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

Edema Leg Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05312060
• Other study ID #: 0014626/22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Edema Leg

Intervention

Device:
• PC Pneumatic compression
Pneumatic compression of the operated limb

Other:
• AE Antithromboembolic exercises
Exercises for the edema

Locations

Country	Name	City	State
Italy	Istituto di Cura Città di Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Luca Marin

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Berliner JL, Ortiz PA, Lee YY, Miller TT, Westrich GH. Venous Hemodynamics After Total Hip Arthroplasty: A Comparison Between Portable vs Stationary Pneumatic Compression Devices and the Effect of Body Position. J Arthroplasty. 2018 Jan;33(1):162-166. doi: 10.1016/j.arth.2017.08.005. Epub 2017 Aug 24. — View Citation

Fujisawa M, Naito M, Asayama I, Kambe T, Koga K. Effect of calf-thigh intermittent pneumatic compression device after total hip arthroplasty: comparative analysis with plantar compression on the effectiveness of reducing thrombogenesis and leg swelling. J Orthop Sci. 2003;8(6):807-11. — View Citation

Kakkos SK, Caprini JA, Geroulakos G, Nicolaides AN, Stansby G, Reddy DJ, Ntouvas I. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Sep 7;9:CD005258. doi: 10.1002/14651858.CD005258.pub3. Review. Update in: Cochrane Database Syst Rev. 2022 Jan 28;1:CD005258. — View Citation

O'Reilly RF, Burgess IA, Zicat B. The prevalence of venous thromboembolism after hip and knee replacement surgery. Med J Aust. 2005 Feb 21;182(4):154-9. — View Citation

Pitto RP, Hamer H, Kühle JW, Radespiel-Tröger M, Pietsch M. [Hemodynamics of the lower extremity with pneumatic foot compression. Effect on leg position]. Biomed Tech (Berl). 2001 May;46(5):124-8. German. — View Citation

Pitto RP, Young S. Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and patient compliance. A comparative, prospective clinical trial. Int Orthop. 2008 Jun;32(3):331-6. Epub 2007 Feb 15. Erratum in: Int Orthop. 2008 Jun;32(3):337. Int Orthop. 2008 Jun;32(3):337. — View Citation

Santana DC, Emara AK, Orr MN, Klika AK, Higuera CA, Krebs VE, Molloy RM, Piuzzi NS. An Update on Venous Thromboembolism Rates and Prophylaxis in Hip and Knee Arthroplasty in 2020. Medicina (Kaunas). 2020 Aug 19;56(9). pii: E416. doi: 10.3390/medicina56090416. Review. — View Citation

Westrich GH, Specht LM, Sharrock NE, Sculco TP, Salvati EA, Pellicci PM, Trombley JF, Peterson M. Pneumatic compression hemodynamics in total hip arthroplasty. Clin Orthop Relat Res. 2000 Mar;(372):180-91. — View Citation

Williams KJ, Ravikumar R, Gaweesh AS, Moore HM, Lifsitz AD, Lane TR, Shalhoub J, Babber A, Davies AH. A Review of the Evidence to Support Neuromuscular Electrical Stimulation in the Prevention and Management of Venous Disease. Adv Exp Med Biol. 2017;906:377-386. Review. — View Citation

Zhao JM, He ML, Xiao ZM, Li TS, Wu H, Jiang H. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. Cochrane Database Syst Rev. 2014 Dec 22;(12):CD009543. doi: 10.1002/14651858.CD009543.pub3. Review. — View Citation

Outcome

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

External Links

•   Declaration of Helsinki