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

Primary Purpose

Surgical Blood Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Saline-coupled Bipolar Sealer

Unipolar electrocautery

About this trial

This is an interventional treatment trial for Surgical Blood Loss focused on measuring Total Knee Arthroplasty, Surgical Blood Loss, Electrocautery, Perioperative Blood Conservation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients scheduled for primary unilateral total knee arthroplasty with Dr. Krauss or Dr. Segal
Preoperative Hemoglobin >11mg/dL
Preoperative platelet count of >150,000
Age >18
Patient is freely able to provide consent
American Society of Anesthesiologists (ASA) classification I-III (Appendix J)
Patient willing to complete all study related procedures

Exclusion Criteria:

Patients allergic to aspirin
Patients with an intolerance to aspirin
Patients with a contraindication to Apixaban
Any patient who is not a candidate for venous thromboembolism (VTE) risk stratification according to the calculated Caprini Risk Assessment Score. This includes, but is not limited to, any patient who cannot be prescribed ASA 81 mg bid or Apixiban 2.5 mg bid for VTE prophylaxis
Patients who for any reason are not a candidate for the use of the monopolar electrocautery
History of venous thromboembolism (Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)) within 12 months prior to the date of surgery
Mitral valve replacement or aortic valve replacement with additional risk factor for stroke (atrial fibrillation, previous thromboembolism, left ventricular dysfunction, hypercoagulable conditions)
Active cancer
Inheritied thrombophilia, eg: Factor V Leiden, Protein C and S deficiencies, Antithrombin deficiency, Prothrombin 20210A mutations
Acquired thrombophilia, eg: Lupus anticoagulant, antiphospholipid antibody syndrome
Patients taking clopidogrel (Plavix), ticagrelor(Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg)
Patients unable to get intravenous tranexamic acid (TXA) for any reason
Patients requiring anticoagulant treatment prior to surgery
History of stroke or trans-ischemic attack
Serum creatinine > 2.8 mg/dl
History of hepatic failure
Any medical condition that in the opinion of the investigator would require special fluid management protocols during or after surgery
Allergy to TXA
Preoperative hemoglobin < 11
Preoperative platelets < 150,000
Blood transfusion within 1 month of surgery
ASA classification IV or V
Patients who are unwilling to undergo blood transfusion, if necessary
Evidence of active (systemic or local) infection at time of surgery
Patients who have habitual opioid use
Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-reported questionnaires
Fixed motor deficit affecting functional assessment of the knee
Patients unable to have spinal anesthesia
Patients receiving erythropoietin therapy for anemia
Patients who are unable to stop their daily aspirin, aspirin-like products, and/or non-steroidal anti-inflammatory agents 7 days prior to surgery for any reason
Patients with a contraindication for the pneumatic tourniquet applied in the operating room

Sites / Locations

Syosset Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Saline-coupled bipolar sealer

Unipolar electrocautery

Outcomes

Primary Outcome Measures

Hemostasis

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

Secondary Outcome Measures

Functional Outcomes

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.

Wound Infection

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

Full Information

NCT ID

NCT03952546

First Posted

August 11, 2016

Last Updated

February 10, 2023

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT03952546

Brief Title

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

Official Title

A Prospective, Randomized, Single-blinded, Non-inferiority Study to Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer Compared to the Unipolar Electrocautery in Primary Unilateral Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

May 7, 2019 (Actual)

Primary Completion Date

June 9, 2021 (Actual)

Study Completion Date

June 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate whether the saline-coupled bipolar sealer compared to the unipolar electrocautery provides superior hemostasis in patients undergoing primary unilateral total knee arthroplasty. This will be a prospective, randomized, single-blinded, non-inferiority study in patients scheduled for a primary unilateral total knee arthroplasty (TKA) with Dr. Eugene Krauss or Dr. Ayal Segal. The restriction of this study to two surgeons will limit variations in the outcomes being measured due to differences in surgical technique.

Detailed Description

Total joint arthroplasty can result in significant blood loss. Minimizing blood loss has led to multiple blood conservation strategies in orthopaedic procedures. The use of unipolar electrocautery or the saline-coupled bipolar sealer are methods used to reduce intraoperative bleeding. Saline-coupled bipolar sealer technology initially demonstrated promising results in the literature when it was reported that this technology had superior efficacy by reducing blood loss and transfusion requirements in orthopaedic surgery. However, the saline-coupled bipolar sealer technology comes at a significantly higher cost when compared to the unipolar electrocautery. A bipolar electrode costs an additional $450.00 per case, whereas, the unipolar electrocautery catheter is included in all the pre-packaged orthopedic surgical trays. The added cost of the saline-coupled bipolar sealer was offset by the potential savings in the reduced need for blood transfusions. A single blood transfusion is estimated to be $750-$1200. This cost includes both the direct cost of the blood and the additional nursing time needed. Recent publications have challenged the superiority of the saline-coupled bipolar sealer in hemostasis. These randomized clinical trials (RCT) have not supported superiority of this method when compared to standard unipolar electrocautery and the continued use of the saline-coupled bipolar sealer has been questioned. The purpose of this study is to investigate whether the saline-coupled bipolar sealer compared to the unipolar electrocautery provides superior hemostasis in patients undergoing primary unilateral total knee arthroplasty. This will be a prospective, randomized, single-blinded, non-inferiority study in patients scheduled for a primary unilateral TKA with Dr. Eugene Krauss or Dr. Ayal Segal. The restriction of this study to two surgeons will limit variations in the outcomes being measured due to differences in surgical technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Blood Loss

Keywords

Total Knee Arthroplasty, Surgical Blood Loss, Electrocautery, Perioperative Blood Conservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

Blinding of the principal investigator and operating staff is not possible. However, all attempts will be made to keep this information from the hospital staff caring for the patients in the postoperative period. The patient and the postoperative hospital staff will be blinded to the treatment arm. The OR staff will be trained not to discuss this information with the patient. During the transition of care from the OR to the Post Anesthetic Care Unit (PACU) the treatment arm will not be included in the verbal patient report. The lack of this information is not required to effectively manage the patient in the postoperative period and will not affect patient care. Postoperatively medical care is managed by the hospitalist, medical doctors specializing in the care of hospitalized patients.

Allocation

Randomized

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Saline-coupled bipolar sealer

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

Unipolar electrocautery

Intervention Type

Device

Intervention Name(s)

Saline-coupled Bipolar Sealer

Other Intervention Name(s)

Aquamantys System(TM)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Unipolar electrocautery

Other Intervention Name(s)

Covidien ForceTriad(TM)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hemostasis

Description

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

Time Frame

Postoperative day 1

Secondary Outcome Measure Information:

Title

Functional Outcomes

Description

Time Frame

8 weeks

Title

Wound Infection

Description

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

Time Frame

90 days postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled for primary unilateral total knee arthroplasty with Dr. Krauss or Dr. Segal Preoperative Hemoglobin >11mg/dL Preoperative platelet count of >150,000 Age >18 Patient is freely able to provide consent American Society of Anesthesiologists (ASA) classification I-III (Appendix J) Patient willing to complete all study related procedures Exclusion Criteria: Patients allergic to aspirin Patients with an intolerance to aspirin Patients with a contraindication to Apixaban Any patient who is not a candidate for venous thromboembolism (VTE) risk stratification according to the calculated Caprini Risk Assessment Score. This includes, but is not limited to, any patient who cannot be prescribed ASA 81 mg bid or Apixiban 2.5 mg bid for VTE prophylaxis Patients who for any reason are not a candidate for the use of the monopolar electrocautery History of venous thromboembolism (Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)) within 12 months prior to the date of surgery Mitral valve replacement or aortic valve replacement with additional risk factor for stroke (atrial fibrillation, previous thromboembolism, left ventricular dysfunction, hypercoagulable conditions) Active cancer Inheritied thrombophilia, eg: Factor V Leiden, Protein C and S deficiencies, Antithrombin deficiency, Prothrombin 20210A mutations Acquired thrombophilia, eg: Lupus anticoagulant, antiphospholipid antibody syndrome Patients taking clopidogrel (Plavix), ticagrelor(Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg) Patients unable to get intravenous tranexamic acid (TXA) for any reason Patients requiring anticoagulant treatment prior to surgery History of stroke or trans-ischemic attack Serum creatinine > 2.8 mg/dl History of hepatic failure Any medical condition that in the opinion of the investigator would require special fluid management protocols during or after surgery Allergy to TXA Preoperative hemoglobin < 11 Preoperative platelets < 150,000 Blood transfusion within 1 month of surgery ASA classification IV or V Patients who are unwilling to undergo blood transfusion, if necessary Evidence of active (systemic or local) infection at time of surgery Patients who have habitual opioid use Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-reported questionnaires Fixed motor deficit affecting functional assessment of the knee Patients unable to have spinal anesthesia Patients receiving erythropoietin therapy for anemia Patients who are unable to stop their daily aspirin, aspirin-like products, and/or non-steroidal anti-inflammatory agents 7 days prior to surgery for any reason Patients with a contraindication for the pneumatic tourniquet applied in the operating room

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugene S. Krauss, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Syosset Hospital

City

Syosset

State/Province

New York

ZIP/Postal Code

11791

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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