A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert
Phase: NA
Conditions: Arthroplasty, Knee
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
 
Triathlon PSR Outcomes Study  
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center evaluation of the clinical outcomes of the 
Triathlon Total Knee System using the Triathlon PSR Tibial Insert 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Triathlon PSR Tibial Insert 
Protocol Number: 
103 
510(k) Clearance Number: 
190402 
 
Version 1.1 
Date:  13-Apr-2021 
CONFIDENTIAL 
 
This document is confidential and the property of Stryker Orthopaedics.  No 
part of it may be transmitted, reproduced, published or used by other persons 
without prior written authorization from Stryker.

 
CONFIDENTIAL 
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Page 2 
 
 
 
 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
1 
New 
Ajay Rastogi 
1.1 
Synopsis – Study Device 
Introduction 
Section 3.2 – Additional Devices 
Appendix B 
Ajay Rastogi 

Triathlon PSR Outcomes Study 
 
    
Stryker Clinical Study Protocol 
 
 
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Page 3 
Table of Contents 
STUDY SYNOPSIS ....................................................................................................................................... 1 
EVALUATION SCHEDULE .......................................................................................................................... 5 
1 
INTRODUCTION .................................................................................................................................. 6 
1.1 
BACKGROUND ................................................................................................................................ 6 
2 
CLINICAL STUDY PLAN ..................................................................................................................... 7 
2.1 
STUDY DESIGN .............................................................................................................................. 7 
2.2 
STUDY CENTERS ............................................................................................................................ 7 
2.3 
NUMBER OF SUBJECTS ................................................................................................................... 7 
3 
DEVICE DESCRIPTION ...................................................................................................................... 8 
3.1 
STUDY DEVICE ............................................................................................................................... 8 
3.2 
ADDITIONAL DEVICES ..................................................................................................................... 8 
4 
STUDY PROCEDURES ....................................................................................................................... 9 
4.1 
SUBJECT RECRUITMENT AND SCREENING ....................................................................................... 9 
4.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................... 9 
4.3 
EARLY WITHDRAWAL OF SUBJECTS............................................................................................... 10 
5 
STUDY DETAILS ............................................................................................................................... 12 
5.1 
STUDY OBJECTIVES AND EVALUATION SCHEDULE .......................................................................... 12 
5.2 
RADIOGRAPHIC OUTCOMES .......................................................................................................... 12 
6 
ADVERSE EVENTS ........................................................................................................................... 13 
6.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 13 
6.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 15 
6.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 16 
6.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 17 
6.3.2 
Device Retrieval Process ...................................................................................................... 17 
6.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 18 
6.5 
MEDICAL MONITORING ................................................................................................................. 18 
7 
DATA MANAGEMENT ...................................................................................................................... 19 
7.1 
DATABASE ................................................................................................................................... 19 
7.2 
CONFIDENTIALITY ......................................................................................................................... 19 
7.3 
SOURCE DOCUMENTS .................................................................................................................. 19 
7.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 20 
7.5 
DATA QUERIES ............................................................................................................................ 20 
7.6 
PROTOCOL DEVIATIONS ............................................................................................................... 20 
7.7 
RECORDS RETENTION .................................................................................................................. 20 
8 
STATISTICAL PLAN ......................................................................................................................... 21 
8.1 
STUDY OBJECTIVES ..................................................................................................................... 21 
8.1.1 
Primary Objective Analysis .................................................................................................... 21 
8.1.2 
Secondary Objective Analyses.............................................................................................. 21 
8.2 
SAFETY ....................................................................................................................................... 22 
8.2.1 
Safety Parameters ................................................................................................................. 22 
8.2.2 
Safety Analyses ..................................................................................................................... 22 
8.3 
MISSING DATA ............................................................................................................................. 22 
8.4 
STATISTICAL METHODOLOGY ........................................................................................................ 22 
8.4.1 
Data Summary....................................................................................................................... 22 
8.4.2 
Sample Size Justification ...................................................................................................... 23 

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8.4.3 
Interim Analyses .................................................................................................................... 23 
8.4.4 
Analysis Population ............................................................................................................... 23 
9 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................. 23 
9.1 
STUDY MONITORING PLAN ............................................................................................................ 23 
9.2 
AUDITING AND INSPECTING ........................................................................................................... 24 
10 
PUBLICATION PLAN ........................................................................................................................ 24 
11 
RISK/BENEFIT ASSESSMENT ......................................................................................................... 25 
11.1 
RISK CATEGORY .......................................................................................................................... 25 
11.2 
POTENTIAL RISK .......................................................................................................................... 25 
11.3 
EXPECTED COMPLICATIONS .......................................................................................................... 27 
11.4 
PROTECTION AGAINST RISKS........................................................................................................ 27 
11.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 28 
12 
ETHICAL CONSIDERATIONS .......................................................................................................... 28 
13 
STUDY FINANCES ............................................................................................................................ 29 
13.1 
FUNDING SOURCE ........................................................................................................................ 29 
13.2 
CONFLICT OF INTEREST ................................................................................................................ 29 
13.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 29 
14 
REFERENCES ................................................................................................................................... 30 
 
 
 

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Page 5 
List of Appendices 
 
Appendix A 
 
FDA 510(k) Clearance Letters 
Appendix B 
 
Component Listing 
Appendix C 
 
Model Informed Consent Form 
Appendix D 
 
Suggested Radiographic Technique 
Appendix E 
 
Retrieved Implant Analysis Protocol 
Appendix F 
 
Draft Specifications for Electronic Case Report Forms 
Appendix G 
 
Draft Radiographic Evaluation Form Specifications  
Appendix H 
 
Product Labeling 
 
 
 
 
 

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Page 6 
List of Tables and Figures 
TABLE 1: ACCEPTABLE ADDITIONAL DEVICES .................................................................................... 8 
TABLE 2: ACCEPTABLE ACCESSORY DEVICES ................................................................................... 9 
FIGURE 1. ADVERSE EVENT DECISION TREE ...................................................................................... 14 
 
 
 
 
 

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List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CPTi 
Commercially Pure Titanium 
CSM 
Clinical Study Manager 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
International Conference of Harmonization Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
PI 
Principal Investigator 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-36 
Short Form-36 
TKA 
Total Knee Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene
 
 

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Study Synopsis 
 
Title 
A prospective, post-market, multi-center evaluation of the clinical 
outcomes of the Triathlon Total Knee System using the Triathlon PSR 
Tibial Insert 
Short Title 
Triathlon PSR Outcomes Study 
Protocol Number 
103 
Phase 
Post-market 
Methodology 
This study is a prospective, post-market, non-randomized evaluation of 
the change between the preoperative and postoperative SF-36 
outcomes in a consecutive series of primary total knee arthroplasty 
(TKA) patients who meet the eligibility criteria and received the 
Triathlon Globalization Knee System.  
Study Duration 
 Enrollment period of 24 months  
 Follow-up of each primary cemented TKA case to 10 years 
 Approximate 12-year total duration 
Number of Centers 
2 - 8 centers 
Hypothesis 
The SF-36 physical scores at 2 years for subjects receiving a cemented 
Triathlon Total Knee with the Triathlon PSR insert is comparable with 
that of historical Triathlon PS cemented constructs. 
Objectives 
Primary: 
 
To compare the SF-36 physical scores for subjects receiving a 
cemented Triathlon Total Knee with the Triathlon PSR insert to 
scores for subjects who received historical Triathlon PS 
cemented constructs at 2-years postoperative. 
 
Secondary Objectives: 
 
To evaluate the change between the preoperative and 
postoperative EQ-5D scores. 
 
 
To evaluate range of motion (ROM) at 2-years postoperative. 
 
 
To evaluate the survivorship of the Triathlon PSR insert at 10-
years postoperative.  

Triathlon PSR Outcomes Study 
 
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Additional Data 
Collection 
 
Subject demographics and medical histories are collected (age, 
sex, primary diagnosis, BMI, comorbidities, medications used, 
smoking history, alcohol use, education level, employment status, 
confounding orthopedic problems, etc.). 
 
 
2011 KSS will be presented with respect to improvement from 
preoperative scores.   
 
 
The Forgotten Joint Score (FJS) will be collected at 2-years 
postoperative. 
 
 
Assessment of radiographic outcomes using Anteroposterior (AP), 
Mediolateral (ML) and Merchant radiographs. 
 
 
A Follow-up Questionnaire is administered to assess patient 
satisfaction, pain, study device survivorship and capture adverse 
events (AEs). 
 
 
Collection and evaluation of device related AEs and unanticipated 
adverse device effects (UADEs). 
Statistical 
Methodology 
Primary Objective: 
 The mean SF-36 physical score at 2-years postoperative will 
be compared to 47.3 (the reference score from the historical 
control) with a non-inferiority margin of 2.5 points.  
 A two sided 90% confidence interval will be computed for the 
mean SF-36 score. If the lower bound is greater than 44.8, 
the non-inferiority hypothesis holds. 
 
Secondary Objectives: 
 
The change of EQ-5D from preoperative to postoperative will be 
compared using a paired t-test. 
 
The mean ROM at 2-years postoperative will be compared to the 
reference value from the historical control (124 degrees) with an 
error margin of 5 degrees. A TOST (two one-sided test) will be 
used to test the difference. 
 
A Kaplan-Meier survival curve for all-cause revision/removals will 
of the Triathlon PSR insert will be displayed at 10-years 
postoperative. The survival rate will also be presented with a two-
sided 95% confidence interval.  
Number of Cases 
A total of 250 cases (knees) will be enrolled in the study.  
 
Cases must receive the appropriate study device to count toward 
enrollment. 

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Study Device 
Required Components: 
 
Triathlon PSR Insert (X3 EtO) 
 
Compatible Stryker tibial baseplates, femoral components, and patellar 
components must be used in accordance with the applicable 
Instructions for Use and Surgical Technique(s). All components must 
be cemented with respect to the bone. 
 
Additionally, a variety of compatible Triathlon device accessories may 
be used, as indicated in the surgical protocol. 

Triathlon PSR Outcomes Study 
 
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Inclusion/Exclusion 
Criteria 
Inclusions: 
A. Patient has signed an IRB/EC approved; study specific 
Informed Patient Consent Form. 
 
B. Patient is a male or non-pregnant female, skeletally mature, 
age 18-75 years at time of study device implantation. 
 
C. Patient has a diagnosis of Non-Inflammatory Degenerative 
Joint Disease (NIDJD). 
 
D. Patient is a candidate for primary cemented total knee 
replacement. 
 
E. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations and 
rehabilitation. 
 
Exclusions: 
1. Patient has a Body Mass Index (BMI) > 45. 
 
2. Patient is already participating in the study for a contralateral 
total knee replacement. 
 
3. Patient has a diagnosis of avascular necrosis or inflammatory 
arthritis. 
 
4. Patient has an active or suspected latent infection in or about 
the affected knee joint at time of study device implantation. 
 
5. Patient has any mental or neuromuscular disorder which  would 
create an unacceptable risk of prosthesis instability, prosthesis 
fixation failure, or complications in postoperative care. 
 
6. Patient has a compromised bone stock which cannot provide 
adequate support to the prosthesis. 
 
7. Patient is immunologically suppressed or receiving steroids in 
excess of normal physiological requirements (e.g. > 30 days). 
 
8. Patient is diagnosed with lumbar radicular pain. 
 
9. Patient has severe instability of the knee joint secondary to the 
absence of collateral ligament integrity and function. 
 
10. Patient has a known sensitivity to device materials. 
 
11. Patient is a prisoner. 
Reference Therapy 
Reference Control: Triathlon PS Cemented Femur with PS Insert (X3 
and N2Vac), Triathlon Primary Cemented Baseplate, and Triathlon 
Patellar Component (X3 and N2Vac) 
 
ClinicalTrials.gov Identifier: NCT00957021 

Triathlon PSR Outcomes Study 
 
 
 
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     Evaluation Schedule 
Evaluation 
 
Preop 
X-rays 
(-1 yr) 
CRFs 
(-4 mos) 
Intraop 
6 wks 
(+ 3 wks) 
1 yr 
(+ 2 mos) 
2 yrs 
(+ 2 mos) 
3 yrs 
(+ 3 mos) 
4 yrs 
(+ 4 mos) 
5 yrs 
(+ 4 mos) 
Annually 
6, 7, 8, 9 yrs 
(+ 4 mos) 
10 yrs 
(+ 4 mos) 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
 
 
 
Demographics & 
Medical History 
X 
 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
 
 
 
Preoperative KSS 
X 
 
 
 
 
 
 
 
 
 
Postoperative KSS 
 
 
X 
X 
X 
 
 
X 
 
X 
FJS 
 
 
 
 
X 
 
 
 
 
 
SF-36 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
EQ-5D 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Radiographs: 
AP/ML/Merchant View 
X 
 
X 
X 
X 
 
 
X 
 
X 
Follow-up Questionnaire 
 
 
 
 
 
X 
X 
 
X 
 
X: Evaluation is required for all cases. 
   
KSS: The 2011 KSS is a standardized instrument with both patient-reported outcomes and surgeon completed sections that evaluate function, satisfaction, expectations and range of 
motion. 
FJS: The FJS is a 12-item questionnaire assessing a patient’s ability to forget his/her artificial joint in everyday life. 
SF-36: The SF-36 is a standardized 36 item patient reported outcome questionnaire that evaluates general health and well-being. 
EQ-5D: The EQ-5D is a standardized instrument for use as a measure of health outcome.  
Follow-up Questionnaire: The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, study device survivorship and AEs. 
AP View: Radiographic view of the knee containing the femoral component, medial and lateral femoral epicondyles, and tibial component. 
ML View: Radiographic view of the knee containing the patella, patellar component, and overlapping posterior condyles of the femoral and tibial component. 
Merchant View: Radiographic view of the knee containing the articular surface of the patella and femur. 
 

Triathlon PSR Outcomes Study                                                                                         
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Stryker Clinical Study Protocol  
 
 
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This document is a protocol for a human research study.  This study will be conducted in 
compliance with the protocol, Good Clinical Practice (GCP) Standards, Health Insurance 
Portability and Accountability Act (HIPAA) requirements, applicable Food and Drug 
Administration (FDA; 21 Code of Federal Regulations (CFR)), European, and International 
Organization for Standardization (ISO) regulations (ISO 14155).  
1.1 Background 
Primary total knee arthroplasty (TKA) has consistently shown to reliably relieve pain and 
improve function for patients suffering from end-stage knee arthritis.1 
  
The Triathlon Knee system is designed to meet patients’ reasonable expectations for patient 
satisfaction and return to function. As a next-generation knee replacement, the Triathlon Knee 
System closely mimics natural knee motion providing mobility with stability through or exceeding 
150° of flexion2. The Triathlon design criteria are realized through component features including 
an anatomic, deep flexion radius, flared posterior condyles, a patented Rotary Arc and an 
anatomic patellofemoral track.  
 
Studies of kinematics and biomechanics have identified a constant radius in natural knee motion 
centered about the transepicondylar axis3,4,5. The Triathlon Knee System is the first of its kind 
with a patented anatomic radius. Centering the anatomic radius about the transepicondylar axis 
provides ligament isometry, not only in full extension and 90° of flexion, but through the entire 
range of motion. The anatomic radius is designed to mimic natural knee motion, enhancing 
stability and mobility in activities such as descending and ascending stairs or any similar activity 
requiring stability at deep flexion angles. 
 
With the number of patients receiving TKA rising annually, it has become increasingly important 
to accommodate cultural needs to achieve increased rotation in deep flexion for safe, deep knee 
bending. Posterior-stabilized (PS) implants have been shown to allow for higher flexion than 
cruciate-retaining (CR) implants making them better candidates to support the desired range of 
motion6. 
 
1 Introduction 

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Axial rotation is an important consideration when looking to develop safe, high flexion implants. 
Natural axial rotation is approximately 30° through 120° of flexion. Replicating this degree of 
axial rotation in high-flexion implants is important in supporting the extensor mechanism at deep 
flexion and maximizing range of motion7. 
 
The Triathlon (PSR) tibial insert has been designed to accommodate the need for deep knee 
bending by reducing rotational constraint in deep flexion. The insert maintains key Triathlon PS 
design features including the post size and location, 45° tibial post-femoral cam engagement, 
Rotary Arc & Sagittal profile, and 10°-110° single radius flexion. The posterior reduction of the 
PSR insert allows the knee to better replicate the degree of normal axial rotation during deep 
knee bending. The Triathlon PSR insert is cleared for use under K190402. See Appendix A for 
clearance letters.  
 
2 Clinical Study Plan 
2.1 Study Design 
A prospective, post-market, multi-center design will be employed.  Radiographs will be assessed 
by an independent reviewer. 
2.2 Study Centers 
Cases will be enrolled at two to eight centers.  There is no maximum limit to the number of cases 
that a center may enroll.  In the event that a center far exceeds enrollment at other centers, Stryker 
may ask the center to cease enrollment so as not to skew the data.  All participating centers will 
comply with the federal regulations regarding patient informed consent and Institutional Review 
Board (IRB) or Ethics Committee (EC) approval.  Non-compliance of a study center may result in 
termination of the center’s participation in the study. 
2.3  Number of Subjects 
Cases will be enrolled until at least 250 cases have received the Triathlon Total Knee System 
with the Triathlon PSR insert.  
 

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3 Device Description 
3.1 Study Device 
All cases in this post-market study will receive a Triathlon PSR insert.   
 
The Triathlon PSR insert is intended to be used as a component in primary TKAs receiving a 
Triathlon Total Knee System. Fabricated from X3 ultra-high molecular weight polyethylene 
(UHMWPE), the insert is designed to reduce rotation constraint at deep flexion. The insert must 
be used with a compatible Triathlon baseplate, PS femoral component, and patellar component.  
For the purposes of the study, all components must be cemented with respect to the bone. 
 
The Triathlon PSR insert is available in 9 sizes (Size 0-8) and 8 thicknesses (9, 10, 11, 12, 14, 
16, 19, and 22 mm). Only Sizes 1-8 will be used in this study. All Triathlon PSR inserts will have 
a catalog number with the following format: 
 
8532-G-XXX-E 
 
The full listing of permissible Triathlon PSR catalog numbers may be found in Appendix B. 
3.2 Additional Devices 
The following Stryker compatible devices are to be used, according to this study protocol: 
Table 1: Acceptable Additional Devices  
Required Additional Components 
5515-F-XXX  
Triathlon PS Cemented Femur 
5520-B-XXX 
Triathlon Primary Cemented Tibial Baseplate 
5521-B-XXX 
Triathlon Universal Tibial Baseplate 
5550-G-XXX 
Triathlon Patellar Component, Symmetric (X3) 
5550-G-XXX-E Triathlon Patellar Component, Symmetric (X3 EtO) 
5550-L-XXX 
Triathlon Patellar Component, Symmetric (N2Vac) 
5551-G-XXX 
Triathlon Patellar Component, Asymmetric (X3) 
5551-G-XXX-E Triathlon Patellar Component, Asymmetric (X3 EtO) 
5551-L-XXX 
Triathlon Patellar Component, Asymmetric (N2Vac) 
 
Any on-label, compatible accessories may also be used. This includes, but is not limited to:  
 
 
 
 
 

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Table 2: Acceptable Accessory Devices  
Acceptable Additional Components 
5575-X-000  
Triathlon Femoral Distal Fixation Pegs 
5540-A-YYY 
Triathlon Femoral Distal Augment & 
Locking Screws 
5 mm 
5541-A-YYY 
10 mm  
5542-A-YYY 
15 mm 
5543-A-Y00 
Triathlon Femoral Posterior Augment & 
Locking Screws 
5 mm 
5544-A-Y00 
10 mm  
5545-A-YYY 
Triathlon Tibial Augment 
5 mm 
5546-A-YYY 
10 mm  
5549-A-1YY 
Triathlon Tibial Cone Augment 
Symmetric 
5549-A-2YY 
Asymmetric 
5560-S-YYY 
Triathlon Cemented Stem 
5565-S-0YY 
Triathlon Fluted Stem 
100 mm 
5566-S-0YY 
150 mm 
5570-S-0Y0 
Triathlon Offset Adaptor  
5571-S-0YY 
Triathlon Stem Extender 
 
 
The compatible Stryker components are listed in the surgical protocol and Appendix B. 
 
In the case of any uncertainty regarding device compatibility, the current version of the Triathlon PS 
surgical protocol should be reviewed. 
4 Study Procedures 
4.1  Subject Recruitment and Screening 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  Advertising for the study at each center will be at the discretion of the investigator.  All 
handouts, brochures, advertisements, etc. must be approved by the IRB/EC prior to the 
dissemination of any recruitment materials to potential subjects.  
 
During the preoperative visit, patients that are possible candidates for this study will be screened 
to determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, the 
investigator will propose participation in the study to the patient, according to GCP guidelines.  
Patients must sign an IRB/EC approved Informed Patient Consent Form prior to participation in 
the study, as well as prior to any data collection. 
4.2   Patient Informed Consent and Guidelines 
All patients for this study will be provided an Informed Patient Consent Form describing this study 
and providing sufficient information for them to make an informed decision about their 

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participation.  The Informed Patient Consent Form must contain all elements required by the FDA 
under 21 CFR Part 50, in addition to any other elements required by state, local and institutional 
policies.  For international sites, the applicable country regulations are required.  See Appendix 
C for a copy of the Model Informed Patient Consent.  This will be submitted with the protocol for 
review and approval by the IRB/EC for the study.  All patients must provide written consent after 
having had adequate time to consider their participation in the study.  The formal consent of a 
patient, using the IRB/EC approved Informed Patient Consent Form, must be obtained before that 
patient is submitted to any protocol related procedures that are not part of normal care.  Written 
documentation of consent must be provided on the Informed Patient Consent Form’s signature 
page in addition to a note in the patient medical records indicating the date that consent was 
obtained.  The investigator-designated research professional obtaining the consent must also 
sign this Informed Patient Consent Form.  The patient or his/her legal representative should 
receive a signed copy of the Informed Patient Consent Form, according to GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
 
Use a current IRB/EC approved copy of the Informed Patient Consent Form. 
 
Review thoroughly with the patient, allowing adequate time to consider participation in the 
study and ask questions, before having them sign. 
 
After the patient has consented to the procedures, ensure he/she signs and dates the 
Informed Patient Consent Form. 
 
The person obtaining consent also signs and dates the signature page. 
 
Provide a copy of the signed Informed Patient Consent Form to the patient. 
 
If required, provide the hospital with a copy of the signed Informed Patient Consent Form. 
 
Maintain the signed original in the patient’s study chart. 
4.3  Early Withdrawal of Subjects 
When and How to Withdraw Subjects 
In the event that the subject is discontinued by the investigative center prior to the final study 
evaluation, the subject will be notified by the center that he/she is no longer in the study and a 
Study Termination eCRF will be completed.   
 
The following is a list of reasons for which subjects may be withdrawn and the date of termination 
that should be used on the Study Termination eCRF in each situation.  This list is not all inclusive: 
 

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Termination Reason 
 
 
 
Date of Termination 
Death 
 
 
 
 
 
Date of death 
Investigative center termination  
 
Date of study close-out visit 
Lost to follow-up  
 
 
 
Date Stryker termination approval given 
Voluntary withdrawal 
 
 
 
Date subject notified center of withdrawal 
Revision/removal of study device  
 
Date of revision/removal procedure 
Study device not implanted 
 
 
Date of surgery 
Surgery not performed 
 
 
 
Date Stryker termination approval given 
 
 
At the time of study surgery, it is required that the following components are implanted to be 
included in the analysis: 
o Triathlon PSR Tibial Insert 
o Compatible Triathlon Tibial Baseplate 
o Compatible Triathlon PS Femoral Component  
o Compatible Patellar Component 
 
All components must  be cemented with respect to the bone. 
 
Exchange of the Triathlon PSR Tibial Insert for any reason constitutes a failure and study 
termination for the subject. 
 
If revision of any other component occurs during the study, the event does not constitute a failure 
or study termination. 
 
If the subject fails to return for his/her follow-up appointments, every effort should be made to 
contact the subject to assess his/her health status.  If, after attempting to contact the subject 
through three documented phone calls and a certified letter, the subject still does not respond, 
he/she will be considered lost to follow-up.  A Study Termination eCRF will be completed only 
after notifying Stryker of the subject’s status and being given approval to terminate. 
   
In the event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  Preoperative data must be current within 4 months of the study 
surgery and will need to be re-collected if the surgery is rescheduled more than 4 months from 
the initial data collection.  If the surgery is not to be rescheduled or if the subject is no longer 

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considered an appropriate study candidate, a Study Termination eCRF may be completed only 
after notifying Stryker of the subject’s status and after Stryker has given approval to 
terminate. 
 
When a subject completes the study according to protocol at the final study evaluation, a Study 
Termination eCRF will be completed. 
5 Study Details 
5.1 Study Objectives and Evaluation Schedule 
The primary and secondary study objectives, as well as additional data collection are listed in 
Objectives and Additional Data Collection sections of the Study Synopsis (pages 8 and 9) For 
the evaluation schedule, please reference page 12.  
5.2 Radiographic Outcomes 
Radiographs will be taken and collected in the anteroposterior (AP), mediolateral (ML), and 
merchant views for the preoperative, 6-week, 1-, 2-, 5, and 10-year intervals. The suggested 
radiographic technique for the views required is included in Appendix D. 
 
Radiographs will be evaluated by an independent reviewer throughout the course of the study.  
Parameters for radiographic failures will follow the guidelines that have been set by the Knee 
Society8. Radiographic analysis of the tibial component will employ seven zones (Zone 1 – Zone 
7) in the AP view and three zones (Zone 1 – Zone 3) in the lateral view. Radiographic analysis 
of the femoral component will employ seven zones (Zone 1 - Zone 7) in the lateral view. 
Radiographic analysis of the patellar component will employ five zones (Zone 1 – Zone 5) in the 
merchant view. Numerous parameters will be reviewed including radiolucency, gaps and 
subsidence.  Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is 
defined as radiolucency present. Subsidence is defined as settling of the prosthetic component 
in bone and, for this study, is measured by looking at the change in position of the tibial 
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intervals.  Cases that present with tibial baseplate subsidence of greater than 5 mm or at least 2 
mm radiolucencies in all zones within a single view will be considered radiographic failures. 
 
 
6 Adverse Events 
6.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
 
 
All AEs that meet the definition of serious (see page 22) and occur within the perioperative 
period (intraoperative to hospital discharge) to 90 days postoperative  
 
All AEs related to the operative site, regardless of seriousness or time of occurrence 
 
On postoperative functional evaluations, investigators and SCs will be prompted to question 
subjects as to whether they have seen a doctor for any reason, been hospitalized for any reason 
or have a current impediment to their function. 
 
For the 6-, 7-, 8-, 9-year intervals, only a Follow-up Questionnaire will be administered. SCs will 
be responsible for following up with the subjects regarding any questionable responses received 
on the Follow-up Questionnaire. If it is determined upon this further investigation that a protocol-
defined AE has occurred, the SC will be responsible for completing an AE eCRF, submitting the 
event to Stryker, and reporting the event to the IRB as required.  
 
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
 
 
 
 
 
 
 
 
 
 

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Figure 1. Adverse Event Decision Tree 
 
 
 
 
 
 
No 
Yes 
Yes 
Start 
Site becomes 
aware of 
Adverse Event 
Is the event 
related to the 
operative 
site? 
Does the AE 
meet the 
criteria for 
Seriousness? 
Do NOT report 
to Stryker 
Did the event 
occur within the 
perioperative 
period to 90 
days 
postoperative? 
Report AE to 
Stryker via AE 
eCRF 
End 
Yes 
No 
No 

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General Physical Examination Findings 
At screening for inclusion into the study, any clinically significant abnormality should be recorded 
as a preexisting condition and reported on the Demographics eCRF.  From the time of consent 
forward, any new clinically significant findings or abnormalities that meet the definition of a 
protocol defined AE must also be recorded and documented as an AE. 
Adverse Event Reporting Period 
The study period during which AEs must be reported is normally defined as the period from the 
initiation of any study procedures to the end of the study treatment follow-up.   The start of study 
procedures is considered to be the point of consent.  Any AEs which fit the protocol defined 
reportable events must be reported from the time of consent until study completion. 
 
At each contact with the subject the investigator must seek information on AEs by specific 
questioning and, as appropriate, by examination.  Information on protocol defined AEs should be 
recorded immediately in the source document and also in the appropriate AE module of the eCRF.  
All clearly related signs, symptoms and abnormal diagnostic procedure results should be recorded 
in the source document and grouped under one diagnosis, as appropriate.  The clinical course of 
each event should be followed until resolution or until it is determined at the end of the study that 
the AE will not resolve. 
 
All operative site events occurring at any time as well as all serious adverse events (SAEs) 
occurring within the perioperative period to 90 days postoperative will be collected and compared 
to published data.  It is expected that the AE rates reported for the Triathlon Total Knee with the 
Triathlon PSR insert will be comparable to those for historical Triathlon PS cemented constructs.  
 
6.2 General Adverse Event Definitions 
Following is a list of general AE definitions.  For the purposes of this study, only SAEs occurring 
within the perioperative period to 90 days postoperative, excluding elective procedures, as well 
as all AEs related to the operative site should be reported.   
Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation subject, which changes the 
medical baseline of the subject.  An AE can be an unfavorable and unintended sign, symptom or 

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disease, whether or not related to the study device (AEs may also be referred to as complications).  
See Section 6.1, Reporting of Adverse Events, for the AE reporting requirements for this study. 
 
Anticipated Adverse Event 
An anticipated AE is an AE, of which the nature, severity or degree of incidence is known and 
identified in applicable product labeling, published literature or the study protocol. The list of 
anticipated events is provided in Section 11, Risk/Benefit Assessment. 
 
Serious Adverse Event 
A SAE meets one or more of the following definitions: 
 
Led to death 
 
Led to serious deterioration in the health of the subject, that either resulted in the 
following: 
o A life-threatening illness or injury 
o A permanent impairment of a body structure or a body function 
o An in-patient or prolonged hospitalization  
o A medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
 
Led to foetal distress, foetal death or a congenital abnormality or birth defect 
 
Adverse Device Effect 
An adverse device effect (ADE) is a negative change in the subject’s health that may have been 
caused by, or associated with, the use of the device. 
 
Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) is any serious adverse effect on health, safety 
or any life-threatening problem or death caused by, or associated with, a device if that effect is a 
problem or death not previously identified in nature, severity or degree of incidence, or any other 
unanticipated serious problem associated with a device and related to the rights, safety or welfare 
of subjects. 
6.3 Study Sponsor Notification by Investigator 
Of reportable AEs, certain events must be submitted to Stryker within 24 hours for timely 
notification: 

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Adverse events that require time sensitive reporting: 
An adverse event should be reported to Stryker Clinical Research either by telephone/fax/email 
within 24 hours of the site becoming aware of the event if any of the following apply: 
 
The AE occurs intraoperatively or is related to the surgical procedure. 
 
The AE is considered by the investigator to be device related or if the investigator 
is uncertain regarding the device related assessment; 
 
The AE required a reoperation of the study knee or a revision of any study knee 
components. 
 
At the time of the initial report, the following information should be provided: 
 
Subject number 
 
A description of the event 
 
Date of onset 
 
Current status 
 
Whether study treatment was 
discontinued 
 
Investigator assessment of the 
association between the event and 
the study treatment 
 
An AE eCRF for an AE meeting the criteria above should be completed within 24 hours of the 
investigative center’s awareness, and the de-identified source documentation should be 
submitted to Stryker within 24 hours of the investigative center’s awareness.  These reports will 
be evaluated by Stryker to determine if a Product Inquiry (PI) is required. 
 
It is recommended that all other reportable AEs are submitted through eCRF entry within 2 weeks. 
6.3.1  Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the EC or IRB 
according to their specific requirements.  Copies of each report and documentation of 
EC/IRB notification and receipt will be kept with the investigator’s study files. 
6.3.2  Device Retrieval Process 
If the study device is removed for any reason, Stryker may retrieve the Triathlon PSR 
Insert and/or adjacent tissues for analysis to help characterize potential device-related 
complications.  In the event that the Triathlon PSR Insert is removed from a study subject, 

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the procedure outlined in the Retrieved Implant Analysis Protocol (Appendix E) should 
be followed, as allowed by the hospital and institution.  In addition: 
 
1. 
When revision of a study subject is scheduled, the study coordinator (SC) should 
contact the Clinical Study Manager (CSM) or other Stryker Clinical Research 
personnel assigned to the project, as soon as possible. 
2. 
Stryker Clinical Research will send a retrieval container to the SC. 
3. 
After the device is explanted, the SC or an identified Stryker field representative 
will retrieve the device and place it in the retrieval container, following the 
instructions in Appendix E. 
4. 
The SC, an identified field representative or Stryker Clinical Research will complete 
a Product Inquiry (PI). 
5. 
If not completed by Stryker Clinical Research, the PI should be emailed to Stryker 
Product Surveillance at soprodexreports@stryker.com, as well as to the Clinical 
Research email addresses listed on the Sponsor Contact Sheet. 
6. 
The PI should be attached to the retrieval container and sent to Product 
Surveillance.  A de-identified operative report should be included, when available. 
7. 
Stryker Clinical Research will follow up with Product Surveillance to obtain a PI 
number. 
8. 
A summary of results will be provided to the investigator upon his/her request. 
6.4 Recording of Adverse Events 
All protocol defined AEs occurring during the study period must be recorded; this includes events 
that occur between visit intervals.  The clinical course of each event should be followed until 
resolution or stabilization. 
6.5 Medical Monitoring 
It is the responsibility of the investigator to oversee the safety of the study at his/her center.  This 
safety monitoring will include careful assessment and appropriate reporting of AEs, as previously 
noted.  Stryker will conduct formal investigations via the Product Surveillance Department of those 
AEs which are submitted through our PI System.  
 

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7 Data Management 
7.1  Database 
Data will be collected at each center and entered into Stryker’s Electronic Data Capture (EDC) 
system.  The system can be accessed remotely by each investigative center and the data entered 
will be managed by Stryker.  Subject data will be processed and monitored according to the 
protocol schedule by Stryker or Stryker representatives.  Draft specifications to support eCRFs 
and electronic radiographic evaluation forms are provided in Appendices F and G, respectively. 
7.2  Confidentiality 
This study will comply with the 2002 HIPAA privacy rule.  As such, Stryker will only collect that 
information which is necessary to support the objectives of the clinical study.  Stryker will take 
precautions to ensure that data received is as de-identified as possible.  In the case that some 
identified information is received, Stryker will ensure that any identifying information is not 
reported.  Study subjects will authorize Stryker to use their health information in support of the 
clinical study during the informed consent process.  Should a subject choose to withdraw 
authorization, Stryker may use data collected prior to the withdrawal of authorization.  
7.3  Source Documents 
Source data include all information, original records of clinical findings, observations or other 
activities in a clinical study necessary for evaluation of the study.  Source data are contained in 
source documents.  Examples of these original documents and data records include:  hospital 
records, clinical and office charts, study worksheets, laboratory notes, memoranda, subject 
questionnaires, pharmacy dispensing records, recorded data from automated instruments, 
radiographs, subject files, and records kept at the pharmacy, at the laboratories and at medico-
technical departments involved in the clinical study. 
All data points collected during preoperative and follow-up visits must be documented in the 
subject’s chart.  This includes range of motion values, pain and function as well as AEs and 
additional comments.  The informed consent process should also be documented in the patient 
chart.  Monitors, defined further in Section 9, will be comparing the eCRFs against source 
documents for accuracy.  The monitors will seek to draw a reference between each data point on 
the eCRF and the subject’s chart.  Thus, one cannot derive pain, ROM or function based on a 
chart note that reads “Patient doing well.”  Every effort should be made to ensure complete source 
documentation.  

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Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
7.4  Electronic Case Report Forms 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be documented.  All missing data must be explained.  It is expected that eCRFs 
be completed and that any forms requiring signature are electronically signed by the investigator 
within 2 weeks of the evaluation date. 
7.5  Data Queries 
If errors or omissions are noted by Stryker upon review of the data entered into the eCRFs, a 
query will be sent to the center within the EDC system.  Queries should be answered in a clear 
and comprehensible manner.  
7.6  Protocol Deviations 
Any major deviation from this protocol will be recorded by the Sponsor and must be reported to 
the EC/IRB by the investigational site according to their reporting procedures.  Major protocol 
deviations for this study may include the following; this list may not be all-inclusive:  
 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
 
Patient enrolled does not meet the inclusion/exclusion criteria 
 
Protocol specified study component(s) not implanted 
 
Visit deviations, including: 
o Unavailable primary endpoint 
 
If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
7.7  Records Retention 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or 2 years after the date of investigative center termination. These documents 
should be retained for a longer period if required by an agreement with Stryker. 
 

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8 Statistical Plan 
8.1 Study Objectives 
8.1.1   Primary Objective Analysis 
The primary hypothesis to be tested will be that the mean SF-36 Physical Score (PCS) at 
2-years postoperative with a cemented Triathlon Total Knee with the Triathlon PSR Insert 
is not worse than 47.3 with a non-inferiority margin of 2.5 points. That is, the following 
hypothesis will be tested: 
 
                              H0: µ <= 47.3 – 2.5  vs  HA: µ > 47.3 – 2.5   
 
Here, µ is the mean SF36 PCS at 2-years postoperative with a cemented Triathlon Total 
Knee with the Triathlon PSR insert. The reference value of 47.3 was derived from Triathlon 
PS study where subjects received a cemented Triathlon PS Total Knee with the PS Insert. 
(NCT00957021). 
 
A 90% two-sided confidence interval (CI) will be computed for the mean SF36 PCS at 2-
years postoperative. If the lower bound of the CI is greater than 44.8, then the non-
inferiority holds. If the lower bound of the CI is greater than 47.3, then the mean SF36 
PCS at 2-years postoperative is superior to 47.3. 
8.1.2   Secondary Objective Analyses 
The Kaplan-Meier survival curve of all-cause revision and removal of the Triathlon PSR 
insert will be displayed using SAS/PROC LIFETEST at 10-years postoperative. The 
survival rate at 10 years will be presented with a 95% CI.  
 
The ROM at 2 years will be compared with 124 degrees, as derived from Triathlon PS 
study, using an equivalence margin of 5 degrees. A TOST (two one-sided test) will be 
used with SAS/PROC TTEST to test the difference. 
 
The change between the preoperative and postoperative EQ-5D TTO scores will be 
tested with Paired T-tests. 
 
The analysis for the additional data collected is in Section 8.4.1. 

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8.2 Safety 
8.2.1  Safety Parameters 
Safety parameters include all protocol-defined adverse events as well as all-cause 
revision and/or removal of any component of the Triathlon Total Knee with the Triathlon 
PSR Insert. For details regarding protocol-defined adverse events, see Section 6.1. 
8.2.2  Safety Analyses 
The frequency and percentage of all protocol-defined adverse events will be tabulated. 
All protocol-defined adverse events will be tabulated, and a 95% CI will be 
presented. For details regarding protocol-defined adverse events, see Section 6.1. 
8.3 Missing Data 
 
No missing data will be imputed. 
8.4 Statistical Methodology 
8.4.1  Data Summary 
Descriptive statistics will be computed for all baseline conditions and demographic 
parameters. That is, for continuous data, the N, mean, standard deviation, 
minimum value and maximum value will be computed. For categorical data, the frequency 
will be computed. The data will be presented by appropriate subgroups (e.g., center). 
 
For all additional data collected that are not required for direct support of a study objective, 
data will be summarized according to visit. For parameters represented by continuous 
variables (e.g., BMI), the summaries will consist of the N, mean, standard 
deviation, minimum, and maximum values. For categorical variables (e.g., comorbidities), 
the frequency and percentage in each category will be presented. 
 
Radiographic data will be presented for each visit interval at which radiographs are 
collected. The frequency and percentage of radiographic failures will also be presented 
accordingly. 
 
Documentation of statistical analyses will be performed utilizing SAS® software version 
9.3 or higher. 

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8.4.2  Sample Size Justification 
Based on the Triathlon PS clinical study, it is reasonable to have a SF36 PCS reference 
value of 47.3 (with a standard deviation of 10.7) at 2-years postoperative. Two hundred 
cases are needed to have a power of 95% to detect that the mean SF36 PCS at 2-years 
postoperative is non-inferior to the reference value with a margin of 2.5 at 5% 
significance level. After factoring in a 20% lost to follow-up rate, a total of 250 cases will 
be needed.  
8.4.3  Interim Analyses 
No interim analysis is planned. 
8.4.4  Analysis Population 
Per Protocol Population:  
The study population for analysis will include all non-censored subjects who received a 
cemented Triathlon Total Knee with the Triathlon PSR insert and are available for primary 
objective evaluation at the 2-year primary endpoint. 
 
The primary and secondary objective analyses will be based on the per protocol 
population. 
 
Safety Population:  
The safety population will include all non-censored subjects who received a cemented 
Triathlon Total Knee with the Triathlon PSR insert. 
 
9  Study Monitoring, Auditing, and Inspecting 
9.1  Study Monitoring Plan 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects 
involved in a clinical investigation and the quality and integrity of data submitted as a result of the 
investigation. 
Each investigational site conducting this study will be monitored at least once per year, with 
additional monitoring as necessary. The investigator will allocate adequate time for such 
monitoring activities.  The investigator will also ensure that the monitor or other compliance or 

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quality assurance reviewer is given access to all study-related documents and study-related 
facilities, as applicable, and has adequate space to conduct the monitoring visit, when applicable.  
The monitor will review all source documents and compare them to the data contained in the 
eCRFs, in addition to performing a periodic review of regulatory documents such as EC/IRB 
approvals.  The monitors will need the following: 
 
An area where they can review study data, when monitoring is conducted on site 
 
Access to eCRF data for all cases 
 
Access to source documentation 
 
Regulatory documents 
 
Time to discuss findings with the SC and the investigator  
9.2  Auditing and Inspecting 
A quality assurance audit is a form of review that provides additional confidence to the sponsor 
concerning the validity and accuracy of clinical study data that may be submitted to the FDA or 
for publication.  The purpose of investigator audits is to ensure that the investigator has 
maintained all study information according to the sponsor’s protocol and standard operating 
procedures and in compliance with FDA regulations. 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, 
Stryker and/or government regulatory bodies of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data).  The investigator will 
ensure the capability for inspections of applicable study-related facilities. 
 
10 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted to 
a peer-reviewed journal at the time the study cohort reaches 2 years and 10 years of follow-up.  
Early results with regard to surgical information and postoperative biomechanics may be 
published prior to the 2-year time point.  Additional publication proposals may also be made by 
investigators at any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 
 

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At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 2- and 10-year multi-center publications are submitted.  Although Stryker 
will not be involved in coordinating these independent manuscripts, all publications of the data 
shall be submitted to Stryker for review prior to submission for publication.  Stryker shall not edit 
or otherwise influence the publications other than to ensure that confidential information is not 
disclosed, that no off-label use of Stryker devices is promoted and that the data is accurately 
represented.  Any publications resulting from this study must be submitted to Stryker for review 
at least 60 days prior to submission of publication. 
 
11  Risk/Benefit Assessment 
11.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of the 
primary TKA procedure.  
11.2  Potential Risk 
The study involves the routine assessment of a primary TKA procedure.  The Triathlon PSR Tibial 
Insert has been cleared for use by the FDA, is CE certified, and will be used according to the 
labeling included in Appendix H.  Breach of data privacy is a known risk.  All study assessments, 
patient and physician evaluations as well as radiographs will be kept confidential and will comply 
with the HIPAA privacy rule. 
 
While the expected life of TKA components is difficult to estimate, it is finite.  These components 
are made of foreign materials, which are placed within the body for the potential restoration of 
mobility or reduction of pain.  However, due to the many biological, mechanical and 
physiochemical factors which affect these devices but cannot be evaluated in vivo, the 
components cannot be expected to indefinitely withstand the activity level and loads of normal 
healthy bone. Surgeons should counsel patients against having unrealistic expectations about 
the lifetime of the device. 
 
Risks associated with primary TKA include the following: 
 

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 
Dislocation of the femoral, tibial, or patellar prosthesis can occur due to inappropriate 
patient activity, trauma or other biomechanical considerations. 
 
 
Loosening of total knee components can occur. Early mechanical loosening may result 
from inadequate initial fixation, latent infection, premature loading of the prosthesis, 
component malalignment or trauma. Late loosening may result from trauma, infection, 
biological complications including osteolysis, or mechanical problems, with the 
subsequent possibility of bone erosion and/or pain. 
 
 
Fatigue fracture of total knee components, including tibial, femoral and patellar 
components, has occurred in a small percentage of cases. Knee component fracture may 
result due to inadequate support of the component by the underlying bone or poor 
component fixation. 
 
 
Peripheral neuropathies, nerve damage, circulatory compromise and heterotopic bone 
formation may occur. 
 
 
Serious complications may be associated with any total joint replacement surgery.  These 
complications include, but are not limited to: infection; genitourinary disorders; 
gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary 
disorders, including emboli; myocardial infarction or death. 
 
 
With all implanted devices, asymptomatic, localized progressive bone resorption 
(osteolysis) may occur around the prosthetic components as a consequence of foreign-
body reaction to the particulate matter of metal and UHMWPE.  Particulate is generated 
by interaction between components as well as adhesion, abrasion and fatigue.  
Secondarily, particulates can be generated by third body wear.  Osteolysis can lead to 
future complications, including loosening, necessitating the removal and replacement of 
prosthetic components. 
 
 
Wear of polyethylene components has occurred, and literature reports have associated 
its occurrence with bone resorption, loosening and infection. 
 

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 
Soft tissue imbalance and/or laxity has been related to component malalignment, which 
may result in early wear and/or failure of the implant. 
 
 
Intraoperative fissure, fracture, or perforation of the femur or tibia can occur due to 
impaction of the component into the prepared femur or tibia.  Postoperative femoral or 
tibial fracture can occur due to trauma, the presence of defects or poor bone stock. 
 
 
Asymptomatic, localized progressive bone resorption (osteolysis) may occur around the 
prosthetic components as a consequence of foreign-body reaction to the particulate 
matter of metal, UHMWPE and/or ceramic. Particulate is generated by interaction 
between components as well as adhesion, abrasion and fatigue. Secondarily, 
particulates can be generated by third body wear. Osteolysis can lead to future 
complications, including loosening, necessitating the removal and replacement of 
prosthetic components.  
 
 
Metal sensitivity reactions have been reported following joint replacement. 
11.3  Expected Complications  
Complications associated with TKA procedures, such as those performed with the study device, 
have been reported. These include the potential for but are not limited to: infection, 
genitourinary disorders, gastrointestinal disorders, vascular disorders, bronchopulmonary 
disorder, myocardial infarction, injury to the knee’s neurovascular structures, loosening of the 
components, osteolysis, heterotopic bone formation, deep vein thrombosis, pulmonary 
embolism, metal sensitivity reactions, intraoperative or postoperative fracture of the femur, 
patella or tibia, and the need for re-operation, revision, arthrodesis of the involved joint, 
amputation of the limb and death. The safety analysis will include tabulation of AE rates as well 
as revision/removal rates. 
11.4  Protection Against Risks 
Subjects will be treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or wellbeing 
of the subject, this deviation will be promptly reported to both the EC/IRB and Stryker.   

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This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
11.5  Potential Benefits to the Subject 
There is no guarantee that subjects will personally benefit from inclusion in this study.  Subjects 
may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance.  This study seeks to provide clinicians information about this 
device by comparing it to published results for other similar devices.  Information gathered in this 
study may benefit others undergoing this procedure in the future. 
 
12 Ethical Considerations 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56 as well as 45 CFR Parts 160 and 164, 
as well as ISO 14155. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
EC/IRB for formal approval of the study conduct.  The decision of the EC/IRB concerning the 
conduct of the study will be made in writing to the investigator and a copy of this decision will be 
provided to Stryker before commencement of this study.  The investigator may be asked to 
provide a list of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided an Informed Patient Consent Form 
describing this study and providing sufficient information for patients to make an informed decision 
about their participation.  This Informed Patient Consent Form must be modified to contain center 
specific information and submitted with the protocol for review and approval by the EC/IRB for the 
study.  The formal consent of a patient, using the EC/IRB approved Informed Patient Consent 
Form, must be obtained before that patient is submitted to any study procedure.  This Informed 
Patient Consent Form must be signed by the patient or legally acceptable surrogate and the 
investigator-designated research professional obtaining the consent.  
 
 
 

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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
13 Study Finances 
13.1  Funding Source 
This study is financed by Stryker. 
13.2  Conflict of Interest 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 
Committee-sanctioned conflict management plan that has been reviewed and approved by 
Stryker prior to participation in this study.   
13.3  Subject Stipends or Payments 
Subject attrition can occur for a variety of reasons, including a subject’s loss of health insurance 
coverage.  In a case where a patient has lost health insurance coverage and no other coverage 
is available, Stryker may, on a case-by-case basis, reimburse investigators for office visits and 
radiographic charges for subjects involved in this study in order to facilitate data retrieval.  The 
physician or the office staff should contact the CSM prior to scheduling the subject to discuss this 
possibility and receive pre-approval.  After receipt of the completed data forms, the physician 
must submit either evidence of coverage denial (e.g. explanation of benefits) or a letter explaining 
that the subject does not have insurance.  Other visits, procedures and assessments done other 
than those specified in the protocol will not be reimbursed.  Reimbursement may be provided 
under the following conditions: 
 
Study subjects lose insurance coverage after enrollment into the study 
 
An insurance carrier refuses to pay for a follow-up visit and/or radiographs     
 
An insurance carrier refuses to provide a subject referral to see the investigator for follow-
up  
Additionally at pre-determined study visit intervals, Stryker may reimburse subjects with a modest 
stipend for protocol-required data collection. This stipend system must be approved by the 
Institution’s IRB prior to implementation and will be based upon individual IRB approval from each 
site. 
 
 

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This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
 
1. Brown EC, Scuderi GR, Clarke HD. The Painful Total Knee Arthroplasty: Diagnosis and 
Management. Orthopedics. 2006; 29:129-136.   
2. Stryker Literature Number LTKDR 
3. Hollister AM, Jatana S, Singh AK, Sullivan WW, Lupichuk AG. The Axes of Rotation of the 
Knee. Orthopaedic Laboratory, Harbor-UCLA Medical Center, Torrance. Clin Orthop.1993; 
290:259-268. 
 
4. Freeman, M., et al. Tibiofemoral Movement—Studies in the Cadaveric and Living Knee using  
MRI, Dissection and RSA. British Editorial Society of Bone and Joint Surgery. 2001. 
 
5. Churchill DL, Incavo SJ, Johnson CC, Beynnon BD. The Transepicondylar Axis Approximates 
the Optimal Flexion Axis of the Knee. Clin Orthop. 1998; 356:111-118. 
 
6. Maruyama S., Yoshiya S., Matsui N., et al. Functional Comparison of Posterior Cruciate-
Retaining Versus Posterior Stabilized Total Knee Arthroplasty. J Arthroplasty. 2004; 
19:349. 
7. Tamaki M., Tomita T., Yamakazi T., et al. In Vivo Kinematic Analysis of a High-Flexion, 
Posterior-Stabilized, Mobile-Bearing Knee Prosthesis in Deep Knee Bending Motion. J 
Arthroplasty. 2008; 24: 972-978 
8. Ewald  FC. The Knee Society Total Knee Arthroplasty Roentgenographic 
Evaluation and Scoring System. Clin Orthop and Relat Res. 1989; 248: 9-12. 
  
14 References