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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Blood Loss

Intervention / Treatment
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* Device: Saline-coupled Bipolar Sealer
* Device: Unipolar electrocautery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Saline-coupled bipolar sealer | Device: Saline-coupled Bipolar Sealer<br>* 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.<br>* Other names: Aquamantys System(TM);|
| Active Comparator: Control Arm<br>Unipolar electrocautery | Device: Unipolar electrocautery<br>* 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.<br>* Other names: Covidien ForceTriad(TM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis | Postoperative day 1 estimated blood loss as calculated by the Gross' Formula | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| Wound Infection | Participants were assessed for any wound infection within 90 days of surgery. | 90 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Surgical Blood Loss, Electrocautery, Perioperative Blood Conservation