Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05312060
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2022-03-27
Brief Title:
Pneumatic Compression Versus Anti-thromboembolic Exercises for Patients Undergoing Total Hip Arthroplasty
Sponsor:
Luca Marin
Organization:
University of Pavia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Students 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 Pearsons chi-square test or with Fishers exact test
All tests will be two-tailed the level of significance is set at alpha 005 statistical significance if p value 005
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 Students 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 Pearsons chi-square test or with Fishers exact test
All tests will be two-tailed the level of significance is set at alpha 005 statistical significance if p value 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None