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

Surgical Blood Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952546
• Other study ID #: HS16-0236
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: June 9, 2021

Study information

• Verified date: February 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Surgical Blood Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Syosset Hospital	Syosset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (28)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis	Postoperative day 1 estimated blood loss as calculated by the Gross' Formula	Postoperative day 1
Secondary	Functional Outcomes	Functional outcomes measured by the 2011 "Knee Society Score". The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.	8 weeks
Secondary	Wound Infection	Participants were assessed for any wound infection within 90 days of surgery.	90 days postoperatively