Effect of Compression Therapy on Postoperative Swelling and Pain, Among Patients With a BMI ≥30 kg/m2, After Total Knee Arthroplasty: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Swelling of the knee after operation
研究概览
简要总结
The number of severely obese patients who has knee replacement surgery is rising. Obesity increases the risk of the postoperative swelling. A complication which can cause pain and discomfort as well as complicate and prolong rehabilitation.
The aim of the present pilot study is to examine the effect of a compression stocking on postoperative swelling and pain among patients with a BMI ≥30 kg/m2, after total knee arthroplasty. The hypothesis is that the use of a medical elastic compression stocking for 14 days postoperatively may reduce postoperative swelling by two cm.
The pilot study will furthermore provide useful information for feasibility which will be used to decide whether or not a larger study should be initiated.
详细描述
In Denmark approximately 9000 knee replacements were performed in 2015. Almost 7000 of the procedures performed were total knee arthroplasties.
A total knee arthroplasty is a common procedure performed as treatment for knee arthritis.
In 2015, 39,9% of the patients in Denmark who had knee replacement surgery were severely obese with a BMI ≥30 kg/m2.
The percentage of severely obese patients who has knee replacement surgery is rising and studies have shown that obesity increases the risk of postoperative complications.
A danish cross-sectional study found that swelling with a prevalence of 90,7% was the most frequent patient-reported complication after knee arthroplasty. A common postoperative complication after total knee arthroplasty and severe obesity increases the risk of postoperative swelling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Planned for total knee arthroplasty
- •BMI ≥30 kg/m2, aged 18 or older
- •Speaks, reads and understands Danish
- •Written informed consent.
排除标准
- •Peripheral Arterial Disease
- •Arterial insufficiency
- •No palpable puls at the arteria dorsalis pedis
- •Severe atherosclerosis
- •Leg ulcers
- •Skin disease
- •Fragile "tissue paper" skin
- •Neuropathy or other cause of sensory impairment
- •Allergy to the stocking material
- •Massive leg edema or pulmonary edema from congestive cardiac failure,
- •Deformity of the leg or unusual leg shape or size preventing correct fit
- •Patient that cannot cooperate. For example does not understand the concept of Visual Analogue Scale (VAS) or is not able to use the compression stocking
- •Pregnancy
研究组 & 干预措施
compression stocking
The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery.
干预措施: Thigh compression stocking (Device)
Conventional treatment
The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery.
结局指标
主要结局
Swelling of the knee after operation
时间窗: Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery
Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.
次要结局
- Swelling of the calf after the operation.(Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery)
- Swelling of the ankle after the operation.(Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery)
- Pain after the operation.(Assessment of pain from baseline and 1, 2, 14 days after surgery)
研究者
Linda Mie Christensen
Nurse
Naestved Hospital