A Randomized Controlled Trial to Evaluate the Effectiveness of Cryocompression After Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery
研究概览
简要总结
The overall aim of this study is to evaluate the effectiveness of a cryocompression device after total knee arthroplasty (TKA) compared to standard therapy.
详细描述
The aim of this study is to investigate the effect of cryocompression after total knee arthroplasty (TKA) compared to a control group without cryocompression. The effect on the following parameters will be evaluated: knee and osteoarthritis outcome score (KOOS), patient satisfaction, knee girth, skin temperature, knee range of motion, morphine consumption, pain perception, the length of stay, the 10-metre walk test and the timed-up-and-go.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Diagnosed Arthritis of the Knee
- •Planned implantation of a primary total knee arthroplasty by the Regionalspital Surselva AG
排除标准
- •Decompensated hypertension in the affected area
- •Acute inflammatory phlebitis in the affected area
- •Patients with acute paroxysmal cold hemoglobinuria, or cryoglobulinemia
- •Significant vascular disruption in the affected area
- •History of pulmonary embolism or risk factors for deep vein thrombosis or pulmonary embolism in the affected area
- •No increased venous or lymphatic return in the affected leg is desired due to e.g. carcinoma
- •Raynaud's disease
- •Hypersensitivity to cold
- •Fear of cold/compression
结局指标
主要结局
Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Knee girth
Consumption of morphine
时间窗: 6 weeks after surgery
Consumption of morphine in number of pills
Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Range of motion of the knee
Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems
Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
Skin temperature of the knee
Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
A general physical performance test used to assess mobility, balance and locomotor performance
Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
To measure the intensity of pain
Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery
时间窗: preoperatively, postoperatively (4th day) and 6 weeks after surgery
To assess walking speed in meters per second over 10 metres
Length of stay
时间窗: 6 weeks after surgery
Length of stay in the hospital in days
Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation
时间窗: each day of hospitalisation
To measure the patient satisfaction of the cryocompression therapy from 0 to 10
次要结局
未报告次要终点