Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05312060
Enrollment
48
Registered
2022-04-05
Start date
2022-04-11
Completion date
2022-09-30
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema Leg

Keywords

Total hip arthroplasty, functional capabilities, Pneumatic compression, antithromboembolic exercises

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).

Interventions

DEVICEPC Pneumatic compression

Pneumatic compression of the operated limb

OTHERAE Antithromboembolic exercises

Exercises for the edema

Sponsors

Luca Marin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Operated limb edemaTen dayscircumference 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

MeasureTime frameDescription
Perceived PainTen daysPerceived pain, assessed with Numeric Rating Scale. Where 0 is no pain and 10 is the maximum pain felt
Functional capabilityTen DaysWalking capability, assessed with 20 meters walking test
Operated lower limb range of motionTen DaysKnee and ankle range of motion

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026