Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Early functional outcomes
研究概览
简要总结
Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.
详细描述
The aim of this protocol is to compare standard care and fast track total knee arthroplasties. The fast track care consists of:
- preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
- antalgic protocol administered only orally
- early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position.
The standard care consists of usual antalgic and physiotherapy post-operative care:
- Antalgic protocol consist in intravenous drugs
- the first physiotherapy session is the day after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty
- •* BMI \< 32
- •* Time up ang go test \13 g/dl
- •* patients eligible for spinal anesthesia
- •* presence of a care-giver
排除标准
- •psychiatric diseases
- •preoperative use of crutches
- •preoperative HB < 13 g/dl
研究组 & 干预措施
fast track total knee arthroplasties
patients treated using fast track care protocol
干预措施: fast track care protocol (Procedure)
standard care total knee arthroplasties
patients treated using standard care protocol
干预措施: standard care protocol (Procedure)
结局指标
主要结局
Early functional outcomes
时间窗: Third post operative day
Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day. This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results.
次要结局
- hospital staying(Third day after surgery)
- Number of transfusions(Third day after surgery)
- Analgesic consumption(Third day after surgery)
- Knee Society Score (KSS) at third month(third month after surgery)
- Knee Society Score (KSS) at sixth month(sixth month after surgery)
- Knee Society Score (KSS) at twelfth month(twelfth month after surgery)
- Oxford Score (OS) at 6 weeks(6 weeks after surgery)
- Incidence of early major complications(Third day after surgery)
- Oxford Score (OS) at sixth month(sixth month after surgery)
- Knee Society Score (KSS) at 6 weeks(6 weeks after surgery)
- Oxford Score (OS) at third month(third month after surgery)
- Oxford Score (OS) at twelfth month(twelfth month after surgery)