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The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent sequential compression with cold therapy and is designed for single patient use in the home. Additionally, it can track patient compliance. This study will examine if there is a difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a cooling device/MCD system.
In recent years there has been significant progress towards more effective and practical thromboprophylaxis in joint replacement surgeries. Since Aspirin 325mg twice daily has been recently included as a nationally approved venous thromboembolism (VTE) prophylaxis in the Surgical Care Improvement Project (SCIP) protocols for low risk total knee arthroplasty (TKA) patients, it is necessary to optimize multimodal prophylaxis methods. These include reduced tourniquet time, early mobilization, and mechanical compression devices (MCDs). MCDs are commonly used as part of the in-hospital VTE prophylaxis measures; however, it has not been demonstrated in clinical trials that optimal prophylaxis methods would be enhanced by prolonged use of a MCD after discharge. In order to achieve this, a potentially valuable solution has recently been made available to the outpatient population. The Cothera VPulse(tm) is a MCD that combines rapid intermittent sequential compression with cold therapy. It is designed for single patient use in the home and includes technology to track patient compliance. The purpose of this study is to examine if there is a difference in DVT occurrence over 3 weeks after tourniquet-less TKA and multimodal prophylaxis with or without extended MCD use in a cooling device/MCD system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin only | Placebo Comparator | Patients receive aspirin therapy |
|
| extended compression | Experimental | aspirin and extended compression therapy in combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended compression | Device | Home use of extended compression therapy and aspirin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DVT Occurence | DVT Occurence measured by physical assessment and duplex ultrasound images for DVT detection | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patient satisfaction will be measured 10 days postop using the EuroQol standardized instrument | 10 days |
| Mobilization | Patient activity level will be measured using the standardized UCLA Activity Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Snyder, MD | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hosptial | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28159420 | Derived | Snyder MA, Sympson AN, Scheuerman CM, Gregg JL, Hussain LR. Efficacy in Deep Vein Thrombosis Prevention With Extended Mechanical Compression Device Therapy and Prophylactic Aspirin Following Total Knee Arthroplasty: A Randomized Control Trial. J Arthroplasty. 2017 May;32(5):1478-1482. doi: 10.1016/j.arth.2016.12.027. Epub 2016 Dec 23. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 24, 2021 | |
| Reset | Mar 19, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 24, 2021 | Mar 19, 2021 |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin |
| Other |
standard therapy of aspirin |
|
| 10 days |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |