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Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01003080
First received: October 27, 2009
Last updated: March 4, 2011
Last verified: March 2011
History of Changes
  Purpose

The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.


Condition Intervention Phase
Knee Arthroplasty
 Device: Aquamantys Device
Other: Standard of care treatment for hemostasis during a total knee arthroplasty.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Drain Output. [ Time Frame: First 24 hours following surgery. ] [ Designated as safety issue: Yes ]
    This is a measure of the average drain output collected in the first 24 hours following surgery.


Secondary Outcome Measures:
  • Change in Hemoglobin and Hematocrit. [ Time Frame: First three days after surgery. ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient indicated for total knee arthroplasty

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003080

Locations
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
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Sun Jin Kim, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Dr. Sun Jin Kim, MD (Principal Investigator), Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01003080     History of Changes
Other Study ID Numbers: 09-05-145
Study First Received: October 27, 2009
Results First Received: November 19, 2010
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
The evaluation of hemostasis during total knee arthroplasty using the aquamantys device.

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013