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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Hemostasis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for primary unilateral total knee arthroplasty with Dr. Krauss or Dr. Segal
- •Preoperative Hemoglobin >11mg/dL
- •Preoperative platelet count of >150,000
- •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
排除标准
- •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
结局指标
主要结局
Hemostasis
时间窗: Postoperative day 1
Postoperative day 1 estimated blood loss as calculated by the Gross' Formula
次要结局
- Functional Outcomes(8 weeks)
- Wound Infection(90 days postoperatively)