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

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Knee Arthroplasty

Treatments: Device: Aquamantys Device; Other: Standard of care treatment for hemostasis during a total knee arthroplasty.

Study type: Interventional

Funder types: Other

Identifiers

NCT01003080

09-05-145

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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111 participants in 2 patient groups

TKA with the Aquamantys for hemostasis

Experimental group

Description:

This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.

Treatment:

Device: Aquamantys Device

TKA without the Aquamantys for hemostasis

Active Comparator group

Description:

This group will receive total knee arthroplasty using the standard treatment for hemostasis.

Treatment:

Other: Standard of care treatment for hemostasis during a total knee arthroplasty.