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

Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003080
• Other study ID #: 09-05-145
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Device:
• Aquamantys Device
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.

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.

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital-Division of Montefiore Medical Center	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drain Output.	This is a measure of the average drain output collected in the first 24 hours following surgery.	First 24 hours following surgery.