Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty
Conditions: Pain, Postoperative
Sponsor: Masimo Corporation

 
 
Official Title: Feasibility of Bridge for Post-
Operative Pain Management in Hip 
Arthroplasty 
 
Date of Protocol: 24May2022 
 
NCT Number:   
NCT05017701 

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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CONFIDENTIAL AND PROPRIETARY   
© 2023 Masimo Corporation (Unpublished) 
All Rights Reserved 
                                                                   Page 2 of 31 
 
 
 
1 
 INTRODUCTION 
This document is a clinical investigational plan for a human research study. The study will be conducted in accordance with 
the ethical principles that have their origin in the Declaration of Helsinki. By participating in the study, the Investigator 
agrees to adhere to all stipulations of this protocol, the conditions of IRB approval, federal and local regulatory 
requirements, 21 CFR 812, ISO-14155 and International Conference on Harmonization Good Clinical Practice guidance ICH 
GCP.  
1.1 
Background and Rationale 
The aim of the current project is to investigate the effectiveness of Auricular Percutaneous Electrical Nerve Field 
Stimulation (PENFS) device in the management of post-operative pain following hip arthroplasty. In 2020, an estimated 
498,000 primary total hip arthroplasties are expected to be performed in the US and forecast to grow by over 30% in the 
next 5 years driven by significant gains in quality of life post joint replacement, an aging population, and an obesity 
epidemic with increasing osteoarthritis (OA) incidences [1]. Despite the availability of non-opioid treatments for 
postoperative pain following THA, approximately 90% of patients were still prescribed opioids within 60 days from 
discharge [2].  Postoperative pain can have a negative effect on patient tolerance of rehabilitation exercises, which is 
important to help return to normal functioning. As compared to the present use of opioids for perioperative pain 
management, the use of a complementary, non-pharmacologic approach offers the advantage of analgesia without the 
associated side effect and eliminating the potential risk of opioid addiction stemming from exposure to the drug. If 
effective, this alternative approach may revolutionize post-operative pain management and have a substantial impact on 
health care costs and morbidity. 
Masimo Corporation develops technologies that help reduce the risks associated with prescribed opioids, such as overdoses 
and opioid use disorder. In particular, opioid use disorder is a serious public health issue that negatively impacts many 
communities around the world, and the current opioid epidemic has led to a renewed interest in exploring non-
pharmacological techniques to treat post-operative pain. In the United States, over $600 billion is spent every year on 
opioid addiction, including $79 billion related to opioid addiction following surgery. Furthermore, an increasing number of 
patients are suffering from other known adverse effects of opioid use following surgery, including post-operative nausea 
and vomiting, respiratory depression, immunosuppression, and constipation.  
Despite many initiatives to decrease the use of opiates in the perioperative setting, opioids continue to be regularly 
prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the 
percentage of patients who develop an opioid use disorder following surgery is not well understood. To date, there has 
been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor 
that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using 
opioids for extended periods of time after surgery. Therefore, in order to combat this growing health crisis at the ground 
level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical 
population in order to change the incidence of post-operative opioid addiction.  
Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be 
effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of 
auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable 
stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of 
auricular stimulation for the perioperative management of pain in surgical patients, despite the demonstration that 
auriculotherapy has been shown to relieve pain in the postoperative setting.  
Bridge™ is a battery operated and disposable Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) device that 
is FDA cleared for the treatment of symptoms related to opioid withdrawal, conditions that include pain and nausea and 

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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2.2 
Device Accountability 
2.2.1 
Receipt of Study Devices 
Masimo may ship or hand-carry devices and study supplies to the investigative site. Upon receipt of the of the study device 
and supplies, an inventory must be performed and the Equipment Shipment Check Form (FRM-2713) and the Device 
Accountability Log (FRM-3407) will be completed for each device and signed by the receiver. It is important that the 
designated study staff counts and verifies that the shipment contains all the items noted in the shipment inventory.  Any 
damaged or unusable study devices in a given shipment will be documented in the study files. The investigator must notify 
the study sponsor of any damaged or unusable study devices that were supplied to the investigator’s site. 
2.2.2 
Use of Study Device 
Use of devices will be documented on case report forms (CRF) for each subject. Any unused devices must be returned to 
the Sponsor at the end of the study or before product expiration date. 
2.2.3 
Return or Destruction of Study Device 
At the completion of the study, there will be a final reconciliation of study devices. This reconciliation will be logged on the 
device accountability log. Any discrepancies noted will be investigated, resolved, and documented prior to return or 
destruction of unused study devices. Devices destroyed on site will only be upon written instruction from the Sponsor and 
will be documented in the study files. 
2.3 
Risk/Benefits 
Benefits: There may be direct benefits to the enrolled subjects. The Bridge device may be used as an aid to reduce post-
operative pain symptoms if they receive the active device. There are no anticipated benefits to subjects who receive the 
sham device. 
Device risks: The Bridge device is to be operated by, or under the supervision of, qualified personnel only. Read the manual, 
directions for use, all precautionary information, and specifications before use. Refer to the Operator’s Manual for safety 
information, warnings, and cautions. 
• 
The device is contraindicated for use by patients with cardiac pacemakers, hemophilia and psoriasis vulgaris. 
• 
The device should only be applied to healthy, clean, intact skin. 
• 
The device therapy is limited to 120 hours, after which the device is disposable. 
• 
The appliance is splash-proof but not water tight. When showering, the device must not be allowed to come into 
direct contact with water. 
• 
The device is also contraindicated for use in patients with a previous history of sensitivity to compound benzoin 
tincture, which is used to attach the elecrodes to the ear.  
3 
STUDY OBJECTIVES 
The aim of this research is to gather data regarding the feasibility of the Bridge system for the management of pain 
following total hip arthroplasty (THA; a.k.a. total hip replacement).  
4 
STUDY DESIGN 
This is a prospective, randomized, blinded, sham-controlled study design in up to 60 subjects. Individuals scheduled for 
primary total hip arthroplasty will be approached and consented for the trial. Patients undergoing primary unilateral total 

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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CONFIDENTIAL AND PROPRIETARY   
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hip surgery will be expected to be discharged on the day of surgery, or the next day but no later than 48 hrs following 
surgery. The anticipated duration of subject participation in this study will be approximately 1 month. 
4.1 
Study Arms 
4.1.1 
Treatment Arm 
Bridge auricular therapy will be given in addition to standard of care. Research coordinators that have been trained in 
placing the Bridge device will apply the device in the immediate post-operative setting (post-anesthesia care unit, PACU). 
The device will be attached according to the instructions for use provided. Pain scores using a numerical scale will be 
collected at rest and movement, as well as total opioid consumption and the device tolerability. These measurements will 
be obtained in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 
and 120 hours post-operatively. The active device will deliver an electrical pulse sequence for 120 hours (5 days). 
If the patient should be discharged prior to 120 hours post-operatively, they will be asked to continue wearing the device 
for the remainder of the 120 hour period. Each subject will be asked to complete a diary via REDCap every day following 
discharge until the postoperative day (POD) 5, on POD 7 and POD 30 to document pain level and amount of opioids 
consumed.  The subject will participate in a daily teleconference call where the goal will be to review the placement of the 
device and subject’s functional recovery up to POD 5. Functional recovery will be assessed using the Timed Up and Go 
(TUG) assessment to assess mobility. To further assess functional recovery subject will also be asked to complete the 12-
Item Short Form Survey (SF-12) on Post-Op day 30, which will also evaluate the subject’s quality of recovery. Data post-
hospital discharge regarding pain scores, opioid consumption, and device tolerability will be collected from the subject 
every day for 5 days following the placement of the device.  
4.1.2 
Control Arm 
Same treatment as in the active arm with the only exception being the use of a sham Bridge device. The sham Bridge device 
will be identical in appearance to the active device but will have no electrical current and no electrode needles.  
4.2 
Study Endpoints 
The study endpoints are designed to evaluate the impact of Bridge on pain scores and amount of opioids consumed.  
4.2.1 
Primary Endpoints 
The primary study endpoints are the change in pain scores and opioid consumption from the day of surgery through post-
operative day 5 between sham and active groups. 
4.2.2 
Secondary Endpoints 
Secondary end points will include opioid consumption from the day of surgery to 30 days post-op, daily changes in pain 
using the Numeric Rating Scale (NRS) on a scale 0-10 from the day of surgery through post-operative day 30, incidence of 
post-operative nausea and vomiting (PONV), time to oral intake, time to ambulation, time to discharge from the recovery 
room, time to discharge from the hospital, and the tolerability of the device using a numeric scale from 1-10 obtained via a 
follow up phone call 5 days after the surgery.  
5 
CLINICAL TEST SITE 
Site 1:  
University of Pittsburgh Medical Center (UPMC) Shadyside Hospital 
5230 Centre Avenue  
Pittsburgh, PA 15232 

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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Site 2: 
UPMC  Passavant Hospital 
9100 Babcock Blvd 
Pittsburgh, PA 15237 
 
6 
SUBJECT SELECTION AND WITHDRAWAL 
6.1 
Number of Subjects 
Up to 60 subjects will be enrolled in this study with a potential interim review of the data after 30 patients.  
6.2 
Inclusion Criteria 
• 
Subject is 18 years of age or older 
• 
Subject scheduled for elective primary unilateral total hip arthroplasty (THA) 
• 
Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days 
• 
Subject has given written informed consent to participate in the study 
6.3 
Exclusion Criteria 
• 
Subjects with a PROMIS Anxiety raw score of >19  
• 
Subjects who are pregnant or breastfeeding 
• 
Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators) 
• 
Subjects with hemophilia 
• 
Subjects with Psoriasis vulgaris 
• 
Subjects with a history of active depression, anxiety or catastrophizing  
• 
Subjects with active alcoholism or drug abuse 
• 
Subjects with severe chronic pain condition that requires daily preoperative opioid dependence 
• 
Subjects deemed not suitable for the study at the discretion of the principal investigator 
• 
Subjects who are concurrently participating in any other research study 
6.4 
Study Timelines 
Each individual subject will actively participate for the duration of approximately 5 days. There will be a follow-up phone 
interview at POD 7 and POD 30. This study is anticipated to require up to 6 months for completion of patient enrollment. 
6.5 
Subject Status 
Subjects will be classified according to the following statuses: 
• 
Screened – all subjects who met inclusion criteria per chart review and approached for consent. 
• 
Enrolled – all subjects who went through the informed consent process and signed the informed consent form. 

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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• 
Screen Failure – subjects who do not meet all eligibility criteria after giving informed consent. Upon determination 
that the subject does not meet all eligibility criteria, the reason for the subject’s ineligibility will be documented on 
the Screening and Enrollment Log. 
• 
Completed – subjects who wear the Bridge device for 120 hours, and complete all assements through post-
operative day 5. 
• 
Withdrawn – subjects who do not complete study either because they voluntarily choose not to participate further 
in the study and withdraw their consent, or they are discontinued from the study per PI discretion.  
• 
Lost to Follow-up – subjects who are unreachable for assessments during the 1 week and/or 1 month post-
operative follow-up. This includes subjects who completed study or were withdrawn from the study but did not 
withdraw their consent. Subjects will be classified as lost to follow-up if study staff is not able to reach them after 
three attempts. 
6.6 
Subject Withdrawal 
All enrolled subjects have the right to withdraw their consent at any time during this study.  All data collected until the time 
of subject withdrawal will remain in the study database and will be used for analysis.  If a subject is withdrawn from the 
study, the reason for withdrawal will be recorded on the CRF. 
6.7 
Subject Discontinuation by Investigator  
An Investigator may discontinue a subject from the study, with or without the subject’s consent for any reason that may, in 
the Investigator’s opinion, negatively affect the well-being of the subject, subject non-compliance,  or if the IRB stops the 
study for any reason. If a subject is discontinued from the study, the Investigator will promptly inform the subject. The 
reason for discontinuation will be recorded on the CRF. 
7 
STUDY PROCEDURES 
7.1 
Subject Recruitment and Pre-Screening 
Persons scheduled for elective total hip arthroplasty will be approached and screened by a Principal Investigator, nurse or 
research staff for suitability for this study. Persons who meet all of the inclusion and none of the exclusion criteria will be 
asked if they are interested in participating in the study. A subject is considered enrolled in the study once the subject’s 
written informed consent has been documented. Consent may be obtained pre-surgery. 
If the subject signs the Informed Consent form and is identified later as failing to meet all eligibility criteria, the subject will 
be classified as a screen failure. Upon determination that the subject does not meet all eligibility criteria, the reason for the 
subject’s ineligibility will be documented on the Screening and Enrollment Log for the study. In the event that a subject 
leaves the study prematurely or is withdrawn from the study, another subject may be recruited.  
A partial waiver of HIPAA authorization is being requested for the pre-screening process for this study. The pre-sreening 
process would require study personnel to access personal health information to identify prospective subjects without 
HIPAA authorization, and this would occur prior to introducing them to the study or obtaining informed consent. Informed 
consent and HIPAA authorization will be obtained for all patients who are interested in participation; however, the pre-
screening process would require a partial waiver of HIPAA authorization, as the research study could not be practicably 
carried out without this partial waiver of authorization. The participants’ rights and welfare are not adversely affected by 
the waiver. Patients’ protected health information (PHI) will not be inappropriately reused or disclosed to any other person 
or entity. To further safeguard all protected health information, the data collected for the purposes of this study will not be 
labeled with any personal identifying information, or with a code that can be linked to personal identifying information. The 
data will not be stored with any protected health information identifiers.   

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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7.2 
Informed Consent Process 
The Investigator(s) and/or staff delegated for this task are responsible for conducting the informed consent process and for 
obtaining written informed consent and the HIPAA/data protection authorization from each potential subject before any 
study-specific procedures required by the clinical protocol are performed.  The Investigator shall not allow subjects to 
participate in the study or consent any subjects prior to receiving IRB approval of the consent process. 
Informed consent should be obtained in written format and using a form approved by the local IRB and Sponsor in 
accordance with applicable federal and provincial regulations. The informed consent may be signed on paper or 
electronically, as approved by the IRB. The informed consent process may be conducted remotely via videoconference 
(Zoom, Teams, etc.).  After a patient is deemed eligible from the screening process, study team members will approach the 
patient or schedule a videoconference to explain the study. If the consenting will be conducted remotely, the informed 
consent document shall be securely provided to the subject prior to the scheduled videoconference.  The study staff will 
thoroughly explain the purpose, procedures of the study in respect to subject’s involvement and responsibilities, potential 
risks and benefits, subject’s rights and privacy of the data collected. In addition to the full disclosure of the risks and 
benefits of participating in the study, patients will be informed that their participation is voluntary and their decision will 
not impact patient care.  They will be given adequate time to ask questions regarding the study and to discuss with family 
and friends before making the decision. At this point the subject will be asked to sign the research consent form. If consent 
is being obtained remotely, consents will be signed electronically using an e-signature service such as Adobe sign, DocuSign, 
etc. by both the subject and the person obtaining consent. 
All signed consent and HIPAA forms will be kept at the site and are only accessible to study team members.  If the patient 
refuses to participate, the patient will not be enrolled in this study.  The original signed consent will be filed in a secure, 
locked cabinet with the subject’s other original study documents.  A copy of the signed consent should be filed in the 
hospital/clinical chart.  A copy of the signed consent and HIPAA/data protection authorization must be provided to the 
subject. The Principal Investigator (PI) is responsible for ensuring any new information related to the study will be provided 
to the subject. The subject may need to be re-consented to continue participation, if required by the IRB. 
The subject will be assigned a non-identifying subject number for the data collected in this study. The Investigator shall 
retain a copy of the signed informed consent document in each subject’s record. The subject shall be provided with a copy 
of the signed informed consent document.  
7.3 
Study Procedures 
Study procedures will be conducted according to the schedule outlined in Table 1 below and recorded in REDCap. See 
Appendices for scales, questionnaires, and assessments to be used in the study. Any adjustments to or replacements of 
these appendices will be justified with documentation in study files. 
 
 

Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty                            CHEL0001  
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Table 1: Schedule of Assessments 
 
Assessment 
Screening 
(Pre-
Operative) 
Day 0 
(Day of 
Surgery) 
Post-Op) 
Day 1 
(24 hrs 
Post-Op) 
Day 2 
(48 hrs 
Post-Op) 
Day 3 
(72 hrs 
Post-Op) 
Day 4 
(96 hrs 
Post-Op) 
Day 5 
(120 hrs 
Post-Op) 
Day 7 
(Post-Op) 
Day 30 
(Post-Op) 
Informed Consent 
and Eligibility 
X 
 
 
 
 
 
 
 
 
Screening PROMIS 
Anxiety 
X 
 
 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical & Surgical 
History ¹ 
X 
 
 
 
 
 
 
 
 
Medication History² 
X 
 
 
 
 
 
 
 
 
EKG³ 
X 
 
 
 
 
 
 
 
 
PROMIS Pain 
Catastrophizing 
Scale⁴ 
X 
 
 
 
 
 
X 
 
 
 Perceived Stress 
Scale⁵ 
X 
 
 
 
 
 
X 
 
 
PROMIS Depression6 
X 
 
 
 
 
 
X 
 
 
PROMIS Anxiety7 
 
 
 
 
 
 
X 
 
 
Opioid Consumption⁸ 
 
X21 
X 
X 
X 
X 
X 
X 
X 
Numeric Rating Scale 
(NRS)⁹ 
X22 
X21q 6hrs 
for the 
first 
24hrs 
X 
X 
X 
X 
X 
X 
X 
Post-Operative 
Nausea Vomiting 
(PONV) Scale10 
X22 
X 
X 
X 
X 
X 
X 
X 
X 
SOC Post-Surgical 
Assessments11 
 
X 
X 
X 
X 
X 
X 
 
 
Device Tolerability 
Scale12 
 
X21 
X 
X 
X 
X 
X 
 
 
Device Placement 
Check 13 
 
X 
X 
X 
X 
X 
X 
 
 
Device Removal and  
Disposal 14 
 
 
 
 
 
 
X 
 
 
Patient’s Functional 
Recovery15 
 
 
X 
X 
X 
X 
X 
X 
X 
Patient Satisfaction 
Questionnaire 16 
 
 
 
 
 
 
X 
 
 
Quality of recovery 
after joint 
replacement17 
 
 
 
 
 
 
 
 
X 
End of Study 
Assessment18 
 
 
 
 
 
 
X 
 
 
ICU admission or 
hospital re-admission 
(including re-
admission due to 
pain related issues)19 
 
X 
X 
X 
X 
X 
X 
X 
X 
Safety and Adverse 
Events20 
 
X 
X 
X 
X 
X 
X 
X 
X 

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1. 
Relevant medical and surgical history within last 90 days to be collected as part of pre-surgical standard of care from Electronic 
Medical Records (EMR). Family medical history may also be collected.  
2. 
Medication history to include any history of opioid use and any other relevant medications within last 90 days. 
3. 
EKG records to be collected as part of pre-surgery and results and interpretation entered in REDCap. 
4. 
The Pain Catastrophizing Scale (PCS) will be completed during Screening and on POD Day 5. Sample questionnaire in Appendix 
A. 
5. 
The Perceived Stress Scale will be completed during Screening and on POD Day 5. Sample questionnaire in Appendix B. 
6. 
PROMIS assessment for Depression will be collected during Screening and on POD 5. Sample questionnaire in Appendix C.  
7. 
PROMIS assessment for Anxiety will be collected during Screening and on POD 5. Sample questionnaire in Appendix D. 
8. 
Opioid Consumption will be assessed by collecting total amount of Opioids consumed from day of surgery through POD 30.  
9. 
Subject will report on their level of pain using the NRS (Appendix E) on a daily basis from prior to surgery through POD 30.  
10. PONV will be assessed immediately following surgery up to POD 30, and will be assessed on a 0-10 scale. 
11. Standard of care assessments including time to oral intake (liquid and regular diet), time to bowel movement, time to discharge 
from recovery room and discharge from hospital may be collected as they occur or from the EMR. 
12. Device Tolerability will be assessed during the daily telemedicine visit on POD1-POD5 using a 0-10 scale measurement (10-8 
excellent; 7-5 good, 4-2 fair and 2-0 poor). 
13. Device Placement Check will be done immediately the device is placed while subject is in the PACU and then daily via a 
telemedicine visit. 
14. Subjects will keep the Bridge device on for a maximum of 5 days. Subjects who remove device prior to POD 5 will be withdrawn 
from the study. Prior to discharge subject will be provided with instructions on proper care of the device at home and 
instructions on proper removal and disposal of the Bridge device. 
15. Patient functional recovery will be assessed by a series of questions listed in REDCap and by completing the SF-12 Survey 
(Appendix F) on POD 30. 
16. Subject will complete the American Pain Society Patient Outcome Questionnaire on POD 5 which will capture overall 
satisfaction with pain management.  
17. Quality of Life Assessment to be used is the Centers for Disease Control and Prevention Health-Related Quality-of-Life 14-item 
Measure (HRQOL-14). See Appendix G.   
18. End of Study Assessment survey will be completed on POD5.   
19. Post discharge data regarding subject readmission to hospital, ICU admission and any other issues may be obtainined from 
EMR. 
20. AEs and SAEs which occur after consent and through Day 30 will be collected and recorded in REDCap.  
21. These measurements will be obtained in the recovery room, prior to leaving the recovery room, and every 6 hours during the 
first 24 hours, and at 48, 72, 96, and 120 hours post-operatively.  
22. To be done upon presentation to the preoperative staging area on the day of surgery.  
 
7.3.1 
Preoperative 
During the pre-operative period, the Investigator and/or staff delegated for this task shall verify eligibility criteria for the 
subject. If the subject does not meet all eligibility criteria and they have already been enrolled into the study, they will be 
notified and removed from the study. As part of the eligibity screening, subjects with a PROMIS Anxiety raw score of >19 
will be removed from the study. 
Following written consent the subject’s demographic information, including but not limited to, age, weight, height, race, 
and ethnicity will be recorded on the CRF. In addition, a complete medical, vital signs, medication (including opioids), and 
surgical history, family medical history (chronic pain, addiction, cardiac, cancer, etc) EKG, PROMIS (Patient-Reported 
Outcomes Measurement Information System) assessments covering anxiety, depression and pain catastrophizing may be 
captured. 
The Investigator and/or site staff delegated for the task will first ask subjects upon presentation to the preoperative staging 
area on the day of surgery to rate their pain (NRS scale), anxiety (PROMIS), and nausea (PONV scale). 

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7.3.2 
Intraoperative 
The surgery will be perfomed under spinal plus sedation. Intraoperative patient management will be according to standard 
of care protocol.  
7.3.3 
Postoperative 
Once the surgery is over and the patient is transferred to the recovery room, the patient will continue to receive 
postoperative pain control per standard of care, as determined by the anesthesia and surgical teams. Research assessments 
that will be collected by the research team will include:  approximately 24, 48, 72, 96 and 120 hours post-operative pain 
scores collected at rest and movement, total opioid consumption, as well as the device tolerability. Other common medical 
information that may be collected include vital signs, time to bowel movement, PONV, time to oral intake (liquid and 
regular diet), time to discharge from recovery room, time to hospital discharge, intensive care unit (ICU) admission, 
readmission to the hospital, readmission due to pain related issues, quality of recovery after joint replacement and patient 
satisfaction related to pain management.  
7.3.4 
Blinding and Randomization 
7.3.4.1 Subjects will be randomized at point of enrollment. 
7.3.4.2 Subjects will be randomly assigned to one of the 2 treatment groups (active and sham) in equal ratios. 
Randomization will be done using a randomized block design, with blocks of 6.  
7.3.4.3 A randomization table will be kept with the sponsor. Study coordinators will be unblinded to the study 
device, and will be aware of whether the device is active or sham during device placement. These study 
coordinators will not be involved in data collection for study outcomes. All other study staff will be 
blinded to group allocation, including the PI, the study staff contacting and collecting data from the 
subject after device placement. The subject will remain blinded as to whether they received an active or 
sham device  
7.3.4.4 Unblinding  subject’s treatment assignment to the entire study staff will only be done when necessary (i.e. 
for the treatment of an adverse event).  
7.3.4.5 Because subjects with the active device may experience a sensation associated with the electrical pulses, 
there will be no overlap of when subjects have the device placed. Our goal is to minimize participant 
overlap in their time in the clinic, to further ensure there is no discussion of the experience with the 
device that might contribute to attempts to guess whether the person received an active or sham device. 
Finally, all participants will complete an end of study assessment in which they will answer questions 
regarding which condition assignment they believe they received, and why they believe this. 
7.3.5 
Bridge Device Placement 
7.3.5.1 Medical staff trained and delegated to the task, will place the device on the subject in the PACU. The ear 
shall be cleaned with alcohol wipes and transilluminated to mark the vascular branches. The needles shall 
be placed in the dorsal and ventral aspects of the ear within 1–1.5 mm of the vascular branches, but not 
on main arterial branches. 
7.3.5.2 The generator will be attached with adhesive to the skin behind the ear just over the mastoid process.  
7.3.5.3 A photograph should be taken immediately after device placement to use as a reference for where the 
leads should be. No identifying features shall be captured on the photograph. 
7.3.6  
Bridge Device Home Instructions 

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Subjects will be instructed on proper maintenance of the Bridge device prior to being discharged from the hospital per the 
instructions for use. Device tolerability and proper placement will be assessed via teleconference with the subject daily for 
5 days post-surgery. The device is not waterproof and will not function properly if exposed to water. When showering or 
washing hair, subjects should instructed to protect the device and not allow it to come into contact with water.  
To ensure the leads remain in place, subjects will be instructed to perform a “pinch test”every 3-4 hours routinely while 
wearing the device. This is done by gently pressing the leads between the thumb and pointing finger. The pinch test can 
also be done after waking up, after showering, or if experiencing discomfort at one of the leads.  
If the device becomes detached or the subject removes it prior to the 120 hours, the subject should notify site staff 
immediately. These subjects will be considered withdrawn from the study. 
7.3.7 
Discharge  
Patients undergoing primary unilateral total hip surgery will be expected to be discharged on the day of surgery, or the next 
day but no later than 48 hrs following surgery. A daily teleconference will be conducted to verify the placement of the 
device and the patient’s functional recovery. After 120 hrs, each subject will be asked to remove the device and dispose of 
it in their home according to removal instructions provided by the research team. Data post-hospital discharge regarding 
pain scores, opioid consumption, and device tolerability will be collected and entered in REDCap daily from the subject for 5 
days following the placement of the device, and postoperatively at 1 week and 1 month. On postoperative day five the 
subject will complete a PROMIS anxiety, depression and pain catastrophizing questionnaires. 
7.3.8 
Study Follow-up 
Subjects will be contacted via a phone call for follow-up visits at 1 week and 1 month. Subjects who are withdrawn from 
study but do not withdraw consent will be included in the follow-up. Subjects who withdraw their consent for study 
participation will not be contacted for follow-up.  
7.3.9  
Study Completion 
The subject is considered to have completed the study after they have worn the Bridge device for 120 consecutive hours.  
8 
STATISTICAL PLAN 
8.1 
Sample Size 
This study may enroll up to 60 subjects. Descriptive statistics will be presented as mean ± SD. Continuous variable will be 
reported as median (95 % confident interval). Using SPSS, a one tailed unpaired t-test will be performed to assess the 
difference in pain between groups. Overall difference between groups over the 5 days will be assessed using an analysis of 
variance follow by Bonferroni test. Alpha is set up at 0.1. 
8.2 
Acceptance criteria 
The primary outcome measured will be the total opioid consumption for the 5 day period following surgery. Secondary 
outcome will include pain, PONV, and functional recovery at 24, 48, 72, 96 and 120 hrs post operatively. The subject will be 
asked to rate the tolerance of the device using a 1-5 scale (1 being extremely poorly tolerated and 5 being extremely well 
tolerated) every postoperative day until day 5.  Safety and Adverse Events not related to the surgery or the hip implant will 
be collected postoperatively every day for the first 5 days, and at 1 week and 1 month. 
8.3 
Definitions 
The definitions for adverse event, adverse device effect, serious adverse event, serious adverse device effect, and 
unanticipated adverse device effect are provided below (ISO 14155:2011, 21 CFR 812.3(s)). 

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• 
Adverse Event (AE): an adverse event is any untoward medical occurrence in a subject which need not be related 
to the device under investigation. 
• 
Adverse Device Effect (ADE): an adverse device effect is any untoward or unintended response to a medical device 
which may result from insufficiencies in the instructions for use or deployment of the device, or from use error.  
• 
Serious Adverse Event (SAE): a serious adverse event is an adverse event that results in death, inpatient 
hospitalization, severe or permanent disability, a life threatening illness or injury, fetal distress, fetal death, a 
congenital abnormality, a birth defect, or medical or surgical intervention to prevent permanent impairment to 
body or structure. 
• 
Serious Adverse Device Effect (SADE): a serious adverse device effect is an adverse device effect that results in 
death, inpatient hospitalization, severe or permanent disability or is life threatening. 
• 
Unanticipated Adverse Device Effect (UADE): any serious adverse effect on health or safety or any life threatening 
problem or death caused by or associated with, a device, if the effect, problem, or death was not previously 
identified in nature, severity or degree of incidence in the investigational plan, or application (including a 
supplementary plan or application) or any other unanticipated serious problem associated with a device that is 
related to the rights, safety or welfare of subjects.  Refer to the Device Risk Analysis and Risk Assessment section 
for details on anticipated adverse device effects. 
8.4 
Anticipated Adverse Events: 
• 
Bleeding or infection at the puncture site 
• 
Skin irritation 
• 
Pain at the site of application 
• 
Allergic contact dermatitis to the compound benzoin tincture. 
8.5 
Adverse Event Reporting: 
• 
All Adverse Events, both Anticipated and Unanticipated, must be recorded within the CRF on the Adverse Event 
Report Form. 
• 
All Adverse Events must be promptly reported to the Sponsor.  
• 
All Unanticipated Adverse Device Effects will be also reported to both the Sponsor and the IRB.   
• 
Both Serious Adverse Events and Unanticipated Adverse Device Effects must be reported to the Sponsor within 48 
hours. All other Adverse Events should be reported to the Sponsor within 5 business days.  
• 
All Serious Adverse Events will be also reported to the IRB per IRB reporting requirements.  These reports may 
include, but will not be limited to: date of onset; brief description of the events; their treatment; whether they 
resulted in death, inpatient hospitalization, severe or permanent disability or were life threatening; their 
relationship to the study device; and resolution. 
8.6 
Deviations from the study protocol 
Deviations from the protocol must receive both Sponsor and the investigator’s IRB approval before they are initiated with 
the exception that under emergency circumstances, deviations from the protocol to protect the rights, safety and well-
being of human subjects may proceed without prior approval of the sponsor or the IRB. Any protocol deviations initiated 
without Sponsor and the investigator’s IRB approval that may affect the scientific soundness of the study, or affect the 
rights, safety, or welfare of study subjects, must be documented and reported to the Sponsor and to the investigator’s IRB 

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as soon as a possible, but no later than 5 working days of the protocol deviation. If protocol deviations continue to occur 
frequently at a study site, a corrective and preventive action (CAPA) may be opened by the Sponsor.   
8.7 
Withdrawal of IRB approval 
An investigator shall report to the sponsor a withdrawal of approval by the investigator’s reviewing IRB as soon as possible, 
but no later than 5 working days of the IRB notification of withdrawal of approval. 
9 
VULNERABLE POPULATIONS 
9.1 
Definition 
Vulnerable populations are defined as disadvantaged sub-segment of the community requiring utmost care, special 
considerations and protections in research. This study will recruit subjects from the following: economically disadvantaged 
or unemployed, educationally disadvantaged and/or Non-US citizens.  
9.2 
Protection of vulnerable subjects  
• 
Educationally disadvantaged subjects will be provided ample time to ask questions and comprehend information.  
• 
Medical care will be provided to these subjects if they are injured as a direct result of participating in this research 
study. The cost of treatment for any research related injury will be covered by Masimo.  
9.3 
Subject Compensation 
Subjects will be compensated for their participation in the study.  
9.4 
Responsible Parties 
The IRB will review research with vulnerable populations and evaluate consent, level of risk, coercion, and the reason for 
choosing this particular subject population. The IRB will be responsible for determining what practices will include 
continuing review for compliance while monitoring these studies.  
The Investigator holds the ultimate responsibility for protecting the rights, safety, and welfare of research subjects by 
ensuring that all regulations and proper documentation of consent is handled in a compliant and timely manner. 
10 
DATA MANAGEMENT 
10.1 
Confidentiality of Records 
Information about the subjects will be kept confidential. The data will be stored on a password protected database on a 
secure server, accessible only to the Investigators.  Study data that will be released to Masimo and other regulatory 
authorities will be de-identified and will only pertain to study data collection, demographics, device location of the sensor, 
and the recordings from the pulse oximeter.  
10.2 
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, 
recorded data from automated instruments, and copies or transcriptions certified after verification as being accurate and 
complete. For this study, the case report forms may also be used as source worksheets.  
10.3 
Case Report Forms 

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An EDC system will be utilized to capture study data and compliant with 21 CFR Part 11. Data entry will be performed by 
site personnel after completing an appropriate training. Modifications to EDC will be made if deemed necessary by the 
study Sponsor. 
Study data will be collected in electronic case report forms (eCRFS) but may also be collected on paper CRFs. Data will be 
entered into the case report form by study personnel delegated to the task by the study investigator.  CRFs will be 
completed for all subjects, including those who do not complete study and/or are withdrawn from study. Reason for 
withdrawal from study will be documented. Data Collected on the CRFs will include the following information, but not 
limited to : inclusion/exclusion criteria, whether patient consent was obtained before start of study, demographic 
information, patients medical, surgical and medication histories, pre and post-surgical assessments listed in Table 1, 
occurrence of any adverse event, protocol deviation, and device deficiencies, etc. The CRFs will be signed by the PI to attest 
that the data is complete and accurate.  
CRF entries will be verified by study monitor and any errors or inconsistencies will be queried to the site on an ongoing 
basis. Query resolution will be assessed and confirmed by study monitor during site visit. The final, completed eCRFs will be 
initialed/signed and dated by the PI or delegated personnel. 
10.4 
Record Retention 
All study information, including but not limited to study correspondence, study logs, device accountability records, consent 
forms, subject records, and copies of CRFs should be maintained in the Investigator site files.   
Study records shall be retained during the study and for a minimum of two years after date of study closure or date when 
records are not required to support 510(k) clearance. The Institution’s own retention policies and regulations may apply in 
addition to the minimal requirement.  
The Sponsor is responsible for verifying study data, retaining records, analyzing data, and authoring study reports. 
11 
MONITORING PLAN 
11.1 
As the Sponsor of this clinical investigation, Masimo Corporation is required by 21 CFR Part 812, of the Food and 
Drug Administration regulations to monitor and oversee the progress of the investigation.  The monitor(s) assigned 
by Masimo Corporation to this task will be a direct employee from the Clinical Research department trained on 
departmental SOPs on conduct and monitoring of sponsored studies. 
11.2 
In accordance with good clinical practices guidelines, there will be at least three scheduled monitoring visits to 
ensure overall regulatory compliance of the study: 
• 
An initiation visit, prior to any subject enrollment to confirm site readiness, and to document training on the 
study protocol and procedures, and use of equipment. 
• 
At least one monitoring visit during enrollment when 10-15% have been enrolled, a visit when approximately 
30 subjects have been enrolled, and approximately every 3 months thereafter.  
• 
A final close out visit after the last patient had finished the study.  
• 
NOTE DURING COVID-19 PANDEMIC: on-site monitoring visits may be unlikely. Monitoring activities may be 
modified or postponed until such a time that restrictions prohibiting travel and hospital access are lifted. 
11.3 
The monitor will contact and visit the investigator and will be allowed, on request, to have access to all source 
documents needed to verify the entries in the CRFs and other GCP-related documents (IRB approvals, IRB 
correspondences, and ICFs) provided that subject confidentiality is maintained in agreement with HIPAA 
regulations.  

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11.4 
It will be the monitor’s responsibility to inspect the CRFs at regular intervals throughout the study, to verify the 
adherence to the protocol and the completeness, consistency and accuracy of the data being entered on them.  
11.5 
During each visit, the monitor will also verify presence of informed consent, adherence to the inclusion/exclusion 
criteria, and documentation of SAEs/SADEs and protocol deviations/violations, and check CRF against source 
documentation. 
11.6 
After each visit, the monitor will provide a monitoring report to the investigator within 4 weeks of visit completion. 
The monitoring report will detail findings and open action items observed during the visit. It is the responsibility of 
the Principal Investigator and Study Coordinator(s) to respond to the findings of the monitoring report, and 
complete any open action items as soon as possible but no later than 60 days of receiving the monitoring report. 
Any open action items not completed within the time allowed may be sufficient grounds for study site suspension 
or termination; it will be up to the sponsor to determine whether any incomplete action items are sufficient 
grounds for suspension or termination. See Section 13 for details on suspension and termination.  
11.7 
Depending on the quality of the data and/or changes to factors affecting patient safety, additional monitoring visits 
may be necessary according at the sponsor’s discretion. 
11.8 
The Investigator will provide the monitor access to all necessary records to ensure the integrity of the data (21 CRF 
812). 
12 
ADMINISTRATIVE ASPECTS 
12.1 
Protection of Human Subjects 
Per 21 CFR 50, written consent must be obtained from each subject prior to any study procedures in accordance with 
applicable federal, state, and study site regulations. The Investigator must keep a copy of the signed consent form in each 
subject’s record and provide a copy to the subject as well. The Investigator shall not allow a subject to participate in a study 
or sign consent prior to IRB approval.  
Prior to the start of data collection or subject enrollment, the Investigator must provide documentation of IRB approval of 
the study protocol and a copy of the approved informed consent form (21 CFR 50).  
All subjects will be monitored closely throughout the study. The following measures will be taken to ensure the privacy of 
subjects: 
• 
A code (unique identification) number for each subject will be kept on file. 
• 
Only their correspondence identification number will identify subjects. 
• 
Access to the documents and data will only be made to the Investigators and study staff in the study.  
• 
The confidentiality of these documents will be protected to the extent provided by the law.  
12.2 
Institutional Review Boards 
The Sponsor and/or Investigator must submit the protocol to the appropriate IRB and obtain a copy of the written and 
dated approval letter.  
The approval letter should state the name of the documents reviewed, date of review, date of approval, and reference the 
study name (protocol title, study number, and version). 
The informed consent used by the Investigator must be reviewed and approved by the Sponsor prior to submission to the 
IRB. The Investigator cannot enroll subjects until a copy of the approved informed consent is obtained from the IRB.  

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Any amendments to the protocol or informed consent should be submitted to the IRB for review and approval per 21 CFR 
56. The IRB should be notified of any changes that may affect conduct of the study or pose safety risks to the subjects. 
12.3 
Confidentiality 
All data collected will be kept confidential and de-identified. It can only be accessed by researchers and will be used for 
research purposes only.  
12.4 
Protocol Amendments 
Any changes made to the clinical investigational plan/study protocol will be documented by way of an amendment. Before 
submitting protocol amendment to the IRB for approval, the protocol amendment must be agreed upon and signed by both 
the Investigator and the Sponsor. The Investigator shall not make any changes to the protocol without Sponsor approval 
and documented approval from the IRB. Both PI and Sponsor will retain the IRB approval letter and approved protocol as 
confirmation that the protocol amendment was approved.  
12.5 
Suspension or Termination of Study Site 
The Sponsor can suspend or prematurely terminate the PI’s and study site’s participation in the study, particularly if 
Sponsor finds serious non-compliance by the PI or site, and if such non-compliance was not resolved in a timely manner. 
The Sponsor will document the decision to suspend or terminate the investigation in writing. A suspended study site cannot 
enroll new subjects.  
If the Sponsor determine that the study site’s compliance to GCP and federal regulations to be inadequate at any point 
during the study, and Sponsor move to suspend or terminate the study site, the Sponsor will provide notification in writing 
to the principal investigator and IRB as necessary. The study site is eligible for reinstatement upon correction of any findings 
and any open action items prior to the suspension, and provides a written guarantee that the same non-compliance will not 
reoccur in the future. Site can only resume patient enrollment upon receiving written notification of reinstatement from 
the Sponsor and/or IRB.  
12.6 
Termination of Clinical Investigation/Study due to UADE 
The clinical investigation may be terminated if Sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to the subjects. Termination shall occur not later than 5 working days after the Sponsor makes this 
determination, and not later than 15 working days after the Sponsor first received notice of the effect.  
The Sponsor may resume the terminated clinical investigation with prior IRB approval if the device is non-significant risk.  
13 
AGREEMENT BETWEEN INVESTIGATOR AND SPONSOR REGARDING RESPONSIBILITIES FOR GOOD 
CLINICAL PRACTICE 
International Conference of Harmonization (ICH) E6 Good Clinical Practice guidance is an international ethical and scientific 
quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. 
It specifies general requirements intended to: 
• 
Protect the rights, safety and well-being of human subjects, 
• 
Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, 
• 
Assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the 
conformity assessment of medical devices. 
The Principal Investigator of the clinical investigation shall: 

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• 
Obtain and maintain IRB approval of the study. 
• 
Ensure all subjects are consented prior to enrollment, per FDA Code of Federal Regulations titled 21 CFR 50. 
• 
Ensure only appropriately trained personnel will be involved in clinical investigation. 
• 
Maintain study records mentioned in the CIP. 
• 
Maintain logs for study team delegation, site visit/monitoring, equipment disposition, study team training, subject 
recruitment and enrollment. 
• 
Evaluate all adverse events and adverse device effects and determining whether the study is safe to continue. 
• 
Allow the sponsor to conduct periodic monitoring of study activities to ensure GCP compliance. 
• 
Not promote device prior to clearance by FDA for commercial distribution, except for academic purposes and 
scientific presentations. 
The Sponsor shall insure existence and record of all necessary compliance documents, and will conduct monitoring visits to 
ensure appropriate conduct of the study 
14 REVISION HISTORY 
Version Number 
Version Date 
Summary of Revisions Made: 
1.0 
21Jun2021 
Original Version 
2.0 
23Nov2021 
Added PROMIS Anxiety score eligibility criteria and clarified sham 
device information. 
Updated Table 1. Schedule of Assessments.  
Added option of documenting informed consent electronically. 
3.0 
27Apr2022 
Added a second site. 
15 REFERENCES 
1. Singh, et al: Projections for TJA use The Journal of Rheumatology 2019; 46:doi:10.3899/jrheum.170990 
2. Shah, R. et al: Opioid Use and Pain Control After Total Hip and Knee Arthroplasty in the US, 2014 to 2017. JAMA 
Network Open. 2020;3(7):e2011972. doi:10.1001/jamanetworkopen.2020.11972 
3. Chelly, et al: Auricular Nerve Stimulation Using The NSS-2 Bridge® Device For Perioperative Analgesia In Kidney 
Donors. American Society of Anesthesiologist Abstract. 2020 
4. Bijur, P.E., W. Silver, and E.J. Gallagher, Reliability of the visual analog scale for measurement of acute pain. Acad 
Emerg Med, 2001. 8(12): p. 1153-7 
5. Scott, J. and E.C. Huskisson, Graphic representation of pain. Pain, 1976. 2(2): p. 175-84 
6. Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and Validation. Psychol Assess, 1995; 
7(4): 524-32. 
7. Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and 
Social Behavior, 24, 386-396.  
8. Cella, et al. “The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested 
its first wave of adult self-reported health outcome item banks: 2005-2008.” Journal of clinical epidemiology vol. 
63,11 (2010): 1179-94. doi:10.1016/j.jclinepi.2010.04.011 
9. Ware, et al: A 12-Item Short-Form Health Survey, Medical Care: March 1996 - Volume 34 - Issue 3 - p 220-233 

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10. Gordon DB, et al. American Pain Society Recommendations for Improving the Quality of Acute and Cancer Pain 
Management: American Pain Society Quality of Care Task Force. Arch Intern Med. 2005;165(14):1574–1580. 
doi:10.1001/archinte.165.14.1574. 

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16 APPENDICES 
Appendix A: Pain Catasrophizing Scale- English [6] 
 
 
 

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Appendix B: Perceived Stress Scale [7] 
 
 
 
 
 
 
 

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Appendix C: PROMIS Emotional Distress-Depression Short-Form [8] 
 
 
 
 
 
 
 

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Appendix D: PROMIS Emotional Distress- Anxiety- Short-Form [8] 
 
 
 
 
 
 
 

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Appendix E: Numeric Pain Rating Scale [9] 
 
 
 
 

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Appendix F: 12-Item Short Form Survey [9] 
 
 
 

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Appendix G: CDC HRQOL-14 “ Healthy Days Measure 
 
 
 

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