Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01003080|
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : April 7, 2011
Last Update Posted : April 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Knee Arthroplasty||Device: Aquamantys Device Other: Standard of care treatment for hemostasis during a total knee arthroplasty.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: TKA with the Aquamantys for hemostasis
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
Device: Aquamantys Device
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
Active Comparator: TKA without the Aquamantys for hemostasis
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
Other: 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.
- Drain Output. [ Time Frame: First 24 hours following surgery. ]This is a measure of the average drain output collected in the first 24 hours following surgery.
- Change in Hemoglobin and Hematocrit. [ Time Frame: First three days after surgery. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003080
|United States, New York|
|Jack D. Weiler Hospital-Division of Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Sun Jin Kim, MD||Montefiore Medical Center|