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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Operated limb edema
Study Overview
Brief Summary
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).
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •total hip arthroplasty, scheduled surgery
- •aged between 50 and 80 at the time of recruitment
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.
Arms & Interventions
Pneumatic Compression (PC)
The PC will undergo two daily 30-minute sessions of sequential pneumatic compression.
Intervention: PC Pneumatic compression (Device)
Antithromboembolic exercises (AE)
AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes.
Intervention: AE Antithromboembolic exercises (Other)
Outcomes
Primary Outcomes
Operated limb edema
Time Frame: 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
Secondary Outcomes
- Operated lower limb range of motion(Ten Days)
- Functional capability(Ten Days)
- Perceived Pain(Ten days)
Investigators
Luca Marin
Principal Investigator
University of Pavia