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

Not Applicable

Completed

• Conditions: Knee Arthroplasty
• Interventions: Device: Aquamantys Device; Other: Standard of care treatment for hemostasis during a total knee arthroplasty.

• Registration Number: NCT01003080
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2010-11-19
• Results First Submitted QC: 2011-03-04
• Results First Posted: 2011-04-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TKA with the Aquamantys for hemostasis	Aquamantys Device	This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
TKA without the Aquamantys for hemostasis	Standard of care treatment for hemostasis during a total knee arthroplasty.	This group will receive total knee arthroplasty using the standard treatment for hemostasis.

Primary Outcome Measures

Name	Time	Method
Drain Output.	First 24 hours following surgery.	This is a measure of the average drain output collected in the first 24 hours following surgery.

Trial Locations

Locations (2)

Jack D. Weiler Hospital-Division of Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States