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

Luca Marin

Status: Unknown

Conditions: Edema Leg

Treatments: Other: AE Antithromboembolic exercises; Device: PC Pneumatic compression

Study type: Interventional

Funder types: Other

Identifiers

NCT05312060

0014626/22

Details and patient eligibility

About

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).

Full 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).

Enrollment: 48 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Pneumatic Compression (PC)

Experimental group

Description:

The PC will undergo two daily 30-minute sessions of sequential pneumatic compression.

Treatment:

Device: PC Pneumatic compression

Antithromboembolic exercises (AE)

Active Comparator group

Description:

AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes.

Treatment:

Other: AE Antithromboembolic exercises