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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014