Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
|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|
|Primary Completion Date :||April 2010|
|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. ]
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|