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
Verified date | May 2022 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto di Cura Città di Pavia | Pavia |
Lead Sponsor | Collaborator |
---|---|
Luca Marin |
Italy,
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
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 |
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