A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Phase: NA
Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip
Sponsor: Zimmer Biomet

 
 
mymobility Clinical Study – CLU2018-13CH 
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mymobility® Clinical Study 
A Prospective Multicenter Longitudinal Cohort Study of the mymobility Platform 
CLU2018-13CH 
Version 4.0 
14 February 2022 
Global 
 
 
STUDY SPONSOR 
Zimmer Biomet 
Clinical Affairs Department 
1800 West Center Street, MS #4020 
Warsaw, IN 46580 
800-613-6131 
 
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Biomet 
except as otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold 
this information in confidence and not distribute or disclose it to others (except where required by  
applicable law) or use it for unauthorized purposes.  In the event of any actual or suspected breach 
of this obligation, Zimmer Inc. must be promptly notified.  Duplication and distribution of this 
document in any form or shape requires prior approval from Zimmer Biomet.  
 

 
 
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STATEMENT OF COMPLIANCE 
Only the Principal Investigator is required to sign during initial site start-up process.   
The study is conducted in accordance with ISO 14155 Standard for Clinical Investigation of Medical 
Devices For Human Subjects – Good Clinical Practice(i), the ICH Guideline on Good Clinical Practice(ii), 
the Declaration of Helsinki(iv), and is in accordance with US Code of Federal Regulations 21 CFR Parts 
11, 50 and 56(iii), as well as any regional or national regulations, as appropriate. IRB or EC approval 
for each site will be obtained prior to conducting this study, as applicable. 
 
The investigator agrees: 
• 
To assume responsibility for the proper conduct of the study at this site and supervise all testing 
involving human subjects. 
• 
To conduct the study in compliance with this protocol, any future amendments, and with any other 
study conduct procedures provided by the Sponsor. 
• 
To ensure that the requirements for obtaining informed consent from each subject are met.   
• 
Not to implement any changes to the protocol without written agreement from the Sponsor and 
prior review and written approval from my institutional review board except where necessary to 
eliminate an immediate hazard to subjects. 
• 
That I am thoroughly familiar with the appropriate use of the investigational product, as described 
in this protocol and any other information provided by the Sponsor. 
• 
That I am aware of, and will comply with, good clinical practice (GCP) and all applicable regulatory 
requirements. 
• 
To ensure that all persons assisting me with the study are adequately informed about the 
investigational product and have been trained on their study-related duties and functions as 
described in the protocol. 
 
 
Investigator Signature:  
Date: 
 
Printed Name:  
 
 
 
 
 
 

 
 
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Contents 
I. 
Contact Information/List of Investigators ............................................................................................. 4 
II. 
Abbreviations ........................................................................................................................................... 5 
III. 
Study Synopsis........................................................................................................................................ 6 
IV. 
Data Collection Overview .................................................................................................................... 10 
V. 
Introduction and Purpose .................................................................................................................... 11 
VI. 
Study Objectives ................................................................................................................................... 12 
VII. 
Study Design and Endpoints ............................................................................................................... 14 
VIII. 
Study Population ................................................................................................................................... 15 
IX. 
Study Device Information .................................................................................................................... 16 
X. 
Study Procedures ................................................................................................................................. 19 
XI. 
Pathway Specific Procedures ............................................................................................................. 23 
XII. 
Reporting ................................................................................................................................................ 28 
XIII. 
Safety Management ............................................................................................................................. 36 
XIV. Monitoring .............................................................................................................................................. 39 
XV. 
Risk Analysis ......................................................................................................................................... 39 
XVI. Statistical Methods ................................................................................................................................ 41 
XVII. Quality Control & Quality Assurance ................................................................................................. 43 
XVIII. Suspension or Premature Termination of the Clinical Investigation ............................................. 44 
XIX. Vulnerable Populations ........................................................................................................................ 44 
XX. 
Document History ................................................................................................................................. 44 
XXI. References ............................................................................................................................................. 47 
XXII. Appendices ............................................................................................................................................ 50 
 
 
 
 

 
 
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I. 
Contact Information/List of Investigators 
Title 
mymobility® Clinical Study 
Protocol Number 
CLU2018-13CH 
Study Sponsor Contact 
Information 
Zimmer Biomet US, Inc. (or its subsidiary), referred to herein 
as “Zimmer Biomet” 
1800 West Center Street, MS #4020 
Warsaw, IN 46580 
Phone: 800-613-6131 
Regional Sponsor Contact Information: 
Toermalijnring 600 
3316 LC  Dordrecht 
Netherlands 
 
Zimmer Gmbh 
Sulzerallee 8 
CH – 8404 Winterthur 
Zimmer Biomet Pty Ltd 
12 Narabang Way 
Belrose, NSW 2085 
02-9485-5611 
Monitoring Contact Information Zimmer Biomet or designee  
Investigational Site Information  
This study will include up to 36 sites.  Details regarding the 
sites involved will be maintained in the Sponsor’s Trial Master 
File. 
Mymobility Technical Support 
Information 
a. Technical Support Email  
support@zbmymobilitysolutions.com 
b. Technical support at 844.799.8208 
Responses will be provided within one business day. 
 
 
 
 

 
 
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II. 
Abbreviations 
App 
Smartphone Application 
ACF 
Acute Care Facility 
ASC 
Ambulatory Surgery Center 
CI 
Confidence Interval 
EC 
Ethics Committee (also referred to as IRB in US) 
eCRF 
Electronic Case Report Form 
ePro 
Electronic Patient Reported Outcomes 
EDC 
Electronic Data Capture 
EMEA 
Europe, the Middle East and Africa 
EQ-5D-5L 
EuroQol-5 Dimensions-5 Levels (Health-Related Quality of Life Survey) 
ER 
Emergency Room 
GDPR 
General Data Protection Regulation 
HIPAA 
Health Insurance Portability and Accountability Act 
HOOS, JR. 
Hip Disability and Osteoarthritis Outcome Score (Short Form) 
ICF 
Informed Consent Form (US only: Informed Consent and Authorization) 
IFU 
Instructions for Use 
IRB 
Institutional Review Board (also referred to as EC OUS) 
KOOS, JR. 
Knee Injury and Osteoarthritis Outcome Score (Short Form) 
MUA 
Manipulation Under Anesthesia 
PKA 
Partial Knee Arthroplasty (Replacement) 
POD 
Post-Operative Day 
PROM 
Patient-Reported Outcome Measure 
PT 
Physical Therapy 
RCT 
Randomized Controlled Trial 
ROC 
Receiver Operating Characteristics 
ROM 
Range of Motion 
SOC 
Standard of Care 
SIV 
Site Initiation Visit 
SLS 
Single Leg Stance Test 
SNF 
Skilled Nursing Facility 
SOC 
Standard of Care 
THA/THR 
Total Hip Arthroplasty (Replacement) 
TJA/TJR 
Total Joint Arthroplasty (Replacement) 
TKA/TKR 
Total Knee Arthroplasty (Replacement) 
TUG 
Timed Up and Go Test 
 
 
 

 
 
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III. 
Study Synopsis 
Title  
mymobility® Clinical Study 
Protocol Number 
CLU2018-13CH 
Sponsor 
Zimmer Biomet US, Inc. (or its subsidiary), referred to herein 
as “Zimmer Biomet” 
Manufacturer 
Zimmer Biomet 
Study Device(s) 
mymobility App 
Study Objectives/Endpoints 
(RCT) 
To determine if mobile application-guided education and 
exercise paired with accurate and sensitive activity monitoring, 
captured from consumer wearables for the entire episode of 
care can provide a viable (and potentially improved) 
alternative to current standard of care (SOC) for hip and knee 
arthroplasty. 
Primary Endpoint: Non-inferior results between the current 
SOC and the mymobility platform for all-cause 30-day 
readmission rates. 
Secondary endpoints include KOOS, JR. (Knee); HOOS, JR. 
(Hip), manipulation under anesthesia (knee), single leg stance 
test, timed up and go (TUG), satisfaction for those subjects 
who complete the mymobility program compared to those who 
complete traditional, standard of care education and 
rehabilitation.   
Economic Analysis: Determine if subjects who complete the 
mymobility program incur less cost and fewer resources than 
subjects receiving traditional SOC.  Potential data collection 
points include: number of PT visits, discharge disposition, ER 
visits, readmissions, reoperations, unscheduled surgeon visits, 
and time processing paperwork and approvals for the entire 
episode of care (30 days prior to surgery through 90 days 
post-op). 
Indications/Target population 
Inpatient and outpatient (including ASC) subjects indicated for 
unilateral, primary total or partial knee arthroplasty or total hip 
arthroplasty who meet the inclusion/exclusion criteria for study 
participation. 
Inclusion/Exclusion criteria 
Inclusion Criteria 
• 
Subject must be 18 years of age or older. 
• 
Subject qualifies for a primary, unilateral total or 
partial knee arthroplasty, based on a physical exam 

 
 
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and medical history. 
• 
Investigator plans to treat subject with a 
commercially-available device, used on-label 
according to the manufacturer’s instructions for use, 
as part of their clinical care. 
• 
Subject owns and maintains an iPhone capable of 
pairing to the Apple Watch, supporting iOS updates 
and is compatible with the mymobility App.  
• 
Subject is willing and able to complete the protocol 
required follow-up. 
• 
Subject is able to read and understand the language 
used in the mymobility App for their region. 
• 
Subject is willing and able to provide written Informed 
Consent and Authorization by signing and dating the 
IRB/EC approved Informed Consent Form and 
Authorization. Where applicable, subject must also 
be willing to provide authorization for use of 
protected health information in accordance with local 
privacy laws. 
• 
Subject is mobile with no more than a single 
cane/single crutch assist preoperatively. 
Exclusion Criteria 
• 
Subject is a current alcohol or drug abuser. 
• 
Subject has inflammatory arthropathies which would 
interfere or compromise the activity profiles within 
this study. 
• 
Subject is considered a member of a protected 
population (e.g., prisoner, mentally incompetent, 
etc.). 
• 
Subject is currently participating in any other surgical 
intervention, physical therapy or pain management 
study which would compromise the results of this 
study. 
• 
Subject requires simultaneous or staged bilateral 
replacements, staged <90 days apart. Subjects can 
be enrolled into the study for the second, staged 
arthroplasty if scheduled >89 days after their first, 
contralateral replacement. 
Additionally, subjects who complete the entire study (1 year) 
for one joint may be enrolled for a second joint. 
 

 
 
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Study Design 
This is a post-market prospective, multi-center longitudinal 
study in subjects undergoing primary TKA, THA, or PKA. The 
study will contain three cohorts. The first cohort (“Pilot and 
Time Cohort”) will consist of a pilot cohort of subjects and will 
primarily serve to determine site study staffing needs and time 
required for various elements of study execution. The second 
cohort (“RCT Cohort”) will consist of a randomized controlled 
subject cohort and will compare outcomes of mobile 
application-guided exercises, education and activity with SOC 
pathways (including PT, if applicable). The third cohort 
(“Correlative Analytics Cohort”) will seek to collect enough 
data to enable the creation of predictive algorithms for 
outcomes of joint replacement. All subjects will receive a TKA, 
THA, or PKA using SOC procedures and commercially-
available devices used on-label according to the 
manufacturer’s instructions for use. After the joint replacement 
procedure, subjects will then complete prescribed post-
operative activities, such as in-person physical therapy 
according to SOC or performing exercises as scheduled 
through the mymobility App. Follow-up assessments will be 
conducted at approximately 30 days and 90 days post-op, and 
virtual assessments (including subject questionnaires and 
recording of medical events/adverse events) will occur at 
approximately 180 days and 365 days post-op. 
Clinical Phase 
Post-market 
Sample Size  
Up to 10,500 subjects, including 500 control subjects receiving 
SOC PT in the RCT Cohort, will be enrolled during all three 
cohorts. 
Length of Study 
The maximum duration of subject participation in the study 
will be approximately 17 months. Subject participation will 
start after obtaining informed consent, and will continue for up 
to 14 months (12 months +/- 60 days) after the index 
procedure.    
• 
Pre-op (up to 180 days prior to surgery) 
• 
Surgery 
• 
30 days (+/- 14 days) – 1 Month / Early post-op 
• 
90 days (+/- 21 days) – 3 Month  
• 
180 days (+/- 42 days) virtual visit – 6 Month 
• 
365 days (+/- 60 days) virtual visit – 12 Month / 1 Year 
Subject recruitment is expected to require approximately 24 
months, for a total study duration of 40 months. 
 

 
 
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Materials and Methods 
Inclusion of up to 10,500 subjects, including 500 control 
subjects. Prospective follow up visits until 1 year post-
operative 
Data Collection 
• 
Electronic Data Capture system 
• 
mymobility App 
• 
Apple Health & Fitness Recorder 
Statistical Reporting 
Data collected will be summarized descriptively and will be the 
basis of study reports. Statistical analysis will be conducted by 
Zimmer Biomet or its designee. 
Scores/Performance 
Assessments 
• 
KOOS, JR. (for PKA or TKA subjects only) 
• 
HOOS, JR. (for THA subjects only) 
• 
Customized Questionnaire(s) 
• 
Range of Motion (ROM) 
• 
EQ-5D-5L 
• 
Resource utilization data (office visits, PT visits, ER 
visits, readmissions) 
Standards 
The study is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical practice. 
• 
ICH Guideline on Good Clinical Practice 
• 
The Declaration of Helsinki (DoH) - Ethical principles 
for medical research involving human subjects. 
• 
US Code of Federal Regulations 21 CFR Parts 11, 50, 
and 56 
 
 

 
 
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IV. 
Data Collection Overview 
Source document worksheets will be provided to the sites to assist with data collection.  
Sites will be encouraged to utilize these worksheets, however their use will not be required 
if other source documentation is available for the data points including direct entry into an 
electronic data capture (EDC) system.  All data collected manually by the site (i.e. not 
collected via mymobility or directly into the EDC system) will be entered into an EDC 
system. 
 Data Collection Activities 
Pre-op 
Surgical & 
Discharge 
1 Month 
Post-Op 
3 Month 
Post-op 
6 Month 
Virtual  
12 Month 
Virtual  
Informed Consent 
X 
 
 
 
 
 
Inclusion/Exclusion Criteria  
X 
 
 
 
 
 
Randomization (RCT only) 
X 
 
 
 
 
 
Demographic & History Form* 
X 
 
 
 
 
 
Physical Exam  
X 
 
X 
X 
 
 
Procedure & Perioperative Information 
 
X 
 
 
 
 
Other Device Documentation 
 
♦ 
 
 
 
 
Chart Review*  
 
 
 
X 
 
X 
Patient Questionnaire #1 (EDC)* 
● 
 
 
 
 
 
Patient Questionnaire #2 (EDC)* 
 
 
● 
 
 
 
Patient Questionnaire #3 (EDC)* 
 
 
 
● 
 
 
EQ-5D-5L (EDC)* 
● 
 
● 
● 
● 
● 
KOOS, JR, HOOS, JR (via mymobility App).  
Control patients will complete in the EDC* 
● 
 
● 
● 
● 
● 
Adverse Event Form 
 
♦ 
♦ 
♦ 
♦ 
♦ 
Medical Event Log 
 
♦ 
♦ 
♦ 
♦ 
♦ 
Protocol Deviations* 
 
♦ 
♦ 
♦ 
♦ 
♦ 
♦ 
Study Completion* 
♦ 
♦ 
♦ 
♦ 
♦ 
♦ 
Time Documentation (Pilot Only) 
X 
X 
X 
X 
 
 
X Completed by Investigator or Designee 
● Completed by subject (required) 
♦  Completed by Investigator or Designee as applicable 
* 
Forms that can be directly entered into the EDC system 

 
 
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V. 
Introduction and Purpose 
Postoperative rehabilitation after total joint arthroplasty (TJA) has traditionally been initiated 
via discharge to a rehabilitation facility or through formal outpatient physical therapy (PT).1  
This has resulted in the cost of approximately $648 million per year for PT after primary 
TJA, with up to 25% of these costs utilized on less common modalities.2  As elective TJA 
patients have increased their mobility in the early postoperative period and hospital or 
ambulatory surgery center (ASC) length of stay has decreased over time, patient-initiated 
therapy has become an emerging alternative for postoperative recovery.  Previous 
randomized controlled trials have demonstrated that monitored home exercises can have 
equivalent outcomes when compared to formal outpatient PT after TJA for both range of 
motion (ROM) and patient reported outcome measures (PROMs).3-8  However, there 
remains a substantial subgroup of patients (up to 20%) who may crossover to formal PT 
following patient-initiated therapy, highlighting a potential opportunity to provide an 
optimized home program that provides more effective simulated physical therapy in the 
postoperative TJA period. 
PROMs have previously provided subjective measurements of patient pain, function and 
satisfaction after TJA. Unfortunately, objective measurements (e.g. measurements of 
physical function) are often lacking after TJA.  Previous studies demonstrate that early 
initiation of activity after TJA can improve functional outcomes, suggesting that activity level 
may serve as a quantifiable measurement of  recovery during the postoperative period.9  
Accelerometers and pedometers have been utilized to characterize preoperative function 
prior to TJA,10 postoperative function after total hip arthroplasty (THA),11 postoperative 
function after total knee arthroplasty (TKA),12-17 and postoperative function after TJA.18  
However, the resultant physical objective measurements (i.e. step count, stair climbing and 
chair rising) have not been found to correlate with more formal outcomes scores, including 
patient satisfaction, Western Ontario and McMaster Universities Osteoarthritis Index 
(WOMAC) and Short Form Health Survey (SF-36).19-20  In one study, these objective 
measurements were passively collected utilizing an activity monitor for 48 hour intervals at 
6 weeks and 6 months postoperatively.20  Active systems, such as mobile applications 
accessed through electronic smartphones or tablets, interface directly with patients and are 
able to provide pre- and postoperative instructions with the intent of improving guidance for 
performing daily therapeutic exercises.21  To the best of our knowledge, no study has been 
conducted utilizing an active care management system monitoring physical function while 
providing daily feedback for pre- and postoperative care for TJA. 
Active biometric monitoring systems, such as the Apple Watch, have the ability to monitor 
step count, stair climbing, standing duration, exercise calorimetry, number of exercise 
minutes, and patients’ heart rate (i.e. average, variability) both at rest and when performing 
exercises.22  When coupled with an episode of care management application on a mobile 
platform, TJA patients can be continuously monitored, given important reminders, and 
instructed to conduct daily rehabilitative exercises autonomously.  The combination of a 
mobile platform coupled with a consumer wearable device (e.g., smartwatch) has the 

 
 
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potential to revolutionize perioperative care for TJA. 
The randomized controlled arm of this study aims to demonstrate non-inferiority of the 
mymobility smartphone (mobile) application (App) with Apple Watch platform in a TJA 
episode of care, by comparing subjects who receive standard of care (SOC), formal 
outpatient PT to a study group of subjects who complete remotely guided education and 
exercise via a mobile application, along with a wearable device.  The correlative signature 
arm will compile key mymobility data, which includes data collected from an Apple Watch, 
from across the episode of care in TJA to a larger dataset, which will be analyzed to better 
understand and predict rare events and complications within this population.  The purposes 
of the study are to evaluate the following measures and, as applicable, compare them to 
the comparator group results: 
1. Determine if physical measurements and PROMs are similar between groups 
2. Determine if subject satisfaction is higher in the study group 
3. Determine the economic benefits to practices, patients and payers 
4. Determine if complication outcomes are similar in the study group 
5. Determine if the combination of data collected through an episode of care 
management application on a mobile platform combined with objective physical 
measurements can be utilized to predict the probability of post-operative 
complications, discharge disposition, ROM, and other PROM scores. This data set 
will also be used for future product feature development such as risk stratification, 
correlative signature modeling, and algorithm development. 
VI. 
Study Objectives 
Primary Objectives: The study objectives are to evaluate clinical outcomes, economics, 
and satisfaction with mymobility and the Apple Watch while developing a correlative 
heuristic considering multiple endpoints within the THA, TKA and PKA populations.  To 
accomplish the objectives of this multifaceted protocol, the study has been broken into 
three cohorts with varying objectives.  All mymobility study subjects will ultimately be part 
of the Correlative Analytics cohort.  Additional objectives for each cohort are listed below. 
A. Pilot & Time Cohort (Cohort I) 
Primary Objectives 
1. Determine study and product onboarding requirements (time and staff)  
2. Determine time required for instrumentation of mymobility App and Apple Watch 
3. Determine study execution requirements (time and staff)  
4. Verify enrollment assumptions and customized survey content 
5. Determine time required to attain subject understanding of use of Apple Watch 

 
 
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features (steps, stand hours, active calories, exercise minutes, heart rate - resting, 
walking, variability, flights climbed) 
B. Randomized Controlled Trial (RCT) Cohort (Cohort II) 
Primary Objective 
1. Demonstrate non-inferiority of the study group, when measuring 30-day all cause 
readmission rates, when compared to the control group who will undergo standard 
of care education and an outpatient PT regimen. 
C. Correlative Analytics Cohort (Cohort III) 
In addition to traditional data collection mechanisms, four passive outcome measures will 
be captured among all mymobility study subjects via the Apple Watch sensors in 
combination with the mymobility App, attempting to develop correlative measures to assist 
surgeons in understanding and managing risk in their patient populations.  These 
correlative outcomes will be measured using steps, stand hours, active calories, exercise 
minutes, heart rate (average, resting, walking, and variability), and flights climbed that will 
be analyzed in statistical models (including multivariate regression models).  Details and 
methodology are provided in Section XVI. 
Primary Objectives 
1. Assess the differences in episode of care data compiled, collected, and delivered 
in the mymobility platform to correlate the incidence of the seven most common 
post TJR medical complications (UTI, ileus, MI, pneumonia, DVT/PE, prolonged 
wound drainage, wound infection).  
2. Assess the ability of preoperative and episode of care data compiled, collected, and 
delivered in the mymobility application (from, among other sources, the Apple 
Watch sensor platform) to correlate with discharge disposition (home vs. non-home 
- ACF or SNF)  
3. Identify 90-day mymobility data points which correlate with 30-day post op ROM 
data (90 degrees of flexion) within the TKA and PKA populations. 
4. Assess the ability of postoperative data compiled, collected, and delivered in the 
mymobility application (from, among other sources, the Apple Watch sensor 
platform) collected during postoperative days 0-90 to predict which subjects will 
have a “very satisfied” or “satisfied” score on the Patient Satisfaction component of 
Patient Questionnaire #3 at 90 days. 
Secondary Objectives 
1. Utilize the unique patient clinical data that is available with the mymobility 
application to correlate early post-operative outcomes of various implant groups 
(e.g. brand, type, manufacturer) to preoperative and postoperative activity profiles, 
surgical techniques, patient attributes, and other routine outcomes data collected.  

 
 
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2. To provide a real-world data set on the mymobility cohort, including physiologic 
monitoring data, that enables ongoing exploratory data analysis and retrospective 
cohort study that will inform future product feature development and research. An 
example of such analysis that would support surgeons to make patient-specific 
recommendations is: study subjects could be “binned” according to 5-year age 
grouping (age 30-34, 35-39, etc.) and BMI (20-24, 25-30, etc.), and regression 
analysis could be used to correlate watch sensor data with superior outcomes. 
Statistically valid correlations would enable product features that support a surgeon 
to more easily identify whether or not a given patient’s activity is following a pattern 
associated with superior clinical outcome. 
VII. Study Design and Endpoints 
This is a multi-center, staged cohort study evaluating clinical outcomes, economics, and 
satisfaction with mymobility in the episode of care for the primary THA, TKA and PKA 
populations.  Up to 10,000 subjects will be participating in the mymobility platform. 
Approximately 500 subjects will participate as a control group in the RCT cohort described 
in Section XI.  Up to 36 sites globally will contribute to this study.  Each investigator will be 
experienced in total knee arthroplasty (TKA), partial knee arthroplasty (PKA) or total hip 
arthroplasty (THA). 
Each Principal Investigator will be responsible for obtaining Institutional Review Board 
(IRB) or Ethics Committee (EC) approval as required prior to conducting the study.  In order 
to avoid potential selection bias, each Investigator will offer study participation to each 
eligible subject presenting as a candidate for partial or total knee replacement or total hip 
arthroplasty using approved, commercially-available devices used on-label according to 
the manufacturer’s instructions for use.  The device selection criteria are discussed in 
Section VIII. 
Eligible candidates who express interest in study participation will be offered Informed 
Consent.  All potential study subjects will be required to participate in the Informed Consent 
process and will not be considered enrolled in the study until the candidate has signed and 
dated the IRB/EC approved subject Informed Consent Form (ICF).  Study data cannot be 
collected until the candidate has completed the informed consent process and signed and 
dated the IRB/EC approved ICF. 
All study subjects will undergo preoperative and postoperative clinical evaluations as part 
of the standard of care at each institution.  Post-operative clinical evaluations will be 
conducted after surgery (30 and 90 days).  A virtual visit, utilizing the mymobility App or 
EDC system, will occur at 180 and 365 days post-op.   
The target population is patients who have made the decision to undergo a total hip, total 
knee, or partial knee replacement.  The target population is further defined in the 
inclusion/exclusion criteria in Section VIII.  

 
 
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RCT: Primary Endpoint  
1. Demonstrate non-inferiority of the study group in the number of readmissions 
through 30 days post-op.   
RCT: Secondary Endpoints 
1. Non-inferiority of the mymobility cohort for PROMs (HOOS, JR., KOOS, JR.) and 
EQ-5D-5L. 
2. Manipulation Rates (knee), Timed Up and Go (TUG) and single leg stance test 
(SLS). 
3. Satisfaction/Engagement: Assess differences between the study groups in subject 
satisfaction from Custom Satisfaction Survey(s).  
4. Resource Utilization:  Assess differences in resource-utilization in the study group 
for the entire episode of care (90 days postoperative).  Potential data collection 
points include number of PT visits, discharge disposition, emergency room visits, 
readmissions, reoperations, unscheduled surgeon visits, and reduction in time 
processing paperwork and approvals from PT. 
VIII. Study Population 
The study population for primary statistical analysis will be comprised of individuals who 
require primary, unilateral total or partial knee arthroplasty, or total hip arthroplasty and 
satisfy the inclusion/exclusion criteria outlined in this section of the protocol.  In order to 
avoid potential selection bias, each Investigator will offer study participation to each eligible 
patient presenting as a candidate for primary, unilateral total or partial knee arthroplasty, 
or total hip arthroplasty using any approved, commercially-available PKA, TKA or THA 
device used on-label according to the manufacturer’s instructions for use.  Eligible 
candidates who express interest in study participation will be offered an Informed Consent 
Form.  
The current Version 4 of the study protocol narrowed the eligibility to total knee and partial 
knee arthroplasty, removing total hip arthroplasty.  Previously enrolled patients who 
received THA will continued to be followed as part of the study.  Additionally, patients with 
planned THA surgery and approached for participation prior to implementation of this 
protocol will be allowed to enroll. 
A. Inclusion Criteria 
1. Subject must be 18 years of age or older. 
2. Subject qualifies for a primary, unilateral total or partial knee arthroplasty, based on 
physical exam and medical history. 
3. Investigator plans to treat subject with a commercially-available device, used on-
label according to the manufacturer’s instructions for use, as part of their clinical 

 
 
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care. 
4. Subject owns and maintains an iPhone capable of pairing to the Apple Watch, 
supporting iOS updates, and is compatible with the mymobility App.  
5. Subject is willing and able to complete the protocol required follow-up. 
6. Subject is able to read and understand the language used in the mymobility App for 
their region 
7. Subject is willing and able to provide written Informed Consent and Authorization 
by signing and dating the IRB/EC approved Informed Consent and Authorization 
Form . Where applicable, subject must also be willing to provide authorization for 
use of protected health information in accordance with local privacy laws. 
8. Subject is mobile with no more than a single cane/single crutch preoperatively. 
B. Exclusion Criteria 
1. Subject is a current alcohol or drug abuser as defined by the investigator. 
2. Subject is considered a member of a protected population (e.g., prisoner, mentally 
incompetent, etc.). 
3. Subject has systemic inflammatory arthropathies which would interfere or 
compromise the activity profiles within this study. 
4. Subject is currently participating in any other surgical intervention, physical therapy 
or pain management study which would compromise the results of this study. 
5. Subject requires simultaneous or staged bilateral replacements, staged <90 days 
apart. Subjects can be enrolled into the study for the second, staged arthroplasty if 
scheduled >89 days after their first, contralateral replacement. 
Additionally, subjects who complete the entire study (1 year) for one joint may be 
enrolled for a second joint as a new subject.  
IX. 
Study Device Information 
A. mymobility Product Description 
The mymobility App is a mobile software platform designed to facilitate remote episode of 
care management and asynchronous communication between the provider care team and 
their patient via provider-approved care plans and engagement communications.  Current 
care pathways have been developed for: Total Hip Replacement, Total Knee Replacement 
and Partial Knee Replacement.  Designed for the orthopedic population, mymobility also 
integrates wearable data from the Apple Watch into provider dashboards, providing 
enhanced understanding and monitoring of patients throughout the episode of care.  This 
study will utilize version 1.01 of the mymobility App and all future versions as they are 
released. Version dates will be captured for the purpose of analysis.   

 
 
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Subjects will be provided an Apple Watch to pair with their iPhone for use in the study.  If 
subjects already own a Series 3 or newer Apple Watch, they will be able to use their watch 
for the study purposes.  Details of watch use and data safety are detailed in Sections XI 
and XII. 
B. mymobility App Overview 
1. Patient To Do List 
The login screen shows “To Do List”, which identifies assigned activities to be 
completed during the patient’s episode of care.  Examples include: an education ePub 
(Preparing the Operative Site), a Patient Reported Outcomes Measure (KOOS, JR.), 
and an exercise routine (Week 1 Routine).  Once the patient completes an activity, a 
check mark will appear next to the item signifying completion. 
                                                         
2. Patient Dashboard 
By selecting “My Stats,” patients will see a similar screen.  Here certain items tracked 
by the mymobility application have shared visibility to the patient and care team.  These 
stats include, but are not limited to: education, questionnaire, exercise completion, or 
steps collected by the Apple Watch over the last week with a line graph showing trends.  
 
 
                            

 
 
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3. Patient Exercises 
While completing assigned exercises, the patient will follow audio/video instructions as 
shown in the below example.  The application provides a verbal description of the 
exercise and shows the movement from a variety of angles to communicate correct 
form to the patient.  Patients self-report the number of repetitions performed for each 
exercise. 
 
                                                            
4. Apple Watch Integration 
The essential application on the Apple Watch reminds the patient about activities on 
their To Do list as a convenient reminder without requiring the patient to open the 
application on the phone.  The application also collects step counts and other HealthKit 
data (as described above), which is shared with the patient’s care team at their consent 
and with their authorization.  The mymobility application will sync directly with the Apple 
Watch once the application is installed on the iPhone.  Progress updates are easily 
accessible on the Apple Watch as seen on the below images. Apple HealthKit data 
points of steps, stand hours, active calories, exercise minutes, heart rate (resting, 
walking, and variability), and stairs will be essential for creation of correlative statistical 
models of these biometric measurements with post-op complications and outcomes as 
described above. 
 

 
 
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5. Provider Dashboard 
When the surgeon or a designated member of their team logs in to the clinician 
dashboard, a display of the care team’s patients is immediately visible.  Patients are 
sorted by metrics tracked through the mymobility application and a flagging 
system/message icons are displayed to alert care team members to important activities 
for each patient.  Clinicians can perform a variety of tasks in the dashboard, including 
creating new patients and searching specific groups of patients.  
 
X. 
Study Procedures 
A. Screening 
Potential subjects will be screened from each investigator’s subject population. Subjects may 
be pre-screened for eligibility based on the inclusion and exclusion criteria. The site will 
maintain a Screening Log to track all screened subjects, including subjects who do not meet 
the study criteria and those who decline to participate. The log will document general 
demographic information for each screened patient as well as reasoning for patients who do 
not enroll.  
B. Offer Study Participation 
Study participation will be offered to each eligible patient presenting as a potential candidate.  
Eligible candidates who express interest in study participation will be offered Informed 

 
 
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Consent.  Prior to patient involvement in the study, the patient must participate in the 
Informed Consent process and sign and date the IRB/EC-approved ICF.  
C. Informed Consent Process 
For candidates that express interest, the Investigator or Designee will describe relevant study 
information, including the purpose, procedures, alternative treatments, possible risks, and 
potential benefits associated with study participation.  The Investigator or Designee will also 
describe the types of patient information that may be collected or analyzed during the study 
and with whom that information may be shared.  The Investigator or Designee will also 
review, along with the candidates, the ICF approved by both the governing IRB/EC and the 
study Sponsor.  Candidates shall have sufficient time to read and understand the IRB/EC 
approved ICF and discuss whether they wish to participate in the study.  Candidates will be 
asked to acknowledge whether all of their questions and concerns have been addressed to 
their satisfaction.  Any questions that candidates may have will be addressed appropriately 
by the Investigator or Designee.  Candidates will be further instructed that they are free to 
obtain additional information from the Investigator or Designee at any time, that they are free 
to decline participation, and that they are free to withdraw their consent and authorization 
and discontinue their participation at any time without prejudice but for the requirement to 
return the watch if they withdraw prior to completing the final follow-up visit. 
The Informed Consent process may be completed in-person or through an IRB/EC approved 
remote method.  After completing the Informed Consent process, candidates who agree to 
enter the study must sign and date the IRB/EC approved ICF.  The ICF must be signed and 
dated prior to onboarding.  Study data will not be collected until the ICF has been signed and 
dated.  If the candidate does not wish to participate (does not sign and date the ICF), data 
for that candidate will not be collected for this study.        
A copy of the signed and dated ICF must be provided to the study subject.  The original 
signed and dated ICF is to be filed in the subject’s medical record, study subject binder, or 
regulatory binder. 
D. Subject Enrollment 
Once the ICF has been signed and dated by the subject, the subject will be considered 
enrolled in the study.  A unique subject identification number (Subject ID) will be assigned to 
each participating subject.   
This unique Subject ID number will be used throughout the study for identification.  The 
subject will be considered an active study subject after receiving training in the appropriate 
use, participation and functionality of the mymobility platform and Apple Watch.  In the event 
that the subject does not undergo knee or hip arthroplasty as outlined in the inclusion criteria, 
the subject will be considered a screen failure and a Study Completion Form will be used 
to document the subject’s exit from the study. 
E. Baseline/Preoperative Assessment 
The following baseline/pre-operative data will be collected at the time of enrollment: 

 
 
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1. Inclusion/Exclusion Criteria 
a. Randomization (RCT cohort only, recorded in EDC) 
2. Demographics & History Form 
3. Pre-op Physical Exam 
a. Knee/Hip specific assessments including ROM  
4. EQ-5D-5L 
5. KOOS, JR. or HOOS, JR. 
6. Patient Questionnaire #1 
7. Protocol Deviations (as applicable) 
8. Study Completion (as applicable) 
Subjects may be consented up to 180 days prior to surgery.  Preoperative forms, 
mymobility App registration, and Apple Watch distribution must be completed during the 
pre-op interval.  The suggested visit window to allow best utilization of pre-operative 
mymobility App content is 14-30 days prior to the surgery.     
Data from Standard of Care (SOC) assessments performed prior to enrollment may be 
used provided that data was obtained within 180 days of surgery and the patient consented 
to its use.  In the event that surgery is rescheduled to a date greater than 180 days from 
enrollment, the site should reaffirm study participation with the subject prior to surgery and 
reobtain study assessments.   
Physical exam assessments are intended to be completed at in-person visits.  However, 
remote visits may be utilized to capture assessments if institutional restrictions prevent an 
in-person visit. Protocol deviations will document incomplete data. 
F. Surgical Technique 
Standard operative procedures will be followed and all surgical procedures will be 
performed under aseptic conditions.  Investigators will implant all commercially-available 
partial or total knee components or total hip components in compliance with corresponding 
labeling requirements and in accordance with appropriate surgical technique(s).  
G. Surgical and Discharge (Data Collection) 
The following data will be collected about the surgery and immediate post-operative period, 
up to and including subject discharge: 
1. Procedure & Perioperative Information  
a. Implants and instrumentation data 
b. Length of Stay and Discharge Disposition 
2. Other Device Documentation (as applicable) 

 
 
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3. Adverse Event Form (as applicable) 
4. Medical Event Log (as applicable) 
5. Protocol Deviations (as applicable) 
6. Study Completion (as applicable) 
Previously enrolled patients who received a hip resurfacing procedure will be classified as 
total hip arthroplasty.  Additionally, if the actual procedure differs from the procedure 
selected on the inclusion/exclusion form, then the inclusion/exclusion form should be 
updated to the actual procedure.  
H. Postoperative Follow-up Procedures (Data Collection) 
Postoperative clinical evaluations/assessments will be conducted at the following visit 
intervals: 
Clinical Interval 
Target Visit Timeframe 
(from Surgery) 
Approximate Window in 
Days 
 1 month (30 days) 
30 days 
-/+ 14 days 
 3 month (90 days) 
90 days 
-/+ 21 days 
 6 month (180 days) 
180 days 
-/+ 42 days 
 1 year (365 days) 
365 days 
-/+ 60 days 
The following clinical data will be collected postoperatively: 
1. Post-op Physical Exam  
a. Single Leg Stance (SLS) and Timed Up and Go (TUG) test. (RCT Only) 
b. Knee/Hip specific assessments including ROM  
2. EQ-5D-5L 
3. KOOS, JR. or HOOS, JR.  
4. Patient Questionnaire #2 (at 30 day visit) 
5. Patient Questionnaire #3 (at 90 day visit) 
6. Chart Review (at 90 and 365 day visits) 
a. Complications, readmissions, ER visits, non-SOC visits, physical therapy 
7. Medical Event Log (as applicable) 
8. Adverse Event Form (as applicable) 
9. Protocol Deviation (as applicable) 

 
 
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10. Study Completion (as applicable) 
Sites will be required to follow subjects postoperatively for 365 days +/- 60 days.  Unless 
the study is otherwise closed, data will continue to be collected until the subject completes 
the study per the protocol, voluntarily withdraws from the study, is withdrawn from the study 
by the investigator, is lost to follow-up, undergoes revision to remove the implanted device, 
or expires.  See Management of Incurrent Events (Section XII) for additional details. 
Reason(s) for study completion must be documented on the Study Completion Form. 
Post-op physical exam assessments are intended to be completed at in-person visits.   
However, remote visits may be utilized to capture assessments if institutional restrictions 
prevent an in-person visit.  Protocol deviations will document incomplete data. 
XI. 
Pathway Specific Procedures 
A. mymobility Procedures – Correlative Analytics Cohort (N=10,000) 
These study procedures apply to all study subjects in all cohorts who have signed the ICF 
and are selected to receive the mymobility platform.  The correlative analytics cohort 
includes all subjects in all three cohorts of the study who receive the mymobility platform.  
Procedures for control subjects in the RCT cohort are discussed in Section XI. 
1. Preoperative Visit (up to 180 days before surgery) 
i. If not previously completed, the subject will go through the full informed 
consent process and will sign and date the EC/IRB-approved ICF as outlined 
in Section X. 
ii. Subject registration for the mymobility App includes the creation of a study 
Subject ID number via the study EDC system and placement into the master 
Zimmer Biomet electronic data collection (EDC) database. 
iii. During the download of the mymobility App to the iPhone, the coordinator and 
subject will: 
• Verify that the phone and Apple Watch operating systems (iOS and Watch 
OS) software are current. 
o Should an update of iOS or Watch OS be required, where possible, 
the update should be completed while the patient is at the site. In 
some situations, internet connectivity issues can cause significant 
delays with updating an OS.  Under these circumstances the patient 
may complete the update at home.  Additionally, Zimmer Biomet 
may approve a remote onboarding and watch pairing process for 
specific sites.   
• Turn on measurements of correct HealthKit data types. 

 
 
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• Review instructions on pairing of the Apple Watch, daily charging 
instructions, how to look at activity rings, set alerts, and other 
functionalities.  
iv. At this time, subjects with a compatible model of  iPhone  will also download 
the Apple Health and Fitness Recorder App to their iPhone.  Following the 
download, the coordinator and subject will: 
• Validate the correct data is being captured from the Apple Watch to the 
Apple Health and Fitness Recorder App. 
v. Subjects who do not already own an Apple Watch Series 3 or newer will 
receive one for use in the study. 
2. Preoperative Time period (approximately 30 days before surgery) 
i. Subjects will begin to receive mymobility educational material through the App 
on their phones.  
ii. Collection of mymobility data will begin.  This will include within-App questions 
that are answered by the subject, care plan adherence data and full time 
HealthKit data collected by the Apple Watch (steps, flights climbed, HR, stand 
hours) - transferred to the mymobility platform, except for times when the 
Apple Watch is being charged.  At this time, applicable subjects will also have 
data collected by the Apple Health and Fitness Recorder App. 
iii. mymobility study subjects will follow the entire prescribed pathway of 
educational content, PROMs surveys, disposition questionnaires, and 
exercises until day of surgery in addition to their institution’s standard of care 
preoperative procedures including education, classroom work and medical 
clearances. 
iv. Research coordinators or clinical staff may call subjects to remind them to 
complete all tasks as directed by mymobility and to confirm that they are 
charging and wearing the Apple Watch daily, not having problems using 
mymobility or the Apple Watch, etc.  Study subjects will also be provided a 
direct phone number to the office research coordinator if they have questions 
regarding the mymobility App or Apple Watch functions.  
• Research coordinators should contact mymobility Technical Support to 
document any problems subjects are having with mymobility usage.  
• Research coordinators can also review the clinical dashboard to assess if 
study subjects are using the mymobility care platform and, together with 
the clinical team, will contact study subjects at clinically appropriate 
timelines who do not appear to be adhering to their daily, assigned 
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3. Discharge Disposition and Prescribed Physical Therapy  
i. It is intended that after surgery, study subjects will utilize the monitored 
home exercises within the mymobility platform to reduce the need for in 
person outpatient physical therapy.  Physical therapy prescribed at time of 
discharge will be documented on the Procedure & Perioperative 
Information Form with the clinical reasoning.   
ii. All subjects receiving physical therapy will remain in the analysis of the study 
group.   
iii. If subjects are discharged to a postoperative nursing facility, they will 
continue using the mymobility with Apple Watch application(s) and continue 
to track all prescribed mymobility activities and passively-collected 
biometrics as described above. 
4. Week 1 after surgery 
i. Study subjects will begin their assigned, mymobility guided, home-based care 
pathway immediately upon discharge (these subjects will also have had the 
extensive preoperative teaching pathway from mymobility to prep them for 
their independent post-op therapeutic exercises). 
ii. Study subjects are recommended not to have any scheduled home PT visits 
or home health visits, however, should subjects require these services they 
may be prescribed physical therapy and remain in the study. 
iii. For those study subjects not receiving physical therapy, the surgeon’s office 
may contact patients during the first post-op week to ensure they are 
comfortably using the mymobility App with Apple Watch platform in the place 
of standard physical therapy.  
5. Postoperative Week 2 through Day 90 
i. Study subjects will be encouraged not to participate in any formal outpatient 
post-operative physical therapy, however the surgeon has the opportunity to 
prescribe physical therapy at any time and for any duration during the course 
of recovery.  
ii. Around the time of the 30-day and the 90-day time points, subjects will be 
asked to complete a PROM survey that they will receive through the 
mymobility App.  In addition, an EQ-5D-5L and general satisfaction(s) 
question will be sent via email through the EDC system.   
iii. Post-operative clinical evaluations will be conducted after surgery (30 and 90 
days).  

 
 
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6. Postoperative Day 91 to 365 
i. Subjects will continue wearing their Apple Watch and will keep the mymobility 
App active.  They will continue to receive messages and recovery tips for 365 
days following their surgery. 
ii. 180 days after surgery, subjects will be asked to complete a PROM survey 
that they will receive through the mymobility App.  In addition, an EQ-5D-5L 
questionnaire will be sent to them via email through the EDC system.   
iii. 365 days after surgery, subjects will be asked to complete a final PROM 
survey that they will receive through the mymobility App.  In addition, an EQ-
5D-5L questionnaire will be sent to them via email through the EDC system.   
7. End of Study 
i. Subject participation will conclude after the final (365 day) PROM 
survey/satisfaction questionnaires are completed.   
ii. Subjects may uninstall the mymobility App and/or Apple Health and Fitness 
Recorder from their iPhone.    
B. Additional Cohort-Specific Procedures 
1. Pilot & Time Study Cohort (N = up to 300, up to 6 centers) 
This is an office workflow-focused cohort that will also evaluate study  and product 
onboarding requirements (time and staff), time requirements for instrumentation of the 
mymobility App and Apple Watch, study execution requirements (time and staff), 
verifying enrollment assumptions and customized survey content, and time required to 
attain subject understanding of how to use Apple Watch features (steps, stand hours, 
active calories, exercise minutes, heart rate - resting, walking, variability, flights 
climbed) 
i. All pilot study subjects will undergo all study procedures outlined in listed in 
Section XI. 
ii. Additional time and resource data utilization regarding the instrumentation, 
onboarding and monitoring of subjects with the mymobility platform will be 
captured. 
2. Randomized Controlled Trial (RCT) Cohort (N = 1,000) 
For sites participating in both the Pilot and RCT cohorts, enrollment in the RCT cohort 
will begin once enrollment is complete at the site for the pilot cohort.  Randomization 
will occur during the pre-operative visit after subjects have signed the ICF for 
participation in the study.  A standard, stratified 1:1 randomization of total hips, total 
knees, and partial knees will be used to assign subjects to either the mymobility/Apple 
Watch study group or the standard of care control group.  Stratification will ensure that 
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and study patients. 
a. Study Group (N=500) 
Once randomization is completed, all subjects who were randomized to the 
mymobility group (mymobility/Apple Watch platform) will undergo all routine study 
procedures outlined in Section XI.  In addition, each subject will: 
i. 
At the preoperative, 30 day and 90 day visits, subjects will undergo a 
physical exam.  
ii. 
At the 30 day and 90 day visits, subjects will undergo a Timed Up and Go 
(TUG) assessment and Single Leg Stance (SLS) assessment.  A description 
of each assessment is listed below: 
a. TUG assessment: the subject will be asked to rise from a sitting 
position, walk 3 meters as quickly as they feel safe and comfortable, 
turn around and walk back to take a seat in the chair.  They will be 
timed from initiation of standing to a return to the sitting position.  The 
subject will get one practice trial prior to scoring the assessment. 
b. SLS assessment: Three, one-minute maximum, timed observations 
will be obtained.  The average of the three timed observations will 
be calculated at the time of data analysis. 
b. Control Group (N=500) 
Subjects randomized to the control group will undergo traditional, standard of care 
procedures at their institution without the use of the mymobility platform 
i. Control subjects will receive the standard of care (SOC) at the institution, 
including postoperative PT, and go through normal preoperative standard of 
care including joint camp classes, preoperative medical clearance, and 
traditional preoperative education. 
ii. Control subjects will not be provided with the Apple Watch or mymobility App. 
iii. Control subjects will go through each institution’s standard of care (SOC) 
perioperative management pathway. 
iv. Control subjects will complete the same PROM surveys and patient 
questionnaires as the mymobility group but they will be completed through the 
EDC system or on paper. 
v. Control subjects will complete all Timed Up and Go, Single Leg Stance and 
ROM assessments, equivalent to the mymobility group above. 

 
 
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XII. Reporting 
A. Activities Required Prior to Initiation of the Study 
1. Institutional Review Board/Ethics Committee Informed Consent Approval 
A Sponsor-approved Informed Consent Form (ICF) template (Appendix 3) will be 
provided for IRB or EC submission and approval.  If the IRB or EC requires revisions 
to the provided ICF, the requested revisions must be submitted by the Investigator to 
the Sponsor for review and approval.  Once the Sponsor has reviewed and approved 
the revision, the ICF will be re-submitted to the IRB or EC for final review and 
approval.  A copy of the final IRB or EC approved ICF must be submitted to the 
Sponsor. 
B. Clinical Data Collection/Submission 
The Sponsor will collect all data in a central database (e.g. EDC, mymobility, HealthKit).   
The Sponsor will manage the collection of data into the Apple Health and Fitness Recorder 
App.  The management of all study data received by the Sponsor will be the responsibility 
of the Sponsor or its designee.  The use or disclosure of all protected health information 
will comply with all relevant data privacy and data security laws and requirements.  All 
information will be treated with strict adherence to professional standards of confidentiality 
and will be held by the Sponsor under adequate security and restricted accessibility.  
Data analysis will be conducted by the Sponsor or designee.  All data will be encrypted 
and all personnel in the data management team will comply with relevant data privacy 
and data security laws and requirements.  All electronic systems used to create, modify, 
maintain, or transmit study records will be validated according to 21 CFR Part 11(iii).  Title 
21 CFR Part 11 of the Code of Federal Regulations deals with the FDA (U.S. Food and 
Drug Administration) regulatory guidelines on electronic records and electronic signatures 
in the United States.  Appropriate audit trails exist on both the front and back end of the 
data management systems.  The database will be subject to quality control checks and 
the resulting output will be used to generate data queries.  Each participating Investigator 
will receive study reports on their own data and the collated data for the whole study 
group.  Study metrics, e.g. summary tables, graphical output and descriptive statistics will 
be produced and may be available as hard copy.  Strict confidentiality of individual 
hospital data will be maintained. 
Reports and communications relating to study subjects will typically identify each subject 
only by the subject’s initials (except in regions prohibited by regulations), assigned study 
Subject ID number, date of surgery, operative side, and date of birth (or year of birth 
depending on local regulations).  This code must be clearly linked to the subject identity 
and can only be decoded by the study center.  This does not include reports and 
communications transmitted via mymobility App, which are only able to be viewed by the 
subject and study center personnel.  
Data collected by the Apple Watch will be transferred to the mymobility application from the 

 
 
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HealthKit application.  HealthKit data is not transferred to Apple in connection with the 
study.  Additional electronic clinical data collected by/entered into the mymobility App by 
the Investigator or subject will be transmitted directly to the Sponsor via the mymobility 
App.  Apple may receive certain information from the Apple Health and Fitness Recorder 
App and the Sponsor, but Apple will never receive any data that directly identifies any 
participant of the study.  Any data Apple receives as part of the study will not be combined 
with any data any participants separately choose to provide to Apple as part of their use of 
Apple products or services, such as iTunes.  Apple will use any data received as part of 
this study in its health and fitness research and in its product development, design, and 
improvement activities. 
For selected US sites, data elements such as subject co-morbidities, diagnosis, 
readmissions, ER visits and hospital visits may be obtained utilizing the OrthoVal program 
instead of manual chart reviews.  
1. Summary of Case Report Form Data Collection 
Study data will be collected on source documents, which may include study-specific 
worksheets provided by the Sponsor, or direct entry into the EDC system.   
The following source document worksheet completion guidelines should be followed: 
• 
Complete carefully and accurately. 
• 
Complete header information consistently across all source document 
worksheets for each individual study subject (when study-specific forms are 
used). 
• 
Be sure that data on the source documents match that which is entered 
through the electronic data capture (EDC) system. 
• 
Use the study subject’s unique Subject ID number assigned as instructed.  Do 
not provide information that is not requested on the source document 
worksheet. 
• 
Ensure that all fields are completed.  For fields completed by the subject, 
efforts should be made to obtain any missing responses prior to the subject 
completing their visit. 
2. Data Submission 
Data captured on source document worksheets will be submitted directly to the 
Sponsor by electronic data capture and submission via a method approved by the 
Sponsor.  Every effort must be made to ensure data submission to the Sponsor is 
made within 30 days of the visit completion. 
3. Quality Assurance of Data 
The Investigator should ensure the accuracy, completeness, legibility, and 
timeliness of the data reported to the Sponsor in the source document worksheets 
and in all required reports.  Data reported on the source document worksheets and 
clinic records should be consistent, or the discrepancies should be explained.  All 

 
 
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electronic systems used to create, modify, maintain, or transmit electronic study 
records will be validated according to 21 CFR Part 11(iii).  The Sponsor will maintain 
quality control systems, in accordance with the Sponsor’s policies and procedures.  
The Sponsor disclaims any responsibility for ensuring the accuracy of information 
collected by the Apple Watch or HealthKit application. 
The standard procedures for handling and processing records will be followed per 
ISO 14155:2020(i) and Zimmer Biomet Standard Operating Procedures (SOPs) for 
this study. 
4. Patient Surveys Date of Completion 
Dates within the EDC may differ based on time zones factors.  A similar thing 
occurs within mymobility where study reports from the Sponsor may show a 
different date than what the clinic user sees within the mymobility dashboard.  The 
Sponsor will accept +/-2 days between audit trail dates and what is inputted into 
the EDC by the site or patient.   
C. Reporting Requirements 
1. Investigator Reporting Responsibilities 
The Investigator should ensure the accuracy, completeness, legibility, and 
timeliness of data reported to the Sponsor in accordance with this protocol.  The 
Investigator or Designee will provide periodic reports to their IRB/EC as required to 
maintain IRB or EC approval throughout the study and will provide any required 
final reporting to the IRB or EC upon study completion/termination.  A copy of all 
IRB or EC re-approval letters must be submitted to the Sponsor.  If the IRB or EC 
terminates or suspends its approval of the study, the Investigator or Designee will 
suspend study-related activities and will promptly notify the Sponsor.  The 
Investigator should also promptly provide written reports to the Sponsor and the 
IRB or EC regarding any changes significantly affecting the conduct of the study 
and/or increasing risk to the subjects. 
2. Retention of Records 
Study records in the possession of the Investigator must be retained by the 
Investigator or Designee for a minimum of 2 years from the Investigator’s study 
termination date, or per applicable local law, regulatory and/or IRB or EC 
requirements (whichever time period is greater).  Measures shall be taken to 
prevent accidental or premature destruction of study records. 
D. Management of Incurrent Events 
1. Failure to Obtain Informed Consent and Authorization 
Study data will not be collected until the Informed Consent has been signed and 
dated by the candidate.  If a candidate does not wish to participate (does not sign 
and date the Informed Consent), data for that candidate will not be collected for this 

 
 
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study. 
2. Medical Events / Adverse Events 
See Section C Safety Management – Medical Events/Adverse Events Section of 
this protocol for additional information regarding adverse event classifications.   
All new medical issues or problems reported by patients or found during chart 
review will be noted on the Medical Event Log, which will contain steps to 
determine whether the event should be considered a reportable adverse event.   
Medical events include: 
• 
New medical problems 
• 
New resource utilization such as non-routine visits to a physician, hospital, 
emergency department, or urgent care center.  Routine surgery follow-up 
visits, vaccinations, and wellness/standard of care visits should not be 
considered Medical Events. 
All medical events determined to be reportable adverse events are required to be 
reported on the Adverse Event Form.  The completed Adverse Event Form must 
be submitted to the Sponsor in a timely manner.  The Investigator or Designee will 
also promptly provide the Sponsor with any additional requested information 
required for the Sponsor to comply with regulatory requirements (including requests 
for medical records).  If applicable per their reporting requirements, the Investigator 
or Designee will also report applicable adverse event(s) to their IRB/EC. 
Adverse events include: 
• 
Medical event that is one of the common post-TJR complications 
• 
Medical event that has a relationship to the mymobility app, Apple Watch, 
procedure, or implant. 
• 
Study joints that receive a treatment of manipulation under anesthesia 
A medical event which is considered to be a normal post-operative symptomology 
or observation following any joint replacement surgery (e.g. joint pain, swelling, 
decreased range of motion, incisional pain) should not be classified as an adverse 
event unless it is considered to be more severe, of longer duration, is otherwise 
more pronounced than is typical, or is serious.  Refer to Section XIII for the 
definition of a Serious Adverse Event.Events occurring after the index joint 
arthroplasty procedure discharge which are determined by the investigator to not 
be related to the joint arthroplasty procedure, device, use of the mymobility 
application or Apple Watch, should not be classified as adverse events, regardless 
of severity or seriousness.   
Medical and adverse event collection will begin only after the patient has study 
surgery. 
 

 
 
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Specific instructions regarding Medical Events and Adverse Events: 
• 
Readmission is defined as admittance to a hospital following discharge after the 
index joint surgery.  This includes readmissions for observation as well as same 
day readmission/discharge.  Prolonged hospitalization after the index joint 
surgery is not considered a readmission.   
• 
If multiple medical events are all associated with the same medical issue, then 
it may be appropriate that only one adverse event is completed, rather than an 
adverse event for every medical event. 
• 
Knee codes 30 to 60 are to be used for study joint knee events 
• 
Hip codes 70 to 97 are to be used for study joint hip events 
• 
Codes 01 to 29 are general or non-study joint events 
 
 
Reporting and Documentation of Adverse Events and Adverse Device 
Effects  
Adverse Events and Adverse Device Effects will be documented on the Adverse 
Event Report form over the whole time of the investigation including information on 
the date of onset, treatment and resolution, as well as assessment of both the 
seriousness and the relationship to the study device.  Further, the outcome of 
complications will be documented and any changes in outcome are to be updated 
during the course of the study.  In case of early termination of the study, further 
follow-up of the patient shall proceed according to the hospital’s standard 
procedure. 

 
 
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Reporting and Documentation of Serious Adverse Events, Serious Adverse 
Device Effects, and Device Deficiencies 
Serious Adverse Events and Serious Adverse Device Effects will be reported to the 
Sponsor as soon as possible.  The incidence will be documented on the Adverse 
Event Report form over the whole time of the investigation including information on 
the date of onset, treatment and resolution, as well as assessment of both the 
seriousness and the relationship to the study device based on the evaluation of the 
investigator.  The outcome of such complications will be documented and any 
changes in outcome will be updated during the course of the study.  In case of early 
termination of the study, further follow-up of the study subject shall proceed 
according to the hospital’s standard procedure. 
Device Deficiencies (including the device, mymobility App, and Apple Watch) that 
did not lead to an adverse event but could have led to a medical occurrence if 
suitable actions had not been taken, if intervention had not been made, or if 
circumstances had been less fortunate shall be reported to the Sponsor as soon as 
possible. 
The Investigator is responsible for reporting all SAEs, SADEs and Device 
Deficiencies that could have led to a SADE to the Ethics Committee or Institutional 
Review Board if required by national regulations or by the EC/IRB. 
The Sponsor is responsible for determining the final classification of adverse 
events. 
3. Revision 
In the event that removal of one or more of the implanted devices used in the joint 
arthroplasty procedure is necessary, the Investigator will determine the best 
treatment and/or revision method for the subject. 
Once the revision surgery has been completed, the Investigator or qualified 
Designee must complete an Adverse Event Form.  Subjects who have tibial 
articulating surface exchanges may remain enrolled in the study.  All other revisions 
will result in the subject being terminated from the study and a Study Completion 
Form must be completed.   
4. Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if it is deemed to 
be in the subject’s best interest or the subject does not consent to continue in the 
study after being informed of changes in the research that might affect them.  The 
reason for the Investigator’s withdrawal of the subject must be documented on the 
Study Completion Form. 

 
 
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5. Subject Withdrawal 
Study subjects may choose to withdraw from the study at any time, for any 
reason.  If possible, a final evaluation will be completed for any subject who no 
longer wishes to participate in the study.  The reason for the subject withdrawal 
must be documented on the Study Completion Form. 
6. Lost to Follow-up 
A study subject will be considered lost to follow-up after they have missed two 
consecutive visits and attempts to locate and evaluate the subject using the 
procedure outlined below have failed.  All attempts to contact the subject are to be 
documented in the subject’s study files and on the Study Completion Form. 
Missed visit(s) also must be documented using the Protocol Deviations form.  The 
first three contact attempts should be made by telephone, email, or message 
through the mymobility app, with additional attempts as outlined in the following 
table: 
If 
Then 
a response is not received after 
three (3) phone calls, emails, or 
messages through the mymobility 
app 
The Investigator or Designee should 
send a certified letter to the subject 
requesting a response. 
all attempts to contact the subject 
are unsuccessful or the subject is 
contacted and chooses to 
withdraw from the study 
A Study Completion Form will be 
completed and will specify the reason the 
subject is no longer participating in this 
study.  If the subject has already 
received an Apple Watch, the coordinator 
will have the subject unpair and return 
the Apple Watch as soon as possible and 
will track this on the Device 
Accountability Log.  Return mailers will 
be provided for subjects who have 
moved or are unable to come into the 
clinic to return the Apple Watch.  
Subjects will be instructed that they may 
uninstall the mymobility and/or Apple 
Health and Fitness Recorder Apps if 
desired.   

 
 
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If attempts are made to contact a patient to schedule a visit and the patient is 
determined to be lost to follow-up, then additional attempts will not be required for 
watch retrieval.   
7. Protocol Deviations 
Investigators should not deviate from the study protocol unless it is to eliminate 
hazard to the patient.  If a protocol deviation does occur, the deviation must be 
documented on the Protocol Deviation Form and submitted to the Sponsor.  Each 
significant deviation will be reported to the IRB/EC, if applicable, within the 
appropriate deadlines stipulated by the appropriate regulatory authorities.  
Significant deviations are defined as those impacting or potentially impacting 
patient safety. 
Site-facing forms that are partially or completely missed should be documented as 
protocol deviations.  Protocol deviations will not be required for patient-facing 
surveys that are partially or completely missed.  Partially or completely missed 
patient surveys for patients enrolled under a previous protocol version will also not 
require protocol deviations.  Additionally, protocol deviations will not be required for 
out of window patient-facing surveys. 
Chart reviews are required at the 3 month and 1 year intervals.  The intention is that 
the review identifies potential medical and adverse events that have not been 
previously reported.  A chart review will provide the same information whether it is 
completed in-window or late out-of-window.  As such, protocol deviations will not 
be required for conducting late chart reviews. 
8. Study Termination 
Study subject participation is expected to end upon completion of the subject’s last 
follow-up visit (365 days) unless the subject voluntarily withdraws from the study, is 
withdrawn from the study by the Investigator, is lost to follow-up, undergoes revision 
to remove the implanted device, or expires.  Reason(s) for study completion must 
be documented on the Study Completion Form. 
Some patients might not respond to 1 year surveys and can be considered Lost to 
Follow-up.  Surveys completed beyond 18 months postop should not be collected 
or entered into the EDC.   
If the Sponsor decides to terminate the study early, the Sponsor will inform the 
Investigators of the reason for early study termination.  It is the responsibility of the 
Investigators to inform their IRB/EC as applicable according to local and national 
laws/regulations. 
9. Modification of the Protocol 
All amendments to this protocol shall be agreed to by the Sponsor and the 
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implementation.  Approval of the applicable IRB/EC must be obtained prior to 
implementation, if required according to the local and/or national laws/regulations.  
XIII. Safety Management  
Adverse events are required to be reported on the Adverse Event Report case report 
form.  The completed Adverse Event Report case report form must be submitted to the 
Sponsor in a timely manner.  The Investigator or Designee will also promptly provide the 
Sponsor with any additional requested information required for the Sponsor to comply 
with regulatory requirements.  If applicable per their reporting requirements, the 
Investigator or Designee will also report applicable adverse event(s) to their IRB or EC. 
A. Medical Events/Adverse Events Definitions and Classifications 
An adverse event is synonymous with complication or medical event. Adverse events will be 
classified by type, severity, and outcome and may be collected systematically or non-
systematically. 
The following definitions are from ISO 14155:2020(i). 
Classification of the Event 
Adverse Event (AE): 
An adverse event is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device and whether 
anticipated or unanticipated. 
 
Note 1:  This definition includes events related to the investigational medical device or 
the comparator. 
 
Note 2:  This definition includes events related to the procedures involved. 
 
Note 3:  For users or other persons, this definition is restricted to events related to the 
use of investigational medical devices or comparators.  
 
Serious Adverse Event (SAE): 
A Serious Adverse Event is any adverse event that led to any of the following: 
a. death. 
b. serious deterioration in the health of the subject, users, or other persons as 
defined by one or more of the following: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including 
chronic diseases, or 
3. in-patient or prolonged hospitalization, or 

 
 
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4. medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function; 
5. fetal distress, fetal death, a congenital abnormality, or birth defect including 
physical or mental impairment. 
 
Note:  Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse 
event. 
 
Adverse Device Effect (ADE): 
An Adverse Device Effect is an adverse event related to the use of an investigational 
medical device. 
 
Note 1:  This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment implantation, installation, or operation, or any 
malfunction of the medical device. 
 
Note 2: This definition includes any event resulting from use error or from intentional 
misuse of the medical device. 
 
Note 3: This includes ‘comparator’ if the comparator is a medical device. 
 
Serious Adverse Device Effect (SADE): 
A Serious Adverse Device Effect is an adverse device effect that has resulted in any of 
the consequences characteristic of a serious adverse event. 
Intensity of Symptoms 
Mild: 
The subject is aware of the sign or symptom, but finds it easily tolerated.  The event is of 
little concern to the subject and/or little clinical significance.  The event is not expected to 
have any effect on the subject’s overall health or well-being. 
 
Moderate: 
The subject has discomfort enough to cause interference with or a change in usual 
activities.  The event is of some concern to the subject’s health or well-being and may 
require medical intervention and/or close follow-up. 
 
Severe: 
The event interferes considerable with the subject’s usual activities.  The event is of 
definite concern to the subject and/or poses substantial risk to the subject’s health or 
well-being.  The event is likely to require medical intervention and/or close follow-up and 
may be incapacitating or life threatening.  Hospitalization and treatment may be required. 

 
 
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Note:  The term “severe” refers to the intensity of the event and can be used with any 
event, without regard to whether or not it meets the criteria for being classified as 
“serious” or “unanticipated”.  For example, a subject can have a severe headache, but it 
is not a serious event.  
Outcome Definitions 
The outcome is in relationship to the Adverse Event, not the treatment rendered for the 
event (if any). 
 
Resolved: 
The adverse event has been resolved and/or no further treatment is required to treat the 
reported condition or illness.   
 
Tolerated: 
The adverse event will most likely never be resolved.  The subject “tolerates” the illness 
or condition as a matter of life. 
 
Pending: 
Treatment or diagnostic studies were prescribed for the adverse event and the outcome 
of the adverse event is not yet known. 
 
Study Withdrawal: 
Due to the adverse event, the subject was withdrawn from the study. 
 
Device Removal: 
The adverse event resulted in the removal of an implanted device. 
 
Reoperation of Affected Joint: 
The adverse event resulted in reoperation of the study joint, but the reoperation did not 
include removal of an implanted device. 
 
Death: 
The outcome indicates the subject died as a direct result of the reported adverse event.  
Collection Approach 
The type of approach taken to collect adverse event information may be systematic or non-
systematic. 
 
Systematic: 
Based on checklists, questionnaires, or tests. 
 
 
Non-Systematic: 

 
 
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Based on spontaneous reporting and recording. 
XIV. Monitoring 
Prior to initiating the clinical study, the Sponsor, or its designee, will conduct a site initiation 
visit (SIV) to ensure the Investigator(s) and study staff understands the study protocol and 
requirements.  Prior to study initiation, the Investigator must have a fully executed CTA and 
IRB or EC approval of the study protocol and the study Informed Consent Form (ICF). 
During the course of the study, the Sponsor, or designee, will conduct periodic central or 
onsite monitoring and maintain contact with the study staff to monitor compliance and 
evidence of adverse events, in accordance with the Sponsor’s policies and procedures. 
The Sponsor will address any identified non-compliance with the executed CTA, study 
protocol, and applicable regulatory requirements. 
If onsite monitoring visit(s) are deemed appropriate by the Sponsor, the Investigator will 
permit representatives of the Sponsor’s monitoring team to have direct access to inspect 
all source data/documents, study documents/binders, corresponding sections of study 
subject medical/hospital records, and any other documents relevant to the study.  All 
Sponsor onsite visits (including site initiation) will be documented using the Site Monitoring 
Visit Log. 
XV. Risk Analysis 
The control group in this study receives the institutional standard of care, which may vary 
from no post-operative rehabilitation to inpatient rehabilitation.  The study group is 
managed with one specific postoperative protocol: the utilization of computer-based 
perioperative care.  Computer-based rehabilitation protocols have been previously 
described and are the standard of care at many institutions.  The specific computer-based 
platform utilized in this study includes an Apple Watch and the mymobility application.  
While this combination of new technologies provides the patient and surgeon with a more 
structured, efficient and informed perioperative experience, there is no specific intervention 
or postoperative recommendation involved in this study that is considered to be outside of 
the current standard of care.  The study group is receiving one of the current standards of 
perioperative care, being delivered through a novel combination of technologies. 
There are several categories of risk that may be relevant in this study. 
A. Risks 
1. Risk of Privacy Breach 
The Sponsor has put in place physical, electronic, and administrative safeguards to 
help protect the privacy of health information.  However, as is the case with all 
applications, the Sponsor unfortunately cannot guarantee security for data collected, 
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permission. 
2. Intraoperative Risk 
The study does not involve any alteration to the surgical procedure being performed.  
Therefore, there is no risk of any intraoperative complication due to this study. 
3. Risk of Additional Rehabilitation with Apple Watch and mymobility Platform 
There is negligible risk of intervention in the study group, considering that                 
computer-guided postoperative rehabilitation programs are already considered within 
the standard of care after a joint arthroplasty.  Many centers across the country have 
demonstrated the success and equivalency of a variety of postoperative rehabilitation 
programs, including a) no formal physical therapy, b) computer-guided therapy, c) 
home physical therapy, d) outpatient physical therapy, and e) inpatient rehabilitation. 
All of these postoperative rehabilitation strategies fall within the standard of care.  The 
degree, frequency, or formality of postoperative therapy has never been demonstrated 
to have a detrimental effect on surgical recovery or impact the complication rate.  To 
the contrary, the recent literature3-8 has demonstrated that alternative programs to 
formal physical therapy are safe, increase patient satisfaction, and are cost-effective. 
4. Risk of Failure to utilize the Apple Watch/mymobility combination 
If a subject fails to properly utilize the study’s technology platform, they would receive 
no specific guidance for rehabilitation after their joint arthroplasty.  There is minimal 
physical risk of this failure, as having no formal guidance after surgery is one of the 
current standards of care.   
5. Skin irritation 
The Apple Watch may cause a rash on the wrist or pressure artifacts (sores). 
B. Minimization of risk 
All protected health information will be appropriately managed and protected in                 
HIPAA-compliant systems with currently appropriate standards of data management. 
GDPR regulation is to be followed for EMEA subjects.  All Australian participants are 
covered by the provisions relating to the European subjects.  
All control and study subjects will have standard follow-up appointments with their care 
team, and either standard or augmented communication options to contact their care 
team.  This allows for ample opportunity for the care team to intervene for any subject 
who appears to require additional rehabilitation services.  These additional services are 
allowed in the control and study group when a subject is found to require additional 
rehabilitation.   
C. Indemnity 
If an injury is caused to a patient as a result of procedures undertaken in accordance 
with the Study, the Sponsor is liable for damages resulting from the study. 

 
 
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XVI. Statistical Methods 
Subjects using the mymobility application will be evaluated for pain, function, quality of life, 
and early post-operative outcomes.  Data collected in this study will be summarized 
descriptively and descriptive summaries will be the basis of any study reports issued. 
These summaries may be used for interim study reports and may also be used to support 
regulatory submissions, presentations, and/or publications.  Additional surgical technique 
and instrumentation data may be collected and evaluated. 
A. General Statistical Methods 
Statistical methodology will consist of summarizing collected data descriptively.  
Categorical data (e.g., gender or race) will be summarized using counts and percentages, 
and 95% Confidence Interval (CI), over the time periods of interest.  Continuous data, such 
as age, will be summarized by using means, medians, standard deviation, minimum, 
maximum, and 95% CI over the time periods of interest.  Routine summaries of 
complication data is represented by frequencies and percentages.  Subgroup analysis on 
a variety of data will also be performed.  Exploratory data analyses using statistical models 
to discover relationships between demographics, subject adherence, HealthKit data and 
outcomes will also be performed.  
B. General Assumptions 
The primary endpoint will be subjected to a power analysis, allowing for an estimation of 
the number of RCT subjects needed to demonstrate clinically significant differences 
between outcome measures.  Below is the initial analysis on the primary endpoint.  
1. Readmission Rate 
A 2015 journal article in PLOS ONE used meta-analyses and the University of 
Wisconsin demonstrated the overall 30-day readmission rate to be 5.4%.31  The 5.4% 
readmission rate is similar to the readmission rates reported in a 2016 JOA article on 
readmission rates for hips (% across all orthopedics 5.8%) and a 2017 JBJS article on 
readmission rates for knees (5.8%).    
Based on an assumed readmission rate of 5.4% in both the control and study group 
and a non-inferiority margin of 4.5%, a total sample size of 794 patients will provide 
80% power while controlling the alpha-error at 0.05. 
C. Sample Size   
1. RCT cohort 
The RCT cohort will include 1,000 subjects.  This is based on the sample size of 794 
required to show non-inferiority on the readmission rate endpoint.  Accounting 
conservatively for 20% Loss-to-follow-up, 1,000 subjects will ensure the study is 
adequately powered.  This study is powered appropriately to show non-inferiority 
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i. This study is designed to show that the mymobility group is non-inferior to the 
control group using one primary study endpoint.  This will be shown using a 
closed testing method in which the primary endpoint of readmission rate is 
compared using α=0.05.  Study success requires that the study group 
successfully demonstrates non-inferiority on this end point using the statistical 
methods described. 
2. Apple Watch/mymobility Correlative Analytics 
Although there is no well-defined method to calculate the power of a predictive model 
before it has been developed, the low rate of certain outcomes such as manipulation 
under anesthesia, readmission, embolism, etc. will increase the number of subjects 
needed to create a reliably predictive tool that could be used to correlate events and 
data in order to make claims in clinical decision making.  Generally, very large numbers 
are required to demonstrate predictive power for a predictive statistical model. A goal 
of 10,000 subjects has been set, with interim analyses at 2,500, 5,000 and 7,500 
subjects to determine continued need for subject enrollment.  Assuming a complication 
rate of ~3% and a discharge rate of ~5% to postoperative rehab facility in the study 
population of 10,000 subjects in the Correlative Analytics Cohort, this implies that 300 
subjects will have some type of complication and 500 subjects will be discharged to a 
rehab facility.  Given the fact that our goals are to identify high positive predictive value 
and area under the curve (AUC) upper and lower threshold values of Apple Watch 
measured and transmitted biometric data (steps, stand hours, active calories, exercise 
minutes, heart rate - resting, walking, variability, flights climbed), using multivariate 
regression to correlate with post-op complications, and risks of discharge to rehab 
facility, we would conclude that a Predictive Signatures Study group of at least 10,000 
subjects will be required.  
Examples of other studies in the total joint literature that have used multivariate 
regression models to provide clinically useful cutoff values are provided below: 
 
i. Study #1 – Assessing patients for joint replacement; Can pre-operative Oxford 
hip and knee scores be used to predict patient satisfaction following joint 
replacement surgery and to guide patient selection?32 
• N = 3307 subjects 
• In this study, even having an N of 3307 study subjects was not sufficient 
to produce receiver operating characteristics (ROC) model that was able 
to predict satisfaction after THA.  
ii. Study #2 – The use of receiver operating characteristics analysis in determining 
erythrocyte sedimentation rate and C-reactive protein levels in diagnosing 
periprosthetic infection prior to revision total hip arthroplasty.33  
• N = 479 subjects 

 
 
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• In this study, a population of 479 who had an infection (analogous to our 
population of 300-500 subjects who either has some type of complication 
or is discharged to a rehab facility) was required to produce lower limit 
threshold values of C-reactive protein and erythrocyte sedimentation rate 
to diagnose infection.  
iii. Study #3 – Relation between surgeon volume and risk of complications after 
total hip arthroplasty: propensity score matched cohort study.34  
• N = 37,881 subjects 
• In this study, a population of ~38,000 subjects (with approximate 
complication rate of 2%) was required to create a received operator curve 
with high PPV threshold values of number of hospital and surgeon cases 
required to minimize risk of complications after THA. 
Based on this sampling of high quality predictive and risk-modeling studies from the 
TJA literature, we conclude that a study population of at least 10,000 subjects is 
required to produce clinically useful predictive ROC curves and high PPV threshold 
values for passively measured Apple Watch measured and transmitted physiologic 
metrics.  As noted earlier, interim analyses will be performed at 2,500, 5,000 and 7,500 
subjects to determine emerging heuristics related to complication predictions. 
XVII. Quality Control & Quality Assurance 
The Investigator will be required to permit representative(s) of the Sponsor’s monitoring 
team to inspect all Case Report Forms and corresponding sections of the study patients 
office records and/or hospital original medical records.  These audits will be done for quality 
assurance purposes, i.e. verifying adherence to the Clinical Investigation Plan and the 
completeness and accuracy of the data being entered on the Case Report Forms. 
The Clinical Investigation Plan will be provided to all participating study centers.  The 
Investigators will be fully trained in the proper reporting and submission of trial data prior 
to patient enrolment.  Completed Case Report Forms will be reviewed before entering the 
data into a central database by the Sponsor. 
The Clinical Study Manager is responsible for generating data queries for missing or 
unclear data if needed.  It is the responsibility of the Clinical Study Manager to ensure data 
quality. 
There are regular meetings between the Investigators and Zimmer Biomet Clinical Affairs 
staff.  Written correspondence to all sites is used to inform the Investigators of routine study 
details and to update them on study status. 

 
 
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XVIII. Suspension or Premature Termination of the Clinical 
Investigation 
If the Sponsor decides to terminate the study early, the Sponsor will inform the 
Investigators of the reason for early study termination.  It is the responsibility of the 
Investigators to inform their IRB/EC as applicable according to local and national 
laws/regulations.  Investigator disqualification criteria leading to exclusion from the clinical 
study include fraud, misconduct and serial non-compliance. 
A. Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if it is deemed to be in 
the subject’s best interest or the subject does not consent to continue in the study after 
being informed of changes in the research that might affect them.  The reason for the 
Investigator’s withdrawal of the subject must be documented on the Study Completion 
Form. 
B. Subject Withdrawal 
Study subjects may choose to withdraw from the study at any time, for any reason. If 
possible, a final evaluation will be completed for any subject who no longer wishes to 
participate in the study.  The reason for the subject withdrawal must be documented on the 
Study Completion Form. 
C. Study Termination 
Study subject participation is expected to end upon completion of the subject’s last follow-
up visit (365 days) unless the subject voluntarily withdraws from the study, is withdrawn 
from the study by the Investigator, is lost to follow-up, undergoes revision to remove the 
implanted device, or expires.  Reason(s) for study completion must be documented on the 
Study Completion Form. 
XIX. Vulnerable Populations 
Per the study exclusion criteria, vulnerable and/or protected populations will not be enrolled 
in this study. 
XX. Document History 
Version  
Date 
Description of Change 
Person in Charge 
of Change 
1.0 
15 May 2018 
Initial Document 
Erin Osborn 
2.0 
11 Jun 2019 
• Updated terminology/formatting throughout 
• Increase number of sites to 36 
• Expansion of study scope from United States 
to global, with applicable changes to 
accommodate clinical study 
regulations/processes outside the US 
Dave Van Andel 

 
 
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• Inclusion/Exclusion Criteria updated 
− Requirement for diagnosis of 
osteoarthritis removed 
− iPhone SE excluded from phones 
allowed 
− Language requirement updated to reflect 
global nature of study 
− Requirement for authorization for use of 
protected health information added where 
applicable 
− Exclusion criterion added for 
inflammatory arthropathies 
− Participation in other studies only an 
exclusion if it would compromise the 
results of this study 
− Exclusion criterion for staged or bilateral 
replacements updated/clarified to allow 
the second replacement to be enrolled 
under certain circumstances 
• Follow-up time frames converted from 
months to days 
• Pre-operative interval expanded to up to 90 
days prior to surgery 
• Removal of language specifying return of 
watches upon study completion 
• Clarification of ability to use data obtained 
from standard of care visits for screening 
• Reference to crossover removed. Crossover 
form name changed to “Prescribed Physical 
Therapy” form  
• Addition of guidelines/documentation to allow 
greater flexibility in prescribing physical 
therapy after surgery 
• Download of Apple Research App added to 
pre-op visit 
• Clarification that protocol deviations will not 
be issued for incomplete PROMs or other 
patient-facing questionnaires. 
3.0 
23 Jun 2020 
• Protocol reformatted into current Sponsor 
template.  Formatting, terminology, and 
paragraph changes throughout document 
• Sponsor name changed to Zimmer Biomet 
• Changed mymobility to a registered 
trademark 
• Clarified that Statement of Compliance 
signature is only required by the Principal 
Investigator during the site start-up process 
Scott Abshagen 

 
 
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• Added Netherlands address as a regional 
Zimmer Biomet contact location 
• Removed Appendix 4 – Investigational Site 
information 
• Added additional technical support email 
address 
• Added abbreviations 
• Expanded inclusion criteria to any 
commercially available THA, TKA, or PKA 
implant used on-label according to 
Instruction for Use.  Removed requirement 
that only Zimmer Biomet implants must 
used.   Created the “Other Device 
Documentation” form to collect non-Zimmer 
Biomet implant information. 
• Clarified the inclusion criteria for iPhone 
model requirement.   
• Clarified the inclusion criteria that patient 
must be single cane/single crutch assist 
preoperatively. 
• Added language that subjects who complete 
the entire study for one joint may be enrolled 
for a second joint. 
• Indicated on the data collection chart which 
forms can be entered directly into the EDC 
• Incorporated remote study activities such as 
informed consent, onboarding, and study 
assessments 
• Clarified the preoperative interval of up to 
180 days for consent, assessments, and 
patient surveys or questionnaires.  90 to 14 
days preop for onboarding into mymobility. 
• Removed TUG/SLS as a preoperative data 
collection point for the RCT cohort 
• Added Chart Review as a 90 day and 365 
day form to the postoperative data collection 
listing 
• Removed the Prescribed Physical Therapy 
form 
• Clarified that the Apple Research App is 
officially called the Apple Health and Fitness 
Recorder.  Added language about data 
sharing with Apple.  
• Added Medical Event / Adverse Event 
flowchart  
• Added specific Medical Event / Adverse 
Event instructions, including definition of 
readmission 

 
 
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• Added language about SAE and SADE 
reporting.  Removed UADE definition. 
• Clarified that lost to follow-up process begins 
after patient has missed two consecutive 
study visits 
• Added that email and mymobility app can be 
used for contact attempts if patient is 
potentially lost to follow-up 
• Added language about protocol deviation 
reporting  
• Added Quality Control and Quality 
Assurance section 
• Added minimization of risk language 
specifically for Australia  
• Updated guideline references 
4.0 
14 Feb 2022 
• Updated inclusion criteria by removing total 
hip arthroplasty as eligible surgery 
• Included language about screening practices 
• Updated ISO reference and applicable 
definitions 
• Clarified protocol deviation reporting 
requirements for out of window patient 
surveys, missed patient surveys, and late 
chart reviews 
• Clarified preoperative interval and timing of 
informed consent, preoperative forms, and 
mymobility app registration 
• Clarified classification of hip resurfacing 
procedures 
• Clarified medical event and adverse event 
reporting requirements 
• Clarified patient survey dates of completion 
• Specified watch retrieval requirements if 
patient is also lost to follow-up 
• Clarified that subjects with tibial articulating 
surface exchanges may remain enrolled in 
the study 
Scott Abshagen 
XXI. References 
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Following Discharge after Total Hip and Total Knee Replacement: A Survey of Current 
Practice at High-Volume NHS Hospitals in England and Wales. Musculoskeletal Care 
2013;11(1):31-8. 
2. Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation 
and Physical Therapy After Primary TJA. J Arthroplasty 2015 Jul;30(7):1121-6. 

 
 
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3. Han ASY, Nairn L, Harmer AR, Crosbie J, March L, Parker D, et al. Early rehabilitation after 
total knee replacement surgery: A multicenter, noninferiority, randomized clinical trial 
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5. Kramer JF, Speechley M, Bourne R, Rorabeck C, Vaz M. Comparison of clinic- and home-
based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res 
2003(410):225-34. 
6. Mockford BJ, Thompson NW, Humphreys P, Beverland DE. Does a Standard Outpatient 
Physiotherapy Regime Improve the Range of Knee Motion After Primary Total Knee 
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7. Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, et al. In-Home 
Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee 
Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am 2015 Jul 
15;97(14):1129-41. 
8. Austin MS, Urbani BT, Fleischman AN, Fernando ND, Purtill JJ, Hozack WJ, Parvizi J, 
Rothman RH. Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A 
Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Apr 19;99(8):648-655. 
9. Lisi C, Caspani P, Bruggi M, Carlisi E, Scolè D, Benazzo F, et al. Early rehabilitation after 
elective total knee arthroplasty. Acta Bio-Medica Atenei Parm 2017;88:56–61. 
10. Naal FD, Impellizzeri FM. How active are patients undergoing total joint arthroplasty?: A 
systematic review. Clin Orthop Relat Res. 2010 Jul;468(7):1891-904.  
11. Toogood 
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The monitoring of activity at home after total hip arthroplasty. Bone Joint J. 2016 Nov;98-
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12. Luna IE, Peterson B, Kehlet H, Aasvang EK. Individualized assessment of post-
arthroplasty recovery by actigraphy: a methodology study. J Clin Monit Comput. 2017 
Dec;31(6):1283-1287. 
13. Almeida GJ, Irrgang JJ, Fitzgerald GK, Jakicic JM, Piva SR. Validity of physical activity 
measures in individuals after total knee arthroplasty. Phys Ther. 2016 Jun;96(6):898-907. 
14. Lützner C, Kirschner S, Lützner J. Patient activity after TKA depends on patient-specific 
parameters. Clin Orthop Relat Res. 2014 Dec;472(12):3933-40. 
15. Hayes DA, Watts MC, Anderson LJ, Walsh WR. Knee arthroplasty: a cross-sectional study 
assessing energy expenditure and activity. ANZ J Surg. 2011 May;81(5):371-4.  
16. Brandes M, Ringling M, Winter C, Hillmann A, Rosenbaum D. Changes in 
physical activity and 
health-related 
quality 
of 
life 
during 
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first 
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after total knee arthroplasty. Arthritis Care Res (Hoboken). 2011 Mar;63(3):328-34. 
17. Almeida GJ, Irrgang JJ, Fitzgerald GK, Jakicic JM, Piva SR. Reliability of Physical Activity 
Measures During Free-Living Activities in People After Total Knee Arthroplasty. Phys Ther. 
2016 Jun;96(6):898-907.  

 
 
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18. Crizer MP, Kazarian GS, Fleischman AN, Lonner JH, Maltenfort MG, Chen AF. Stepping 
Toward Objective Outcomes: A Prospective Analysis of Step Count After Total Joint 
Arthroplasty. J Arthroplasty. 2017 Sep;32(9S):S162-S165.  
19. Senden R, Grimm B, Meijer K, Savelberg H, Heyligers IC. The importance to including 
objective functional outcomes in the clinical follow up of total knee arthroplasty patients. 
Knee. 2011 Oct;18(5):306-11. 
20. Vissers MM, de Groot IB, Reijman M, Bussmann JB, Stam HJ, Verhaar JA. Functional 
capacity and actual daily activity do not contribute to patient satisfaction after total 
knee arthroplasty. BMC Musculoskelet Disord. 2010 Jun 16;11:121. 
21. Kim K, Pham D, Schwarzkopf R. Mobile Application Use in Monitoring Patient Adherence 
to Perioperative Total Knee Arthroplasty Protocols. Surg Technol Int. 2016 Apr;28:253-60. 
22. Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, 
Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during 
Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. 
23. Fillingham YA, Darrith B, Lonner JH, Culvern C, Crizer M, Della Valle CJ. Formal physical 
therapy may not be necessary after unicompartmental knee arthroplasty: A randomized 
clinical trial. J Arthroplasty. 2018. doi: S0883-5403(18)30197-9 [pii]. 
24. Chughtai M, Kelly JJ, Newman JM, et al. The role of virtual rehabilitation in total and 
unicompartmental knee arthroplasty. The Journal of Knee Surgery. 2018. 
25. Kramer JF, Speechley M, Bourne R, et al. Comparison of clinic- and home-based 
rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res 2003; 410: 225–
234. 
26. Tousignant M, Moffet H, Boissy P, et al. A randomized controlled trial of home 
telerehabilitation for post-knee arthroplasty. J Telemed Telecare 2011; 17(4): 195–198.  
27. Russell TG, Buttrum P, Cert G, et al. Internet-based outpatient telerehabilitation for patients 
following total knee arthroplasty: A randomized controlled trial. J Bone Joint Surg Am 2011; 
93(2): 113–120.  
28. Piqueras M, Marco E, Coll M, et al. Effectiveness of an interactive virtual telerehabilitation 
system in patients after total knee arthoplasty: A randomized controlled trial. J Rehabil Med 
2013; 45(4): 392–396. 
29. Cabana F, Boissy P, Tousignant M, et al. Interrater agreement between telerehabilitation 
and face-to-face clinical outcome measurements for total knee arthroplasty. Telemed J E 
Health 2010; 16(3): 293–298.  
30. Russell TG, Buttrum P, Wootton R, et al. Rehabilitation after total knee replacement via 
low-bandwidth telemedicine: The patient and therapist experience. J Telemed Telecare 
2004; 10(Suppl. 1): 85–87. 
31. Bernatz JT, Tueting JL, Anderson PA. Thirty-day readmission rates in orthopedics: A 
systematic review and meta-analysis. PLoS One. 2015;10(4):e0123593.  
32. Judge A, Arden NK, Price A, et al. Assessing patients for joint replacement: Can pre-
operative oxford hip and knee scores be used to predict patient satisfaction following joint 
replacement surgery and to guide patient selection? The Journal of bone and joint 
surgery.British volume. 2011;93(12):1660-1664. 

 
 
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33. Ghanem E, Antoci V,Jr, Pulido L, Joshi A, Hozack W, Parvizi J. The use of receiver 
operating characteristics analysis in determining erythrocyte sedimentation rate and C-
reactive protein levels in diagnosing periprosthetic infection prior to revision total hip 
arthroplasty. Int J Infect Dis. 2009;13(6):444. doi: 10.1016/j.ijid.2009.02.017 [doi]. 
34. Ravi B, Jenkinson R, Austin PC, et al. Relation between surgeon volume and risk of 
complications after total hip arthroplasty: Propensity score matched cohort study. BMJ. 
2014;348:g3284. 
Guideline References: 
i. ISO 14155:2020. International Standard for Clinical investigation of medical devices for 
human subjects – Good clinical practice. 
ii. ICH E6(R2). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice. 
iii. CFR – Code of Federal Regulations Title 21. Available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.   
iv. World Medical Association Declaration of Helsinki. WMA Declaration of Helsinki – Ethical 
Principles for Medical Research Involving Human Subjects. 64th WMA General Assembly, 
Fortaleza, Brazil, October 2013. 
XXII. Appendices 
1. Worksheets 
2. Study Logs 
3. Informed Consent Form (ICF) template