Trial Outcomes & Findings for To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty (NCT NCT03952546)

Results Overview

Postoperative day 1 estimated blood loss as calculated by the Gross' Formula

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

211 participants

Primary outcome timeframe

Postoperative day 1

Results posted on

2023-02-15

Participant Flow

Patients were recruited from the private office practice of the three surgeons who participated in the clinical trials. The first patient signed consent on May 7, 2019. The last patient was consented on 3/10/2021.

47 patients were screen failures due to either the blood work not meeting the study enrollment criteria, an exclusion for spinal anesthesia, or the patient decided not to proceed with enrollment in the study.

Participant milestones

Participant milestones
Measure	Saline-Coupled Bipolar Sealer 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. Other Names: Aquamantys System(TM)	Unipolar Electrocautery 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. Other Names: Covidien ForceTriad(TM)
Overall Study STARTED	82	82
Overall Study COMPLETED	82	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline-Coupled Bipolar Sealer n=82 Participants 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. Other Names: Aquamantys System(TM)	Unipolar Electrocautery n=82 Participants 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. Other Names: Covidien ForceTriad(TM)	Total n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=82 Participants	0 Participants n=82 Participants	0 Participants n=164 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=82 Participants	36 Participants n=82 Participants	74 Participants n=164 Participants
Age, Categorical >=65 years	44 Participants n=82 Participants	46 Participants n=82 Participants	90 Participants n=164 Participants
Age, Continuous	64.3 Years STANDARD_DEVIATION 8.3 • n=82 Participants	66.1 Years STANDARD_DEVIATION 8.9 • n=82 Participants	65.1 Years STANDARD_DEVIATION 8.6 • n=164 Participants
Sex: Female, Male Female	54 Participants n=82 Participants	45 Participants n=82 Participants	99 Participants n=164 Participants
Sex: Female, Male Male	28 Participants n=82 Participants	37 Participants n=82 Participants	65 Participants n=164 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	82 participants n=82 Participants	82 participants n=82 Participants	164 participants n=164 Participants

PRIMARY outcome

Timeframe: Postoperative day 1

Postoperative day 1 estimated blood loss as calculated by the Gross' Formula

Outcome measures

Outcome measures
Measure	Treatment Arm n=82 Participants Saline-coupled bipolar sealer 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.	Control Arm n=82 Participants Unipolar electrocautery 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.
Hemostasis	924 milliliters Interval 178.0 to 1861.0	1062 milliliters Interval 218.0 to 2053.0

SECONDARY outcome

Timeframe: 8 weeks

Population: 6 participants in the Treatment Arm-Saline-coupled bipolar sealer and 6 participants in the Control Arm-Unipolar electrocautery did not complete the Knee Society Score Questionnaire, therefore, only 76 patients in each of the arms were included in the statistical analysis.

Functional outcomes measured by the 2011 "Knee Society Score". The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.

Outcome measures

Outcome measures
Measure	Treatment Arm n=76 Participants Saline-coupled bipolar sealer 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.	Control Arm n=76 Participants Unipolar electrocautery 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.
Functional Outcomes	56.45 score on a scale Interval 51.57 to 61.34	61.79 score on a scale Interval 58.19 to 65.39

SECONDARY outcome

Timeframe: 90 days postoperatively

Participants were assessed for any wound infection within 90 days of surgery.

Outcome measures

Outcome measures
Measure	Treatment Arm n=82 Participants Saline-coupled bipolar sealer 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.	Control Arm n=82 Participants Unipolar electrocautery 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.
Wound Infection	1 Number of events	3 Number of events

Adverse Events

Saline-Coupled Bipolar Sealer

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Unipolar Electrocautery

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Saline-Coupled Bipolar Sealer n=82 participants at risk 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. Other Names: Aquamantys System(TM)	Unipolar Electrocautery n=82 participants at risk 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. Other Names: Covidien ForceTriad(TM)
Infections and infestations Wound Infection	1.2% 1/82 • 90 days This clinical trial is designed to compare two commercially available medical devices commonly used in surgical procedures. The devices were used according to the manufacture's guidelines. The clinical trial assessed patients for any return to OR due to bleeding or a hematoma, delayed wound healing, wound infections, any venous thromboembolism events, and skin burns.	3.7% 3/82 • 90 days This clinical trial is designed to compare two commercially available medical devices commonly used in surgical procedures. The devices were used according to the manufacture's guidelines. The clinical trial assessed patients for any return to OR due to bleeding or a hematoma, delayed wound healing, wound infections, any venous thromboembolism events, and skin burns.

Additional Information

Nancy Dengler, RN, MS Clinical Research Nurse

Northwell Health System

Phone: 516-496-2637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place