Pneumatic Compression Versus Anti-thromboembolic Exercises for Patients Undergoing Total Hip Arthroplasty

Study Overview
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Brief Summary
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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
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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: circumference of the distal third of the thigh circumference of the proximal third of the leg range of motion of the knee flexion range of motion of the ankle dorsiflexion The following assessments will also be carried out: perceived pain, with the Numeric Rating Scale of Pain (NRS) functional capability, with 20 m walk test (20 m). Walking autonomy will be carried out at T1 with the 6 minutes walking test (6MWT). STATISTICAL ANALYSIS Quantitative variables will be described with mean and standard deviation if normally distributed, with median and interquartile range if not normally distributed. Categorical variables will be expressed with counts and percentages. Continuous variables will be compared between the two groups with Student's t test or with the analogous non-parametric Mann-Whitney test, considering the normality of the distribution (evaluated with graphical methods or with the Shapiro-Wilk test). Possible associations between categorical variables will be evaluated with Pearson's chi-square test or with Fisher's exact test. All tests will be two-tailed; the level of significance is set at alpha 0.05 (statistical significance if p value <0.05).

Official Title
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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

Conditions
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Edema Leg

Intervention / Treatment
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* Device: PC Pneumatic compression
* Other: AE Antithromboembolic exercises


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic Compression (PC)<br>The PC will undergo two daily 30-minute sessions of sequential pneumatic compression. | Device: PC Pneumatic compression<br>* Pneumatic compression of the operated limb<br>* Other names: I-Press®, I-Tech Medical Division, Martellago, Italy;|
| Active Comparator: Antithromboembolic exercises (AE)<br>AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. | Other: AE Antithromboembolic exercises<br>* Exercises for the edema<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operated limb edema | 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 | Ten days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Pain | Perceived pain, assessed with Numeric Rating Scale. Where 0 is no pain and 10 is the maximum pain felt | Ten days | 
| Functional capability | Walking capability, assessed with 20 meters walking test | Ten Days | 
| Operated lower limb range of motion | Knee and ankle range of motion | Ten Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, functional capabilities, Pneumatic compression, antithromboembolic exercises