Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee -The KNEETAPE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in leg circumference between day 1 and day 8 (in cm)
研究概览
简要总结
Postoperative edema is a common condition affecting wound healing and function. Traditionally, manual lymphatic drainage and compressive bandages have been employed to reduce swelling. Kinesiotaping might be an alternative approach. To analyse the efficacy, cost-effectiveness, satisfaction, quality of life, functional outcome and and morbidity of the use of kinesiotape for the treatment of postoperative edema after knee replacement surgery, compared to standard manual lymphatic drainage with compression (i.e. compressive stockings or bandages) or sham taping.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be blind to the difference between kinesio- and sham-taping, allowing a double blinded design for the evaluation of the effect of kinesio- versus other tapes. Patient blinding for kinesiotaping versus manual lymphatic drainage is not feasible. The assessment of the primary outcome i.e. the assessment of leg circumference on day 1 and 8 will be performed by a blinded assessor unaware of the treatment allocation.
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
- •Joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery
- •Informed Consent as documented by signature
排除标准
- •Isolated retropatellar replacement or revision surgery for infection
- •Contraindications to manual lymphatic drainage and compression treatment (i.e. compressive stockings or bandages) e.g. heart failure
- •Contraindication to kinesiotape treatment, e.g. hypersensitivity to medical glue
- •Dermatoses at or around the surgical site
- •Suspected or confirmed local infection
- •Participation in another trial with investigational drug within the 30 days preceding and during the present trial
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Inability for consent or assent by the patient, or lack of proxy consent in assenting patients with signs of incapacity.
结局指标
主要结局
Change in leg circumference between day 1 and day 8 (in cm)
时间窗: day 1 postoperatively before start of intervention and every day thereafter for 7 days
Leg circumference will be measured at three levels (joint space, 5cm proximal, 5cm distal) with each three measurements performed by one assessor in all patients and time points. The primary endpoint will be the mean of the three measurements
次要结局
- Change in leg circumference between day 0 and day 8 (in cm)(day 0 preoperative and day 1 postoperatively before start of intervention and every day thereafter for 7 days)
- Change in leg circumference between day 0 and after 6 weeks and 12 weeks (in cm)(day 0 preoperative and after 6 weeks and 12 weeks after start of intervention)
- Change in range of motion of knee (in degree)(day 1 postoperatively before start of intervention and at day 8 after start of intervention and after 6 and 12 weeks after start of intervention)