Clinical trial NCT05312060: Pneumatic Compression Versus Anti-thromboembolic Exercises for Patients Undergoing Total Hip Arthroplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edema Leg
Keywords: Total hip arthroplasty
functional capabilities
Pneumatic compression
antithromboembolic exercises
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

* 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Operated limb edema
timeFrame: Ten days
Secondary outcomes:
measure: Perceived Pain
timeFrame: Ten days
measure: Functional capability
timeFrame: Ten Days
measure: Operated lower limb range of motion
timeFrame: Ten Days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituto di Cura Città di Pavia
Study officials:
affiliation: University fo Pavia
name: Luca Marin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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