N/A
N=164
To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty
Surgical Blood Loss
Bottom Line
View on ClinicalTrials.gov: NCT03952546 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Hemostasis — 924; 1062 milliliters — p=0.1254
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Saline-coupled Bipolar Sealer (Device); Unipolar electrocautery (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemostasis |
924; 1062 | 0.1254 |
| SECONDARY Functional Outcomes |
56.45; 61.79 | <0.05 sig |
| SECONDARY Wound Infection |
1; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03952546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.