Effect of Compliance Controlled Postoperative Compressive Stockings Therapy After Total Knee Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Knee Function KSS 6 weeks postoperative
研究概览
简要总结
Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function.
In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor.
Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.
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 (Care Provider)
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
- •Patients receiving a total knee replacement
- •Written consent of the study participant
排除标准
- •Peripheral arterial disease II, III or IV
- •Diabetes mellitus
- •Systemic inflammatory diseases
- •Benign or malignant neoplasms
- •Revision interventions
- •Right heart failure
- •pulmonary edema
- •Open / chronic skin lesions
结局指标
主要结局
Knee Function KSS 6 weeks postoperative
时间窗: 6 weeks postoperative
Knee Society Score - KSS
Knee Function WOMAC 1 year postoperative
时间窗: 1 year postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Knee Function WOMAC 12 weeks postoperative
时间窗: 12 weeks postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Knee Function KSS 12 weeks postoperative
时间窗: 12 weeks postoperative
Knee Society Score - KSS
Knee Function WOMAC 6 weeks postoperative
时间窗: 6 weeks postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Pain 6 weeks postoperative
时间窗: 6 weeks postoperative
Visuelle Analogskala - VAS (1-10)
Pain 1 year postoperative
时间窗: 1 year postoperative
Visuelle Analogskala - VAS (1-10)
Knee Function KSS 1 year postoperative
时间窗: 1 year postoperative
Knee Society Score - KSS
Pain 12 weeks postoperative
时间窗: 12 weeks postoperative
Visuelle Analogskala - VAS (1-10)
次要结局
- Swelling 1 year postoperative(1 year postoperative)
- Swelling 12 weeks postoperative(12 weeks postoperative)
- Compliance first 6 weeks postoperativ(First 6 weeks postoperativ)
- Swelling 6 weeks postoperative(6 weeks postoperative)