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

NCT01003080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-09-21

Study results available
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Summary

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

Conditions

  • Knee Arthroplasty

Interventions

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.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Sun Jin Kim, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01003080 on ClinicalTrials.gov