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

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

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Key information

Conditions

Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquamantys Device

Device

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

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

Other

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.

Primary outcomes

Drain Output.

Time frame: First 24 hours following surgery.

This is a measure of the average drain output collected in the first 24 hours following surgery.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Oct 28, 2009
Registry last updated: Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed