To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

NACompletedINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

May 7, 2019

Primary Completion Date

June 9, 2021

Study Completion Date

June 9, 2021

Conditions
Surgical Blood Loss
Interventions
DEVICE

Saline-coupled Bipolar Sealer

The Aquamantys® System is a commercially available device used routinely used in the operating room for a wide variety of surgical cases. It allows for temperatures to stay at approximately 100°C, nearly 200°C less than conventional devices, which produces a tissue effect without the charring associated with other methods. The temperature is sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels, resulting in the reduction in bleeding from both soft tissue and bone. The device can be used to spot coagulate vessels that are actively bleeding or to broadly paint tissue surfaces to prevent bleeding or treat active oozing.

DEVICE

Unipolar electrocautery

The Coviden ForceTriad™ energy platform is a full-featured electrosurgical system that provides electrosurgical cutting and coagulation, bipolar functionality, and vessel sealing in a single generator.

Trial Locations (1)

11791

Syosset Hospital, Syosset

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER

NCT03952546 - To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty | Biotech Hunter | Biotech Hunter