Clinical trial NCT03952546: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Blood Loss
Keywords: Total Knee Arthroplasty
Surgical Blood Loss
Electrocautery
Perioperative Blood Conservation
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients allergic to aspirin
2. Patients with an intolerance to aspirin
3. Patients with a contraindication to Apixaban
4. 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
5. Patients who for any reason are not a candidate for the use of the monopolar electrocautery
6. History of venous thromboembolism (Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)) within 12 months prior to the date of surgery
7. Mitral valve replacement or aortic valve replacement with additional risk factor for stroke (atrial fibrillation, previous thromboembolism, left ventricular dysfunction, hypercoagulable conditions)
8. Active cancer
9. Inheritied thrombophilia, eg: Factor V Leiden, Protein C and S deficiencies, Antithrombin deficiency, Prothrombin 20210A mutations
10. Acquired thrombophilia, eg: Lupus anticoagulant, antiphospholipid antibody syndrome
11. Patients taking clopidogrel (Plavix), ticagrelor(Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg)
12. Patients unable to get intravenous tranexamic acid (TXA) for any reason
13. Patients requiring anticoagulant treatment prior to surgery
14. History of stroke or trans-ischemic attack
15. Serum creatinine \> 2.8 mg/dl
16. History of hepatic failure
17. Any medical condition that in the opinion of the investigator would require special fluid management protocols during or after surgery
18. Allergy to TXA
19. Preoperative hemoglobin \< 11
20. Preoperative platelets \< 150,000
21. Blood transfusion within 1 month of surgery
22. ASA classification IV or V
23. Patients who are unwilling to undergo blood transfusion, if necessary
24. Evidence of active (systemic or local) infection at time of surgery
25. Patients who have habitual opioid use
26. Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-reported questionnaires
27. Fixed motor deficit affecting functional assessment of the knee
28. Patients unable to have spinal anesthesia
29. Patients receiving erythropoietin therapy for anemia
30. 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
31. Patients with a contraindication for the pneumatic tourniquet applied in the operating room

Primary outcomes:
measure: Hemostasis
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Functional Outcomes
timeFrame: 8 weeks
measure: Wound Infection
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
city: Syosset
country: United States
facility: Syosset Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Eugene S. Krauss, MD
role: PRINCIPAL_INVESTIGATOR
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