Pneumatic Compression Versus Anti-thromboembolic Exercises: Effects on Edema of the Lower Limbs and the Outcomes of Patients Undergoing Total Hip Arthroplasty: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Operated limb edema
研究概览
简要总结
This study is a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards.
The main objective is to compare the reduction of postoperative edema following Total Hip Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic compression (PC, experimental group) and patients undergoing postoperative treatment with antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post treatment variations of joint function measurements (joint excursion), referred pain and functional capabilities.
48 patients will meet the criteria listed below will be recruited.
Inclusion criteria:
- total hip arthroplasty under election regime
- aged between 50 and 80 at the time of recruitment, both sexes.
Exclusion criteria:
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent. Participants will be assigned, through a block randomization, to one of the two study groups: experimental group will undergo pneumatic compression treatment (PC), control group will perform antithromboembolic exercises (AE).
For both, the treatment will last 10 working days, starting from the first post surgery day (T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy, graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
Assessments of edema, joint range of motion, pain and functional capabilities will be made at T0 and at the end of the treatment (T1).
详细描述
This study is a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards.
To compare the reduction of postoperative edema following Total Hip Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic compression (PC, experimental group) and patients undergoing postoperative treatment with antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post treatment variations of joint function measurements (joint excursion), referred pain and functional capabilities.
48 patients will be recruited at the Department of Orthopedic Surgery of the City of Pavia, University Hospital.
Participants will be assigned, through a block randomization, to one of the two study groups: experimental group will undergo pneumatic compression treatment (PC), control group will perform antithromboembolic exercises (AE). For both, the treatment will last 10 working days, starting from the first post surgery day (T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy, graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
At T0 and at the end of the treatment (T1) the following assessments of the operated limb will be carried out:
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total hip arthroplasty, scheduled surgery
- •aged between 50 and 80 at the time of recruitment
排除标准
- •obesity (BMI> 30);
- •other orthopedic or neurological pathologies that modify walking ability;
- •pathologies that modify balance (neurological and / or vestibular);
- •contraindications to the use of the medical equipment used in the study;
- •inability to understand and sign informed consent.
结局指标
主要结局
Operated limb edema
时间窗: Ten days
circumference of the distal third of the thigh * circumference of the proximal third of the leg circumference of the distal third of the thigh * circumference of the proximal third of the leg thigh and leg circumference
次要结局
- Operated lower limb range of motion(Ten Days)
- Functional capability(Ten Days)
- Perceived Pain(Ten days)
研究者
Luca Marin
Principal Investigator
University of Pavia