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
Phase: NA
Conditions: Surgical Blood Loss
Sponsor: Northwell Health

 
 
26Sept2019 
 
                        
Protocol Design Template © 2009  
 
 
 
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  
 
 
Regulatory Sponsor: 
NA 
Funding Sponsor: 
NA 
Study Product: 
Aquamantys SystemTM  Medtronics Saline-Coupled Bipolar     
Sealer 
 
Covidien ForceTriadTM  Electrosurgical System 
Unipolar Electrocautery System   
 
Clinical Trials.gov  
 
Protocol Number:               
 
NCT03952546 
 
HS16-0236 
IND/IDE  Number: 
 
Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
Investigators:                         
 
NA 
 
Eugene Krauss, MD, FAAOS, FACS 
Director Orthopaedic Surgery  
Center of Orthopaedic Excellence 
Syosset Hospital  
221 Jericho Turnpike  
Syosset, New York 11791  
ekrauss@northwell.edu 
 
 
Director, Surgical Clinical Quality & Research 
Krasnoff Quality Management Institute 
Northwell Health  
 
 
 
 
Ayal Segal, MD 
Associate Director Orthopaedic Surgery 
Center of Orthopaedic Excellence 
Syosset Hospital

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  
 
 
 
 
Page ii of 33 
 
221 Jericho Turnpike 
Syosset, NY 11791 
 (516) 622-7963 
asegal@ northwell.edu 
 
Barry G. Simonson, MD 
Syosset Hospital  
221 Jericho Turnpike 
Syosset, NY 11791 
(516) 773-7500 
 
Sara Shraibman, MD, FACP 
Site Director of Hospital Medicine 
Syosset Hospital 
221 Jericho Turnpike 
Syosset, NY 11791 
516-496-6400 
sshraibm@northwell.edu 
 
Nancy Dengler, RN, MS 
Research RN 
Syosset Hospital 
221 Jericho Turnpike 
Syosset, NY 11791 
516-496-2637 
ndengler@ northwell.edu 
 
 
MaryAnne Cronin, MS, PharmD, BCPS 
Clinical Pharmacy Coordinator, Orthopedic Surgery 
Syosset Hospital 
221 Jericho Turnpike 
Syosset, NY 11791 
516-496-2644 
mcronin@ northwell.edu 
 
William A. Lorusso, MBA, MS, PA-C 
Syosset Hospital 
221 Jericho Turnpike 
Syosset, NY 11791 
wlarusso@northwell.edu 
 
Andrea Wendland, RPA-C 
Syosset Hospital 
221 Jericho Turnpike 
Syosset, NY 11791

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  
 
 
 
 
Page iii of 33 
 
awendland@northwell.edu 
 
 
Kathleen Altner RN, BSN, MS, ANP 
Orthopedic Nurse Practitioner 
Department of Orthopedics Syosset 
New York Orthopaedic and Spine Center 
833 Northern Blvd, Suite 220 
Great Neck, New York 11021 
Phone:  516-622-7986 
Email: kaltner@northwell.edu 
 
Rose Akamnonu, MSN ANP 
Orthopedic Nurse Practitioner 
Department of Orthopedics Syosset 
New York Orthopaedic and Spine Center 
833 Northern Blvd., Suite 220 
Great Neck, NY 11021 
Tel: 516-622-79440 
Fax: 516-622-7957 
Email: rakamnonu@northwell.edu  
 
Renne Rodriquez, RN 
Syosset Hospital 
221 Jericho Turnpike 
Syosset, NY 11791 
Email: RRodrigue3@northwell.edu 
 
Statistician:                                   
 
 
 
 
 
 
 
 
Performance Site(s): 
 
 
 
Syosset Hospital 
 
 
 
 
Date:  07April2016 
Final Version  
 
 
Amended:   
25May2016, 
03May2019, 
 

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  
 
 
 
 
Page iv of 33 
 
26Sept2019 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Northwell Health.  No part of it may be 
transmitted, reproduced, published, or used by other persons without prior written 
authorization from the study sponsor. 

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  
 
 
 
 
Page v of 33 
 
Table of Contents 
STUDY SUMMARY ..................................................................................................................... 1 
1 
PREVIOUS STUDY HISTORY .......................................................................................... 2 
2 
BRIEF SUMMARY OF RESEARCH ................................................................................ 2 
3 
INTRODUCTION................................................................................................................. 3 
3.1 BACKGROUND ...................................................................................................................... 3 
3.2 INVESTIGATIONAL AGENT ................................................................................................... 6 
3.3 PRECLINICAL DATA ............................................................................................................. 7 
3.4 CLINICAL DATA TO DATE .................................................................................................... 7 
3.5 DOSE RATIONALE AND RISK/BENEFITS................................................................................ 7 
4 
STUDY OBJECTIVES ......................................................................................................... 7 
5 
RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH .................. 8 
6 
STUDY DESIGN ................................................................................................................... 8 
6.1 GENERAL DESIGN ................................................................................................................ 8 
6.2 PRIMARY STUDY ENDPOINTS ............................................................................................. 11 
6.3 SECONDARY STUDY ENDPOINTS .................................. ERROR! BOOKMARK NOT DEFINED. 
6.4 PRIMARY SAFETY ENDPOINTS...................................... ERROR! BOOKMARK NOT DEFINED. 
7 
SUBJECT SELECTION AND WITHDRAWAL ............................................................ 11 
7.1 INCLUSION CRITERIA ......................................................................................................... 11 
7.2 EXCLUSION CRITERIA ........................................................................................................ 12 
7.3 VULNERABLE POPULATIONS .............................................................................................. 13 
7.4 SUBJECT RECRUITMENT AND SCREENING .......................................................................... 13 
7.5 CONSENT PROCESS ............................................................................................................ 14 
7.6 EARLY WITHDRAWAL OF SUBJECTS .................................................................................. 14 
7.6.1 When and How to Withdraw Subjects ....................................................................... 14 
7.6.2 Data Collection and Follow-up for Withdrawn Subjects ......................................... 14 
8 
STUDY DRUG/DEVICE ................................................................................................... 16 
8.1 DESCRIPTION ..................................................................................................................... 16 
8.2 TREATMENT REGIMEN ....................................................................................................... 16 
8.3 METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS ........................................... 17 
8.4 PREPARATION AND ADMINISTRATION OF STUDY DRUG/IMPLANTATION OF STUDY DEVICE
 
17 
8.5 SUBJECT COMPLIANCE MONITORING ................................................................................. 17 
8.6 PRIOR AND CONCOMITANT THERAPY ................................................................................ 17 
8.7 PACKAGING ....................................................................................................................... 17 
8.8 BLINDING OF STUDY DRUG/DEVICE .................................................................................. 17 
8.9 RECEIVING, STORAGE, DISPENSING AND RETURN.............................................................. 18 
8.9.1 Receipt of Drug Supplies/Device .............................................................................. 18 
8.9.2 Storage ...................................................................................................................... 18 
8.9.3 Dispensing of Study Drug/Device ............................................................................. 18 

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  
 
 
 
 
Page vi of 33 
 
8.9.4 Return or Destruction of Study Drug/Device............................................................ 18 
9 
STUDY PROCEDURES .................................................................................................... 18 
9.1 VISIT 1 ............................................................................................................................... 18 
9.2 VISIT 2 ............................................................................................................................... 18 
9.3 VISIT 3 ............................................................................................................................... 19 
9.4 VISIT 4 ............................................................................................................................... 19 
9.5    VIST 5 ................................................................................................................................ 19 
10 RISKS TO SUBJECTS....................................................................................................... 19 
11 POTENTIAL BENEFIT TO SUBJECTS ........................................................................ 19 
12 RESEARCH RELATED HARM/INJURY ...................................................................... 20 
13 PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS .................... 20 
14 STATISTICAL PLAN ........................................................................................................ 20 
14.1 
SAMPLE SIZE DETERMINATION ...................................................................................... 20 
14.2 
STATISTICAL METHODS ........................................... ERROR! BOOKMARK NOT DEFINED. 
15 MEDICAL DEVICE REPORTING ................................................................................. 23 
15.1 
SERIOUS INJURY OR ILLNESS DEFINITION  ..................................................................... 23 
15.2 
MANDATORY MEDICAL DEVICE REPORTING ......................................................... 24 
15.3 
RECORING OF ADVERSE EVENTS.................................................................................... 25 
15.3.1 
EC/IRB Notification by Investigator ..................................................................... 25 
15.3.2 
FDA Notification by Sponsor ................................................................................ 25 
15.4 
UNBLINDING PROCEDURES ............................................................................................ 25 
15.5 
DATA AND SAFETY MONITORING .................................................................................. 25 
16 DATA HANDLING AND RECORD KEEPING ............................................................. 26 
16.1 
CONFIDENTIALITY ......................................................................................................... 26 
16.2 
SOURCE DOCUMENTS .................................................................................................... 26 
16.3 
CASE REPORT FORMS .................................................................................................... 27 
16.4 
RECORDS RETENTION .................................................................................................... 27 
17 STUDY MONITORING, AUDITING, AND INSPECTING ......................................... 27 
17.1 
STUDY MONITORING PLAN ............................................................................................ 27 
17.2 
AUDITING AND INSPECTING ........................................................................................... 27 
18 ETHICAL CONSIDERATIONS ....................................................................................... 28 
19 STUDY FINANCES............................................................................................................ 28 
19.1 
FUNDING SOURCE .......................................................................................................... 28 
19.2 
CONFLICT OF INTEREST .................................................................................................. 28 
19.3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................. 28 
20 PUBLICATION PLAN ...................................................................................................... 29 
21 REFERENCES .................................................................................................................... 30 

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  
 
 
 
 
Page vii of 33 
 
22 ATTACHMENTS ............................................................................................................... 33 

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  
 
 
 
 
Page viii of 33 
 
List of Abbreviations 
 
 
ASA  
American Society of Anesthesiologists 
 
AST 
 
Association of Surgical Technologists 
 
BMI  
Body Mass Index 
 
BID 
 
2 times a day 
 
CC 
 
Cubic Centimeters 
 
CDRH  
Center for Devices and Radiological Health  
 
DVT  
Deep Vein Thrombosis  
 
IV  
 
Intravenous 
 
KG 
 
Kilograms 
 
KSS 
 
Knee Society Score  
 
MG 
 
Milligrams 
 
NS 
 
Normal Saline 
 
OR 
 
Operating Room 
 
PACU  
Post Anesthetic Care Unit 
 
PE 
 
Pulmonary Embolus 
 
PO 
 
By Mouth 
 
PST 
 
Pre-surgical Testing 
 
RCT    
Randomized controlled trial 
 
RF 
 
Radiofrequency 
 
THA   
Total Hip Arthroplasty 
 
TKA    
Total Knee Arthroplasty  
 
TXA     
Tranexamic acid 

 
 
Page 1 of 40 
26Sept2019 
Study Summary  
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  
Short Title 
Saline-coupled bipolar sealer compared to the unipolar electrocautery in primary 
unilateral total knee arthroplasty
Protocol Number 
 
Phase 
 
Methodology 
Prospective, Randomized, Single-Blinded, Non-inferiority Study 
Study Duration 
2  years 
Study Center(s) 
Single-center /Syosset Hospital 
Objectives 
 
Primary Objective 
 
 
To assess whether the unipolar electrocautery is non-inferior to saline-
coupled bipolar sealer with respect to estimated blood loss as calculated by 
Gross’ formula in patients undergoing primary unilateral total knee 
arthroplasty. 
 
Secondary Objective 
 
 
To assess whether the unipolar electrocautery is superior to saline-coupled 
bipolar sealer with respect to hemostasis in patients undergoing primary 
unilateral total knee arthroplasty. 
 
 
To assess whether hospital length of stay in patients undergoing primary 
unilateral total knee arthroplasty is different between the saline-coupled 
bipolar sealer compared to the unipolar electrocautery. 
 
 
To assess whether objective and functional outcomes in patients undergoing 
primary unilateral total knee arthroplasty differ between the saline-coupled 
bipolar sealer compared to the unipolar electrocautery. 
 
 
To assess the safety profile of the saline-coupled bipolar sealer compared to 
the unipolar electrocautery in patients undergoing primary unilateral total 
knee arthroplasty  
Number of Subjects 
164 
Diagnosis and Main 
Inclusion Criteria 
Primary Unilateral Total Knee Arthroplasty (TKA) 
Study Product, Dose, 
Route, Regimen 
Aquamantys SystemTM  Medtronics Saline-Coupled Biopolar Sealer 
Duration of 
administration 
Intraoperative  
Reference therapy 
Covidien ForceTriadTM  Electrosurgical System 
Unipolar Electrocautery System   

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  
 
 
 
 
Page 2 of 33 
 
Statistical Methodology 
The test for non-inferiority will be carried out using a 2-tailed 95% confidence interval 
for the difference (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer) 
in the estimated blood loss between the two groups. δ is the margin of inferiority and 
will be set at 200 cc.  If the upper confidence limit < δ (≥δ) then we will conclude that 
the Unipolar electrocautery system is non-inferior (inferior) to the Saline-coupled 
bipolar sealer.   
 
This test for non-inferiority will only be performed for the primary study endpoint of 
estimated blood loss; all other secondary variables will be tests of superiority of 
Unipolar electrocautery versus Saline-coupled bipolar sealer. 
 
1 
Previous Study History 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes   if yes, please explain:  
 
2 
Brief Summary of Research 
 
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. 1 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.  
 

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  
 
 
 
 
Page 3 of 33 
 
3 
Introduction 
 
This document is a protocol for a human research study. This study is to be conducted according 
to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and 
International Conference on Harmonization guidelines), applicable government regulations and 
Institutional research policies and procedures.  
 
3.1 
Background 
 
Total joint arthroplasty can result in significant blood loss. Transfusion rates have been reported 
to be as high as 39% in total knee arthroplasty.2 Transfused patients are exposed to risks such as 
adverse immunological reactions, disease transmission, intravascular hemolysis, transfusion-
induced coagulopathy, renal impairment or failure, and increased mortality.  Postoperative 
anemia has also been associated with prolonged length of stay and increased hospital costs3.  
Minimizing blood loss has led to multiple blood conservation strategies in orthopaedic 
procedures.   
 
One method of hemostasis in use at Syosset Hospital since March 2013 is the use of intravenous 
antifibrinolytics (tranexamic acid).  The use of tranexamic acid (TXA) in orthopaedic surgery 
has resulted in a 50% reduction in the rate of transfusions4. TXA interferes with clot breakdown. 
Ninety percent of TXA is excreted by the kidneys after approximately 24 hours. However, there 
have been isolated case reports of thrombus formation with intravenous (IV) administration of 
TXA.  Due to this risk, IV TXA is not administered to patients with risk factors for 
thromboembolic events.  
 
Epidural or spinal anesthesia (neuraxil blockade) has been shown to be effective in reducing 
intraoperative blood loss.  Rogers, et al in a meta-analysis of 473 patient in 16 trials reported the 
requirement for a transfusion of two or more units of blood was reduced by about half in patients 
allocate to neuraxial blockade.5  Spinal or Epidural anesthesia causes a sympathetic nerve block 
leading to vasodilatation distal to the site of anesthesia.  This effect is responsible for the 
reduction in bleeding during surgery.  
 
Maintenance of normothermia is also of paramount importance in controlling blood loss in 
orthopedic surgery.  Perioperative hypothermia is defined as a core temperature < 360 C. 
Prospective trials have shown that the maintenance of normothermia is associated with 
reductions in blood loss, the requirements for allogeneic blood products, postoperative 
infections, and shorter hospital stays. 6 
 
Another method used intraoperatively to maintain hemostasis is the application of a pneumatic 
tourniquet.  During TKA a pneumatic tourniquet is applied to the upper part of the thigh on the 
operative limb and inflated to a pressure determined by the surgeon.  The pneumatic tourniquet is 
utilized during extremity surgery to maintain a bloodless field. The tourniquet applies pressure to 
the limb to occlude the blood supply. The tourniquet is released by the surgeon at the end of the 
case and electrocautery is then used to seal any bleeding vessels. 
 

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  
 
 
 
 
Page 4 of 33 
 
The insertion of a suction drain, once a common practice in orthopedic surgery, has become 
controversial.  A closed suction drainage system is believed to increase bleeding because the 
tamponade effect of a closed and undrained wound is eliminated. Multiple publications have 
questioned the routine insertion of drains.  Esler, et al prospectively randomized 100 patients 
undergoing cemented total knee replacement to receive either a single deep closed-suction drain 
or no drain. The total blood loss was significantly greater in those with a drain (568 ml versus 
119 ml, p < 0.01; 95% CI 360 to 520) although those without a drain lost more blood into the 
dressings (55 ml versus 119 ml, p < 0.01; 95% CI –70 to10). There was no statistical difference 
in the postoperative swelling or pain scores, or in the incidence of pyrexia, ecchymosis, time at 
which flexion was regained or the need for manipulation, or in the incidence of infection at a 
minimum of five years after surgery in the two groups.  The authors concluded that there was no 
evidence to support the use of a closed-suction drain in cemented knee arthroplasty, finding it 
merely interfered with mobilization and complicated nursing care. 7 
 
Electrocautery has emerged as an imperative adjunct to surgery across the entire range of 
surgical disciplines. In 1926 William T Bovie, a physicist, developed the electrocautrery.  
Harvey Cushing introduced it into clinical practice.  A diathermy machine converts electricity of 
the main supply (240V; 50 Hz) into high frequency current (>100,000 Hz) to minimize the risk 
of electrical shocks.  In unipolar mode, the current from the diathermy enters the patient through 
the active electrode and exits through the grounding pad.   The unipolar electrocautery results in 
a tissue surface above 4000 C to char tissue. 
 
In saline-coupled bipolar mode the current passes between the two prongs of the electrode 
without any significant flow through the patient and there is no need for the grounding pad.  The 
use of saline-coupled bipolar sealing technology (Aquamantys System®, Medtronic) represents a 
newer approach to reducing blood loss in patients undergoing total joint arthroplasty.  Unlike 
standard electrocautery, which uses unipolar radiofrequency energy, this technology uses bipolar 
radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent 
tissue temperatures from exceeding 100°C.   The temperature is sufficient to shrink collagen 
fibers in blood vessel walls, which seals their lumen resulting in hemostasis without surrounding 
tissue damage2.  Saline-cooled bipolar radiofrequency technology provides a solution to osseous 
bleeding by using saline as a conduit into the interstices of cancellous bone.8 Another advantage 
of this technology over standard electrocautery is the ability to not only spot coagulate vessels 
but also broadly paint surfaces that could ooze after the soft tissues have been closed.2  However, 
the use of this technology has significantly increased the per-case expense of using this device.  
 
The use of the saline-coupled bipolar sealer in orthopedics has become more prevalent based on 
initial publications showing a reduction in intraoperative blood loss and postoperative 
transfusion requirements.  Marulanda, et al conducted a randomized controlled trial (RCT) in 
2009 with 69 primary TKA patients.  Though the bipolar sealer group had a lower mean decline 
in hemoglobin level compared to the unipolar group, there was not a statistically significant 
difference in blood transfusions or postoperative hemoglobin nadir.2  Clinical outcomes were 
assessed by length of stay, range of motion and Knee Society Scores.  There were no differences 
in clinical outcomes between the groups.   
 

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  
 
 
 
 
Page 5 of 33 
 
In 2009 Weeden, et al published a retrospective, matched controlled review of 100 patients who 
had undergone primary total knee arthroplasty by a single surgeon.  The prevalence of both 
autologous and allogeneic transfusion was significantly reduced by 64% in the bipolar sealing 
group.9 However, this study did not measure any functional or safety outcomes.  Additionally the 
authors did not describe their blood transfusion protocols.   
 
Recent publications have challenged the efficacy of the saline-coupled bipolar sealer method of 
hemostasis.  Recently published randomized clinical trials have not supported superiority of this 
method when compare to standard unipolar electrocautery.  Plymale, et al in 2012 conducted a 
RCT in 113 patients undergoing primary TKA.  The patients were randomized to either unipolar 
electrocauterization or the bipolar sealer.  Plymale reported no significant difference in 
postoperative drain output, postoperative hemoglobin and hematocrit values or transfusion 
requirements.2  The study included 3 surgeons.  The patients underwent general or epidural 
anesthesia.  To minimize variability in surgical technique the study developed a strict 
intraoperative coagulation protocol.    All patients in this study had an autotransfusion drain 
inserted and all patients received autodrain transfusions within the first 4 hours postoperatively.  
Blood transfusions were left to the discretion of each surgeon as there were no standard blood 
transfusion protocols in place at the investigative site.   
 
Mixed results have also been found in the use of the saline-coupled bipolar sealer in total hip 
arthroplasty (THA).  Morris in a retrospective study supported previous authors’ findings of 
significant reductions in blood loss and transfusions with the use of the saline coupled bipolar 
sealer in THA. 10  However, in a prospective randomized clinical trial Morris found that there                               
was no clinically significant difference in the actual blood loss, hemoglobin levels, or transfusion 
rates. 11  Zeh, et al also found no clinically relevant advantage for the use of the bipolar sealer in 
comparison to the unipolar sealer for blood management in primary THA. 12  Due to the higher 
cost both authors do not recommend the use of the bipolar sealer for primary THA. 
   
These conflicting results are multifactorial and highlight both the rapidly changing landscape of 
orthopedic surgery and faults in study design.  The restriction of this study to two surgeons will 
limit variations in the outcomes being measured due to differences in surgical technique.  
 
Plymale’s study included patients having either general or epidural anesthesia.  Baseline 
characteristics did not discuss if these groups were evenly distributed.   
 
These studies predate the use of IV TXA in orthopedic surgery and its dramatic effect on 
hemostasis.  Additionally, current trends in allogeneic blood transfusion protocols have also 
changed.  Patients are now transfused at lower hemoglobin levels.  Some of these studies did not 
have a clearly defined transfusion protocol and the transfusion requirements were left to surgeon 
discretion.  This limitation allowed for operator bias of a study clinical outcome.    
 
Another concern for using drain output as an outcome measure is that it has been documented 
that this drainage does not accurately represent postoperative blood loss as the drains do not 
remove all the blood lost.13 In a study by Johansson and colleagues drain output was shown to be 
inaccurate as a measure of postoperative blood loss as the drain does not account for hidden 
blood loss. 14   

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  
 
 
 
 
Page 6 of 33 
 
 
Efficacy and safety data are lacking in these publications as most patients are observed in the 
hospital setting only.  Long term follow-up on clinical outcomes such as range of motion and 
functional assessment scores were not reported in many of the trials.  
 
This study will compare the use of the saline-coupled bipolar sealer with the unipolar 
electrocautery to determine if one method results in increased homeostasis as measured by a 
hemoglobin nadir, reduced allogeneic blood transfusions, and estimated blood loss calculated 
using the Gross’ Formula.  This study will also be assessing the length of hospital stay, 2012 
Knee Society Scores, and the safety profile.   
 
Null Hypothesis: Our hypothesis is that the difference between the mean estimated blood loss in 
the Unipolar electrocautery and the saline-coupled bipolar sealer is greater than or equal to the 
margin of non-inferiority of 200 cc. Also, we propose that the safety and efficacy profile of the 
saline-coupled bipolar vs. the unipolar are clinically equivocal.  
 
3.2 
Investigational Agent-Device 
 
The Aquamantys® System is a commercially available device used routinely used in the 
operating room for a wide variety of surgical cases.  The Aquamantys® System is a patented 
Transcollation® technology, a combination of radiofrequency (RF) energy and saline that 
provides haemostatic sealing of soft tissue and bone during surgery.  The patented integration of 
RF energy and saline delivers controlled thermal energy to tissue. This combination allows the 
device temperature 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.  Suction is used to remove the saline 
from the surgical field. 
 
The Aquamantys System consists of a generator and disposable, single-use hand pieces. 
Medtronic Advanced Energy offers innovative Aquamantys hand pieces that are adept for use in 
orthopaedic surgery, such as the 6.0 Bipolar Sealer and MBS Bipolar Sealer with Light.  Salient 
Surgical Technologies, the original manufacturer of the device was acquired by Medtronic in 
2011.   
 
Aquamantys Disposable Bipolar Devices are sterile, single-use devices which employ RF energy 
and saline irrigation for hemostatic sealing and coagulation. These devices are equipped with a 
dual electrode tip. Saline and electrical lines exit the opposite end of the hand piece from the dual 
electrode. The hand piece is equipped with an on/off button that simultaneously activates both 
RF power and saline flow. A saline fluid delivery line is provided with the device, and includes a 
section of pump tubing and drip chamber. The three-pin electrical connector is designed to be 
plugged into the Aquamantys Pump Generator (Appendix A). 
 

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  
 
 
 
 
Page 7 of 33 
 
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 (Appendix B). 
 
Dr. Krauss has been a practicing orthopaedic surgeon since 1987.  Dr. Segal has been a 
practicing orthopaedic surgeon since 2002.  Both have extensive experience in the use of both 
the saline-coupled bipolar sealer and the unipolar electrocautery.  They are experts in the use of 
these devices and have not had any reportable device related adverse events.  Dr. Barry 
G.Simonson has been a practicing orthopaedic surgery for over 20 years and has extensive 
experience using both the saline-coupled bipolar sealer and the unipolar electrocautery. 
 
The unipolar electrocautery has been in use throughout Northwell Health for over 50 years.  The 
saline-coupled bipolar sealer has been use for about 5-6 years at multiple Northwell Health sites.  
Both systems have a proven safety profile for use in clinical practice. 
 
The operating room staff is specially trained in the proper use of the saline-coupled bipolar sealer 
and the unipolar electrocautery.  The operating room adheres to the Association of Surgical 
Technologists (AST) Standards of Practice for Use of Electrosurgery (Appendix C) and the 
Northwell Electrosurgical Safety Policy (Appendix D). The AST developed these standards of 
practice to protect both the patient and hospital staff.  These practices provide an optimum level 
of patient safety. 
 
3.3 
Preclinical Data 
 
This section is not applicable to this study.  These devices are commercially available. 
 
3.4 
Clinical Data to Date 
 
This section is not applicable to this study.  These devices are commercially available. 
 
3.5 
Dose Rationale and Risk/Benefits 
 
This section is not applicable to this study.   
 
4 
Study Objectives 
 
Primary Objective 
 
 To assess whether the unipolar electrocautery is non-inferior to saline-coupled bipolar 
sealer with respect to estimated blood loss as calculated by Gross’ formula in patients 
undergoing primary unilateral total knee arthroplasty. 
 

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Secondary Objective 
 
 To assess whether the unipolar electrocautery is superior to saline-coupled bipolar sealer 
with respect to hemostasis in patients undergoing primary unilateral total knee 
arthroplasty. 
 
 To assess whether hospital length of stay in patients undergoing primary unilateral total 
knee arthroplasty is different between the saline-coupled bipolar sealer compared to the 
unipolar electrocautery. 
 
 To assess whether objective and functional outcomes in patients undergoing primary 
unilateral total knee arthroplasty differ between the saline-coupled bipolar sealer 
compared to the unipolar electrocautery. 
 
 To assess the safety profile of the saline-coupled bipolar sealer compared to the unipolar 
electrocautery in patients undergoing primary unilateral total knee arthroplasty  
 
 
5 
Resources Available to Conduct the Human Research 
 
For the calendar years 2013 to 2015 Dr. Krauss performed 950 primary total knee arthroplasties 
and Dr. Segal performed 326 primary total knee arthroplasties. 
  
Prior to conducting any study related procedures the Principal Investigator or a designee will 
train all applicable hospital staff on the protocol and study related activities to ensure study 
compliance. 
 
 
6 
Study Design 
6.1 
General Design 
 
This is a prospective, single center, randomized, single-blinded, non-inferiority study to evaluate 
the safety and efficacy of the bipolar sealer compared to the unipolar in primary, unilateral total 
knee arthroplasty.  The restriction of this study to three surgeons will limit variations in the 
outcomes being measured due to differences in surgical technique.  
 
Current preoperative, intraoperative, and postoperative blood management strategies will be 
consistent for all subjects.    
 
Patients seen in the outpatient office and scheduled for primary unilateral TKA by Dr. Krauss, 
Dr. Segal, or Dr. Barry Simonson will be approached for inclusion in the clinical trial.  Dr. 
Krauss, Dr. Segal, Dr. Simonson, or their designee, will discuss the study with the patient.  The 

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patient will be given sufficient time to read the consent and ask any questions.  The informed 
consent will be obtained by Dr. Krauss, Dr. Segal or Dr. Simonson.. No study related procedures 
will be done prior to obtaining the informed consent.  
 
Objective and functional outcomes will be obtained using the 2011 Knee Society Score (KSS).  
The KSS will be completed preoperatively and postoperatively as per the department standard of 
care for all total knee arthroplasty patients.(Appendix E).   
Preoperatively patients taking anticoagulants or antiplatelets, with the exception of aspirin 81 mg 
qd, will be excluded from the study as these medications could adversely affect intraoperative 
and postoperative bleeding.  Patients with any bleeding dyscrasias will also be excluded from the 
study.  Patients are instructed to discontinue aspirin, medications containing aspirin-like 
products, and non-steroidal anti-inflammatory agents seven days prior to surgery.  (Appendix F).   
Patients who are unable to stop these products for any reason will be excluded from the study.   
   
All preoperative patients are seen in pre-surgical testing (PST) within 4 weeks prior to the 
scheduled surgery.  Laboratory testing done as standard of care for all preoperative surgical 
patients are comprehensive metabolic panels and complete blood count.  These laboratory values 
will be used to evaluate the inclusion and exclusion criteria for study enrollment. This study does 
not require any study specific laboratory tests.  Patients are counseled by the nurse practitioner in 
PST on prescription medications, over-the-counter medications, foods, herbs and supplements 
that will interfere with blood clotting and must be discontinued prior to surgery (Appendix G). 
 
On the operative day patients will be interviewed to confirm their agreement to continue in the 
study. Patients will be re-consented by Dr. Krauss, Dr. Segal, or Dr. Simonson, if the date of the 
original consent is greater than 28 days from the date of surgery. The inclusion and exclusion 
criteria will be verified prior to study randomization using the laboratory testing done in PST and 
the preoperative medical history documents.  Patients will be randomized to either the treatment 
arm (saline-coupled bipolar sealer) or the control arm (unipolar electrocautery). The Biostatistics 
Unit will develop a randomization procedure using a permuted block design and the 
randomization process will occur in REDCap using the Randomization Module. The operating 
room (OR) staff will be immediately notified of the treatment arm so that the OR can be 
prepared.  
 
Intraoperative blood management strategies will be consistent for all subjects to avoid any 
confounding factors which could affect postoperative transfusion requirements. Any patients 
unable to be treated according to the department treatment guidelines will be excluded from the 
study. Intraoperatively blood loss is minimized by anesthetic techniques, pharmacologic 
interventions, and surgical techniques.   
 
Anesthetic techniques include spinal anesthesia.  Spinal anesthesia is the preferred method of 
anesthesia for patients having a TKA.  Any patient with preoperative contraindications to spinal 
anesthesia will be excluded from the study.  Unfortunately, due to technical issues in the OR, 
some patients are unable to receive spinal anesthesia and the patient is given general anesthesia.  
Though a rare occurrence these patients will remain on study and included in the study statistics 
as this is an Intent to Treat Study design.   Euthermia is managed by the anesthesiologist with the 
use of warming blankets.  

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Pharmacologic techniques included TXA 1000 mg/100cc Normal Saline infused over 15-30 
minutes x 2 doses.  The first dose will be given prior to incision and the second dose will be 
given when the pneumatic tourniquet is released or at least 60 minutes after the first dose.  Any 
patients unable to be treated according to the department treatment guidelines for IV TXA will 
be excluded from the study (Appendix H).  A closed suction drain is inserted based on the 
surgeon’s clinical decision. 
 
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 electrocautery used is not routinely 
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.  The blood transfusion protocol is consistent for all patients.  Patients 
receive allogeneic blood transfusions when the hemoglobin is < 7 g/dL.  For Hgb >7 g/dL to <8 
g/dL patients are treated only if they are exhibiting clinical symptoms related to the anemia or if 
there is a rapid decline in Hgb.  For Hgb > 8 g/dL patients are treated if they are exhibiting 
clinical symptoms of anemia. 
 
The pneumatic tourniquet will be applied and inflated to maintain a bloodless field. The 
tourniquet pressure is determined by the surgeon.   At the end of the surgery the tourniquet is 
released.  Bleeding vessels are sealed with either the saline coupled bipolar sealer or the unipolar 
electrocautery based on the subject randomization. 
 
Venous thromboembolism prophylaxis in joint replacement consists of both chemical and 
mechanical measures.  All patients have a sequential compression device applied in the operating 
room to the non-operative extremity.  At the end of the surgical case, after the dressing has been 
applied, the sequential compression device is applied to the operative extremity.  Sequential 
compression devices are in use while patients are in bed. 
 
Patients are started on venous thromboembolism prophylaxis postoperative Day 1.  The 
treatment regimen is dependent on the patient’s calculated Caprini Risk Assessment Score. 
(Appendix I). 
Early ambulation for TKA patients begins on postoperative Day 0.  Patients are seen by a 
physical therapist within four hours of discharge from the PACU to begin their ambulation.  
Only acute medical events are valid reasons for a patient not to be ambulated at this time point.  
While hospitalized patients are visited daily by a physical therapist. This study will be assessing 
the physical therapy progress of the patients by collecting the total distance walked each day.  
The physical therapists will be blinded to the treatment arm of the study.   
 
Estimated blood loss will be calculated using the Gross’ Formula.16 This method is being used to 
provide a more standardized method of calculating blood loss. Eipe and Ponniah showed that 
surgical blood loss was underestimated by 64% when clinical methods are used to assess blood-
soaked sponges and blood lost to suction bottles and the vacuum drain17.    
 

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Following discharge patients will be followed in the outpatient office according to the 
postoperative standard of care visit schedule. The 2011 KSS Objective Outcome Measurements 
will be collected at the postoperative 2 week and 8 week visits, or the office visit closest to these 
time points. The 2011 KSS Functional Outcome Measurements will be collected at the 8 week 
visit or the postoperative office visit closest to this time point.  Patients will be followed for 90 
days from the date of surgery for any device related adverse events and surgical site infection. 
 
 
6.2 
Primary Study Endpoints 
 
Primary Study Endpoints: 
 Perioperative estimated blood loss as calculated by the Gross’ Formula  
 
Secondary Study Endpoints:  
 Need for allogeneic red blood cell transfusions 
 Perioperative blood loss as measured by the difference between the: 
o  preoperative hemoglobin and the nadir of the postoperative hemoglobin value 
during the hospital stay 
o the preoperative hematocrit and the nadir of the postoperative hematocrit value 
during the hospital stay 
 Hemoglobin and hematocrit values over time (pre-op, post-op day 0, day 1, day 2, and 
until discharge) 
 Hospital LOS 
 Functional outcomes as measured by: 
o distance walked in feet 
o 2011 Knee Society Scores  
 
Primary Safety Endpoints: 
 Wound infections within 90 days of the date of surgery 
 Device related adverse events within 90 days of the date of surgery 
 
7 
Subject Selection and Withdrawal 
7.1 
Inclusion Criteria 
 
1. Patients scheduled for primary unilateral total knee arthroplasty  
 
2. Preoperative Hemoglobin >11mg/dL 
3. Preoperative platelet count of >150,000 
4. Age >18 
5. Patient is freely able to provide consent 

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6. American Society of Anesthesiologists (ASA) classification I-III (Appendix J) 
7. Patient willing to complete all study related procedures 
 
 
7.2 
Exclusion Criteria 
 
1. Patients allergic to aspirin 
2. Patients unable to take to aspirin for VTE prophylaxis for any reason 
3. Patients with a contraindication to Apixaban  
4. Any patient who is not a candidate for VTE risk stratification according to the calculated 
Caprini Risk Assessment Score (Appendix I).  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 IV TXA for any reason 
13. Patients requiring anticoagulant treatment prior to surgery 
14. History of stroke or TIA 
15. Serum creatinine > 2.8 mg/dl 
16. History of hepatic failure 

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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 
 
7.3 
Vulnerable Populations 
 
No vulnerable patients will be enrolled in this clinical trial.  Only patients who are scheduled for 
elective total knee arthroplasty will be approached for enrollment. 
 
 
7.4 
Subject Recruitment and Screening 
 
Patients scheduled for primary unilateral total knee replacement surgery by Dr. Krauss or Dr. 
Segal will be approached for inclusion in the clinical trial.  
 
 
 

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7.5 
Consent Process 
 
Participation in the clinical trial will be discussed with the patient by the Dr. Krauss, Dr. Segal, 
Dr. Simonson or their designee, when the patient is first scheduled for a total knee arthroplasty.  
The investigator will discuss the following:  
 the purpose/objective of the study 
 the study design (e.g., the number of participants) 
 how patients are assigned to the treatment group 
 participation in this study is not required  
 patients may withdraw from this study at their discretion 
 
Patients will be given ample time to review the consent and ask questions. Those wishing to 
participate will sign the informed consent form. The consent process will be documented by the 
investigator on the study “Enrollment Note”.  A copy of the signed consent will be provided to 
the patient. Patients without capacity to provide informed consent will be excluded from the 
study.  
 
Patients will be reconsented if the consent process  was done >28 days prior to surgery.   
 
 
7.6 
Early Withdrawal of Subjects 
7.6.1 When and How to Withdraw Subjects 
 
Patients may withdraw from the study at any time without bias.   
 
 
7.6.2 Data Collection and Follow-up for Withdrawn Subjects 
 
Any paper documents that contain PHI (e.g., link between the ID to subjects’ identifiers) will be 
stored in a locked cabinet within the research department, separately from any de-identified 
research documents. IRB-approved personnel will be the only individuals with access to any 
research documents containing PHI.  Any electronic documents that contain PHI will be stored 
on REDCap. The Feinstein Institute for Medical Research will be used as a central location for 
data processing and management. Vanderbilt University, with collaboration from a consortium 
of institutional partners, has developed a software toolset and workflow methodology for 
electronic collection and management of research and clinical trial data. REDCap (Research 
Electronic Data Capture) data collection projects rely on a thorough study-specific data 
dictionary defined in an iterative self-documenting process by all members of the research team 
with planning assistance from the Biostatistics Unit of the Feinstein Institute for Medical 
Research. The iterative development and testing process results in a well-planned data collection 
strategy for individual studies.  REDCap servers are housed in a local data center at the Feinstein 
and all web-based information transmission is encrypted. REDCap was developed specifically 

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around HIPAA-Security guidelines and is recommended to Northwell Health researchers by our 
Clinical Research Service, Research Compliance Office and Institutional Review Board. 
REDCap has been disseminated for use locally at other institutions and currently supports 1,244 
active institutional partners and other institutions in 87 countries (www.project-redcap.org). No 
PHI or research data will be stored on any Portable Electronic Devices (e.g., laptops, tablets, 
flash drives, etc.).  Any research data that will be emailed will be de-identified and encrypted. 
PHI will not be emailed to any commercial email addresses (e.g., Gmail, Yahoo, Hotmail). 
 
 
 
 
 
Additional information collected will include: 
1. 
Initals 
2. 
Medical record number 
3. 
Date of surgery 
4. 
Race/Ethnicity 
5. 
Significant past medical and surgical history 
6. 
Age  
7. 
Height (cm) 
8. 
Weight (kg) 
9. 
Body mass index (kg/m2) 
10. 
Calculated Caprini Score 
11. 
Preoperative 2011 Knee Society Score Objective and Functional Assessments 
12. 
ASA classification  
13. 
Length of procedure in minutes (from first incision to incision closure) 
14. 
Pneumatic Tourniquet time (in minutes) 
15. 
Type of anesthesia (spinal/general) 
16. 
Closed Suction Drain inserted (Yes/No)  
17. 
Date drain discontinued (if applicable) 
18. 
Total amount of drainage in cc 
19. 
Temperature on arrival to the PACU 
20. 
Length of time in minutes to reach normothermia in the PACU (T > 360 C) 
21. 
Patient out of bed within 4 hours of discharge from the PACU (Yes/No) 
22. 
Baseline Hemoglobin 

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23. 
Baseline Hematocrit 
24. 
Baseline Platelets 
25. 
Postoperative Day 0 until discharge: 
 Number transfusions  
 Daily Hemoglobin (standard of care for postoperative patients) 
 Daily Hematocrit (standard of care for postoperative patients) 
 Daily Platelets (standard of care for postoperative patients) 
 Ambulation (in feet) 
 Assessment for device related adverse events 
 Assessment for wound infection  
26. 
Discharge disposition 
27. 
Discharge Date 
28. 
Postoperative 2011 Knee Society Score Objective Outcome Measurements will be 
collected at the 2 week and 8 week visits, or the postoperative visit closest to these time-
points 
29. 
The Postopertative 2011 Knee Society Score Functional Outcome Measurements will be 
collected at the 8 week visit or the postoperative visit closest to this time-point. 
30. 
Assessment for wound infection for 90 days from the date of surgery 
31. 
Assessment for device related adverse events for 90 days from the date of surgery 
 
 
8 
Study Drug/Device  
8.1 
Description 
 
See Appendix A & B for details on the commercially available devices being used. 
 
 
8.2 
Treatment Regimen 
 
This section is not applicable for this study. 
 

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8.3 
Method for Assigning Subjects to Treatment Groups 
 
Subjects will be randomly assigned by a 1:1 ratio to either: 
1. Unipolar electrocautery system (Covidien ForceTriadTM  Electrosurgical System)  
2. Saline-coupled bipolar sealer (Aquamantys SystemTM  Medtronics) 
 
The Biostatistics Unit will develop a randomization procedure using a permuted block design 
and the randomization process will occur in REDCap using the Randomization Module.  Details, 
including required record keeping and a well documented single-blind randomization procedure, 
will be further developed upon approval of this protocol.     
 
8.4 
Preparation and Administration of Study Drug/Implantation of Study Device 
 
This section is not applicable for this study. 
 
 
8.5 
Subject Compliance Monitoring 
 
This section is not applicable for this study. 
 
 
8.6 
Prior and Concomitant Therapy 
 
Patients taking clopidogrel (Plavix), ticagrelor(Brilinta), prasugrel (Effient) or warfarin 
(Coumadin) preoperatively will be excluded from enrollment.   
 
 
8.7 
Packaging 
 
This section is not applicable for this study. 
 
 
8.8 
Blinding of Study Drug/Device 
 
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. 

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Postoperatively medical care is managed by the hospitalist, medical doctors specializing in the 
care of hospitalized patients.   
 
 
 
8.9 
Receiving, Storage, Dispensing and Return 
8.9.1 Receipt of Drug Supplies/Device 
 
The saline-coupled bipolar sealer and the unipolar electrocautery are both commercially 
available products routinely used in the OR.  
 
8.9.2 Storage 
 
This section is not applicable for this study. 
 
 
8.9.3 Dispensing of Study Drug/Device 
 
This section is not applicable for this study. 
 
 
8.9.4 Return or Destruction of Study Drug/Device 
 
This section is not applicable for this study. 
 
 
9 
Study Procedures 
9.1 
Visit 1-Preoperative office visit 
 Informed Consent 
 Completion of the Preoperative 2011 Knee Society Score (done as part of the standard of 
care for all preoperative knee arthroplasty patients) 
 
9.2 
Visit 2-Day of Operation 
 Re-consent if applicable 
 Verification of Inclusion/Exclusion Criteria 
 Randomization and Notification of the OR staff 
 

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9.3 
Visit 3-Hospital Postoperative Period: Postoperative Day 0 to Discharge 
 Device Adverse Event assessment 
 Wound infection assessment  
 Blood transfusions assessment 
 Daily Hemoglobin, Hematocrit, and Platelets (standard of care for all postoperative 
surgical patients) 
 Distance walked in feet as document by the Physical Therapy Department 
 Suction drain output (if applicable) 
9.4 
Visit 4-Outpatient Postoperative Period (2 week and 8 week visit, or the visit 
closest to this time-point 
 Device Adverse Event Assessment 
 Assessment for wound infection  
 Completion of the Postoperative 2011 Knee Society Score 
 
9.5 
Visit 5-End of Study Visit (90 days or greater from the date of surgery) 
The patient will be contacted via phone 90 days or greater from the date of surgery to 
collect any adverse events related to the device and for any wound infections or blood 
transfusions+.  All device related adverse events and wound infections will be followed 
until resolved.  Patients enrolled in the study will be contacted using the orthopedic 
department’s standard of care follow-up telephone call script (Appendix M). Three 
attempts will be made to contact the patient.  Patients who are unable to be contacted after 
3 attempts will be considered lost to follow-up.      
 
10 Risks to Subjects 
 
This study does not put the patient at any additional risk. The bipolar sealer and unipolar 
electrocautery are commercially available devices routinely used during orthopaedic surgery.   
Risk factors identified with the use of electrosugery include fires, patient burns, surgical 
personnel injuries and biological hazards, such as plume.  The operating room adheres to the 
Association of Surgical Technologists (AST) Standards of Practice for Use of Electrosurgery 
(Appendix C) and the Northwell Health Electrosurgical Safety Policy (Appendix D). The AST 
developed these standards of practice to protect both the patient and hospital staff.  These 
practices provide an optimum level of patient and operating room staff safety. 
 
 
11 Potential Benefit to Subjects 
 
Participating in this clinical study will contribute to current medical knowledge of these devices. 
The results of this study can make a difference in the care of future patients by providing 
information about the benefits of these interventions. 

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12 Research Related Harm/Injury 
 
This study does not put the patient at any additional risk.   
 
 
13 Provisions to Protect Privacy Interests of Subjects 
 
Potential research patients will be identified in the private orthopaedic outpatient office.  
Enrollment in the trial will be discussed in a private room and the patient will be provided with 
ample time to review the consent and ask questions.  
 
 
14 Statistical Plan 
14.1 Sample Size Determination 
Sample Size Considerations: 
The proposed sample size for this study is 164 subjects (n=82 per group). 
  
As a non-inferiority trial, Unipolar will be considered non-inferior to Bipolar if the difference in 
the mean estimated blood loss as calculated by Gross’ Formula is less than 200 cc (δ=margin of 
inferiority=200 cc).  More formally, let µUnipolar and µBipolar be the mean estimated blood loss for 
the Unipolar system and the Bipolar system, respectively.  The following are the null hypothesis 
and alternative hypothesis: 
H0: 
d = µUnipolar – µBipolar ≥ δ vs.  
HA: 
d = µUnipolar – µBipolar < δ 
 
Based on a previous study “To Evaluate the Safety and Efficacy of IA-TXA in Primary Total 
Joint Arthroplasty” we will assume that the mean estimated blood loss is 1133 cc for both the 
unipolar and bipolar group. The common standard deviation of 511 cc was calculated based on 
the average estimated blood loss standard deviations in the Bipolar system and Unipolar system 
which were 476 cc and 546 cc, respectively (Marulanda, 2009). Based on two surgeons that are 
experts in TKA, less than 200 cc was determined to be a clinically acceptable increase in 
estimated blood loss. Using a 2-sided α-level of 0.05, and a non-inferiority margin of 200 cc, a 
target of 82 subjects per group (n=164 in total) would yield 80% power to determine that the 
Unipolar system is non-inferior to the Bipolar system when the estimated blood loss in the 
Bipolar group is 1133 cc and in the Unipolar group is 1133 cc with a common standard deviation 
of 511 cc.  
 

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Statistical Methods 
 
Primary Study Endpoints: 
 Perioperative estimated blood loss as calculated by the Gross’ Formula  
 
Secondary Study Endpoints:  
 Need for allogeneic red blood cell transfusions 
 Perioperative blood loss as measured by the difference between the: 
o  preoperative hemoglobin and the nadir of the postoperative hemoglobin value 
during the hospital stay 
o the preoperative hematocrit and the nadir of the postoperative hematocrit value 
during the hospital stay 
 Hemoglobin and hematocrit values over time (pre-op, post-op day 0, day 1, day 2, and 
until discharge) 
 Hospital LOS 
 Functional outcomes as measured by: 
o distance walked in feet 
o 2011 Knee Society Scores  
 
Primary Safety Endpoints: 
 Wound infections within 90 days of the date of surgery 
 Device related adverse events within 90 days of the date of surgery 
 
Randomization:  
Subjects will be randomly assigned by a 1:1 ratio to either: 
3. Unipolar electrocautery system (Covidien ForceTriadTM  Electrosurgical System)  
4. Saline-coupled bipolar sealer (Aquamantys SystemTM  Medtronics) 
The Biostatistics Unit will develop a randomization procedure using a permuted block design 
and the randomization process will occur in REDCap using the Randomization Module.  Details, 
including required record keeping and a well documented single-blind randomization procedure, 
will be further developed upon approval of this protocol.     
 
Intention to Treat (ITT):   
The primary analyses will be based on the ITT population.  The ITT population will be defined 
as any subject who is randomized, regardless of which system is used. 
 
 
Interim Analysis and Early Stopping:   
There will be no interim analysis. 
 

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Statistical Methods:  
The test for non-inferiority will be carried out using a 2-tailed 95% confidence interval for the 
difference (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer) in the estimated 
blood loss between the two groups. δ is the margin of inferiority and will be set at 200 cc.  If the 
upper confidence limit < δ (≥δ) then we will conclude that the Unipolar electrocautery system is 
non-inferior (inferior) to the Saline-coupled bipolar sealer.   
 
This test for non-inferiority will only be performed for the primary study endpoint of estimated 
blood loss; all other secondary variables will be tests of superiority of Unipolar electrocautery 
versus Saline-coupled bipolar sealer. 
 
A mixed models repeated measures (MMRM) analysis of variance will be performed separately 
for hemoglobin and hematocrit, to determine whether the two groups behave differently across 
time (pre-op, post-op day 0, post-op day 1, post-op day 2, and until discharge).  The models will 
contain one repeated (within subjects) factor of time, a between factor of group, and a group-by-
time interaction term.   Time will be treated as a fixed effect in the model and an unstructured 
covariance approach will be used.  Results will be reported as adjusted (least squares) means and 
standard errors.  For all analyses, the standard assumptions of Gaussian residuals and equality of 
variance will be tested.  If the standard assumptions are not met, a transformation will be 
performed, and the results will be brought back to the original units and reported as geometric 
means with their corresponding lower and upper confidence limits. 
 
LOS (or “Time to discharge from hospital”) will be analyzed by applying standard methods of 
survival analysis, i.e., computing  the Kaplan-Meier product limit curves, where group (Saline-
coupled bipolar sealer vs. Unipolar electrocautery system) will be the stratification variable.  In 
cases where the endpoint event, “discharge from hospital”, did not occur, the number of days 
until last follow-up will be used and considered ‘censored’.  These two groups will be compared 
using the log-rank test.  The median “time to discharge from hospital” and corresponding 95% 
confidence intervals for each group will be obtained from the Kaplan-Meier/Product-Limit 
Estimates. 
 
A two-sample t-test or Mann-Whitney test will be used to compare the two groups for 
perioperative blood loss and Functional outcomes (i.e. distance walked, Knee Society Scores). 
Estimated blood loss will be calculated using the Gross’ Formula.  The chi-square test or Fisher’s 
exact test, as deemed appropriate, will be used to compare the two groups for wound infections 
and device related adverse events. 
 
A result will be considered statistically significant at the p<0.05 level of significance.  All 
analyses will be performed using SAS version 9.4 (SAS Institute Inc., Cary, NC). 
 
 
 
 
 

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15 Medical Device Reporting 
 
This clinical trial is designed to compare two commercially available medical devices commonly 
used in surgical procedures.  These devices are being used according to the manufacture’s 
guidelines.   
 
This study will adhere to the adverse event reporting regulations of the Centers for Devices and 
Radiological Health (CDRH), part of the Food and Drug Administration (FDA) regulations.  In 
accordance with the Safe Medical Devices Act of 1990 (SMDA) (Public Law 102-629) (21 CFR 
803.32 (c)) ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user 
facilities are required to report all incidents in which a medical device or user error may have 
caused or contributed to the death, serious injury or serious illness of a patient (Appendix K). 
 
 
 
 
15.1 Serious Injury or illness definition 
 
“Serious injury or illness” means those injuries that are life threatening, result in permanent body 
function impairment or permanent damage to a body structure, or necessitate immediate medical 
or surgical intervention to prevent permanent body function impairment or permanent damage to 
a body structure (21 CFR 803.3) (r).   
 
A device may have "caused or contributed to" a patient’s death or serious injury, if the death or 
serious injury was or may have been attributed to the device or the device may have been a factor 
in the death or serious injury because of:  
 
 
o Device failure 
o Malfunction 
o Improper or inadequate device design 
o Manufacture 
o Labeling or 
o User error 
 
15.2 Mandatory Medical Device Reporting 
The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory 
requirements for manufacturers, importers, and device user facilities to report certain device-
related adverse events and product problems to the FDA. The regulation specified that reports be 
filed on FDA Medwatch Form 3500A or an electronic equivalent.  
 
 
Device User Facility Reporting Requirements of Serious Adverse Events: 
A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient 
diagnostic facility, or outpatient treatment facility, which is not a physician’s office.  

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All deaths and serious injuries to which the device has or may have caused or contributed will be 
reported to the IRB, FDA and the manufacturer.  
 
The user facility will also submit annual reports to the FDA by January 1 of each year as 
described in 21 CFR 803.33. 
 
Form 3419 Annual User Facility Report 
o Medical Device Reporting Annual User Facility Report - Form FDA3419 
o Instructions for Completing the Medical Device Reporting Annual User Facility 
Report, Form FDA3419 
The following “Mandatory Reporting Requirements for User Facilities” will be applicable 
for this clinical trial: 
REPORTERWHAT TO 
REPORT 
REPORT 
FORM # 
TO WHOM 
WHEN 
User Facility Device-related Death Form FDA 
3500A 
FDA & Manufacturer 
Within 10 work 
days of becoming 
aware 
User Facility Device-related Serious 
injury 
Form FDA 
3500A 
Manufacturer. FDA only 
if manufacturer unknown
Within 10 work 
days of becoming 
aware 
User Facility Annual summary of 
death & serious injury 
reports 
Form FDA 
3419 
FDA 
January 1 for the 
preceding year 
 
 
All adverse events that do not meet any of the criteria for serious should be regarded as 
non-serious adverse events. Any non-serious adverse event felt to be related to the study 
device will be captured in the source documents and case report form.   
 
Adverse Event Reporting Period 
The study period during which adverse events must be reported is normally defined as the 
period from the initiation of any study procedures to the end of the study treatment follow-
up.  For this study, the study treatment follow-up is defined as 2 months from the date of 
the surgical procedure. 
 

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15.3 Recording of Adverse Events 
Information on all device related serious and non-serious adverse events will be recorded in the 
source document, and also in the appropriate adverse event module of the case report form 
(CRF).  All clearly related signs, symptoms, and abnormal diagnostic procedures results should 
be recorded in the source document, though should be grouped under one diagnosis. 
 
All devices related serious and non-serious adverse events occurring during the study period 
must be recorded.  The clinical course of each event should be followed until resolution, 
stabilization, or until it has been determined that the study treatment or participation is not the 
cause.  Serious adverse events that are still ongoing at the end of the study period must be 
followed up to determine the final outcome.  Any serious adverse event that occurs after the 
study period and is considered to be possibly related to the study treatment or study participation 
should be recorded and reported immediately. 
 
15.3.1 EC/IRB Notification by Investigator 
Reports of all serious adverse events (including follow-up information) must be 
submitted to the EC/IRB according to their policies.  Copies of each report and 
documentation of EC/IRB notification and receipt will be kept in the Clinical 
Investigator’s binder. 
15.3.2 FDA Notification by Sponsor 
 
This section is not applicable as this is an investigator initiated study.   
 
15.4 Unblinding Procedures 
 
The patient can be unblinded to the treatment arm by the Principal Investigator if this 
information is necessary for the patient’s postoperative care. 
 
 
15.5 Data and Safety Monitoring  
15.5.1 Data and Safety Monitoring Plan 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her 
site.  This safety monitoring will include careful assessment and appropriate reporting of all 
adverse events deemed related to the medical device.  Medical monitoring will include a regular 
assessment of the number and type of serious adverse events. 
 
The PI and nurse research coordinator will monitor safety and review adverse events for subjects 
enrolled every 2 months. The PI will prepare a safety report for these regular reviews comprised 
of adverse events and the actions taken. The study protocol will be carried out in accordance 

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with OHRP/FDA/NIH guidelines and requirements. In the event of a serious adverse event 
during the study protocol, it will be reported immediately to the PI. Serious AND Unanticipated 
AND possibly, probably or definitely related AEs will be reported to the IRB within 48 hours of 
the event by the principle investigator as well as to all members of the research team. Data 
including all recorded adverse events will also be reviewed to determine if aspects of the study 
need to be changed or stopped. In addition, the PI will review any and all deviations, adverse 
events and unanticipated problems that may occur to determine their relatedness to the study, 
their severity, and whether they require study changes. In addition, any unanticipated problems 
will be reported to the IRB as per their specific reporting requirements. Anticipated deviations 
will be submitted to the IRB for approval as a protocol exception prior to its initiation, unless 
required to eliminate apparent immediate hazards.   
 
 
16 Data Handling and Record Keeping 
16.1 Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
Those regulations require a signed subject authorization informing the subject of the following:  
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information 
 The rights of a research subject to revoke their authorization for use of their PHI  
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization.  For subjects that have revoked authorization to collect or use PHI, attempts 
should be made to obtain permission to collect at least vital status (i.e. that the subject is alive) at 
the end of their scheduled study period. 
16.2 Source Documents 
 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  Source 
data are contained in source documents   Examples of these original documents, and data records 
include: hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ 
diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated 
instruments, copies or transcriptions certified after verification as being accurate and complete, 
microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and 
records kept at the pharmacy, at the laboratories, and at medico-technical departments involved 
in the clinical trial. 

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16.3 Case Report Forms 
 
The study case report form (CRF) is the primary data collection instrument for the study.  All 
data requested on the CRF must be recorded.  All missing data must be explained.  If a space on 
the CRF is left blank because the procedure was not done or the question was not asked, write 
“N/D”.  If the item is not applicable to the individual case, write “N/A”.   
 
The REDCap software will be the electronic CRF used for this study.  Vanderbilt University, 
with collaboration from a consortium of institutional partners, has developed a software toolset 
and workflow methodology for electronic collection and management of research and clinical 
trial data. REDCap (Research Electronic Data Capture) data collection projects rely on a 
thorough study-specific data dictionary defined in an iterative self-documenting process by all 
members of the research team with planning assistance from the Biostatistics Unit of the 
Feinstein Institute for Medical Research. The iterative development and testing process results in 
a well-planned data collection strategy for individual studies.  REDCap servers are housed in a 
local data center at the Feinstein and all web-based information transmission is encrypted. 
REDCap was developed specifically around HIPAA-Security guidelines and is recommended to 
Northwell Health researchers by our Clinical Research Service, Research Compliance Office and 
Institutional Review Board. REDCap has been disseminated for use locally at other institutions 
and currently supports 1,244 active institutional partners and other institutions in 87 countries 
(www.project-redcap.org).  
 
Records Retention 
 
It is the investigator’s responsibility to retain study essential documents for at least 2 years after 
the last approval of a marketing application in their country and until there are no pending or 
contemplated marketing applications in their country or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product.  These documents 
should be retained for a longer period if required by an agreement with the sponsor.  In such an 
instance, it is the responsibility of the sponsor to inform the investigator/institution as to when 
these documents no longer need to be retained.  
 
17 Study Monitoring, Auditing, and Inspecting 
17.1 Study Monitoring Plan 
This section is not applicable for this study.   
17.2 Auditing and Inspecting 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, 
government regulatory bodies, and University compliance and quality assurance groups of all 
study related documents (e.g. source documents, regulatory documents, data collection 
instruments, study data etc.).  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
 

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Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable University compliance and quality assurance 
offices. 
 
 
18 Ethical Considerations 
 
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), 
applicable government regulations and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
Ethics Committee (EC) or Institutional Review Board (IRB), in agreement with local legal 
prescriptions, for formal approval of the study conduct.  The decision of the EC/IRB concerning 
the conduct of the study will be made in writing to the investigator. 
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 
study.  See Appendix L for a copy of the Subject Informed Consent Form.  This consent form 
will be submitted with the protocol for review and approval by the EC/IRB for the study.  The 
formal consent of a subject, using the EC/IRB-approved consent form, must be obtained before 
that subject is submitted to any study procedure.  This consent form must be signed by the 
subject or legally acceptable surrogate, and the investigator-designated research professional 
obtaining the consent.  
 
19 Study Finances 
19.1 Funding Source 
 
There is no outside funding for this study. 
 
19.2 Conflict of Interest 
 
The investigators have no conflict of interest to report. 
 
19.3 Subject Stipends or Payments 
 
The laboratory tests collected in this study are tests done as standard of care for all orthopedic 
surgical patients.   
 
There will be no payment to the patients for enrollment in the study.   
 

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20 Publication Plan 
 
Investigators intend to publish the results of this study. Any published results will only include 
an aggregate of de-identified data. No protected health information will be disclosed outside of 
Northwell Health for the purposes of this research.  
 
Protected health information may be shared with: 
- 
The Institutional Review Board (IRB) at Northwell Health Hospitals; 
- 
Doctors and staff at the hospital where this research study will take place; 
- 
Doctors and staff at other institutions that are participating in the research study; 
- 
Governmental entities that have the right to see or review your protected health 
information, such as the U.S. Office of Human Research Protections and the FDA. 
 
Protected health information will only be used and/or given to others to perform this research; to 
study the results; and to determine if the research was done correctly. All reasonable efforts will 
be made to maintain confidentiality (in accordance with the measures outlined above). 
21 References 
 
1. Spahn DR, Goodnough LT.  Alternatives to blood transfusion.  Lancet 2013;381:1855  
2. Plymale  M, et al. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective 
randomized trial.  J of arthroplasty  2012; 27:1133-1137 
3. Dunne JR, et al.  Perioperative anemia: an independent risk factor for infection, mortality, 
and resource utilization in surgery.  J Surg Res 2002;102(2):237 
4. Konig G, Hamlin BR, et al. Topical tranexamic acid reduces blood loss and transfusion 
rates in total hip and total knee arthroplasty.  J of arthroplasty 2013;28:1473-1476 
 
5. Rodgers A, Walker N, et al. Reduction of postoperative mortality and morbidity with 
epidural or spinal anaesthesia: results from overview of randomised trials. BMJ 
2000;321:1 
 
6. Tobias. Strategies for minimizing blood loss in orthopedic surgery.  Seminars in 
Hematology 2004;41(1):145 
 
7. Esler C, Blakeway J. The use of a closed-suction drain in total knee arthropalsty. Bone 
Joint Surg [Br] 2003;85-B:215-7 
 
8. Marulanda GA, Ulrich SD, et al. Reductions in blood loss with bipolar sealer in total hip 
arthroplasty.  Expert Rev Med Devices 2008:5(2):125 

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9. 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.Attachments 
 
10. 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;20:352. 
11. Morris MJ, et al.  Randomized blinded study comparing a bipolar sealer and standard 
electrocautery in reducing transfusion requirements in anterior supine intermuscular total 
hip arthroplasty.  J arthroplasty 2013;28:1614-1617 
 
12. Zeh A, Messser J.  The aquamantys system-an alternative to reduced blood loss in 
primary total hip arthroplasty?  J arthoplasty 2010;25:1072 
 
13. Strahovik A, Fokter S. Comparison of drainage techniques on prolonged serous drainage 
after total hip arthroplasty.  J of Arthroplasty 2010;2:244 
 
14. Johansson T, Engquist M, Pettersson LG. Blood loss after total hip replacement: a 
prospective randomized study between wound compression and drainage.                               
J Arthroplasty 2005;20:967. 
15. Yang et al. Bipolar sealer not superior to standard electrocautery in primary total hip 
arthroplasty: a meta-analysis. Journal of orthopaedic surgery and research 2014; 9:92 
 
16. Gibon E, Courpied, J-P. Total joint replacement and blood loss:what is the best equation? 
Inter Ortho. 2013;37:735-739  
 
17. Eipe NP, Ponniah M. Perioperative blood loss assessment-how accurate? Indian J 
Anaesth. 2006;50(1):35-38 
18. Wael K. Barsoum, et al. Prospective Randomized Evaluation of the Need for Blood 
Transfusion During Primary Total Hip Arthroplasty with Use of a Bipolar Sealer.  The 
Journal of  Bone & Joint Surgery Mar 2011, 93 (6) 513-518 
 
19. Kamath, AF, Autsin, DC, et al.  Saline-coupled bipolar sealing in simultaneous bilateral 
total knee arthroplasty.  Clinics of ortho surg 2014;6:298-304. 
 
20. Autotransfusion drains in total knee replacement. Are they alternatives to homologous 
transfusion? Int Orthop. 2007 Apr; 31(2): 235–239. 
 
21. Pfeiffer M, Bräutigam H, Draws D, et al. A new bipolarblood sealing system embedded 
in perioperative strategies vs. a conventional regimen for total knee arthroplasty.GMS 
German Medical Science 2005;3:1. 
 

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22. Clement RC, Kamath AF, et al. Bipolar sealing in revision total hip arthroplasty for 
infection. J arthoplasty 2012;27:1376 
 
23. Barsoum WK, Klika AK, et al.  Prospective randomized evaluation of the need for blood 
transfusion during primary total hip arthroplasty with use of a bipolar sealer 
    The Journal of Bone & Joint Surgery Mar 2011, 93 (6) 513-518  
 
24. 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 
 
25. Suarez JC, Slotkin EM, et al.  Prospective, randomized trial to evaluate the efficacy of a 
bipolar sealer in direct anterior approach total hip arthroplasty. J Arthroplasty 
2015;30:1953. 
 
26. Rosenberg A. Reducing blood loss in total joint surgery with a saline coupled bipolar 
sealing technology.  J of anthroplasty 2007;22(4):82  
 
27.  Saltzman BM, Oni JK. A Review of Bipolar Sealer Use in Modern Total Joint 
Arthroplasty. Ann Orthop Rheumatol. 2014 2(2): 1015. 
 
28. Marulanda GA, et al. Hemostatis using a bipolar sealer in primary unilateral total knee 
arthorplasty.  Am J orthop 2009; 38:E179 
29. 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.  
 
 
 
Appendix: 
 
A. Aquamantys Pump Generator User Guide 
B. Covidien ForceTriad™ 
C. Association of Surgical Technologists (AST) Standards of Practice for Use of 
Electrosurgery  
D. Northwell Electrosurgical Safety Policy 
E. The Knee Society Score 
F. Provider: Medications that require discontinuation prior to joint replacement surgery 
G. Patient: Medications that require discontinuation prior to joint replacement surgery 
H. Tranexamic Treatment Guidelines 
I. Thromboprophylaxis Algorithm 
J. ASA classification  

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K. CDRH Guidance device AE reporting 
L. Subject Informed Consent Form