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| Name | Class |
|---|---|
| DJO Incorporated | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 Healthy Patients without THA | Active Comparator | The 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. |
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| 10 Patients with THA on Post-Op Day 2 | Experimental | The 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiveCare+SFT Supine | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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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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:
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| Name | Affiliation | Role |
|---|---|---|
| Lucian Warth, MD | Hospital for Special Surgery, New York | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9853503 | Background | 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. | |
| 10738427 | Background |
| Label | URL |
|---|---|
| VenaFlow Elite Description on DJO Global's website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Healthy Patients Without THA | The 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. A randomization technique was used to determine laterality and sequence of study events. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing |
| FG001 | 10 Patients With THA on Post-Op Day 2 | The 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. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 Healthy Patients Without THA | The 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. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | cm/s | Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 Healthy Patients Without THA | The 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. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geoffrey Westrich | Hospital for Special Surgery | 212-606-1510 | ortizp@hss.edu |
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| VenaFlow Elite Supine | Device |
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| ActiveCare+SFT Standing | Device |
|
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| VenaFlow Elite Standing | Device |
|
|
| 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. |
| 19264711 | Background | 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. doi: 10.5435/00124635-200903000-00007. |
| 15274256 | Background | 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. doi: 10.1302/0301-620x.86b5.14763. |
| 15513491 | Background | 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. doi: 10.1080/00016470410001466. |
| 18534456 | Background | 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. |
| 14603195 | Background | 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. doi: 10.1016/s0741-5214(03)00792-4. |
| 8288662 | Background | 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. doi: 10.2106/00004623-199401000-00002. |
| 18574271 | Background | 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. |
| 15330019 | Background | 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. doi: 10.1302/0301-620x.86b6.13958. |
| 18534421 | Background | 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. |
| ActiveCare+SVT Description on MCS's website | View source |
| 10 Patients With THA on Post-Op Day 2 |
The 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. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
The 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. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 10 Patients With THA on Post-Op Day 2 | The 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. ActiveCare+SFT Supine VenaFlow Elite Supine ActiveCare+SFT Standing VenaFlow Elite Standing | 0 | 10 | 0 | 10 | 0 | 10 |
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