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

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ClinicalTrials.gov Identifier: NCT03952546
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Northwell Health

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.

Condition or disease Intervention/treatment Phase
Surgical Blood Loss Device: Saline-coupled Bipolar Sealer Device: Unipolar electrocautery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
Saline-coupled bipolar sealer
Device: Saline-coupled Bipolar Sealer
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.
Other Name: Aquamantys System(TM)

Active Comparator: Control Arm
Unipolar electrocautery
Device: Unipolar electrocautery
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.
Other Name: Covidien ForceTriad(TM)




Primary Outcome Measures :
  1. Hemostasis [ Time Frame: Postoperative day 1 to discharge from the hospital ]
    Perioperative estimated blood loss as calculated by the Gross' Formula


Secondary Outcome Measures :
  1. Functional outcomes [ Time Frame: 8 weeks ]
    Functional outcomes measured by the 2011 Knee Society Score

  2. Safety Profile [ Time Frame: 90 days postoperatively ]
    Device emergent adverse events within 90 days of the date of surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952546


Contacts
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Contact: Nancy Dengler, RN, MS 5164962637 ndengler@northwell.edu

Locations
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United States, New York
Syosset Hospital Recruiting
Syosset, New York, United States, 11791
Contact: Nancy Dengler, RN    516-496-2637    ndengler@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Eugene S. Krauss, MD Northwell Health

Publications:
Weeden SH, Schmidt RH, Isabell G. Haemostatic efficacy of a bipolar sealing device in minimally invasive total knee arthroplasty. J Bone Joint Surg Br Proceedings 2009; 91-B:45.
Eipe NP, Ponniah M. Perioperative blood loss assessment-how accurate? Indian J Anaesth. 2006;50(1):35-38
Diedo N, Moore G, et al. Effectiveness of the bipolar sealer in reducing blood loss in total knee arthroplasty. International Journal of Orthopaedic and Trauma Nursing (2013) 17, 29-37
Saltzman BM, Oni JK. A Review of Bipolar Sealer Use in Modern Total Joint Arthroplasty. Ann Orthop Rheumatol. 2014 2(2): 1015
Lyons ST, Morrison K, Bernasek TL. Sensory neuropathy associated with cauterization using bipolar radio frequency device in primary TKA. Paper presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 9-13, 2010; New Orleans, LA

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT03952546     History of Changes
Other Study ID Numbers: HS16-0236
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Northwell Health:
Total Knee Arthroplasty
Surgical Blood Loss
Electrocautery
Perioperative Blood Conservation

Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications