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

NCT03952546 | Completed Results DMC FDA Device

• 1 other identifier: HS16-0236
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Blood Loss

Keywords

Total Knee Arthroplasty; Surgical Blood Loss; Electrocautery; Perioperative Blood Conservation

Outcome Measures

Primary Outcomes (1)

• Hemostasis

  Postoperative day 1 estimated blood loss as calculated by the Gross' Formula

  Postoperative day 1

Secondary Outcomes (2)

• Functional Outcomes

  8 weeks

• Wound Infection

  90 days postoperatively

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Saline-coupled bipolar sealer

Device: Saline-coupled Bipolar Sealer

Control Arm

ACTIVE COMPARATOR

Unipolar electrocautery

Device: Unipolar electrocautery

Interventions

Saline-coupled Bipolar Sealer DEVICE

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.

Also known as: Aquamantys System(TM)

Treatment Arm

Unipolar electrocautery DEVICE

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.

Also known as: Covidien ForceTriad(TM)

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Syosset Hospital

Syosset, New York, 11791, United States

Location

Related Publications (28)

• Spahn DR, Goodnough LT. Alternatives to blood transfusion. Lancet. 2013 May 25;381(9880):1855-65. doi: 10.1016/S0140-6736(13)60808-9.

  PMID: 23706802 BACKGROUND

• Plymale MF, Capogna BM, Lovy AJ, Adler ML, Hirsh DM, Kim SJ. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective randomized trial. J Arthroplasty. 2012 Jun;27(6):1133-7.e1. doi: 10.1016/j.arth.2011.09.016. Epub 2011 Nov 4.

  PMID: 22054904 BACKGROUND

• Dunne JR, Malone D, Tracy JK, Gannon C, Napolitano LM. Perioperative anemia: an independent risk factor for infection, mortality, and resource utilization in surgery. J Surg Res. 2002 Feb;102(2):237-44. doi: 10.1006/jsre.2001.6330.

  PMID: 11796024 BACKGROUND

• Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.

  PMID: 23886406 BACKGROUND

• Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.

  PMID: 11118174 BACKGROUND

• Tobias JD. Strategies for minimizing blood loss in orthopedic surgery. Semin Hematol. 2004 Jan;41(1 Suppl 1):145-56. doi: 10.1053/j.seminhematol.2003.11.025.

  PMID: 14872436 BACKGROUND

• Esler CN, Blakeway C, Fiddian NJ. The use of a closed-suction drain in total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br. 2003 Mar;85(2):215-7. doi: 10.1302/0301-620x.85b2.13357.

  PMID: 12678355 BACKGROUND

• Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008 Mar;5(2):125-31. doi: 10.1586/17434440.5.2.125.

  PMID: 18331175 BACKGROUND

• 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.

  BACKGROUND

• Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010 Oct;20:352-6.

  PMID: 21082586 BACKGROUND

• Morris MJ, Barrett M, Lombardi AV Jr, Tucker TL, Berend KR. Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1614-7. doi: 10.1016/j.arth.2013.01.032. Epub 2013 Mar 16.

  PMID: 23507071 BACKGROUND

• Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system--an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010 Oct;25(7):1072-7. doi: 10.1016/j.arth.2009.10.008. Epub 2010 Jan 22.

  PMID: 20097039 BACKGROUND

• Strahovnik A, Fokter SK, Kotnik M. Comparison of drainage techniques on prolonged serous drainage after total hip arthroplasty. J Arthroplasty. 2010 Feb;25(2):244-8. doi: 10.1016/j.arth.2008.08.014. Epub 2008 Dec 4.

  PMID: 19056215 BACKGROUND

• Johansson T, Engquist M, Pettersson LG, Lisander B. Blood loss after total hip replacement: a prospective randomized study between wound compression and drainage. J Arthroplasty. 2005 Dec;20(8):967-71. doi: 10.1016/j.arth.2005.02.004.

  PMID: 16376249 BACKGROUND

• Yang Y, Zhang LC, Xu F, Li J, Lv YM. Bipolar sealer not superior to standard electrocautery in primary total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Oct 10;9:92. doi: 10.1186/s13018-014-0092-5.

  PMID: 25300445 BACKGROUND

• Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013 Apr;37(4):735-9. doi: 10.1007/s00264-013-1801-0. Epub 2013 Feb 6.

  PMID: 23385607 BACKGROUND

• Eipe NP, Ponniah M. Perioperative blood loss assessment-how accurate? Indian J Anaesth. 2006;50(1):35-38

  BACKGROUND

• Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011 Mar 16;93(6):513-8. doi: 10.2106/JBJS.J.00036.

  PMID: 21411700 BACKGROUND

• Kamath AF, Austin DC, Derman PB, Clement RC, Garino JP, Lee GC. Saline-coupled bipolar sealing in simultaneous bilateral total knee arthroplasty. Clin Orthop Surg. 2014 Sep;6(3):298-304. doi: 10.4055/cios.2014.6.3.298. Epub 2014 Aug 5.

  PMID: 25177455 BACKGROUND

• Abuzakuk T, Senthil Kumar V, Shenava Y, Bulstrode C, Skinner JA, Cannon SR, Briggs TW. Autotransfusion drains in total knee replacement. Are they alternatives to homologous transfusion? Int Orthop. 2007 Apr;31(2):235-9. doi: 10.1007/s00264-006-0159-y. Epub 2006 Jun 8.

  PMID: 16761149 BACKGROUND

• Pfeiffer M, Brautigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005 Dec 13;3:Doc10.

  PMID: 19675727 BACKGROUND

• Clement RC, Kamath AF, Derman PB, Garino JP, Lee GC. Bipolar sealing in revision total hip arthroplasty for infection: efficacy and cost analysis. J Arthroplasty. 2012 Aug;27(7):1376-81. doi: 10.1016/j.arth.2011.11.016. Epub 2012 Jan 21.

  PMID: 22266048 BACKGROUND

• 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

  BACKGROUND

• Suarez JC, Slotkin EM, Szubski CR, Barsoum WK, Patel PD. Prospective, Randomized Trial to Evaluate Efficacy of a Bipolar Sealer in Direct Anterior Approach Total Hip Arthroplasty. J Arthroplasty. 2015 Nov;30(11):1953-8. doi: 10.1016/j.arth.2015.05.023. Epub 2015 May 19.

  PMID: 26093486 BACKGROUND

• Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007 Jun;22(4 Suppl 1):82-5. doi: 10.1016/j.arth.2007.02.018.

  PMID: 17570284 BACKGROUND

• Saltzman BM, Oni JK. A Review of Bipolar Sealer Use in Modern Total Joint Arthroplasty. Ann Orthop Rheumatol. 2014 2(2): 1015

  BACKGROUND

• Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83.

  PMID: 20145794 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Results Point of Contact

• Title: Nancy Dengler, RN, MS Clinical Research Nurse
• Organization: Northwell Health System

ndengler@northwell.edu

516-496-2637

Study Officials

• Eugene S. Krauss, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: May 16, 2019
• Study Start: May 7, 2019
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)