Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
NCT ID: NCT01003080
Last Updated: 2018-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2009-08-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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TKA with the Aquamantys for hemostasis
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
Aquamantys Device
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
TKA without the Aquamantys for hemostasis
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
Standard of care treatment for hemostasis during a total knee arthroplasty.
The active comparator arm will receive the "standard-of-care" for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device.
Interventions
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Aquamantys Device
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
Standard of care treatment for hemostasis during a total knee arthroplasty.
The active comparator arm will receive the "standard-of-care" for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with blood disorders
* Patients on chronic anti-thrombotic medication such as Coumadin
* Patients with a history of deep vein thrombosis
* Patients with a history of pulmonary embolism
18 Years
ALL
Yes
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Sun Jin Kim
Chief of Adult Reconstruction
Principal Investigators
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Sun Jin Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Jack D. Weiler Hospital-Division of Montefiore Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Countries
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Other Identifiers
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09-05-145
Identifier Type: -
Identifier Source: org_study_id
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