Out Patient Surgery for Total Knee and Hip Replacement and Unicompartmental Knee Replacement - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Fulfilment of same day discharge criteria
研究概览
简要总结
The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The design is as an observational prospective study, evaluating patients that fulfil discharge criteria on the day of the surgery. The investigators will further evaluate safety aspects, such a early morbidity and mortality, as well as patient satisfaction.
详细描述
Fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and Unicompartmental Knee arthroplasty (UKA) with length of stay (LOS) of 1-3 is a well established concept for treating hip and knee osteoarthritis, resulting in short reconvalescence, high patient satisfaction, and an excellent safety profile (lower or similar mortality / morbidity compared to conventional pathways with longer LOS). LOS have been significantly reduced during the past decade, and several centers have published even shorter hospitals stays: <24 hours, with patients staying the night at the hospital but also outpatient surgery, with patients being discharged on the day of surgery.
However, these proposed pathways with extremely short LOS, are performed on very selected patients, with few details on patient satisfaction, outcome and most important patient safety. Therefore, it is not possible to draw conclusions on feasibility of outpatient THA, TKA and UKA surgery in a general and unselected population. Further on, there is a need for investigation of safety aspects of outpatient surgery in respect to mortality, morbidity, patient satisfaction and patient reported outcomes. As some, most likely healthy and younger, patients might benefit from outpatient surgery - eg discharge on the day of surgery, while others might not; the first step is to identify the patients that are suitable for outpatient THA and TKA surgery and investigate the safety aspects in respect to mortality, morbidity, patient satisfaction and patient reported outcomes.
Aim:
The aim of this study is to investigate "feasibility" and "safety" of outpatient THA, TKA and UKA surgery, respectively as follows:
Feasibility
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
- •Unselected primary THA/TKA
- •ASA score I/II
- •Can be operated as #1 or #2
- •No sleep apnea treated with CPAP
排除标准
- •Selected primary THA/TKA
- •ASA score > 2
- •Cannot be operated as #1 or #2
- •Sleep apnea treated with CPAP
结局指标
主要结局
Fulfilment of same day discharge criteria
时间窗: 12 hours
On the days of surgery following discharge criteria are continuously evaluated: * \< 500 ml intraoperative blood loss * Back in patient ward \<15.00 * Received instruction from physiotherapist and is safely mobilized * No clinical symptoms of anemia * Pain \<3 while resting, \<5 during exercise. * Spontaneous urination * Post op x-ray is performed and approved * Relatives or friends with patient for \>24 hours * Motivated and accepts same day discharge * Standard discharge criteria fulfilled * Can be discharged before 20.00 If all of the above criteria are fulfilled, the patient can be discharged
次要结局
- Patient reported satisfaction(3 months)
- Use of rescue morphine(7 days)
- Readmissions(3 months)
研究者
Kirill Gromov
MD, PhD
Hvidovre University Hospital