A Phase 4, Prospective, Randomized Trial to Evaluate Postoperative Outcomes in Total Knee Arthroplasy Patients Using the DJO X4 Brace With the Motion Intelligence Platform
Phase: NA
Conditions: Total Knee Replacement
Sponsor: Northwell Health

 
  
 A PHASE 4, PROSPECTIVE, RANDOMIZED TRIAL TO EVALUATE POSTOPERATIVE 
OUTCOMES IN TOTAL KNEE ARTHROPLASTY PATIENTS USING THE DJO X4 BRACE WITH 
THE MOTION INTELLIGENCE PLATFORM  
Protocol Number: 19-0907 
Clinical Trials.Gov NCT04655703 
Principal Investigator: < Eugene S. Krauss, MD> 
Version Number:  v.<1.0> 
<21January2020> 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 
 
 

  
 
ii 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 3 
1.3 
Schedule of Activities (SoA) ............................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Rationale .................................................................................................................................... 5 
2.2 
Background........................................................................................................................................... 6 
2.3 
Risk/Benefit Assessment .................................................................................................................... 7 
2.3.1 
Known Potential Risks ..................................................................................................... 7 
2.3.2 
Known Potential Benefits ................................................................................................ 7 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 8 
4 
STUDY DESIGN ............................................................................................................................................. 9 
4.1 
Overall Design ...................................................................................................................................... 9 
4.2 
Scientific Rationale for Study Design.............................................................................................. 10 
4.3 
Justification for Dose ......................................................................................................................... 10 
4.4 
End of Study Definition ..................................................................................................................... 10 
5 
STUDY POPULATION ................................................................................................................................ 10 
5.1 
Inclusion Criteria ................................................................................................................................ 11 
5.2 
Exclusion Criteria ............................................................................................................................... 11 
5.3 
Lifestyle Considerations .................................................................................................................... 11 
5.4 
Screen Failures .................................................................................................................................. 11 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 12 
6 
STUDY INTERVENTION ............................................................................................................................ 12 
6.1 
Study Intervention(s) Administration ............................................................................................... 12 
6.1.1 
Study Intervention Description ..................................................................................... 12 
6.1.2 
Dosing and Administration ............................................................................................ 19 
6.2 
Preparation/Handling/Storage/Accountability ................................................................................ 19 
6.2.1 
Acquisition and accountability ...................................................................................... 19 
6.2.2 
Formulation, Appearance, Packaging, and Labeling ................................................ 19 
6.2.3 
Product Storage and Stability ....................................................................................... 19 
6.2.4 
Preparation ...................................................................................................................... 20 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 20 
6.4 
Study Intervention Compliance ........................................................................................................ 20 
6.5 
Concomitant Therapy ........................................................................................................................ 20 
6.5.1 
Rescue Medicine ............................................................................................................ 20 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 21 
7.1 
Discontinuation of Study Intervention ............................................................................................. 21 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 21 
7.3 
Lost to Follow-Up ............................................................................................................................... 21 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 22 
8.1 
Efficacy Assessments ....................................................................................................................... 22 
8.2 
Safety and Other Assessments ....................................................................................................... 22 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 23 

  
 
iii 
8.3.1 
Definition of Adverse Events (AE) ............................................................................... 23 
8.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 23 
8.3.3 
Classification of an Adverse Event .............................................................................. 24 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 25 
8.3.5 
Adverse Event Reporting .............................................................................................. 25 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 25 
8.3.7 
Reporting Events to Participants ................................................................................. 26 
8.3.8 
Events of Special Interest ............................................................................................. 26 
8.3.9 
Reporting of Pregnancy ................................................................................................ 26 
8.4 
Unanticipated Problems .................................................................................................................... 26 
8.4.1 
Definition of Unanticipated Problems (UP) ................................................................. 26 
8.4.2 
Unanticipated Problem Reporting ................................................................................ 26 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 26 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 26 
9.1 
Statistical Hypotheses ....................................................................................................................... 26 
9.2 
Sample Size Determination .............................................................................................................. 27 
9.3 
Populations for Analyses .................................................................................................................. 28 
9.4 
Statistical Analyses............................................................................................................................ 28 
9.4.1 
General Approach .......................................................................................................... 28 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 28 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 28 
9.4.4 
Safety Analyses .............................................................................................................. 29 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 29 
9.4.6 
Planned Interim Analyses ............................................................................................. 30 
9.4.7 
Sub-Group Analyses ..................................................................................................... 30 
9.4.8 
Tabulation of Individual participant Data .................................................................... 30 
9.4.9 
Exploratory Analyses ..................................................................................................... 30 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 30 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 30 
10.1.1 
Informed Consent Process ........................................................................................... 30 
10.1.2 
Study Discontinuation and Closure ............................................................................. 31 
10.1.3 
Confidentiality and Privacy ........................................................................................... 31 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 34 
10.1.5 
Key Roles and Study Governance .............................................................................. 34 
10.1.6 
Safety Oversight ............................................................................................................. 35 
10.1.7 
Clinical Monitoring .......................................................................................................... 35 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 35 
10.1.9 
Data Handling and Record Keeping ............................................................................ 35 
10.1.10 
Protocol Deviations ........................................................................................................ 35 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 36 
10.1.12 
Conflict of Interest Policy .............................................................................................. 36 
10.2 
Additional Considerations ................................................................................................................. 36 
10.3 
Abbreviations ...................................................................................................................................... 36 
10.4 
Protocol Amendment History ........................................................................................................... 38 
11 
REFERENCES ............................................................................................................................................. 39 
 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
1 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title:
A phase 4, prospective, randomized trial to evaluate postoperative 
outcomes in total knee arthroplasty (TKA) patients using the DJO X4 brace 
with the Motion Intelligence Platform 
Study Description:
This is a single center, investigator initiated clinical trial using a FDA 
approved, marketed brace called DJO X4.  This phase 4, prospective, 
randomized clinical trial is being conducted to evaluate the use of the X4 
knee brace with the Motion Intelligence platform in patients having 
unilateral TKA. The study is designed to determine if using a “virtual 
rehabilitation” device leads to enhanced recovery following TKA by 
improving patient objective and subjective outcome measures.  These 
primary outcomes will be collected using a validated tool called the Knee 
Society Score (KSS) (Appendix A).   
Patients will be randomized to one to 4 cohorts: 
o Cohort 1- Study group-Home discharge.  Patients randomized to 
this group will be provided with the X4 brace and trained on the 
use of Motion Intelligence platform.   
o Cohort 2- Control group-Home discharge.  Patients randomized to 
this group will serve as the control group.  There will be no 
changes to the standard of care recovery for a TKA patient. 
o Cohort 3- Study group-Inpatient rehabilitation.  Patients 
randomized to this group will be provided with the X4 brace and 
trained on the use of Motion Intelligence platform.   

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
2 
o Cohort 4- Control group-Inpatient rehabilitation.  Patients 
randomized to this group will serve as the control group.  There 
will be no changes to the standard of care recovery for a TKA 
patient. 
 
The aim of this study is to determine if using the X4 brace with the Motion 
Intelligence platform will provide enhanced, cost-effective postoperative 
recovery following total knee arthroplasty 
Objectives:
 
Objectives-Primary: Efficacy
 
To determine if patient postoperative outcomes, measured by the 
Knee Society Score, are improved by using the X4 brace with the 
Motion Intelligence platform 
Objectives-Primary: Safety 
 
To monitor the patient for any device related adverse events 
Objectives-Secondary: Efficacy 
 
To determine if there is a reduction in the rehabilitation costs 
(inpatient or outpatient) by using the X4 brace with the Motion 
Intelligence platform  
 
To evaluate patients satisfaction with the X4 brace with the 
Motion Intelligence platform 
 
To evaluate patients compliance and adherence using the X4 brace 
with the Motion Intelligence platform  
 
To evaluate provider satisfaction using the X4 brace with the 
Motion Intelligence platform  
Endpoints:
Endpoints-Primary: Efficacy 
 
To compare the Knee Society Scores, both objective and subjective 
scores, done preoperatively and at 8 weeks postoperatively 
between the control and study groups 
Endpoints-Primary: Safety 
 
To monitor the patient for any device related adverse events 
Endpoints -Secondary: Efficacy 
 
To compare the number of inpatient days in a rehabilitation center 
between the control and study groups 
 
To compare the number of outpatient visits to a physical therapy 
center between the control and study groups 
 
To evaluate patients satisfaction with the X4 brace with the 
Motion Intelligence platform via the “System Usability Scale” (SUS) 
questionnaire (study group only) 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
3 
 
To measure patient’s compliance using the X4 brace with the 
Motion Intelligence platform by counting how many days they 
used the platform as prescribed within an 8 week period.  A 
patient will be considered compliant if they use the platform once 
a day.  
 
To measure patient’s adherence using the X4 brace with the 
Motion Intelligence platform.  Adherence is defined as performing 
the entire exercise routine as prescribed once a day.  
 
To evaluate provider satisfaction with the X4 brace with the 
Motion Intelligence platform via the “System Usability Scale” (SUS) 
questionnaire (study group only)  
Study Population:
240 female and male patients who have had unilateral total knee 
arthroplasty by Drs. Krauss or Segal 
Phase:
4
Description of 
Sites/Facilities Enrolling 
Participants: 
 
Department of Orthopaedics, Syosset Hospital  
Description of Study
Intervention: 
The X4 brace with the Motion Intelligence platform is intended to 
supplement the postoperative rehabilitation process for total knee 
arthroplasty (TKA). This “Virtual Rehabilitation” has the advantage of 
guiding the patient with their prescribed exercise regimen.  Additionally, 
as this data is available to the surgical team on a daily basis this will allow 
the surgical team to intervene quickly when issues are identified. 
 
Study Duration:
The study is expected to take 1.5 years to complete
Participant Duration:
Consent for participation in the clinical trial will be obtained at any time 
during the preoperative period. Patients will be in the study until they 
have completed their 8 week postoperative surgical office visit.   
 
 
 
 
 
1.2 
SCHEME 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consent
Preoperative Period 
•Total n=240
•Obtain informed consent
•Screen potential participants by inclusion and exclusion criteria
•Obtain history, document
Randomization
Postopertive Day 1 to Discharge  
•Intervention Group 1 (n=120) Patient educated on the use of the X4 brace with the Motion Intelligence Platform
•Control (n=120) No intervention.  Standard of care postopertive treatment regime 
Postopertive Day 1 to Discharge  
•Section 1.3, Schedule of Activities
Study Assessments
Discharge to Postopertive day 14
•Section 1.3, Schedule of Activities
Study Assessments 
Postoperative Day 15-56
•Section 1.3, Schedule of Activities

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
This study does not require any study related screening procedures or diagnostic testing.   
Schedule of Activities: 
 
SOC=Standard of Care   KSS=Knee Society Score 
*Closest visit to this time point 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Total Knee Arthroplasty (TKA) has become a rapid recovery surgery.  Hospital stays are shorter with 
rehabilitation done either in an acute (AR), sub-acute (SAR) rehabilitation center, or at home. Therefore, 
the surgeon and the surgical team are only apprised of the patients’ progress during routine postoperative 
office visits done at 2 and 8 weeks.  This could potentially result in a delay of treatment for any 
complications related to surgery.   

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
6 
Following discharge from the hospital approximately 41% of TKA patients are transferred to an AR or SAR 
for further rehabilitation.  The length of stay in these facilities varies greatly.  The use of a monitoring 
device would allow the surgical team to remotely monitor the patient criteria for a safe discharge.  This 
criteria includes ambulation of 150 feet, ability to climb stairs and the bending of the knee to 110 degrees.  
Therefore, the X4 brace could alert the surgical team of patients who are failing to progress as expected.     
Home based programs require the patient perform prescribed exercise regimens twice a day.  One 
regimen is done with the guidance of a physical therapist (PT).   The second therapy is done by the patient 
without supervision.  Though home based exercises are convenient, assuring patient compliance with 
these prescribed exercise regimens is unknown.  Transition to an outpatient rehabilitation puts an added 
burden on the patient as most will require someone to drive them.  Outpatient rehabilitation is 3 times 
per week leaving the remainder of the exercises up to the patient.  
Patients and their care team need a solution to ensure both the compliance and accuracy with the exercise 
regimen. Currently, there is no method for the surgical team to ensure patients are following the protocols 
and progressing as expected. The surgical team needs a solution which would provide them more timely 
access to patient recovery status, activity and level of compliance.  Additionally, the use of this device 
could also provide needed security for a patient as they are aware their surgical team is monitoring their 
recovery.      
 
2.2 
BACKGROUND  
The X4 Knee brace with the Motion Intelligence platform is unique as it uses both a bio-measurement 
equipment with an interactive application thereby providing the patient with immediate feedback on 
their exercise regime.  The Motion Intelligence platform is comprised of a portable, battery operated, 
microprocessor-controlled, non-invasive patient monitoring device, sensor, and a companion mobile 
application.  The X4 Knee brace is a postoperative brace worn by a patient to monitor compliance to 
prescribed protocol based on the movement and function of the knee joint.  Contained within the X4 
Knee brace is the Mi360 sensor, which collects data autonomously, tracking steps, activity, and range of 
motion of the knee. The device also connects wirelessly to a companion mobile application, Motion 
Intelligence, and streams both real-time and collected data for review and record collection.  Prescribed 
exercises are uploaded into the patient application, with a number of the exercises actively tracked by 
the Mi360 sensor housed in the X4 brace.  Compliance can be tracked by the physician in real-time 
between postoperative visits and any medical staff on a separate dashboard.  
Range of motion in flexion and extension is measured twice daily within the patient application using 
the Mi360 sensor housed in the X4 brace.  This information is then graphically presented on the home 
screen in the patient application over time.  Range of motion can be tracked in real-time between 
postoperative visits by the physician and any medical staff on a separate dashboard. 
Patient pain is measured twice daily within the patient application using a visual analog scale (0-10). 
Patients are familiar with the visual analog scale as this scale is used during their postoperative recovery 
in the hospital.   Patient pain can be tracked in real-time by the physician and any medical staff on a 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
7 
separate dashboard.  A physician dashboard is accessible to the surgical team to enable remote 
monitoring of patients.  A summary of all patient data is made available via a web portal to the surgical 
team. 
In order for virtual rehabilitation systems to become part of the postoperative regimen they must 
demonstrate feasibility, user-friendliness, high patient and clinician satisfaction, clinical efficacy, and an 
acceptable overall cost of care. 1 
The aim of this study is to determine if using the X4 brace with the Motion Intelligence platform will 
provide enhanced, cost-effective postoperative recovery following total knee arthroplasty. 
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
Participation in this study does not create any additional risk for the postoperative TKA patient.  The 
brace is designed not to impede ambulation or range of motion.  The brace is adjustable to ensure 
patient comfort. 
 
The X4 application will collect personal information the subjects provide, such as their name, username, 
password, and other identifying personal information they provide when registering with the 
application. Therefore, there is a potential risk of breach of confidentiality.    
 
2.3.2 KNOWN POTENTIAL BENEFITS  
The X4 brace Motion Intelligence Platform is monitored remotely by the surgical team.  This remote 
monitoring could lead to earlier identification and intervention of postoperative issues for patients 
randomized to the study group.    
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. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
8 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
There are no anticipated problems associated with participation in this study.   
 
3 
OBJECTIVES AND ENDPOINTS 
 
 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
Primary
 
To determine if patient 
postoperative outcomes, 
measured by the Knee Society 
Score, are improved by using 
the X4 brace with the Motion 
Intelligence platform 
 
To monitor the study group 
for any device related adverse 
events 
 
 
 
 
 
To compare the Knee Society 
Scores, both objective and 
subjective scores, done 
preoperatively and at 8 weeks 
postoperatively between the 
control and study groups 
 
 
To monitor the study group for 
any device related adverse 
events 
 
The Knee Society Score is 
a validated tool used for 
assessing outcome in 
total arthroplasty 
patients 
 
 
Patients will be followed 
to ensure there are no 
issues with the utilization 
of the X4 brace 
Secondary
 
 
To determine if there is a 
reduction in the rehabilitation 
costs (inpatient or outpatient) 
by using the X4 brace with the 
Motion Intelligence platform  
 
 
 
 
 
 
To evaluate patients 
satisfaction with the X4 brace 
with the Motion Intelligence 
platform 
 
 
 
 
 
To evaluate patients 
compliance and adherence 
using the X4 brace with the 
Motion Intelligence platform  
 
 
 
 
 
 
To compare the number of 
inpatient days in a rehabilitation 
center between the control and 
study groups 
 
 
To compare the number of 
outpatient visits to a physical 
therapy center between the 
control and study groups 
    
 
To evaluate patient’s 
satisfaction with the X4 brace 
with the Motion Intelligence 
platform via the “System 
Usability Scale” (SUS) 
questionnaire (study group only)
 
 
 
To measure patient’s 
compliance using the X4 brace 
with the Motion Intelligence 
platform by counting how many 
days they used the platform as 
prescribed within an 8 week 
period.  A patient will be 
To evaluate if the X4 
brace provides user-
friendly, cost-effective, 
enhanced patient 
recovery following total 
knee arthroplasty 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
9 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To evaluate provider 
satisfaction using the X4 brace 
with the Motion Intelligence 
platform  
 
considered compliant if they use 
the platform once a day.  
 
 
To measure patient’s adherence 
using the X4 brace with the 
Motion Intelligence platform.  
Adherence is defined as 
performing the entire exercise 
routine as prescribed once a 
day.  
 
 
 
 
 
 
 
To evaluate provider satisfaction 
with the X4 brace with the 
Motion Intelligence platform via 
the “System Usability Scale” 
(SUS) questionnaire (study 
group only)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In order for this 
technology to become 
part a postoperative 
regime the platform 
should be both effective 
and user friendly for the 
provider 
 
 
 
 
 
 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
Hypotheses: The X4 brace with the Motion Intelligence platform will provide an enhanced, cost-effective 
postoperative recovery following total knee arthroplasty (TKA). 
This is a prospective, randomized clinical trial to evaluate the use of the X4 knee brace with the Motion 
Intelligence platform in patients having unilateral TKA. This brace is a FDA approved, marketed product 
being used as per the manufacturer’s (DJO) marketed indications.  Patients will be randomized to one to 
4 cohorts:  
This study is designed to determine if using a “virtual rehabilitation” device leads to enhanced 
recovery following total knee arthroplasty by improving patient objective and subjective outcome 
measures.  These outcomes will be collected using a validated tool called the Knee Society Score (KSS) 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
10 
(Appendix A).  The KSS is a standard of care tool collected for all TKA patients pre-operatively and 
postoperatively at the 8 week visit.  
o Cohort 1- Study group-Home discharge.  Patients randomized to this group will be provided 
with the X4 brace and trained on the use of Motion Intelligence platform.   
o Cohort 2- Control group-Home discharge.  Patients randomized to this group will serve as the 
control group.  There will be no changes to the standard of care recovery for a TKA patient. 
o Cohort 3- Study group-Inpatient rehabilitation.  Patients randomized to this group will be 
provided with the X4 brace and trained on the use of Motion Intelligence platform.   
o Cohort 4- Control group-Inpatient rehabilitation.  Patients randomized to this group will serve 
as the control group.  There will be no changes to the standard of care recovery for a TKA 
patient. 
 
No interim analysis is planned for this study.  Randomization schedule will be done by the statistician 
via RedCap.   
 
The DJO X4 brace will be provided to the patient at no cost.  Study visits, hospitalization, inpatient and 
outpatient rehabilitation costs are standard of care and will be the responsibility of the patient.  There 
will be no payment for participation in this study.  
All study patients will complete a daily “Daily Patient Log” (Appendix B) starting the day after discharge 
from the hospital until postoperative day (POD) 56.  This log will document the patient’s location: 
o Rehabilitation center or 
o Home physical therapy or 
o Physical therapy center 
o Hospital (re-admission) 
o Return to work (if applicable) 
 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Patients who are not randomized to the X4 study cohort will follow the standard of care regimen for TKA 
patients and will be the control group used for comparison.   
 
4.3 
JUSTIFICATION FOR DOSE 
 
Not Applicable. 
 
4.4 
END OF STUDY DEFINITION 
 
The End of Study will be defined as the 8 week (visit closest to this time point) postoperative visit. 
 
5 
STUDY POPULATION 
 
 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
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5.1 
INCLUSION CRITERIA 
Inclusion Criteria: 
1. Age > 18 or < 90 
2. Able to read and speak in English  
3. Patients having a unilateral total knee arthroplasty by Drs. Krauss or Segal 
4. Patients with a smart phone and internet able to access the Motion Intelligence Platform 
5. Patient is freely able to provide consent 
6. Patients willing to comply with the standard of care postoperative visit schedule (2 and 8 weeks) 
7. Agree to complete the KSS 2013 version preoperatively and at the 8 week postoperative visit 
(standard of care) 
8. Agree to complete the study required validated System Usability Scale at the 8 week 
postoperative visit (Appendix C) 
5.2 
EXCLUSION CRITERIA 
Exclusion Criteria: 
1. Surgery covered by workman’s compensation 
2. Physical impairments which in the opinion of the surgeon will effect or limit rehabilitation (e.g.: 
Multiple Sclerosis, Parkinson’s disease) 
3. Limited mobility preoperatively requiring the use of a wheelchair 
4. Chronic opioid use prior to surgery 
5. Alcohol abuse  
6. Participation in another clinical trial 
7. Cognitive limitations which will interfere with the understanding of the Motion Intelligence 
platform 
8. Requirement for a knee immobilizer postoperatively 
5.3 
LIFESTYLE CONSIDERATIONS 
 
There are no lifestyle modifications or requirements for this study.   
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in the clinical trial but are not 
subsequently randomly assigned to the study intervention. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants, to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries from 
regulatory authorities. Minimal information includes demography, screen failure details, and eligibility 
criteria. 
 
 
 
 
 
 

A prospective, randomized trial to evaluate postoperative outcomes in total knee arthroplasty patients using the DJO X4 brace       Version 1.0 
Protocol #1 
 21Jan2020 
 
 
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5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Participation in the clinical trial will be discussed with the patient by Dr. Krauss, Dr. Segal, or a designee, 
when the patient is first scheduled for a unilateral 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 
 
The informed consent and patient product information (Appendix D) will be given to the patient to 
review at home. This will provide the patients with an opportunity to review the device material prior to 
surgery.  The patients will be provided with contact information for the research staff for any questions 
or concerns. Consent will be obtained at any time during the preoperative period. 
This study will not be including any vulnerable or cognitively impaired patients.   
6 
STUDY INTERVENTION 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
Patients will be consented for the study at any time during the preoperative period.  Following the 
surgical procedure the inclusion/exclusion criteria will be confirmed.  Patients meeting study 
inclusion/exclusion will be randomized via the REDCap system when their discharge location (home vs 
inpatient rehabilitation) has been confirmed.  Patients randomized to the X4 brace arm of the study will 
be assisted with downloading the Motion Performance Platform and provided with the X4 brace during 
their hospital stay.  The average length of stay in the hospital is 2 days.  During the hospital stay the 
study team will work with the patient and family members to insure they are adequately trained in the 
use of the device and comfortable using the platform. Contact information will be provided for any 
issues or concerns.   
PROCESS AND PATIENT ON-BOARDING 
POST-OPERATIVE FOLLOWING RANDOMIZATION  
Following randomization the patient will be shown how to apply brace and assisted in downloading the 
Motion Intelligence application from either the Apple iStore or Google Play.  The patient will be assisted 
with pairing the device to the brace.  The patient will be instructed on how to use the application and 
importance of using the application.   

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The patient will be educated to do their exercises twice a day, once in the morning and once in the 
afternoon.  Additionally, the application screen will monitor their progress post-surgery by showing 
them how many steps they have taken in a day, their active time and average flexion and extension.  If 
the patient would like to be reminded that they need to do their exercises, they can set up a reminder 
by going to the “Settings”. 
Exercise Program: 
The Exercise program was developed by some Key Opinion Leaders based on common practice.  The 
investigators have reviewed the program and are in agreement with this program.   These exercises are 
completed throughout the 56 day program and are selected for predetermined time periods (days) after 
surgery (see exercise regime for details on timing): 
1. Ankle Pumps / Ankle Circles 
2. Isometric Quad Sets 
3. Supine Heel Slides 
4. Straight leg raise 
5. Hamstring and Calf Stretch * Hold 10 Seconds* 
6. Clamshells 
7. Seated Heel Slides in Chair 
8. Seated Passive Knee Extension *Hold 30 
Seconds* 
 
Each exercise has a video to show the patient how to complete the exercises.  The patient starts the 
exercise session by selecting the first exercise. They watch the video on how to perform the exercise.  
Once the exercise is completed they select “Done” and move to the next exercise. The exercises must be 
done in order, however, if the patient cannot complete the exercise they can select “skip” and give a 
reason for the skip.  Any exercise that bends the knee will show up on the screen when it is performed.  
Each period the patient has a target range of motion goal for both flexion and extension and a pain goal.  
The patient can see their progress while doing the exercises.  Progress is based on color: with Green 
indicating the patient has reached the target. Yellow and Red indicate that the target has not been 
reached.  At the end of the session the patient will be asked about their pain level and will record their 
highest amount of range of motion (ROM) and then they have a timer for 20 minutes of icing. 
 
 
 
 
 

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Exercise Regimen: 
Postoperative Day (POD) 
  
0-6 
  
  
Range of Motion Flexion - Target 
80 
Range of Motion Extension - Target 
15 
Pain - Target 
7 
Reps 
Sets
Time/Day 
Ankle Pumps / Ankle Circles 
10 
1 
2 
Isometric Quad Sets 
10 
1 
2 
Supine Heel Slides 
10 
1 
2 
Straight leg raise 
Hamstring and Calf Stretch * Hold 10 Seconds* 
Clamshells 
Seated Heel Slides in Chair 
10 
1 
2 
Seated Passive Knee Extension *Hold 30 Seconds* 
10 
1 
2 
 
Postoperative Day (POD) 
7-
13 
  
  
Range of Motion Flexion - Target 
90 
Range of Motion Extension - Target 
10 
Pain - Target 
6 
Rep
s 
Set
s 
Time/Da
y 
Ankle Pumps / Ankle Circles 
10 
1 
2 
Isometric Quad Sets 
10 
1 
2 
Supine Heel Slides 
10 
1 
2 
Straight leg raise 
Hamstring and Calf Stretch * Hold 10 Seconds* 

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Clamshells 
Seated Heel Slides in Chair 
10 
1 
2 
Seated Passive Knee Extension *Hold 30 Seconds* 
10 
1 
2 
 
 
 
 
 
 
 
 
 
 
 
 
Postoperative Day (POD) 
  
14-20 
  
  
Range of Motion Flexion - Target 
100 
Range of Motion Extension - Target 
5 
Pain - Target 
6 
Reps 
Sets
Time/Day 
Ankle Pumps / Ankle Circles 
10 
1 
2 
Isometric Quad Sets 
10 
1 
2 
Supine Heel Slides 
10 
1 
2 
Straight leg raise 
Hamstring and Calf Stretch * Hold 10 
Seconds* 
Clamshells 
Seated Heel Slides in Chair 
10 
1 
2 
Seated Passive Knee Extension *Hold 30 
Seconds* 
10 
1 
2 
 
 
 
 
 
 
 
 
 
 
 
 

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Postoperative Day (POD) 
21-27 
  
  
Range of Motion Flexion - Target 
105 
Range of Motion Extension - Target 
0 
Pain - Target 
5 
Reps 
Sets
Time/Day
Ankle Pumps / Ankle Circles 
Isometric Quad Sets 
Supine Heel Slides 
Straight leg raise 
10 
1 
2 
Hamstring and Calf Stretch * Hold 10 Seconds* 
Clamshells 
10 
1 
2 
Seated Heel Slides in Chair 
10 
1 
2 
Seated Passive Knee Extension *Hold 30 Seconds* 
10 
1 
2 
 
Postoperative Day (POD) 
28-34 
  
  
Range of Motion Flexion - Target 
110 
Range of Motion Extension - Target 
0 
Pain - Target 
5 
Reps 
Sets 
Time/Day 
Ankle Pumps / Ankle Circles 
Isometric Quad Sets 
Supine Heel Slides 
Straight leg raise 
10 
1 
2 
Hamstring and Calf Stretch * Hold 10 Seconds* 
Clamshells 
10 
1 
2 
Seated Heel Slides in Chair 
10 
1 
2 
Seated Passive Knee Extension *Hold 30 Seconds* 
10 
1 
2 

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Postoperative Day (POD) 
35-
41 
  
  
Range of Motion Flexion - Target 
110 
Range of Motion Extension - Target 
0 
Pain - Target 
4 
Reps Sets
Time/Day
Ankle Pumps / Ankle Circles 
Isometric Quad Sets 
Supine Heel Slides 
Straight leg raise 
10 
1 
2 
Hamstring and Calf Stretch * Hold 10 Seconds* 
Clamshells 
10 
1 
2 
Seated Heel Slides in Chair 
10 
1 
2 
Seated Passive Knee Extension *Hold 30 Seconds* 
10 
1 
2 
 
Postoperative Day (POD) 
42-
48 
  
  
Range of Motion Flexion - Target 
115 
Range of Motion Extension - Target 
0 
Pain - Target 
3 
Reps 
Sets 
Time/Day
Ankle Pumps / Ankle Circles 
Isometric Quad Sets 
10 
1 
2 
Supine Heel Slides 
10 
1 
2 
Straight leg raise 
10 
1 
2 
Hamstring and Calf Stretch * Hold 10 Seconds* 

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Clamshells 
10 
1 
2 
Seated Heel Slides in Chair 
Seated Passive Knee Extension *Hold 30 Seconds* 
 
Postoperative Day (POD) 
49-
55 
  
  
Range of Motion Flexion - Target 
115 
Range of Motion Extension - Target 
0 
Pain - Target 
2 
Reps 
Sets 
Time/Day 
Ankle Pumps / Ankle Circles 
Isometric Quad Sets 
10 
1 
2 
Supine Heel Slides 
10 
1 
2 
Straight leg raise 
10 
1 
2 
Hamstring and Calf Stretch * Hold 10 Seconds* 
Clamshells 
10 
1 
2 
Seated Heel Slides in Chair 
Seated Passive Knee Extension *Hold 30 Seconds* 
 
Postoperative Day (POD) 
56 
(End of Study) 
Range of Motion Flexion - Target 
120 
Range of Motion Extension - Target 
0 
Pain - Target 
2 
Reps
Sets
Time/Day 
Ankle Pumps / Ankle Circles 
Isometric Quad Sets 
10 
1 
2 
Supine Heel Slides 
10 
1 
2 

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Straight leg raise 
10 
1 
2 
Hamstring and Calf Stretch * Hold 10 Seconds* 
Clamshells 
10 
1 
2 
Seated Heel Slides in Chair 
Seated Passive Knee Extension *Hold 30 Seconds* 
 
Monitoring the patient 
The Motion Intelligence application allows the patient to send messages to their care team and allows 
the patient to send pictures of their knee if needed.  Additionally there is product support for the 
patient.  This support from DJO is available by phone and email:  
• 
Email support at Misupport@djoglobal.com 
• 
Email at support@motionmd.com 
• 
Phone (844)273-0200 
 
6.1.2 DOSING AND ADMINISTRATION 
 
Not Applicable  
 
 
 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
 
Not Applicable  
 
 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
 
Not Applicable  
 
 
 
6.2.3 PRODUCT STORAGE AND STABILITY 
 
Not Applicable  

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6.2.4 PREPARATION 
 
Not Applicable  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Randomization: 
Prior to randomization, patients will be stratified according to discharge location (home, inpatient 
rehabilitation).  Within each stratum, patients will be randomly assigned in a 1:1 ratio to the X4 brace 
with the Motion Intelligence platform or standard of care.   
The Biostatistics Unit will develop a randomization procedure using a permuted block design within the 
REDCap system ).  Additional details of the procedure, including required record keeping, will be further 
developed upon approval of this protocol.  The Biostatistics Unit has extensive experience in 
implementing and in producing detailed documentation for such procedures. 
Blinding and Concealed Allocation 
 
Due to the nature of the X4 brace, it is not possible to blind the investigators or the participants.  The 
randomization assignment will be obtained from BRMS, after consent has been obtained, after it has 
been determined that the subject has met all inclusion/exclusion criteria, and after the discharge 
location has been determined. 
 
 
6.4 
STUDY INTERVENTION COMPLIANCE 
Patients randomized to the X4 brace cohort are required to access the system twice daily.  Patients who 
have not accessed the system for over 72 hours will be contacted to determine the reason for non-
compliance.   
Compliance and adherence with the X4 brace with the Motion Intelligence platform are secondary 
outcomes of this study.    
6.5 
CONCOMITANT THERAPY 
 
Not Applicable  
 
 
 
6.5.1 RESCUE MEDICINE 
 

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Not Applicable  
 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
Patients may discontinue using the X4 brace, however, this does not mean discontinuation from the 
study.  The brace is single use and patients will not be required to return the brace. 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request.  All analyses 
will be carried out according the ITT principle.  The ITT population will be all patients randomized, 
regardless of whether or not treatment was administered.  All patients will be analyzed in the group to 
which they were randomized.  
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
 
Significant study intervention non-compliance  
 
A medical condition or situation occurs such that continued participation in the study would not 
be in the best interest of the participant 
The reason for participant discontinuation or withdrawal from the study will be recorded in REDCap.  
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for the 8 week postoperative 
visit and is unable to be contacted by the study site staff.  
 
The site will attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study. 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts should be documented in the participant’s medical record or study file.  
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 

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8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
Study Cohort Patients Only (Patients randomized to the X4 brace with the Motion Intelligence 
platform): 
Patients will follow the prescribed exercises available on the patient application, with a number of the 
exercises actively tracked by the Mi360 sensor housed in the X4 brace.  Compliance will be monitored by 
the physician and/or a delegated medical professional between postoperative visits on the Motion 
Intelligence dashboard.  
Range of motion in flexion and extension will be measured twice daily within the patient application 
using the Mi360 sensor housed in the X4 brace.  This information is then graphically presented on the 
home screen in the patient application over time.  Range of motion can be tracked in real-time between 
postoperative visits by the physician and/or a delegated medical professional between postoperative 
visits on the Motion Intelligence dashboard.  
Patient’s will be required to access the application twice daily to enter their pain scores using the visual 
analog scale (0-10).  Patient pain can be tracked in real-time by the physician and/or a delegated 
medical professional between postoperative visits on the Motion Intelligence dashboard.  
All study patients: 
All study patients will complete a daily “Daily Patient Log” starting the day after discharge from the 
hospital until postoperative day (POD) 56.  This log will document the patient’s location: 
o Rehabilitation center or 
o Home physical therapy or 
o Physical therapy center 
o Hospital (readmission) 
o Return to work (if applicable) 
All study patients will be required to complete a preoperative and 8 week postoperative Knee Society 
Score questionnaire.  This questionnaire is a standard of care for all total knee arthroplasty patients 
having surgery by Drs. Krauss and Segal.  
8.2 
SAFETY AND OTHER ASSESSMENTS 
 
This clinical trial does not require any study specific screening tests or procedures.  Preoperative 
screening done as part of the standard of care for a preoperative arthroplasty patient will be used to 
determine patient inclusion and exclusion.  Additionally, there are no required on study lab testing or 
procedures required.   
 
 
   

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8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
Medical Device Reporting: 
This clinical trial is evaluating a commercially available marketed medical device (X4 brace).  The device 
is 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. 
Adverse Event Reporting Period 
The study period during which adverse events must be reported is defined as the period from the 
initiation of any study procedures to the end of the study treatment follow-up.  For this study, the 
initiation of study procedure will be from when the study subject starts using the X4 brace with the 
Motion Intelligence platform through the 8 week postoperative visit. 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
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. 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 
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 

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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 
 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
8.3.3.1 SEVERITY OF EVENT 
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.   
 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 
All adverse events (AEs) must have their relationship to study intervention (device) assessed by the 
clinician who examines and evaluates the participant based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below. In a clinical 
trial, the study product must always be suspect.  
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 

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8.3.3.3 EXPECTEDNESS  
 
The Principal Investigator will be responsible for determining whether an adverse event (AE) is expected 
or unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the study intervention. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  
Events will be followed for outcome information until resolution or stabilization. 
 
 
8.3.5 ADVERSE EVENT REPORTING  
 
This clinical trial consists of postoperative total knee arthroplasty patients.  DRE’s common and expected 
in this group of patients include postoperative pain, nausea, hypotension, anemia, and dehydration.  
Events anticipated and expected in the postoperative arthroplasty patient will not be considered an 
adverse event for collection in the eCRF.  Additionally, there are no study interventions for the control 
group.  This group will be following the standard of care treatment for a total knee arthroplasty patient.  
Therefore, no adverse events related to the study will be occurring in this group. 
 
 
 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
The study investigator shall complete an Unanticipated Adverse Device Effect Form and submit to the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 working 

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days after the investigator first learns of the effect.  The investigator is responsible for conducting an 
evaluation of an unanticipated adverse device effect and shall report the results of such evaluation to 
the Food and Drug Administration (FDA). Thereafter, the investigator shall submit such additional 
reports concerning the effect as FDA requests. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
Not Applicable 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
Not Applicable 
 
8.3.9 REPORTING OF PREGNANCY  
 
 Not Applicable 
 
 
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
 
 Not Applicable 
 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
 
 
Not Applicable  
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
Not Applicable  
 
 
9 
STATISTICAL CONSIDERATIONS  
 
 
9.1 
STATISTICAL HYPOTHESES 
 
 
Primary Efficacy Endpoint(s):  
 

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Knee Society Scores will be obtained prior to surgery, and at 8 weeks postoperatively 
o Objective knee score (completed by the surgeon) 
o 
Subjective knee score (completed by patient)   
 
 
Secondary Efficacy Endpoint(s): 
 All outcomes will be measured at 8 week postoperative visit or the visit closest to this time point  
Outcomes for all patients regardless of discharge location 
o 
Number of outpatient visits to a physical therapy center 
 
Outcomes for patients discharged to inpatient rehabilitation 
o Number of inpatient days in a rehabilitation center  
 
Outcomes for patients randomized to the X4 brace with the Motion Intelligence platform  
o Patient satisfaction with the X4 brace with the Motion Intelligence platform:  Patients will 
complete the System Usability Scale (SUS)  
o Compliance in using the X4 brace with the Motion Intelligence platform:  Patients will be 
instructed to use the X4 brace twice a day.  For each day, a subject will be considered compliant 
if they access the platform at least once a day, and non-compliant if they do not access at all the 
platform that day.   
o Adherence using the X4 brace with the Motion Intelligence platform:  For each day, a subject 
will be considered adherent if they perform the entire exercise routine as prescribed at least 
once a day, and non-adherent if they do not perform the entire exercise routine that day. 
 
 
Primary Safety Endpoint(s) 
 
o Adverse Events related to the X4 brace will be collected in patients regardless of discharge 
location. 
 
 
9.2 
SAMPLE SIZE DETERMINATION 
Sample Size Justification: 
Based on preliminary data (from the Total Knee Arthroplasty Registry), there were 244 patients treated 
under the standard of care, with a KSS subjective score obtained between 6 and 10 weeks after surgery.  
We will use this information to estimate the KSS subjective score for the standard of care group at 8 
weeks after surgery.  The mean KSS subjective score in these patients was 108.5, with a standard 
deviation of 27.5.  We believe that a 10 point improvement is clinically meaningful.  We further assume 
that the scores for those discharged to home, and those discharged to inpatient rehabilitation will be 
similar, (i.e. no interaction between intervention group and discharge location).  Therefore, we will use a 
two sided two-sample t-test to simplify the calculation.  In addition, the KSS subjective scores in our 
preliminary data were normally distributed, and so the calculation uses the raw (untransformed) data.  
A sample size of 120 patients per group will yield 80% power to detect a 10 point difference between 
the two intervention groups using a two sided two-sample t-test at the 0.05 significance level.  As 

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dropout is expected to be very low, no adjustment for attrition will be made.  Therefore, the total 
sample size will be 240 patients (120 per group). 
 
9.3 
POPULATIONS FOR ANALYSES 
Intention to Treat (ITT): 
All analyses will be carried out according the ITT principle.  The ITT population will be all patients 
randomized, regardless of whether or not treatment was administered.  All patients will be analyzed in 
the group to which they were randomized. 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
Descriptive statistics (frequency distribution and percentage for categorical variables; mean, SD, median, 
interquartile range, minimum, maximum for continuous variables) of patient demographics, clinical 
characteristics, and medical history. 
 
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
Statistical Methods: 
Primary Outcomes:  Efficacy 
For each Knee Society Score, (objective score and subjective score), analysis of covariance (ANCOVA) will 
be used to examine the association between that score and intervention group (X4 brace, standard of 
care).  The corresponding pre-op score will be included as a covariate in the model.  Discharge location 
(home, inpatient rehabilitation) will also be included in the model.  If the interaction between 
intervention group and discharge location is significant, then pairwise comparisons of intervention 
group within each discharge location will be examined within the ANCOVA model.  If the usual 
assumptions of the ANCOVA model are not met, either a suitable transformation, or an appropriate 
nonparametric method will be used.   
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Secondary Outcomes: Efficacy 
Outcomes for all patients regardless of discharge location: 
The association between number of outpatient visits to a physical therapy center and intervention group 
will be examined using Poisson regression.   Discharge location (home, inpatient rehabilitation) will also 

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be included in the model.  If the interaction between intervention group and discharge location is 
significant, then pairwise comparisons of intervention group within each discharge location will be 
examined within the Poisson regression model.  If the Poisson model does not fit the data well, 
alternative methods for count data will be considered.   
Outcomes for patients discharged to inpatient rehabilitation: 
Number of inpatient days in a rehabilitation center  
The association between number of inpatient days in a rehabilitation center and intervention group will 
be examined using Poisson regression.   If the Poisson model does not fit the data well, alternative 
methods for count data will be considered.    
Outcomes for patients randomized to the X4 brace with the Motion Intelligence platform: 
The association between patient satisfaction with the X4 brace, as measured by the SUS scale, and 
discharge location (home, inpatient rehabilitation) will be examined using the two sided, two sample t-
test.  If the usual assumptions required for the t-test are not met, either a suitable transformation, or an 
appropriate nonparametric method will be used. 
The association between number of days of compliance and discharge location will be examined using 
Poisson regression.  If the Poisson model does not fit the data well, alternative methods for count data 
will be considered.     
The association between number of days of adherence and discharge location will be examined using 
Poisson regression.  If the Poisson model does not fit the data well, alternative methods for count data 
will be considered. 
Other outcomes: 
Provider satisfaction with the X4 brace, as measured by the SUS scale will be described by calculating 
summary statistics (median, 25th percentile, 75th percentile, minimum and maximum).   
 
 
9.4.4 SAFETY ANALYSES 
 
Safety Outcomes: 
Outcomes for patients randomized to the X4 brace regardless of discharge location 
o Adverse events:  Each subject will be categorized at the end of the study as having had one or 
more adverse events, or not having had any adverse events. 
o Serious adverse events:  Each subject will be categorized at the end of the study as having had 
one or more adverse events, or not having had any serious adverse events. 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 

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Not Applicable 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
Not Applicable 
 
9.4.7 SUB-GROUP ANALYSES 
 
Not Applicable 
 
 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Not Applicable 
 
9.4.9 EXPLORATORY ANALYSES 
 
Not Applicable 
 
 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
 
10.1.1 INFORMED CONSENT PROCESS 
 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting study 
intervention.   
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the participant will be asked to read and review the document. The 

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investigator will explain the research study to the participant and answer any questions that may arise. 
A verbal explanation will be provided in terms suited to the participant’s comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research participants.  
Participants will have the opportunity to carefully review the written consent form and ask questions 
prior to signing. The participants should have the opportunity to discuss the study with their family or 
surrogates or think about it prior to agreeing to participate. The participant will sign the informed 
consent document prior to any procedures being done specifically for the study. Participants must be 
informed that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the informed consent document will be given to the participants for their records. 
The informed consent process will be conducted and documented in the source document (including the 
date), and the form signed, before the participant undergoes any study-specific procedures. The rights 
and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly 
inform study participants and the Institutional Review Board (IRB).  Study participants will be contacted, 
as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Demonstration of efficacy that would warrant stopping    
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination that the primary endpoint has been met 
 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the IRB. 
 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover clinical 
information relating to participants. Therefore, the study protocol, documentation, data, and all other 
information generated will be held in strict confidence. No information concerning the study or the data 
will be released to any unauthorized third party without prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB) and regulatory agencies may inspect all 
documents and records required to be maintained by the investigator, including but not limited to, 

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medical records (office, clinic, or hospital) and pharmacy records for the participants in this study. The 
clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB Institutional policies. 
DJO PRIVACY POLICY-Last Updated: February 2018 
DJO, LLC (“DJO”, “We,” “Our”, or “Us”) takes your privacy very seriously. This privacy policy describes 
Our collection of Personal Data when you use Our mobile App (“App”) for Our X4 knee brace (“Knee 
Brace”). This policy describes Our use and disclosure of such Personal Data, and the steps We take to 
protect such personal data. “Personal Data” means any information relating to an identified or 
identifiable natural person including your health information as described below. By downloading or 
using Our App you agree to and consent to the collection and use of your information as described 
below. 
By accepting this Privacy Policy you expressly acknowledge that you have read and understood Our 
HIPAA Notice of Privacy Practices, which describes how We may use and disclose health information 
about you for treatment, payment or health care operations and for other purposes that are permitted 
or required by law, including the Health Insurance Portability and Accountability Act of 1996, as 
amended from time to time (“HIPAA”). Our HIPAA Notice of Privacy Practices is available at 
http://www.djoglobal.com/corporateinfo/compliance/hipaa. Any conflict between this Privacy Policy 
and the HIPAA Notice Privacy Practices with respect to any PHI (as defined in the HIPAA Notice) shall be 
governed by the HIPAA Notice. If you do not want Us to use your information or your data as stated in 
this Privacy Policy, please do not download or use Our App.  We, with the help of Our partner, have 
developed the App to facilitate the collection of your postoperative knee movement data through the 
DJO Mi360 sensor in the Knee Brace. This will allow your health care provider to access and view the 
data to monitor your knee’s range of motion and rehabilitation process. The App is designed for users 
over 18 years of age who have received access through the registration process. Your health care 
providers will have other policies related to the way they use and disclose information accessible to 
them. Please review your health care providers’ Notice of Privacy Practices or any other Privacy 
Statement they may have.  
Information We Collect 
We collect the following information from you: Personal information that you provide, such as your 
name, username, password, and other identifying personal information you provide when registering 
with the App; Health Information, including identifying information related to your Knee Brace, and data 
from that Knee Brace related to its use, including range of motion and rehabilitation progress; The name 
and contact information of your health care provider; Information related to the timing of the 
transmission of data from your Knee Brace to the web portal accessible by your healthcare provider, and 
your health care provider’s access of that information; and other Information such as comments or 
questions you have provided to us.  In addition to the data listed above, We automatically collect and 
store: Knee Brace event information such as errors, system activity, and the dates and times of your 
activity; Standard log information such as how you used the App.  
How We Use Information We use your contact information to contact you for administrative purposes 
regarding your use of the App. We use the data collected through the App to provide information to 

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your health care provider on your range of motion progress of your Knee Brace and other rehabilitation 
related data. We use the information that We collect through the App to operate, maintain, enhance, 
and provide all features of the App. We also use the information to provide services to respond to 
comments and questions for user support. Aggregated Data is information about some or all of the 
Users of the App, but unlike Personal Data, does not reflect or reference an individually identifiable 
individual. We may use Aggregated Data in research studies, for marketing purposes or other purposes 
in connection with Our business as permitted by applicable law. We will not access your personal 
contacts, other applications, or personal photos. We use standard log files and other automatically-
collected usage data that is essential for the App to function effectively, including to: (i) personalize the 
App such as by remembering information so that it does not need to be re-entered; (ii) monitor and 
analyze the App; (iii) monitor aggregate App usage metrics; and (iv) track your activities on the App.  
How We Disclose Information Except as described in this Privacy Policy, We will not sell, rent, lease, give 
away, disclose or share your contact information, and, except as described below, will not disclose your 
Personal Data that we collect through the App to third parties without your consent. We may provide 
contact or App information to third parties if you consent to Us doing so,as well as in the following 
circumstances: We will provide Personal Data collected through your Knee Brace (such as range of motion 
and rehabilitation related data) to your health care provider. Please note that your health care provider’s 
privacy policy will determine how the health care provider protects your health information. We may 
provide your Personal Data to third parties who provide services on Our behalf. We take steps to limit the 
Personal Data provided to them to that which is reasonably necessary for them to perform their functions. 
We require them by contract to agree to only process the Personal Data in accordance with Our 
instructions and to maintain the security and confidentiality of such information by applying adequate 
technical and organizational security measures. To the extent permitted by applicable law, We may 
disclose your Personal Data if required to do so by law to comply with state and federal laws, in 
response to a court order, judicial or other government subpoena or warrant, or to otherwise cooperate 
with law enforcement or other governmental agencies. We also reserve the right to disclose your 
information that We believe, in good faith, is appropriate or necessary to (i) take precautions against 
liability, (ii) protect ourselves or others from fraudulent, abusive, or unlawful uses or activity, (iii) 
investigate and defend ourselves against any third-party claims or allegations, (iv) protect the security or 
integrity of the App and any facilities or equipment used to make the App available, or (v) protect Our 
property or other legal rights (including, but not limited to, enforcement of Our agreements), or the 
rights, property, or safety of others. We will notify you of any such disclosures.  Information about Our 
users, including Personal Data, may be disclosed and otherwise transferred to an acquirer, successor, or 
assignee as part of any merger, acquisition, debt financing, sale of assets, or similar transaction, or in the 
event of an insolvency, bankruptcy, or receivership in which information is transferred to one or more 
third parties as one of Our business assets, to the extent and in the way as prescribed by applicable law. 
We will combine your Personal Data with those of other App users to create Aggregated Data. 
Do Not Track: We do not track Our App users over time and across third party websites or online 
services to provide targeted advertising, and we do not respond to Do Not Track signals. 
Data Security: We use appropriate physical, managerial and technical safeguards that are designed to 
protect the confidentiality, integrity and security of Personal Data that We collect and maintain against 
accidental or unlawful loss, theft and misuse and unauthorized access, disclosure, alteration destruction, 
or any other type of unlawful processing. We cannot, however, fully guarantee the security of Personal 
Data or other information transmitted through the App. You are responsible for maintaining the 

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confidentiality of your App access information and password. You agree to accept responsibility for all 
activities that occur under your password. 
Rights and Choices 
You may have certain rights regarding the Personal Data we maintain about you. You may have the right 
to request access to receive information about the Personal Data We maintain about you, or have your 
Personal Data rectified, blocked, or deleted if it is incorrect, inaccurate, or outdated. Following your 
request, We will accommodate your request as required by applicable law. You may discontinue 
information collection by uninstalling the App. You may use the standard uninstall processes as may be 
available as part of your mobile device or via the mobile application marketplace. If you have questions 
about your rights and choices in relation to your Personal Data, or would like to request additional 
information, please contact MI360support@djoglobal.com or write to Us at: DJO Global, Attn: MI360 
Support,1430 Decision Street, Vista, CA 92081. 
Changes to Our Privacy Policy 
We may change this Privacy Policy from time to time. Any changes will be posted on the App with an 
updated revision date. In the event that any changes to this Privacy Policy materially alter your rights or 
obligations under this Privacy Policy, We will make reasonable efforts to notify you of the change. For 
example, we may send a message to your email address, if we have one on file, or generate a PUSH 
message or similar notification when you access the App for the first time after such material changes 
are made. You will need access to the App or your email server for access to review and save the revised 
Privacy Policy. Your continued use of the App after the revised Privacy Policy has become effective 
indicates that you have read, understood and agreed to the then current version of this Privacy Policy. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Not Applicable  
 
 
 
 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Provide the name and contact information of the Principal Investigator and the Medical Monitor. 
Principal Investigator
Medical Monitor
Eugene Krauss,MD,FAAOS,FACS
Not Applicable
Syosset Hospital, Northwell 
Health
Institution Name 
221 Jericho Turnpike 
Address
516-496-2637
Phone Number
ekrauss@northwell.edu
Email
 
Steering Committee, Executive Committee, Subcommittee are Not applicable for this study. 
 

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10.1.6 SAFETY OVERSIGHT 
  
Not Applicable  
 
10.1.7 CLINICAL MONITORING 
 
 
Not Applicable  
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
The clinical site will perform internal quality management of study conduct, data documentation and 
completion.  An individualized quality management plan will be developed to describe a site’s quality 
management. The investigational site will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by local and regulatory 
authorities. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the electronic case report 
form (eCRF) derived from source documents should be consistent with the data recorded on the source 
documents.  
 
Clinical data, including device related adverse events (AEs), data will be entered into the REDCap  
system. The data system includes password protection and internal quality checks, such as automatic 
range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be 
entered directly from the source documents. 
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Study document will be retained for 10 years following study termination. 
 
10.1.10 
PROTOCOL DEVIATIONS  
 

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A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
Protocol deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The 
site investigator is responsible for knowing and adhering to the reviewing IRB requirements. Further 
details about the handling of protocol deviations will be included in the MOP. 
 
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY 
 
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.  
 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
Eugene Krauss and Ayal Segal, the study doctors, receives financial support from DJO 
Global, the company that is involved in this study. The money this study doctor receives from this 
company is for work as a consultant and is separate from this study.  The study doctors receive no 
payment for any work related to this study. 
 
10.2 ADDITIONAL CONSIDERATIONS 
Not Applicable. 
 
10.3 ABBREVIATIONS 
The list below includes abbreviations utilized in this template.  However, this list should be customized for 
each protocol (i.e., abbreviations not used should be removed and new abbreviations used should be 
added to this list). 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
AR 
Acute Rehabilitation 
CFR 
Code of Federal Regulations 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 

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DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOC 
Standard of Care 
SOP 
Standard Operating Procedure 
SAR 
Sub-Acute Rehabilitation 
SUS 
System Usability Scale 
TKA 
Total Knee Arthroplasty 
UP 
Unanticipated Problem 
US 
United States 

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Protocol Amendment History 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version
Date
Description of Change
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCES  
Include a list of relevant literature and citations for all publications referenced in the text of the protocol.  
Use a consistent, standard, modern format, which might be dependent upon the required format for the 
anticipated journal for publication (e.g., N Engl J Med, JAMA, etc.).  The preferred format is International 
Committee of Medical Journal Editors (ICMJE). Include citations to product information such as 
manufacturer’s IB, package insert, and device labeling.  
1. Chughtai M, Kelly JJ, Newman JM, et al. The role of virtual rehabilitation in total and 
unicompartmental knee arthroplasty. J Knee Sug 2019;32:105-110. 
 
 
Appendix: 
Appendix A: 2011 Knee Society Score 
Appendix B: Patient Daily Log 
Appendix C: System Usability Scale 
Appendix D: DJO X4 Brace Patient Information  
Appendix E: X4 smart post-op brace and motion intelligence application. PROCESS AND PATIENT ON-
BOARDING