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

Northwell Health

Status

Completed

Conditions

Surgical Blood Loss

Treatments

Device: Unipolar electrocautery

Device: Saline-coupled Bipolar Sealer

Study type

Interventional

Funder types

Other

Identifiers

NCT03952546

HS16-0236

Details and patient eligibility

About

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.

Full 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.

Enrollment

211 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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