CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Aquamantys Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01003080
NCT01003080N/ACompleted

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

Montefiore Medical Center·interventional·Posted Oct 28, 2009·Updated Sep 21, 2018

In Brief

A clinical study evaluating Aquamantys Device and Standard of care treatment for hemostasis during a total knee arthroplasty. for Knee Arthroplasty. Completed, enrolled 111 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2009
Enrollment StartAug 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.7 years ago

Interventions

Aquamantys Devicedevice

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.