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

NCT05312060 | Unknown DMC

• 1 other identifier: 0014626/22
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Edema Leg

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Perceived Pain

  Ten days

• Functional capability

  Ten Days

• Operated lower limb range of motion

  Ten Days

Study Arms (2)

Pneumatic Compression (PC)

EXPERIMENTAL

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

Device: PC Pneumatic compression

Antithromboembolic exercises (AE)

ACTIVE COMPARATOR

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

Other: AE Antithromboembolic exercises

Interventions

PC Pneumatic compression DEVICE

Pneumatic compression of the operated limb

Also known as: I-Press®, I-Tech Medical Division, Martellago, Italy

Pneumatic Compression (PC)

AE Antithromboembolic exercises OTHER

Exercises for the edema

Antithromboembolic exercises (AE)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total hip arthroplasty, scheduled surgery
• aged between 50 and 80 at the time of recruitment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luca Marin: lead

Study Sites (1)

Istituto di Cura Città di Pavia

Pavia, 27100, Italy

Location

Related Publications (10)

• 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):416. doi: 10.3390/medicina56090416.

  PMID: 32824931 BACKGROUND

• 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. doi: 10.5694/j.1326-5377.2005.tb06643.x.

  PMID: 15720169 BACKGROUND

• 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. doi: 10.1007/5584_2016_128.

  PMID: 27620314 BACKGROUND

• 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. doi: 10.1097/00003086-200003000-00020.

  PMID: 10738427 BACKGROUND

• 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.

  PMID: 28927565 BACKGROUND

• Pitto RP, Hamer H, Kuhle JW, Radespiel-Troger 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. doi: 10.1515/bmte.2001.46.5.124. German.

  PMID: 11413908 BACKGROUND

• 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. doi: 10.1007/s00264-007-0326-9. Epub 2007 Feb 15.

  PMID: 17653546 BACKGROUND

• 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. doi: 10.1007/s00776-003-0706-y.

  PMID: 14648269 BACKGROUND

• 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;2014(12):CD009543. doi: 10.1002/14651858.CD009543.pub3.

  PMID: 25528992 BACKGROUND

• 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(9):CD005258. doi: 10.1002/14651858.CD005258.pub3.

  PMID: 27600864 BACKGROUND

Related Links

• Declaration of Helsinki

Study Officials

• Luca Marin, PhD

  University fo Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 5, 2022
• Study Start: April 11, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)