- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952546
To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty
February 10, 2023 updated by: Northwell Health
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syosset, New York, United States, 11791
- Syosset Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
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 Names:
|
Active Comparator: Control Arm
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemostasis
Time Frame: Postoperative day 1
|
Postoperative day 1 estimated blood loss as calculated by the Gross' Formula
|
Postoperative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Outcomes
Time Frame: 8 weeks
|
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
|
Wound Infection
Time Frame: 90 days postoperatively
|
Participants were assessed for any wound infection within 90 days of surgery.
|
90 days postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Spahn DR, Goodnough LT. Alternatives to blood transfusion. Lancet. 2013 May 25;381(9880):1855-65. doi: 10.1016/S0140-6736(13)60808-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Eipe NP, Ponniah M. Perioperative blood loss assessment-how accurate? Indian J Anaesth. 2006;50(1):35-38
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Saltzman BM, Oni JK. A Review of Bipolar Sealer Use in Modern Total Joint Arthroplasty. Ann Orthop Rheumatol. 2014 2(2): 1015
- 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.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2019
Primary Completion (Actual)
June 9, 2021
Study Completion (Actual)
June 9, 2021
Study Registration Dates
First Submitted
August 11, 2016
First Submitted That Met QC Criteria
May 14, 2019
First Posted (Actual)
May 16, 2019
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 10, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS16-0236
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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