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NCT02345642 Clinical Trial

A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Total Hip Arthroplasty Clinical Trial

Official title:
A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02345642
Other study ID # 14064
Secondary ID
Status Completed
Phase N/A
First received January 20, 2015
Last updated September 13, 2017
Start date February 2015
Est. completion date January 2016

Study information
Verified date September 2017
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable) in both the supine an standing position. We will start supine and will take 3 baseline measurements of venous velocity and then apply a device and take 3 measurements of the increase in peak venous velocity. We will repeat this with the second device. We will then have the subject stand and repeat the above with each device. We will randomize the order of the devices in the supine and standing position. This study will involve 10 healthy subjects of various ages and 10 total hip replacements (THR) patients.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2016
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Phase one: 10 healthy test subjects will be included of various ages. They will have each pneumatic compression device applied in the supine and then standing positions.

Phase two: 10 patients following THR on postoperative day #2 will be included. These patients will agree to participate in the study and have to be able to stand for approximately 10 minutes.

Exclusion Criteria:

- Patients with lymphedema

- Patients with peripheral vascular disease (chronic venous insufficiency)

- Patients who do not wish to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ActiveCare+SFT Supine

• VenaFlow Elite Supine

• ActiveCare+SFT Standing

• VenaFlow Elite Standing

Locations
Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (2)
Lead Sponsor Collaborator
Hospital for Special Surgery, New York DJO Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (11)

Ben-Galim P, Steinberg EL, Rosenblatt Y, Parnes N, Menahem A, Arbel R. A miniature and mobile intermittent pneumatic compression device for the prevention of deep-vein thrombosis after joint replacement. Acta Orthop Scand. 2004 Oct;75(5):584-7. — View Citation

Colwell CW Jr, Spiro TE, Trowbridge AA, Morris BA, Kwaan HC, Blaha JD, Comerota AJ, Skoutakis VA. Use of enoxaparin, a low-molecular-weight heparin, and unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. A clinical trial comparing efficacy and safety. Enoxaparin Clinical Trial Group. J Bone Joint Surg Am. 1994 Jan;76(1):3-14. Erratum in: J Bone Joint Surg Am 1994 Mar;76(3):4741. — View Citation

Edwards JZ, Pulido PA, Ezzet KA, Copp SN, Walker RH, Colwell CW Jr. Portable compression device and low-molecular-weight heparin compared with low-molecular-weight heparin for thromboprophylaxis after total joint arthroplasty. J Arthroplasty. 2008 Dec;23(8):1122-7. doi: 10.1016/j.arth.2007.11.006. Epub 2008 Apr 2. — View Citation

Froimson MI, Murray TG, Fazekas AF. Venous thromboembolic disease reduction with a portable pneumatic compression device. J Arthroplasty. 2009 Feb;24(2):310-6. doi: 10.1016/j.arth.2007.10.030. Epub 2008 Apr 8. — View Citation

Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656. — View Citation

Johanson NA, Lachiewicz PF, Lieberman JR, Lotke PA, Parvizi J, Pellegrini V, Stringer TA, Tornetta P 3rd, Haralson RH 3rd, Watters WC 3rd. Prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. J Am Acad Orthop Surg. 2009 Mar;17(3):183-96. — View Citation

Murakami M, McDill TL, Cindrick-Pounds L, Loran DB, Woodside KJ, Mileski WJ, Hunter GC, Killewich LA. Deep venous thrombosis prophylaxis in trauma: improved compliance with a novel miniaturized pneumatic compression device. J Vasc Surg. 2003 Nov;38(5):923-7. — View Citation

Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br. 2004 Jul;86(5):639-42. — View Citation

Silbersack Y, Taute BM, Hein W, Podhaisky H. Prevention of deep-vein thrombosis after total hip and knee replacement. Low-molecular-weight heparin in combination with intermittent pneumatic compression. J Bone Joint Surg Br. 2004 Aug;86(6):809-12. — 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

Westrich GH, Specht LM, Sharrock NE, Windsor RE, Sculco TP, Haas SB, Trombley JF, Peterson M. Venous haemodynamics after total knee arthroplasty: evaluation of active dorsal to plantar flexion and several mechanical compression devices. J Bone Joint Surg Br. 1998 Nov;80(6):1057-66. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Venous Velocity Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded. Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied
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