare Safety Network
Number of Participants with Prosthetic joint infection
时间窗: 2 years postoperatively
Evaluated according to CDC's National Healthcare Safety Network
次要结局
- Preoperative anemia according to WHO's definition(At inclusion, 1 week prior to and one day after surgery)
- Smoking(At inclusion, 1 week prior to surgery)
- Physical activity(At inclusion, 1 week prior to surgery)
- Other postoperative complications(up to two years postoperatively)
- Indication of poor glucose control(At inclusion, 1 week prior to and one day after surgery)
- Control of diabetes(At inclusion, 1 week prior to and one day after surgery)
- Nutritional status(At inclusion, 1 week prior to and one day after surgery)
研究者
Sigurbergur Karason
Professor
Landspitali University Hospital
