ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
Phase: NA
Conditions: Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Sponsor: Zimmer Biomet

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ROSA Total Knee  
Post Market Study 
 
PROSPECTIVE MULTICENTER U.S. STUDY  
OF THE 
ROSA KNEE SYSTEM 
 
Protocol # CMU2018-34K 
 
11/08/2018 – Version 1.0 
09/05/2019 – Version 2.0 
10/14/2019 – Version 3.0 
10/02/2020 – Version 3.1 
 
 
 
 
 
 
STUDY SPONSOR 
Zimmer Biomet Orthopaedics 
Clinical Affairs Department 
1800 West Center Street 
Warsaw, IN 46580 
800-613-6131 
 
 
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Inc. 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 Inc. 

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Table of Contents 
I. 
Document History ………………………………………………………………………………………………………………………..3 
II. 
Study Synopsis ...................................................................................................................................4 
III. 
Data Collection Overview ..................................................................................................................7 
IV. 
Introduction and Purpose..................................................................................................................8 
V. 
Study Objectives ................................................................................................................................9 
VI. 
Study Design ......................................................................................................................................9 
VII. 
Study Population ...............................................................................................................................10 
A. 
Inclusion Criteria .......................................................................................................................10 
B. 
Exclusion Criteria.......................................................................................................................10 
VIII. 
Study Device Information ..................................................................................................................10 
IX. 
Study Procedures..............................................................................................................................11 
A. 
Offer Study Participation ..........................................................................................................11 
B. 
Informed Consent Process ........................................................................................................11 
C. 
Informed Consent Log / Enrollment Log.................................................................................12 
D. 
Subject Enrollment....................................................................................................................12 
E. 
Monitor Log...............................................................................................................................12 
F. 
Delegation of Authority (Site Signature Log) ............................................................................12 
G. 
Baseline/Pre-operative Assessment .........................................................................................13 
H. 
Surgical Technique ....................................................................................................................13 
I. 
Surgical and Immediate Post-surgical Procedures (Data Collection)........................................13 
J. 
Post-operative Follow-up Procedures (Data Collection) ..........................................................13 
K. 
Minimization of Subjects Lost to Follow-up..............................................................................14 
L. 
Radiographic Definitions and Methods ....................................................................................14 
M. 
Recommended Revision Procedure ..........................................................................................15 
X. 
Reporting ...........................................................................................................................................15 
A. 
Prior to Initiation of the Study ..................................................................................................16 
B. 
Clinical Data Collection/Submission..........................................................................................16 
C. 
Reporting Requirements ...........................................................................................................17 
D. 
Management of Incurrent Events .............................................................................................17 
E. 
Medical Events/Adverse Events Definitions and Classifications...............................................20 
F. 
Monitoring of the Study............................................................................................................23 
XI. 
Risk Analysis.......................................................................................................................................23 
A. 
General Surgical Risks ...............................................................................................................23  
B. 
Risks Associated with Total Knee Arthroplasty Procedure/Study Device..................................24 
XII. 
Statistical Considerations ..................................................................................................................24 
A. 
General Statistical Methods......................................................................................................25 
B. 
Sample Size ...............................................................................................................................25 
XIII. 
References .........................................................................................................................................26 
 
Appendices: 
Appendix A 
Sample Informed Consent  
Appendix B 
Case Report Forms  
Appendix C 
Study Logs 

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I. 
Document History 
 
Version No. 
Date 
Description of change 
Author 
Version 1.0 
1 March 2018 
Initial Document 
Tory Sears 
Version 2.0 
5 September 2019 
Additional CRF added to 
Section III – Data Collection 
Overview, and Section IX – 
Study Procedures 
Tory Sears 
Version 3.0 
14 October 2019 
Changes to sections II and VI: 
-Increase in maximum 
enrollment per site.  
-Removal of specific 
requirements regarding 
equivalent enrollment into 
robotic/conventional groups 
Tory Sears 
Version 3.1 
31 Mar 2020 
Changes to section II and VI 
include an increase in 
maximum number of research 
sites from 6 to 10; as well as, 
sites will enroll competitively 
up to the maximum allowed 
per site, or until the max study 
population is achieved. 
Correction of 
typographical/grammatical 
errors throughout document 
Tory Sears 
 
 
 
 
 
 
 
 

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II. Study Synopsis 
 
TITLE: 
ROSA Total Knee Post Market Study 
SPONSOR: 
Zimmer Biomet Inc., Warsaw, IN 
PROTOCOL NUMBER 
CMU2018-34K 
STUDY OBJECTIVES 
The primary objective of this study is to collect and compare clinical 
outcomes data using the commercially available ROSA Knee System and 
conventional instrumentation. 
The assessments will include: 
1. Planned vs actual component positioning. 
2. Workflow efficiency. 
3.   Patient safety based on incidence and frequency of adverse events. 
4.   Clinical performance measured by overall pain and function, quality 
of life data, and radiographic parameters. 
TARGET POPULATION: 
Patients qualifying for primary total knee arthroplasty who meet the 
inclusion/exclusion criteria for study participation 
STUDY DESIGN: 
Prospective, multicenter study, using Zimmer Biomet commercially 
available Persona, Vanguard, and NexGen total knee implant systems.  
STUDY TYPE: 
Post-market 
SAMPLE SIZE: 
A Maximum study enrollment of 300 subjects competitively enrolled at up 
to 10 U.S. sites, with participating sites each enrolling up to 45 Robotic 
knees and up to 30 conventional knees; with a max site enrollment, of up 
to 75 total knees. Once the maximum study enrollment has been reached, 
enrollment at all sites will be closed.  

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LENGTH OF STUDY: 
One-year Post-operative study;  
Post-op follow-up visits include: 6 weeks, 3months, and 1 year.   
Total Enrollment time: 12-18 Months. 
Total Study Length: 2 - 2.5 years 
INCLUSION/EXCLUSION CRITERIA:  
INCLUSION CRITERIA: 
1. Patient is a minimum of 18 years of age 
2.    Independent of study participation, patient is a candidate for 
commercially available Persona, NexGen, or Vanguard knee 
components implanted in accordance with product labeling 
3.   Patient has participated in the study-related Informed Consent 
process  
 4.    Patient is willing and able to provide written Informed Consent by 
signing and dating the IRB or EC approved Informed Consent form 
 5.   Patient is willing and able to complete scheduled study procedures 
and follow-up evaluations 
EXCLUSION CRITERIA: 
1. Patient is currently participating in any other surgical intervention 
studies or pain management studies  
2. Patient has undergone contralateral UKA or TKA within the last 18 
months 
3. Hip pathology with significant bone loss (e.g. avascular necrosis of the 
femoral head with collapse, severe dysplasia of the femoral head or 
the acetabulum) 
4. Hip pathology severely limiting range of motion (e.g. arthrodesis, 
severe contracture, chronic severe dislocation) 
5.  Patient is pregnant or considered a member of a protected population 
(e.g., prisoner, mentally incompetent, etc.) 
6.  Patient has previously received partial or total knee arthroplasty for 
the ipsilateral knee 
 
Note:  During the surgical preparation, if there is presence of strong 
infrared sources or infrared reflectors in the vicinity of the 
NavitrackERs, the subject cannot continue with the study. A 
Study Completion form must be completed. 
 
Note:  The use of Tibial/Fibular Augments and stems, constrained liners, 
and any use of guidance systems are excluded from this study 
 

 
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TESTING ARTICLE 
The ROSA Knee  System 
CLINICAL OUTCOMES MEASURES: 
EQ-5D 
Oxford Knee Score 
CLINICAL PERFORMANCE ASSESSMENTS: Post-Operative Pain & Satisfaction 
Functionality & Range of Motion  
Radiographic parameters 
STATISTICAL REPORTING: 
Performance will be evaluated for pain, function, quality of life, and 
planned component position vs post-op component position.  Data will be 
summarized descriptively additional to evaluation of data on surgical 
technique and instrumentation. Categorical data (e.g., gender or race) will 
be summarized using counts and percentages with 95% Confidence 
Interval (CI) limit over the time period of interest.  Continuous data, such 
as age, will be summarized by using means, medians, SD, minimum, 
maximum, and 95% CI over the time period of interest.  Implant survival 
and return to function will be summarized using a Kaplan-Meier method 
and presented with rates (as percentages) and CI.  Routine summaries of 
complication data is represented by frequencies and percentages.  Sample 
size is based on a longitudinal data collection model and using functional 
outcomes as the primary endpoint of interest. 
 
 
This protocol is written based on guidelines from ISO 14155 : 2011Standard for Clinical Investigation of Medical 
Devices For Human Subjects – Good Clinical Practice (i) the ICH Guideline on Good Clinical Practice(ii), and the 
Declaration of Helsinki (iii) and is in accordance with US Code of Federal Regulations 21 CFR Parts 11, 50 and 56 (ii).  
IRB or EC approval for each site will be obtained prior to conducting this study, as applicable.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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III. Data Collection Overview 
 
The following table indicates the necessary case report forms to be completed at the given time point: 
 
Form Name 
Pre-op Operative 
6 Week 
3 Month 
1 Year 
Informed Consent 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
Demographic Evaluation 
X 
 
 
 
 
Pre-op plan for Conventional 
Instrumentation 
 
X 
 
 
 
Operative Information 
 
X 
 
 
 
Surgical Device Information 
 
X 
 
 
 
Discharge Summary 
 
X 
 
 
 
Physical Exam 
 
 
X 
X 
X 
Objective Knee Assessment 
X 
 
X 
X 
X 
EQ-5D 
 
 
 
 
 
Oxford Knee Score 
 
 
 
 
 
Physician Assessment of 
Radiographs 
  X* 
 
X 
X* 
X 
Adverse Event Report 
 
 
 
 
 
Protocol Deviations 
 
 
 
 
 
Study Completion 
 
 
 
 
 
* Long Leg Radiograph required at this interval 
* Central or Independent radiographic review performed by Sponsor’s designee, if applicable, 
at discretion of the Sponsor 
 
The following table indicates the necessary case report forms required to be completed for 
revision patients: 
 
Form Name 
Revision (as applicable) 
Comments 
Physician Assessment of Post-op 
Radiographs 
 
Mark the “pre-revision” exam period. 
Adverse Event Report 
 
Document adverse event resulting in the 
revision 
Study Completion 
 
Complete indicating “Study Prosthesis 
Removed” under Study Completion Status. 
 
 Completed by Patient 
 X Completed by Investigator or Designee 
  Completed by Investigator or Designee as applicable 
 Central or Independent radiographic review performed by Sponsor’s designee, if applicable, at 
discretion of the Sponsor 
 
 
 
 
 
 

 
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IV. Introduction and Purpose 
 
 
Total knee arthroplasty (TKA) is a reliable treatment option for knee osteoarthritis. As laid out in the 
CERs of the subject instrument system's compatible Zimmer Biomet's TKA implant systems, recent 
systematic reviews1 and orthopaedic registries2, 3 have reported 90% or higher implant survival at 10 
years for TKA. Over the last two decades, there is a growing interest towards perioperative variables 
that are controlled by the orthopaedic surgeon4. These variables include leg alignment, soft tissues 
balance, joint line maintenance and the alignment, sizing and fixation of the components; and each 
of these variables are determinants of arthroplasty outcomes4. Along with the return to premorbid 
function, pain relief is an aim of arthroplasty. Currently, it is estimated that up to 19% of patients 
undergoing total knee arthroplasty may not be satisfied with the outcome5. In a follow-up period 
ranging from 3 months to 5 years, Beswick et al found that 10-34% of patients experienced 
unfavorable pain outcomes after total knee arthroplasty6. They also noted that even in studies 
reporting good patient satisfaction from arthroplasty, an unfavorable pain outcome was reported in 
around 20% of patients after total knee arthroplasty6. 
In addition to patient outcomes, the ultimate shortcoming of an arthroplasty is the need for revision. 
A major factor affecting the rate of knee arthroplasty failure is tibiofemoral alignment. Although there 
is a vivid discussion with regard to the ideal positioning of implant component, there is still wide 
consensus that unintentional component malplacement should be avoided, as this can have an 
adverse impact on implant function and longevity7-10. Revision of joint arthroplasty increases load on 
the health-care system and also incurs significant costs, with a revision total knee arthroplasty 
estimated to cost a multiple of primary procedures, depending on complexity and indication11. 
Therefore, there is an economic, as well as clinical, case for maximizing outcomes from primary knee 
arthroplasties. Further shortcomings of existing strategies are inter-surgeon variability and variation 
in quality of outcomes. There is a lack of precise reproducibility of surgeon's experience, and most 
procedures have a relatively steep learning curve. 
The primary aim of robotics in arthroplasty is precise reproduction of the surgeon's preoperative plan 
during surgery. It is hypothesized that more accurate implant placement will translate to better 
clinical placement, which will translate to better clinical outcomes, although the current data 
supporting improved patient satisfaction are conflicting. Robotics offers several other potential 
advantages. The ability to create a preoperative plan and accurately execute it during surgery using 
intraoperative feedback reduces variation in component placement. This benefit may also be true for 
less experienced surgeons.  
The ROSA Knee System is the natural progression of technology, combining imaging modalities, 
patient specific guides, navigation, and soft tissue respecting philosophies; all applied to one concise 
tool which provides reproducible patient outcomes. In addition, it’s coupled with precision-
engineered industry-leading products: NexGen, Persona, and Vanguard total knee systems. The ROSA 
Knee system provides streamlined workflow that is customizable to surgeon’s needs, and keeps the 
surgeon in control - bridging the patient satisfaction gap through more precise and accurate cuts, and 
providing a personalized fit and positioning that can be adapted to the patient intraoperatively. 
 
 
 

 
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V. Study Objectives 
 
The primary objective of this study is to collect and compare clinical outcomes and surgical data 
using the commercially available ROSA Knee System instrumentation and conventional 
instrumentation. 
This will be done by analysis of validated outcome measurement tools, radiographs and adverse 
event data. 
 
The assessments will include: 
 
1. 
Comparison of planned operative vs. actual operative component position 
2. 
Operative workflow efficiency 
3. 
Patient safety based on incidence and frequency of adverse events. 
4. 
Clinical performance measured by overall pain and function, quality of life data, and 
radiographic parameters.  
 
VI. Study Design 
 
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of 
workflow efficiency, patient pain and function, and adverse event data.  This clinical study will 
include Persona, NexGen, and Vanguard product families using the ROSA  Knee System or 
conventional instrumentation. The primary objective of this study is to collect and compare clinical 
and surgical data using the commercially available ROSA Knee System instrumentation and 
conventional instrumentation. 
 
A maximum of 300 subjects are to be competitively enrolled in this study across all sites; a 
maximum of 10 U.S sites will contribute, with participating sites each enrolling up to 75 implanted 
knees. Sites will enroll up to 45 patients using The ROSA Knee System and up to 30 patients using 
Conventional instrumentation; total study enrollment into these arms are not to exceed 180 
subjects and 120 subjects respectively.   Once the maximum study enrollment has been reached, 
enrollment at all sites will be closed.  
 
Investigators will be skilled in total knee arthroplasty and experienced implanting Persona, NexGen, 
and/or Vanguard knee systems. Each Principal Investigator will be responsible for obtaining 
Institutional Review Board (IRB) approval as required prior to conducting the study.  In order to 
avoid potential selection bias, each Investigator will offer study participation to each consecutive 
eligible patient presenting as a candidate for primary total knee arthroplasty using the 
aforementioned implants.  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 approved Informed Consent Form.  Study data cannot be collected until 
the candidate has completed the Informed Consent process and signed and dated the IRB approved 
Informed Consent Form. All study subjects will undergo preoperative clinical evaluations prior to 
their Robotic-assisted total knee arthroplasty. 
    
At the Sponsor’s discretion, the Sponsor may request copies of radiographs for independent 
radiologic review.  The Sponsor may request one central reviewer for all radiographs independent 

 
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of the surgeon and institution. 
 
VII. Study Population  
 
The study population for primary statistical analysis will be comprised of males and females who 
require primary total knee 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 consecutive eligible patient presenting as a candidate for primary total knee 
arthroplasty using the commercially available (FDA cleared) Persona, Vanguard, and NexGen knee 
systems. Eligible candidates who express interest in study participation will be offered Informed 
Consent. The inclusion/exclusion CRF should not be completed until the study-specific consent form 
has been completed. 
 
a. Inclusion Criteria: 
1. Patient is a minimum of 18 years of age  
2. Independent of study participation, patient is a candidate for commercially available 
Persona, NexGen, or Vanguard knee components implanted in accordance with product 
labeling 
3. Patient has participated in the study-related Informed Consent Process 
4. Patient is willing and able to provide written Informed Consent by signing and dating the 
IRB or EC approved Informed Consent form 
5. Patient is willing and able to complete scheduled study procedures and follow-up 
evaluations 
b. Exclusion Criteria 
1. Patient is currently participating in any other surgical intervention studies or pain 
management studies 
2. Patient has undergone contralateral UKA or TKA within the last 18 months 
3. Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head 
with collapse, severe dysplasia of the femoral head or the acetabulum) 
4. Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, 
chronic severe dislocation) 
5.   Patient is pregnant or considered a member of a protected population (e.g., 
prisoner, mentally incompetent, etc.) 
6.   Patient has previously received partial or total knee arthroplasty for the ipsilateral knee 
 
Note:  During the surgical preparation, if there is presence of strong infrared sources or 
infrared reflectors in the vicinity of the NavitrackERs, the subject cannot continue with 
the study. A Study Completion form must be completed. 
Note:  The use of Tibial/Fibular Augments and stems, constrained liners, and any use of 
guidance systems are excluded from this study 
 
VIII. Study Device Information 
 
The ROSA Knee System and all TKA device components included in this study are commercially 
available (FDA cleared) products. All implantable device components are intended for long-term 
survivorship in accordance with product labeling.  Please refer to the package insert for additional 
instructions, information, and indications for use. The ROSA Knee System is intended to assist the 

 
CMU2018-34k, 10-02-2020, Version 3.1                                                                                                     Page 11 of 26 
 
 
surgeon in providing software-defined spatial boundaries for orientation and reference information 
to anatomical structures during surgery. The ROSA Knee System application will support the 
following Zimmer Biomet total knee systems in both cement and cementless options: 
a. Persona® The Personalized Knee 
Persona knee components included in this study are fixed bearing configurations with 
various component sizes to accommodate anatomical variation. Femoral components 
replicate native A/P with 21 distinct profiles in 2mm increments. 
b. NexGen® Complete Knee Solution 
NexGen’s Primary TKA components in this study will include both fixed and mobile bearing 
configurations. NexGen accommodates both Cruciate Retaining (CR) and Posterior Stabilized 
constraint options. The NexGen Flex knee offers patients a larger range of active flexion, 
accommodating deep flexion up to 155 degrees. 
c. Vanguard® Knee System 
The Vanguard Knee System offers an entire spectrum of knee stability, featuring both Cruciate 
Retaining (CR) and Posterior Stabilized (PS) femoral stabilization options. Component variation 
includes ten femoral component sizes, nine tibial component sizes, and five levels of bearing 
constraints.      
 
IX.  Study Procedures 
 
a. Offer Study Participation 
Study participation will be offered to each consecutive eligible patient presenting as a potential 
candidate for total knee arthroplasty using the commercially available ROSA Knee System.  An 
Enrollment/Informed Consent Log (Appendix C) will be completed to document all individuals 
screened as potential candidates for the study.  Eligible candidates who express interest in study 
participation will be offered Informed Consent.  Prior to patient involvement in the study, the 
patient must participate in the Informed Consent process and sign and date the IRB or EC 
approved Informed Consent.   
 
b. Informed Consent Process 
For candidates that express interest, the Investigator or Designee will describe relevant study 
information, including the purpose, procedures, possible risks, and potential benefits associated 
with study participation.  The Investigator or Designee will also review, along with the candidates, 
the Informed Consent approved by both the governing IRB or EC and the study Sponsor. 
Candidates should be made aware that any and all data collected electronically within the ROSA 
Knee System will be made available to the sponsor for research related purposes. Candidates 
shall have sufficient time to read and understand the IRB or EC approved Informed Consent 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 discontinue their participation 
at any time without prejudice. 
 

 
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After completing the Informed Consent process, candidates who agree to enter the study must 
sign and date the IRB or EC approved Informed Consent.  The Informed Consent must be signed 
and dated prior to the date of the study surgery.   
A copy of the signed Informed Consent must be provided to the study subject.  The original signed 
Informed Consent is to be filed in the subject’s medical record, study subject binder, or regulatory 
binder. 
 
Study data will not be collected until the Informed Consent has been signed and dated.  If the 
candidate does not wish to participate (does not sign and date the Informed Consent), data for 
that candidate will not be collected for this study. 
 
c. Informed Consent and Subject Identification Log 
A Subject Identification/Informed Consent Log (Appendix C) will be maintained at the site 
throughout the course of the study.  The purpose of the log is to provide documentation that all 
enrolled study subjects underwent the Informed Consent process, and signed and dated the IRB 
or EC approved Informed Consent.   All candidates who sign and date the approved Informed 
Consent for the study must be entered in the log.  If a subject signs and dates additional Informed 
Consent(s) after enrollment (e.g., due to a protocol amendment, protocol revisions, etc.), 
subsequent signings will also be recorded in the log.  The Subject Identification/Informed 
Consent will be filed in the site Regulatory Binder for the study.  The proposed date of surgery for 
each subject will be added to the log.  The subject will be considered an active study subject after 
receiving the study device during surgery.  In the event that a subject does not receive the study 
device at the time of surgery, a Study Completion form must be submitted and this will be 
documented as a screen failure. 
 
d. Subject Enrollment 
Once the Informed Consent has been signed and dated by the subject, the subject will be 
considered enrolled in the study. Robotic and conventional patients should be enrolled using a 
consecutive and concurrent approach. A unique case identification number (Case ID) will be 
assigned to each participating subject. This unique case ID number will be used throughout the 
study for identification.  Case ID numbers will be assigned consecutively in ascending order per 
site, with the starting number for a given site defined by the Sponsor. In the event that the subject 
does not receive the study device at the time of surgery, the subject will be considered a screen 
failure and documented on a Study Completion form (see above). In the occurrence of a screen 
failure, the surgeon may have the option to enroll an additional patient as long as the subject did 
not receive the study device. 
 
e. Monitor Log 
The Site Monitoring Visit Log (Appendix C) will be maintained throughout the course of the study.  
The log will contain the visit date, monitor name/signature and the purpose of the visit (i.e. site 
initiation, onsite interim monitoring (as applicable), site close-out, etc.).  The site monitoring visit 
log will be filed in the site Regulatory Binder for the study. 
 
f. Delegation of Authority (Site Signature Log) 
A Delegation of Authority Log (Appendix C) will be maintained throughout the study and will 
contain the names, initials, signatures and study responsibilities of all site personnel/designees 
involved in study procedures and data collection.  The Delegation of Authority Log will be filed in 
the site Regulatory Binder for the study. 
 

 
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g. Baseline / Pre-operative Assessment 
Baseline/pre-operative data to be collected on the following source documents at the time of 
enrollment: 
1. Inclusion/Exclusion Criteria 
2. Demographic Evaluation 
3. Pre-op plan for Conventional Instrumentation (when applicable) 
4. Physician Assessment of Radiographs (Long-Leg) 
5. Objective Knee Assessment 
6. EQ-5D 
7. Oxford Knee Score 
8. Protocol Deviations (as applicable) 
9. Study Completion (as applicable) 
 
h. Surgical Technique 
Through the use of either conventional or robotic techniques, standard operating procedures 
will be followed and all surgical procedures will be performed under aseptic conditions.  
Investigators will implant all commercially available Persona, NexGen, and Vanguard Total Knee 
components in compliance with corresponding labeling requirements, and in accordance with 
appropriate surgical technique(s).  
 
i. Surgical and Immediate Post-Surgical Procedures (Data Collection) 
Surgical and immediate post-surgical data to be collected on the following source documents: 
1. Operative Workflow 
2. Surgical & Operative Information 
3. Discharge Summary 
4. Adverse Event Report (as applicable) 
5. Protocol Deviations (as applicable) 
6. Study Completion (as applicable) 
 
Post-surgical management for study subjects will follow the investigator’s standard of care for 
patients undergoing total knee arthroplasty (e.g. prophylactic antibiotic therapy, prevention of 
deep vein thrombosis, prevention of pulmonary embolism, etc.).  Post-surgical rehabilitative 
therapy will be as prescribed by the investigator. 
 
j. Post-operative Follow-up procedures (Data Collection) 
Post-operative clinical evaluations/assessments will be conducted at the following visit 
intervals: 
 
Clinical Interval 
Interval Window in Days Post-op* 
Approximate Window in Weeks 
or Months Post-op* 
6 weeks 
21 to 63 days 
-/+3 weeks 
3 months 
61 to 120 days  
-/+1 month 
1 year 
300 to 420 days 
-/+2 months 
 

 
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*Visit(s) outside of window will be determined based on Days Post-op 
 
 
Post-operative clinical data will be collected on the following case report forms: 
1.   Physical Exam 
2.   EQ-5D 
3. Oxford Knee Score 
4. Objective Knee Assessment  
5.   Physician Assessment of all Follow-up Radiographs 
6.   Adverse Event Report (as applicable) 
7.   Protocol Deviations (as applicable) 
8.    Study Completion (as applicable) 
 
Subjects will be followed post-operatively for 1 year. 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 a study device, or expires.  See Management of 
Incurrent Events (Section IX, Subsection D of this protocol) for additional details.  Reason(s) for 
study completion must be documented on the Study Completion case report form. 
 
k. Minimization of Subjects Lost to Follow-up 
Subject follow-up is extremely important for the conduct of a clinical study, and the expectation 
is to maintain the highest possible rate of follow-up compliance throughout this study.  During 
the informed consent process and at each follow-up interval, subjects should be counseled on 
the importance of completing future study follow-up intervals. 
 
l. Radiographic Definitions and Methods 
1. Required radiographic views 
  
Radiographs will be performed at the following intervals: 
 
Clinical Interval 
Required Radiograph 
Approximate Visit Window 
Pre-op 
AP and ML long-leg 
Optional: Skyline view 
N/A 
6 Week 
AP and ML short film or long-leg 
Optional: Skyline view 
7-63 days post-op 
3 Month 
AP and ML long-leg 
Optional: Skyline view 
-/+1 month 
1 year 
AP and ML short film or long-leg 
Optional: Skyline view 
-/+2 months 
 
 
Investigators may obtain additional radiographs within their normal standard of care but 
the Sponsor will not require notification, unless an Adverse Event is identified.  

 
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Preoperative Radiographs: 
All preoperative radiographic evaluations performed according to the protocol will be 
reviewed by the Investigator at the time of the evaluation and documented using the 
Physician Assessment of Pre-Op Radiographs form.  Preoperative radiographs will be 
evaluated using Kellgren-Lawrence Osteoarthritis grading for both medial and lateral knee 
compartments.   
 
Anteroposterior (AP) and mediolateral (ML) long-leg radiographs are required for pre-
operative planning of the operative knee. Skyline view radiographs are optional.  Sites 
collecting skyline view as part of their standard of care will be asked to submit these 
radiographs to the Sponsor.  
 
Postoperative Radiographs: 
All postoperative radiographic evaluations performed according to the protocol will be 
reviewed by the Investigator at the time of the evaluation and documented using the 
Physician Assessment of Post-Op Radiographs form.  An Adverse Event Report form must 
be completed for those findings identified as an adverse event. 
 
 
AP and ML long-leg radiographs are required for the 3 month post-operative radiograph of 
the operative knee.  Skyline view radiographs are optional.  Sites collecting skyline view as 
part of their standard of care will be asked to submit these radiographs to the Sponsor.  
 
*The 3 month post-operative film will be used as the baseline radiograph.   
 
 
Radiographs should have similar exposure and must show all TKA components and 
surrounding bone.  For consistency, every effort should be made to capture all radiographic 
views for a given subject using the same institution throughout the study.  However, 
radiographs captured at a different institution may be used for the study, provided they 
meet required study specifications and are captured within the required interval window.  
The investigative site will retain copies (hard copy/CD/digital) of all radiographs referenced 
for the study. 
 
2. Submission to Sponsor 
At the Sponsor’s discretion, study radiographs may be requested from the sites for 
independent radiographic review and assessment of appropriate parameters.  
 
m. Recommended Revision Procedure 
See Management of Incurrent Events (Section IX, Subsection D of this protocol) 
 
X. Reporting 
 
The Sponsor will collect all data in a central database.  The management of all study data 
received by the Sponsor will be the responsibility of the Sponsor or its Designee.  The use or 

 
CMU2018-34k, 10-02-2020, Version 3.1                                                                                                     Page 16 of 26 
 
 
disclosure of all protected health information will comply with the Health Insurance Portability 
and Accountability Act (HIPAA).  All information will be treated with strict adherence to 
professional standards of confidentiality and will be filed by the Sponsor under adequate 
security and restricted accessibility by clinical personnel.  All electronic systems used to create, 
modify, maintain, or transmit study records will be validated according to 21 CFR Part 11(ii).  
Reports and communications relating to study subjects will typically identify each subject only 
by the subject’s initials, assigned study subject Case ID number, date of surgery, operative side, 
and date of birth.  This code must be clearly linked to the patient identity and can only be 
decoded by the study center.   
A. Prior to Initiation of the Study 
1. Clinical Trial Agreement (CTA) 
A fully executed (signed by all required parties) CTA must be on file with the Sponsor prior 
to any investigator participating in this study. 
 
2. Institutional Review Board/Ethics Committee Protocol Approval 
This study protocol must be submitted to and approved by the Investigator’s Institutional 
Review Board (IRB) or Ethics Committee (EC).  A copy of the IRB or EC approval letter must 
be submitted to the Sponsor.   The letter should identify the following: 
• 
Protocol name and/or number 
• 
Date of IRB or EC meeting (if available) 
• 
Date of approval 
• 
Date of expiration 
• 
Signature of IRB or EC 
 
3. Informed Consent 
A Sponsor-approved Informed Consent template (Appendix A Sample) will be provided 
along with the study protocol for IRB or EC submission and approval. If the IRB or EC 
requires revisions to the provided Informed Consent, 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 Informed Consent will be re-submitted to the 
IRB or EC for final review and approval.  A copy of the final IRB or EC approved Informed 
Consent form (ICF) must be submitted to the Sponsor. 
4. ClinicalTrials.gov Registration 
The Sponsor will be responsible for registering this study on www.ClinicalTrials.gov. 
B. Clinical Data Collection/Submission 
1. Summary of Source Document Data Collection 
Study data will be collected on source documents, which may include study-specific 
documents provided by the Sponsor.   
 
The following source document completion guidelines should be followed: 
• 
Complete carefully and accurately. 
• 
Complete header information consistently across all source documents 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 

 
CMU2018-34k, 10-02-2020, Version 3.1                                                                                                     Page 17 of 26 
 
 
• 
Use the study subject’s unique Case ID number assigned as instructed. Do not 
provide information that is not requested on the source document. 
• 
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. 
 
Pre-operative planning and final post-operative component positioning data will be 
extracted from The ROSA Knee System at the discretion of the sponsor. This data will be 
uploaded by the sponsor into the electronic data capture (EDC) system.    
 
2. Data Submission 
Completed source documents 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 14 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 documents and in all required reports.  Data 
reported on the source documents and clinic records should be consistent, or the 
discrepancies should be explained.  All electronic systems used to create, modify, maintain, 
or transmit electronic study records will be validated according to 21 CFR Part 11(ii).  The 
Sponsor will maintain quality control systems, in accordance with the Sponsor’s policies and 
procedures. 
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 or 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 must be retained by the Investigator or Designee for a minimum of 2 years 
from the Investigator’s study termination date, or per applicable regulatory and/or IRB or 
EC requirements (whichever time period is greater).  Measures shall be taken to prevent 
accidental or premature destruction. 
D. Management of Incurrent Events 
1. Failure to Obtain Informed Consent 
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 study. 

 
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2. Reporting and Documentation of  Medical Events, Adverse Events, Adverse Device Effects 
and Device Deficiencies 
 
Reporting and Documentation of Adverse Events and Adverse Device Effects  
Adverse Events and Adverse Device Effects have to 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 has to 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. 
 
Reporting and Documentation of Serious Adverse Events, Serious Adverse Device Effects, 
and Device Deficiencies 
Serious Adverse Events and Serious Adverse Device Effects have to be reported to the 
Sponsor as soon as possible. The incidence has to 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 has to be documented and any changes in outcome have to 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 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, as well. 
The Investigator is responsible for reporting all SAEs, SADEs and Device Deficiencies that 
could have led to a SADE to the Ethics Committee if required by national regulations or by 
the Ethics Committee. 
 
See Section X, Subsection E of this protocol for additional information regarding adverse 
event classifications.  All medical events, regardless of classification, are required to be 
reported on the Adverse Event Report form.  The Investigator or Designee will also 
promptly provide the Sponsor with any additional requested information required for the 
Sponsor to comply with regulatory requirements. 
 
3. Revision 
In the event that removal of one or more of the study knee components is necessary, the 
Investigator will determine the best treatment and/or revision method for the subject. 
 
Prior to revision surgery, the Investigator or qualified Designee must document any 
significant radiographic findings related to the need for revision on the Physician 
Assessment of Post-Op Radiographs form.  An Adverse Event Report form must be 
completed for those findings indicated by an asterisk on the Physicians Assessment of 

 
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Post-Op Radiograph form.  
 
Once the revision surgery has been completed, the Investigator or qualified Designee must 
complete an Adverse Event Report form as well as a *Study Completion form terminating 
the subject from the study.  For the study completion status, select “Study Prosthesis 
Removed”.   
 
*Study completion is only required for subjects with femoral or tibial component revisions.  
Subjects with articular surface revisions will remain in the study. 
 
4. Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if the subject no longer 
meets study inclusion/exclusion criteria.  The reason for the Investigator’s withdrawal of 
the subject must be documented on the Study Completion form. 
 
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 
Subject follow-up is extremely important for the conduct of a clinical study, and the 
expectation is to maintain the highest possible rate of follow-up compliance throughout 
this study.  During the informed consent process and at each follow-up interval, subjects 
should be counseled on the importance of completing future study follow-up intervals. 
In an effort to minimize lost-to-follow-up subjects, the following recommendations and/or 
study requirements are essential to ensure proper patient selection and compliance: 
1. Patient 
Eligibility: 
Subjects 
will 
be 
selected 
according 
to 
the 
study 
inclusion/exclusion criteria and are expected to return for all follow-up visits.  
2. Patients Counseled: Patients will be counseled during the informed consent process 
on the importance of returning for follow-up visits.  
3. Patient Exclusion: Patients who are not willing to return for study required follow-
up visits and/or are not willing to comply with the follow-up schedule will not be 
considered for enrollment into the study. 
4. Contact Tracking: Attempts to contact subjects will be documented in the study 
subject’s medical record. 
A study subject will be considered lost to follow-up after they have missed a visit 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 medical 
record and on the Study Completion form.  Missed visit(s) also must be documented using 
the Protocol Deviations form, unless the visit is retrospective. The first three contact 
attempts should be made by telephone, with additional attempts as outlined in the 
following table: 
 
 
 
 

 
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If 
Then 
a response is not received after three 
(3) phone calls, 
the Investigator or Designee should send a 
letter to the subject explaining the follow-
up agreement per the Informed Consent, 
and requesting a response from the 
subject. 
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. 
 
7. Protocol Deviations 
Investigators should not deviate from the study protocol, unless patient safety is at risk.  If a 
protocol deviation does occur, the deviation must be documented on the Protocol 
Deviation form and submitted to the Sponsor.  If applicable per their reporting 
requirements, the Investigator or Designee will also report applicable protocol deviations to 
their IRB or EC. 
 
8. Study Termination 
Study subject participation is expected to end upon completion of the subject’s last follow-
up visit 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 a study device, 
or expires.  Reason(s) for study completion must be documented on the Study Completion 
form. 
 
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 or EC as applicable according to local and national 
laws/regulations. 
9. Modification of the Protocol/Clinical Investigation Plan 
All amendments to this clinical protocol shall be agreed to by the Sponsor and be recorded 
with a justification for the amendment prior to implementation.  Approval of the applicable 
IRB or EC must be obtained prior to implementation, if required according to the local 
and/or national laws/regulations. 
E. Medical Events/Adverse Events Definitions and Classifications 
An adverse event is any unfavorable or unintended sign, symptom, or disease that impacts the 
operative knee, such as musculoskeletal.  Adverse event is synonymous with complication or 
medical event.   
 
1. Classification of the Event 
Adverse Event (AE)(i): 
An Adverse Event is defined as 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. 

 
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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 investigational 
medical devices. 
 
Serious Adverse Event (SAE)(i): 
A Serious Adverse Event is any adverse event that 
a. 
led to death 
b. 
led to serious deterioration in the health of the subject, that either resulted in: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
c. 
led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
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)(i): 
An Adverse Device Effect is an adverse event related to the use of a 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. 
 
Serious Adverse Device Effect (SADE)(i): 
A Serious Adverse Device Effect is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
Device Deficiency (i): 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance.  
 
NOTE: Device Deficiencies include malfunctions, use errors, and inadequate labelling.  
Device Deficiencies 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, 
as well. 
 
The Sponsor is responsible for determining the final classification of adverse events. 

 
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If an Unanticipated Serious Adverse Device Effect (USADE) is identified it will be promptly 
reported to concerned Investigators and regulatory authorities as required by applicable 
regulatory requirements.  If applicable per their reporting requirements, the Investigator 
or Designee will report the USADE to their IRB or EC. 
 
2. 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 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. 
 
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. 
 
3. 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. 
 
Study Withdrawal: 
Due to the adverse event, the subject was withdrawn from the study. 
 
Device Revision/Removal: 
The adverse event resulted in the removal of a study device. 
 
Death: 
The outcome indicates the subject died as a direct result of the reported adverse event. 

 
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Reoperation of Affected Joint: 
The adverse event resulted in reoperation of the study joint, but the reoperation did not 
include removal of a study device. 
 
4. Collection Approach 
The type of approach taken to collect adverse event information, whether systematic or 
non-systematic. 
 
 
Systematic: 
 
Based on checklists, questionnaires, or tests 
 
 
Non-Systematic: 
 
Based on spontaneous reporting and recording 
F. Monitoring of the Study 
Prior to initiating the clinical study, the Sponsor will conduct a site initiation visit to ensure the 
Investigator(s) and study staff understands the study protocol and requirements and have 
adequate time and resources to implement and conduct the study.  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. 
 
During the course of the study, the Sponsor may conduct periodic central 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 all source 
data/documents, study documents/binders, corresponding sections of study subject 
medical/hospital records, and any other documents relevant to the study, via printed or 
electronic.  All Sponsor visits (including site initiation) will be documented using the Site 
Monitoring Visit Log (Appendix C). 
 
XI. Risk Analysis 
 
This post-market clinical study is classified as minimal risk(ii) and there are no anticipated risks 
specific to study participation other than the potential loss of confidentiality.  There are no 
experimental procedures in this study, and participation in this study is not anticipated to affect the 
medical treatment of enrolled subjects. When used in accordance with product labeling, the risks 
associated with robotic TKA surgery, using Persona, NexGen, and Vanguard knee systems, are 
similar to those of the conventional method used for the same clinical indication or purpose. The 
risks associated with the Robotic Assisted Total Knee Arthroplasty procedure/study device are 
identified below. Unanticipated adverse events can also occur. 
 
A.   General Surgical Risks 

 
CMU2018-34k, 10-02-2020, Version 3.1                                                                                                     Page 24 of 26 
 
 
General surgical risks and post-operative adverse events can occur with any surgery and 
will be discussed with the study subject by the surgeon or surgeon designee, prior to 
informed consent, as part of standard of care. 
 
B.   Risks Associated with Total Knee Arthroplasty Procedure/Study Device 
Potential adverse events associated with total knee arthroplasty include, but are not limited 
to: 
 
Wear of the polyethylene articulating surface 
 
Progressive bone resorption (osteolysis) as a result of foreign-body reaction to 
wear debris 
 
Loosening of the prosthetic knee components 
 
Fracture/damage of the prosthetic knee components 
 
Soft tissue impingement or damage 
 
Dislocation and/or joint instability 
 
Malalignment of the prosthetic knee components 
 
Bone fracture 
 
Nerve damage 
 
Swelling 
 
Infection 
 
Leg length discrepancies 
 
Poor range of motion 
 
Delayed wound healing 
 
Temporary or permanent neuropathies 
 
Pain related to knee arthroplasty and placement of NavitrackERs 
 
Cardiovascular disorders including venous thrombosis, pulmonary embolism, or 
myocardial infarction 
 
Histological reactions resulting in inflammation 
 
Metal sensitivity 
 
Corrosion of metal components (the significance and long-term implications are 
uncertain and await further clinical evidence and evaluation) 
 
Minimization of Risk   
 
Although the total knee implants being used in this study are not the study device, complications 
can still occur. Complications and/or failure of prosthetic implants are more likely to occur in 
patients with unrealistic functional expectations, heavy patients, physically active patients, and/or 
with patients who fail to follow through with the required rehabilitation program. Physical activity 
or trauma can result in loosening, wear, and/or fracture of the implant.  The patient must be 
counseled about the capabilities of the implant and the impact it will have on his or her lifestyle.  
The patient must be instructed about all postoperative restrictions, particularly those related to 
occupational and sports activities and about the possibility that the implant or its components may 
wear out, fail or need to be replaced.  The implant may not last the rest of the patient’s life, or any 
particular length of time. Because prosthetic implants are not as strong, reliable, or durable as 
natural, healthy tissues/bones, all such devices may need to be replaced at some point. 
 
 
 

 
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XII. Statistical Considerations 
 
Performance of the commercially available ROSA Knee System will be evaluated for pain, function, 
quality of life, and operative efficiency.  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.  Implant survival and return to function will be summarized 
using a Kaplan-Meier method and presented with rates (as percentages) and confidence 
intervals.  Routine summaries of complication data is represented by frequencies and 
percentages.  Subgroup analysis per indication will also be performed. 
B. Sample Size 
This study does not have a set of hypotheses to prove and will openly enroll patients to monitor 
and analyze safety and efficacy.  Sample size is capped by a maximum enrollment ceiling per 
site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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XIII. References 
 
1. Mont MA, Pivec R, Issa K, Kapadia BH, Maheshwari A, Harwin SF (2014) Long-term implant 
survivorship of cementless total knee arthroplasty: a systematic review of the literature and meta-
analysis. The journal of knee surgery 27 (5):369-376 
2. No authors listed (2017) Australian Orthopaedic Association National Joint Replacement Registry, 
Annual Report 
3. No authors listed (2017) National Joint Registry for England, Wales and Northern Ireland. 14th 
Annual Report 
4. van der List JP, Chawla H, Joskowicz L, Pearle AD (2016) Current state of computer navigation and 
robotics in unicompartmental and total knee arthroplasty: a systematic review with meta-analysis. 
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA 24 (11):3482-3495 
5. Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD (2010) Patient satisfaction after 
total knee arthroplasty: who is satisfied and who is not? Clinical orthopaedics and related research 
468 (1):57-63 
6. Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P (2012) What proportion of patients 
report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of 
prospective studies in unselected patients. BMJ open 2 (1):e000435 
7. Ritter MA, Davis KE, Meding JB, Pierson JL, Berend ME, Malinzak RA (2011) The effect of 
alignment and BMI on failure of total knee replacement. The Journal of bone and joint surgery. 
American volume 93 (17):1588-1596 
8. Fang DM, Ritter MA, Davis KE (2009) Coronal alignment in total knee arthroplasty: just how 
important is it? The Journal of arthroplasty 24 (6 Suppl):39-43 
9. Abdel MP, Oussedik S, Parratte S, Lustig S, Haddad FS (2014) Coronal alignment in total knee 
replacement: historical review, contemporary analysis, and future direction. The bone & joint 
journal 96-b (7):857-862 
10. Thienpont E, Cornu O, Bellemans J, Victor J (2015) Current opinions about coronal plane 
alignment in total knee arthroplasty: A survey article. Acta orthopaedica Belgica 81 (3):471-477 
11. Kallala RF, Vanhegan IS, Ibrahim MS, Sarmah S, Haddad FS (2015) Financial analysis of revision 
knee surgery based on NHS tariffs and hospital costs: does it pay to provide a revision service? The 
bone & joint journal 97-b (2):197-201 
 
Guideline Reference 
 
i. ISO 14155:2011(E). International Standard for Clinical investigation of medical devices for human 
subjects – Good clinical practice  
 
ii. Barnett Educational Services. 2011 Code of Federal Regulations Reference Guide for Medical 
Devices. Revised April 1, 2011.  
 
iii. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI, World Medical Association 
Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. 59th 
WMA General Assembly, Seoul, October 2008.