Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
1 other identifier
interventional
111
1 country
2
Brief Summary
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
April 7, 2011
CompletedSeptember 21, 2018
August 1, 2018
8 months
October 27, 2009
November 19, 2010
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Drain Output.
This is a measure of the average drain output collected in the first 24 hours following surgery.
First 24 hours following surgery.
Study Arms (2)
TKA with the Aquamantys for hemostasis
EXPERIMENTALThis arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
TKA without the Aquamantys for hemostasis
ACTIVE COMPARATORThis group will receive total knee arthroplasty using the standard treatment for hemostasis.
Interventions
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
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
You may qualify if:
- Patient indicated for total knee arthroplasty
You may not qualify if:
- Patients undergoing revision total knee arthroplasty
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jack D. Weiler Hospital-Division of Montefiore Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Limitations and Caveats
Operator dependent modifications may affect the standardization of the procedure; Surgeon is not blinded to the treatment used on each patient.
Results Point of Contact
- Title
- Dr. Sun Jin Kim
- Organization
- Montefiore Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sun Jin Kim, MD
Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Adult Reconstruction
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
September 21, 2018
Results First Posted
April 7, 2011
Record last verified: 2018-08