A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
October 16, 2017
CompletedOctober 16, 2017
September 1, 2017
4 months
January 20, 2015
November 29, 2016
September 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
10 Healthy Patients without THA
ACTIVE COMPARATORThe 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
10 Patients with THA on Post-Op Day 2
EXPERIMENTALThe 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with lymphedema
- Patients with peripheral vascular disease (chronic venous insufficiency)
- Patients who do not wish to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital for Special Surgery, New Yorklead
- DJO Incorporatedcollaborator
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
Related Publications (11)
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. doi: 10.1302/0301-620x.80b6.8627.
PMID: 9853503BACKGROUNDWestrich 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: 10738427BACKGROUNDJohanson 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. doi: 10.5435/00124635-200903000-00007.
PMID: 19264711BACKGROUNDPitto 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. doi: 10.1302/0301-620x.86b5.14763.
PMID: 15274256BACKGROUNDBen-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. doi: 10.1080/00016470410001466.
PMID: 15513491BACKGROUNDFroimson 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.
PMID: 18534456BACKGROUNDMurakami 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. doi: 10.1016/s0741-5214(03)00792-4.
PMID: 14603195BACKGROUNDColwell 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. doi: 10.2106/00004623-199401000-00002.
PMID: 8288662BACKGROUNDGeerts 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.
PMID: 18574271BACKGROUNDSilbersack 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. doi: 10.1302/0301-620x.86b6.13958.
PMID: 15330019BACKGROUNDEdwards 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.
PMID: 18534421BACKGROUND
Related Links
Results Point of Contact
- Title
- Dr. Geoffrey Westrich
- Organization
- Hospital for Special Surgery
Study Officials
- STUDY DIRECTOR
Lucian Warth, MD
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 26, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2015
Study Completion
January 1, 2016
Last Updated
October 16, 2017
Results First Posted
October 16, 2017
Record last verified: 2017-09