A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Triathlon TS Outcomes Study 
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center study of the outcomes of the 
Triathlon Total Stabilizer (TS) Total Knee System 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Triathlon TS Total Knee System 
Protocol Number: 
65 
510(k) Clearance  Numbers: 
K072221 – October 15, 2007 
 
Version 2.0 
Date:  3/27/2013 
 
 
 
 
 
 
 
 
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 
 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Orthopaedics 
 
 
 
 
 
 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
A 8/3/2007 
New 
Rama Ramakrishnan 
B 9/12/2007 
Statistical analysis and sample size 
are included. 
Knee and Osteoarthritis Outcome 
Score (KOOS) is added. 
Rama Ramakrishnan 
C 10/29/2007 
Modified all study design 
parameters, including but not 
limited to primary and secondary 
objectives, reference therapies, 
inclusion/exclusion criteria, and 
evaluation tools. 
Diana F. Comarato 
D 12/3/2007 
Basis of primary objective changed 
to Knee Society Score (KSS). 
Modified non-inferiority statistical 
analysis and sample size included. 
Additional patient questionnaire 
included.  Joint line (JL) guidelines 
modified.  Entire protocol revised.  
Appendices created. 
Diana F. Comarato 
1.0 3/3/2008 
Draft status removed. 
Diana F. Comarato 
2.0 3/27/2013 
Removed trademark and service 
marks per current Intellectual 
Property guidelines. 
Kristin L. Given 

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Added clarification throughout that 
only cases implanted with the 
required study device will count 
toward the enrollment goal. 
 
Updated study devices and 
description to remove the 
unavailable Triathlon TS Extended 
Condyle Femoral Component and 
Triathlon TS Tibial Insert and 
include N2Vac tibial inserts and 
patellar components. 
 
Added Appendix I. 
 
Updated section 12.3 to remove 
references to outdated 
complication rate data. 
 

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Table of Contents 
STUDY SYNOPSIS .................................................................................................................................................... 1 
EVALUATION SCHEDULE ...................................................................................................................................... 6 
1 
INTRODUCTION ............................................................................................................................................... 7 
1.1 
BACKGROUND ................................................................................................................................ 7 
1.2 
STUDY DEVICE ............................................................................................................................... 9 
1.3 
PRECLINICAL DATA ........................................................................................................................ 9 
1.4 
CLINICAL DATA TO DATE................................................................................................................. 9 
2 
STUDY OBJECTIVES .................................................................................................................................... 10 
2.1 
EFFICACY .................................................................................................................................... 10 
2.1.1 
Primary .................................................................................................................................. 10 
2.1.2 
Secondary ............................................................................................................................. 11 
2.2 
SAFETY ....................................................................................................................................... 13 
3 
CLINICAL STUDY PLAN .............................................................................................................................. 14 
3.1 
STUDY DESIGN ............................................................................................................................ 14 
3.2 
NUMBER OF CENTERS .................................................................................................................. 14 
3.3 
NUMBER OF SUBJECTS ................................................................................................................. 14 
3.4 
ESTIMATED STUDY DURATION ...................................................................................................... 15 
4 
ELIGIBILITY .................................................................................................................................................... 15 
4.1 
INCLUSION CRITERIA .................................................................................................................... 15 
4.2 
EXCLUSION CRITERIA ................................................................................................................... 15 
5 
SUBJECT ENROLLMENT ............................................................................................................................ 16 
5.1 
TREATMENT ASSIGNMENT ............................................................................................................ 16 
5.2 
RANDOMIZATION .......................................................................................................................... 16 
6 
DEVICE DESCRIPTION ................................................................................................................................ 16 
6.1 
STUDY DEVICE ............................................................................................................................. 16 
6.2 
DEVICE RETRIEVAL PROCESS ....................................................................................................... 24 
7 
EVALUATIONS ............................................................................................................................................... 25 
7.1 
PREOPERATIVE VISIT ................................................................................................................... 25 
7.2 
SURGERY .................................................................................................................................... 25 
7.3 
6-WEEK VISIT ............................................................................................................................... 25 
7.4 
6-MONTH INTERVAL ...................................................................................................................... 25 
7.5 
ANNUAL FOLLOW-UP VISITS .......................................................................................................... 25 
8 
ADVERSE EVENTS ....................................................................................................................................... 26 
8.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 26 
8.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 28 
8.3 
STUDY SPONSOR FAX NOTIFICATION BY INVESTIGATOR ................................................................. 29 
8.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 30 
8.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 31 
8.5 
MEDICAL MONITORING ................................................................................................................. 31 
9 
STATISTICAL PLAN ...................................................................................................................................... 31 
9.1 
EFFICACY .................................................................................................................................... 31 
9.1.1 
Primary Efficacy Parameters ................................................................................................. 31 
9.1.2 
Secondary Efficacy Parameters ............................................................................................ 31 

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9.1.3 
Primary Efficacy Hypothesis .................................................................................................. 31 
9.1.4 
Primary Efficacy Analysis ...................................................................................................... 32 
9.1.5 
Secondary Efficacy Analysis ................................................................................................. 32 
9.2 
SAFETY PARAMETERS .................................................................................................................. 32 
9.2.1 
Safety Parameters ................................................................................................................. 32 
9.2.2 
Safety Analysis ...................................................................................................................... 32 
9.3 
MISSING DATA ............................................................................................................................. 33 
9.4 
STATISTICAL METHODOLOGY ........................................................................................................ 33 
9.4.1 
Data Summary....................................................................................................................... 33 
9.4.2 
Sample Size Calculation ....................................................................................................... 33 
9.4.3 
Interim Analyses and Early Stopping Considerations ........................................................... 34 
9.4.4 
Efficacy Patient Populations .................................................................................................. 34 
10 
STUDY PROCEDURES ................................................................................................................................. 35 
10.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 35 
10.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 35 
10.3 
EARLY WITHDRAWAL OF SUBJECTS............................................................................................... 36 
11 
DATA MANAGEMENT .................................................................................................................................. 38 
11.1 
DATABASE ................................................................................................................................... 38 
11.2 
CONFIDENTIALITY ......................................................................................................................... 38 
11.3 
SOURCE DOCUMENTS .................................................................................................................. 38 
11.4 
CASE REPORT FORMS.................................................................................................................. 39 
11.5 
DATA CLARIFICATION FORMS ........................................................................................................ 39 
11.6 
PROTOCOL DEVIATIONS ............................................................................................................... 40 
11.7 
RECORDS RETENTION .................................................................................................................. 40 
12 
RISK/BENEFIT ASSESSMENT ................................................................................................................... 40 
12.1 
RISK CATEGORY .......................................................................................................................... 40 
12.2 
POTENTIAL RISK .......................................................................................................................... 40 
12.3 
EXPECTED COMPLICATIONS AND RATES OF OCCURRENCES ........................................................... 41 
12.4 
PROTECTION AGAINST RISKS........................................................................................................ 42 
12.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 42 
13 
STUDY MONITORING, AUDITING, AND INSPECTING.......................................................................... 42 
13.1 
STUDY MONITORING PLAN ............................................................................................................ 42 
13.2 
AUDITING AND INSPECTING ........................................................................................................... 43 
14 
ETHICAL CONSIDERATIONS ..................................................................................................................... 43 
15 
STUDY FINANCES ......................................................................................................................................... 44 
15.1 
FUNDING SOURCE ........................................................................................................................ 44 
15.2 
CONFLICT OF INTEREST ................................................................................................................ 44 
15.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 44 
16 
PUBLICATION PLAN .................................................................................................................................... 45 
17 
REFERENCES ................................................................................................................................................ 47 
 

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Appendices 
Appendix A 
 
Intraoperative Measurement Protocol 
Appendix B 
 
Suggested Radiographic Technique 
Appendix C 
 
Component List 
Appendix D 
 
Study Advertisements 
Appendix E 
 
Model Informed Patient Consent 
Appendix F 
 
Case Report Forms 
Appendix G 
 
Patient Retention Program 
Appendix H 
 
Guidance for Measurement of Range of Motion 
Appendix I 
 
Retrieval Analysis Protocol 
 

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List of Figures 
 
Figure 1. Triathlon TS Total Knee System .................................................................................18 
 
Figure 2. Adverse Event Decision Tree .....................................................................................27 

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List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
AP 
Anteroposterior 
BMI 
Body Mass Index 
CRF 
Case Report Form 
CSA 
Clinical Study Associate 
CSM 
Clinical Study Manager 
DCF 
Data Clarification Form 
EC 
Ethics Committee 
ECF 
Extended Condyle Femur 
FH 
Fibular Head 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HSS 
Hospital for Special Surgery 
ICMJE 
International Committee of Medical Journal Editors 
IPP 
Inferior Pole of the Patella 
IRB 
Institutional Review Board 
JL 
Joint Line 
KOOS 
Knee and Osteoarthritis Outcome Score 
KSS 
Knee Society Score 
LEAS 
Lower Extremity Activity Scale 
ME 
Medial Femoral Epicondyle 
ML 
Mediolateral 
PER 
Product Experience Report 
PI 
Primary Investigator 
PMMA 
Polymethylmethacrylate 
PS 
Posteriorly Stabilized 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-36 
Short Form-36 
TS 
Total Stabilizer 
TT 
Tibial Tubercle 
TKR 
Total Knee Replacement 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene 

Triathlon TS Outcomes Study                                                                                                                      Page 1 
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Study Synopsis 
 
Title 
A prospective, post-market, multi-center study of the outcomes of the 
Triathlon TS Total Knee System 
Short Title 
Triathlon TS Outcomes Study 
Protocol Number 
65 
Phase 
Post-market 
Methodology 
This study will be a prospective, non-randomized evaluation of the 
change between preoperative and postoperative outcomes for those 
receiving the Triathlon TS Total Knee System.   
Study Duration 
• 
Long term follow-up of each revision total knee replacement 
(TKR) case to 5 years 
• 
Anticipated enrollment period of 53 months 
• 
Approximate 10-year total duration 
Study Center(s) 
12 
Hypothesis 
The mean total KSS change is not 10% worse than, or is superior to, 
the expected change according to published revision TKR data, for 
cases implanted with the Triathlon TS Total Knee System as compared 
from preoperative to 2 years postoperative. 

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Objectives 
Primary: 
• 
To evaluate the change in outcomes from the preoperative time 
point to 2 years postoperative in cases implanted with the 
Triathlon TS Total Knee System, with regard to both 
components of the KSS. 
Secondary: 
• 
To evaluate the effect of JL restoration on postoperative 
stability, anterior knee pain and functional performance.  A 
subset of revision TKR cases will be analyzed by comparing 
between two groups: 
• 
Cases with JL restoration > 5 mm and cases with JL 
restoration ≤ 5 mm 
• 
To evaluate the change between preoperative and 
postoperative outcomes other than the KSS for the Triathlon TS 
Total Knee System group. 
• 
To review radiographic stability, revision rates and 
complications for those implanted with the Triathlon TS Total 
Knee System. 
Number of Subjects 
181 cases implanted with the Triathlon TS Total Knee System as 
required under this protocol 

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Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Inclusions: 
 
A. Patient has signed an IRB approved, study specific Informed 
Patient Consent Form. 
B. Patient is a male or non-pregnant female age 18 years or older 
at time of study device implantation. 
C. Patient is a candidate for revision of all femoral and tibial 
components of a total knee replacement. 
D. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations and 
rehabilitation. 
  
Exclusions: 
 
E. Patient has a Body Mass Index (BMI) > 40. 
F. Patient has an active or suspected latent infection in or about 
the affected knee joint at time of study device implantation. 
G. Patient has a neuromuscular or neurosensory deficiency, which 
limits the ability to evaluate the safety and efficacy of the device. 
H. Patient is diagnosed with a systemic disease (e.g. Lupus 
Erythematosus) or a metabolic disorder (e.g. Paget’s Disease) 
leading to progressive bone deterioration. 
I. Patient is immunologically suppressed or receiving steroids in 
excess of normal physiological requirements (e.g. > 30 days). 
J. Patient has a failed unicondylar knee prosthesis. 
K. Patient has a known sensitivity to device materials.  
L. Patient is a prisoner.  

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Study Device 
Triathlon TS Total Knee System 
 
Required Components: 
• 
Triathlon TS Femoral Component  
• 
Triathlon TS Plus Tibial Insert or 
Triathlon PS Tibial Insert 
• 
Triathlon TS Universal Tibial Baseplate 
 
The femoral component and tibial baseplate must be used in a 
cemented application. 
 
The subject’s patellar component may or may not be revised based 
upon surgeon discretion.  If revised, a Triathlon Patellar Component 
must be used, and in a cemented application. 
 
Additionally, a variety of Triathlon TS device accessories may be used. 
Reference Therapy 
Comparison of preoperative to postoperative outcomes, both within the 
study group and with respect to published revision TKR data. 

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Statistical 
Methodology 
 
Primary: 
 
A one-sided 95% confidence interval of the total KSS change from 
preoperative to 2 years postoperative (2 years - preoperative) will be 
computed at 2 years postoperative.  For the non-inferiority comparison, 
the lower bound of this confidence interval will be compared with 63 
points (10% worse than the expected improvement).  For the superiority 
comparison, the lower bound of this confidence interval will be 
compared with 70 points (the expected improvement). 
 
Secondary: 
 
An independent group t-test or a nonparametric test will be used to 
compare the secondary numerical parameters (e.g. KSS, HSS, KOOS) 
between the JL restoration subgroups at 1, 2 and 5 years 
postoperative; and a Chi-square test or Fisher’s exact test will be used 
to compare the secondary categorical parameters (e.g. postoperative 
stability, anterior knee pain and functional performance) between the 
subgroups.  In addition, a paired t-test or Wilcoxon rank sum test will be 
used to compare the change in outcomes other than the KSS from 
preoperative to 1, 2 and 5 years postoperative within the Triathlon TS 
Total Knee System group.  The radiographic stability rates, adverse 
event (AE) rates and revision rates with 95% confidence intervals will 
be presented in tables. 
 

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Evaluation Schedule 
 
Evaluation 
Preoperative 
(4 months prior 
to surgery) 
Intraoperative 
6 weeks 
(+ 2 weeks) 
6 months 
(+ 2 weeks) 
1 year 
(+ 2 months) 
2 years 
(+ 2 months) 
5 years 
(+ 2 months) 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
Demographics & 
Medical History 
X 
 
 
 
 
 
 
Preoperative 
KSS 
X 
 
 
 
 
 
 
Previous Implant 
Information 
 
X 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
Postoperative 
KSS 
 
 
X 
 
X 
X 
X 
SF-36 
X 
 
 
X 
X 
X 
X 
KOOS 
X 
 
 
X 
X 
X 
X 
Hospital for 
Special Surgery 
(HSS) 
Patella Score 
X 
 
 
X 
X 
X 
X 
LEAS 
X 
 
 
X 
X 
X 
X 
Radiographs: 
Anteroposterior 
(AP), 
Mediolateral 
(ML) & Merchant 
(30° of flexion) 
X 
 
X 
 
X 
X 
X 
 
KSS: The KSS is a subjective outcomes tool completed by the investigator that measures 
function, pain, and motion. 
SF-36:  Short Form-36 (SF-36), is a 36 item patient questionnaire that evaluates general health 
and well being. 
KOOS: The KOOS is a self-administered patient questionnaire that assesses pain, symptoms, 
activities of daily living, sport and recreation function, and knee-related quality of life (QOL). 
HSS Patella Score: The HSS Patella Score incorporates both subjective symptoms and 
objective data specific to the patellofemoral joint. 
LEAS: The Lower Extremity Activity Scale (LEAS) is a self-administered patient evaluation 
designed to reflect patient activity.  
 

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1 Introduction 
 
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, associated 
Federal regulations, and all applicable research requirements. 
1.1 Background 
As the population ages, so does the incidence of arthritis and subsequent primary TKR.  
Frequency of revision for failed TKR increases as well, aimed at alleviating pain and improving 
function following time-dependent primary implant failure or complications such as infection and 
fracture.1  The primary goals of revision TKR are to alleviate pain and provide the patient with 
stable, well-functioning TKR through optimal implant fixation and restoration of knee 
biomechanics.  Appropriate TKR biomechanics are established through adequate flexion-
extension gap balancing, proper mechanical and rotational alignment, proper patellofemoral 
mechanics and restoration of the JL.2 
 
Revision TKR outcomes typically decline with each successive revision.3  However, patient 
expectations of postoperative function, pain relief and adequate QOL may not be adjusted for 
the expected decline in functional results observed in revision TKR.  Some long-term data exists 
to describe the effectiveness of revision TKR.  Sheng et al.4 performed a meta-analysis of 
publications on patient outcomes following revision TKR.  Thirty-three studies with a total 
number of 1356 patients were included in this analysis, which reported increased function and 
motion compared to preoperative scores.  The main indication for revision reported is aseptic 
loosening (55%). Other reasons include polyethylene wear (11%), instability (10%), infection 
(7%), progression of disease (4%), osteolysis (4%), bone fracture (4%), component failure (3%), 
stiffness (1%) and pain of unknown origin (1%).  Instability can be caused by malposition of the 
JL, imbalance in flexion and extension gaps or incompetence of the posterior cruciate ligament. 
 
There is little existing data reporting outcomes for a single type of revision TKR prosthesis, such 
as the Triathlon TS Total Knee System.  To date, differences between various revision TKR 
implant systems are not reported in the scientific literature.5  Long-term outcomes data among a 
new generation of revision TKR prostheses is needed. 

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In addition to improving patient outcomes, one of the challenges in revision TKR is restoration of 
the JL.  Improper positioning of the JL has been shown to lead not only to instability but also to 
an increased incidence of anterior knee pain and decreased flexion.6  Malposition may also lead 
to patellar infera and posterior soft tissue impingement by the femoral component.  Mason et 
al.7, in a study of six cadaver knees, investigated four anatomic landmarks for locating the JL 
during revision knee surgery – the medial femoral epicondyle (ME), the fibular head (FH), the 
tibial tubercle (TT), and the inferior pole of the patella (IPP).  In this study, the distance between 
the ME and the JL showed very small patient-to-patient variability.  As a result, it was concluded 
that the ME is a reliable and reproducible landmark for JL measurements. 8 
 
Additionally, Mahoney and Kinsey9 retrospectively reviewed JL restoration and clinical outcomes 
in 22 consecutive femur revision cases. The authors used specialized instruments and were 
able to restore JL to within 2 mm of anatomic position in 12 of the 22 knees.  Flexion and 
extension gap balancing and ME referencing were reliable methods of measuring and achieving 
proper position of the JL.   
 
As a secondary objective, this outcomes study of the Triathlon TS Total Knee System will also 
examine the effect of JL restoration on a subset of revision TKR cases with a non-replaced 
contralateral knee at the time of study surgery.  The effect will be evaluated by comparing 
between cases with JL restoration > 5 mm and cases with JL restoration ≤ 5 mm.  As little as 5 
mm of displacement from the JL can cause laxity in midflexion or tightness, even in a gap-
balanced knee.10 
 
For all cases, at the time of study surgery, surgeons will intraoperatively measure, in millimeters, 
the distance between the ME and the JL in full extension and in 90° of flexion.  This 
measurement will be taken before removal of the previous implants as well as after implantation 
of the final Triathlon® TS Total Knee System. 
 
Additionally, preoperative and postoperative measurements of JL will be taken from AP 
radiographs, as the distance from the proximal tip of the FH to the distal most aspect of the 
femoral component.  When the contralateral knee is non-replaced, the measurement will be 
taken on both sides.  These additional measurements will be obtained during independent 
radiographic review to eliminate interobserver and intraobserver error. 

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The protocol for measuring JL is referenced in Appendix A.  Stability, anterior knee pain and the 
functional component of the KSS will be evaluated with respect to JL. 
1.2 Study Device 
The Triathlon TS Total Knee System has been developed as platform knee technology for 
Stryker Orthopaedics.  The Triathlon TS Total Knee System, cleared for use under FDA 510(k) 
K072221, includes femoral components fabricated from cast cobalt-chromium-molybdenum 
alloy, distal and posterior femoral augments, fluted stems, stem extenders, offset adapters, tibial 
inserts fabricated from ultra high molecular weight polyethylene (UHMWPE) and a patellar 
component also made from UHMWPE.  When mated with the Triathlon TS Universal Tibial 
Baseplate fabricated from cast cobalt-chrome-molybdenum alloy and tibial augments, these 
parts provide a total stabilizing knee replacement.  The Triathlon TS Total Knee System 
features an anatomic radius and shortened posterior condyles.  These features may allow 
patients to achieve a greater range of motion (ROM) and greater stability throughout their ROM.  
Data in support of these marketing claims will be collected in the Triathlon TS Outcomes Study.   
1.3 Preclinical Data 
The following bench tests were conducted on the Triathlon TS Total Knee System components: 
Description of the test 
               Report ID 
Static Shear    
           
– RD-06-122 
Femoral Stem Boss Fatigue  
– RD-06-127 
Femur Fatigue  
          
– RD-06-126 
Single Axis Fatigue            
– RD-06-123 
Varus/Valgus Constraint        
– RD-06-121 
Multi Axis Fatigue  
          
– RD-06-120 
Fluted Stem Fatigue            
– RD-06-119 
Range of Constraint            
– RD-06-124 and RD-06-125 
Copies of all test reports are available at Stryker Orthopaedics.   
1.4 Clinical Data to Date 
This study is the first prospective data collection on the Triathlon TS Total Knee System.  To 
date, early data from this study have been presented at the 2012 meetings of the International 

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Congress for Joint Reconstruction and the Southern Orthopaedic Association.  The abstract is 
summarized below. 
 
Title 
Authors 
Summary 
Anatomic Boss Position 
Decreases the Need for 
Offset in Revision Total Knee 
Arthroplasty 
Hitt, Kirby; Stoker, Manoshi; 
Howard, Michael; Mittal, 
Yogesh and Heekin, David 
Among 83 cases enrolled at 5 
sites, 90.4% did not require a 
femoral offset; this is in 
contrast to previous reports 
that femoral offset adapters 
were needed in 55.4% of 
cases to achieve optimal joint 
line reconstruction.  The 
authors concluded that the 
design of this system 
inherently reduced the need 
for use of the offset adapter in 
the majority of cases due to 
the anatomic boss position. 
  
 
2 Study Objectives 
2.1 Efficacy 
2.1.1 Primary 
The primary objective of this study will be to evaluate the change in outcomes from the 
preoperative time point to 2 years postoperative in cases implanted with the Triathlon TS 
Total Knee System, with regard to both components of the KSS.  The change seen from 
preoperative to postoperative time points will be evaluated within the Triathlon TS group 
and will also be compared to published revision TKR data.  It is expected that the 
change in the Triathlon TS group is non-inferior, or superior, to the published changes 
reported. 

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2.1.2 Secondary 
The secondary objectives of this study will be to evaluate the effect of JL restoration on 
revision TKR with specific reference to effect on postoperative stability, anterior knee 
pain and functional performance at 2 and 5 years postoperatively.  It is expected that the 
Triathlon® TS group with JL elevation > 5 mm is non-inferior to the Triathlon TS group 
with JL elevation ≤ 5 mm. 
 
All outcomes other than the change in KSS, already analyzed as the primary objective, 
will be analyzed from preoperative to 1, 2 and 5 years postoperatively. 
 
Additionally, the long-term performance of the Triathlon TS Total Knee System for 
revision TKR will be evaluated with regard to radiographic stability, revision rate and 
complications when reviewed against published data.   
   
Clinical Outcome 
Clinical outcomes will be evaluated via the total KSS, including pain, motion and 
function, preoperatively and at the 6-week, 1, 2 and 5-year visits. 
 
 
Patient Outcomes  
Four different tools will be used to assess patient health-related QOL preoperatively and 
at the 6-month, 1, 2 and 5-year visits.   
 
The SF-36 is a 36 item patient questionnaire that evaluates general health and well 
being by measuring components of physical and mental health.  The KOOS will be used 
to collect information specific to osteoarthritis outcomes and consists of six areas: 
symptoms, stiffness, pain, functions of daily living, sports and recreational activities and 
QOL.11  The HSS Patella Score incorporates both subjective symptoms and objective 
data specific to the patellofemoral joint.12  The LEAS is a tool that has recently been 
developed and validated to evaluate the level of patient activity.13  
 
Radiographic Outcomes 

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Radiographs will be taken and collected in the AP, ML, and Merchant (30° of flexion) 
views for the preoperative, 6-week, 1, 2 and 5-year intervals.  See Appendix B for the 
radiographic technique to be used. 
 
Radiographs will be evaluated by an independent reviewer for radiolucency of all 
components, and subsidence for the tibial and femoral components of the Triathlon TS 
Total Knee System.  JL measurements will also be taken according to Appendix A.    
 
Patellar component positioning will be assessed to determine the presence of tilt and/or 
displacement.  Parameters for radiographic failures will follow the guidelines that have 
been set by the Knee Society.14  The scoring system for each of the three components is 
determined by measuring the width of the radiolucent lines for each of the zones in 
millimeters for each of the three components.  The total widths are added for each zone 
for each of the three prostheses.   The total produces a numerical score for each 
component.   Failure is defined as a score of 10 or greater, regardless of symptoms.  A 
migrating or shifting prosthesis, with or without the disappearance of radiolucent lines, 
should be considered as a possible or impending failure regardless of the score. 
 
Performance Requirements 
Radiographic analysis of the femoral component will employ seven zones (Zone 1 – 
Zone 7) in the ML view; analysis of the tibial component will employ three zones (Zone 1 
– Zone 3) in the ML view and seven zones (Zone 1 – Zone 7) in the AP view; analysis of 
the patellar component will employ five zones (Zone 1 – Zone 5) in the Merchant (30° of 
flexion) view.  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 is related to 
the distance between fixed bony landmarks on the tibia and the prosthesis.  It should be 
noted that Knee Society guidelines state that direct subsidence without angular 
movement cannot be detected because there is no reference point.15 
 
Surgical Details 
In order to promote efficiency in the operating room, the Triathlon Total Knee 
Instrumentation was consolidated, color coded and configured in modules that 

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correspond to the surgical procedure.  To assess efficiency, measures of surgical time 
will be collected to support future improvements. 
 
JL measurements will also be taken intraoperatively according to Appendix A.  
Investigators will measure, in millimeters, the distance between the ME and the JL.  This 
measurement will be taken in extension and at 90° of flexion, both before and after 
implantation of the Triathlon TS Total Knee System. 
 
Intraoperative gap measurements will also be obtained by using lamina spreaders to 
measure the tibio-femoral distance of the medial and lateral compartments in full 
extension and at 90° of flexion immediately upon removal of the primary implant and 
adequate debridement of fibrous tissue down to viable bone.  Once the lamina 
spreaders have been applied within each compartment, a ruler should be utilized against 
the bone to record the distance between the tibia and femur, in millimeters, if the 
distance cannot be read directly from the instrument. 
 
If available for intraoperative gap measurements, investigators should utilize a femoral 
tibial tensor spreader which additionally allows applied force to be read so that 
consistency is maintained in both extension and flexion.  This type of instrument may 
allow for proper tensing of the medial and lateral ligaments and femoral component 
rotation, to achieve flexion-extension gap balance. 
 
There are numerous measurements required intraoperatively.  Appendix A should be 
referenced for a full summary on required intraoperative measurements.  The majority of 
intraoperative data required is not standard.  Appendix A should be referenced in detail 
so that all source documentation is reflective of non-standard data points collected.  All 
surgical details needed for data collection can be found in Appendix F, on the Surgical 
Details Case Report Form (CRF). 
2.2 Safety 
All operative site events as well as all serious adverse events (SAEs), excluding elective 
procedures, will be collected and reviewed against published data.  It is expected that the AE 
rates reported for the Triathlon TS Total Knee System will be comparable to those reported in 

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the literature for similar revision TKR systems.  Details regarding AE definitions, recording and 
reporting are in Section 8 of this protocol, Adverse Events. 
 
3 Clinical Study Plan 
3.1 Study Design 
A prospective, post-market, multi-center design will be employed.  Radiographs will be 
assessed by an independent reviewer. 
3.2 Number of Centers 
Under Version 1.0 of the protocol, cases were enrolled at 12 centers in the United States.  
These centers will continue to enroll under Version 2.0.  The enrollment goal ranges from 15 to 
26 revision TKR cases implanted with the Triathlon TS Total Knee System per center.  The 
enrollment goal range is dependent upon the number of participating centers.   Although a 
range is presented, there is no maximum limit to the number of cases that a center may enroll.  
In the event that a center far exceeds the enrollment goal, 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 IRB approval.  Non-compliance of a study 
center may result in termination of the center’s participation in the study. 
3.3 Number of Subjects 
Cases will be enrolled in this study until 181 receive the Triathlon TS Total Knee System as 
required under this protocol.  All cases will receive, at a minimum: 
• 
Triathlon TS Femoral Component in a cemented application 
• 
Triathlon TS Plus Tibial Insert or the Triathlon Posteriorly Stabilized (PS) Tibial Insert 
• 
Triathlon TS Universal Tibial Baseplate in a cemented application. 
The subject’s patellar component may or may not be revised, based upon surgeon discretion.  If 
revised, a Triathlon Patellar Component must be used, and in a cemented application.  
Additionally, a variety of device accessories may be used.  All components are described in 
detail in Section 6 of this protocol, Device Description.   

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3.4 Estimated Study Duration  
The enrollment period is estimated to be 53 months; cases will be evaluated as per the 
evaluation schedule until each case reaches 5 years.  To allow for a learning curve with the use 
of the system, enrollment of cases into the study will commence when 3 cases have been 
completed at the center using the Triathlon TS Total Knee System. 
 
4 Eligibility 
 
The following criteria will be used to distinguish patients eligible for enrollment into this study. 
4.1 
Inclusion Criteria 
A. Patient has signed an IRB approved, study specific Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female age 18 years or older at time of study device 
implantation. 
C. Patient is a candidate for revision of all femoral and tibial components of a total knee 
replacement. 
D. Patient is willing and able to comply with postoperative scheduled clinical and 
radiographic evaluations and rehabilitation. 
 
 
4.2 
Exclusion Criteria 
E. Patient has a Body Mass Index (BMI) > 40. 
F. Patient has an active or suspected latent infection in or about the affected knee joint at 
time of study device implantation. 
G. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to 
evaluate the safety and efficacy of the device. 
H. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic 
disorder (e.g. Paget’s Disease) leading to progressive bone deterioration. 
I. Patient is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements (e.g. > 30 days). 
J. Patient has a failed unicondylar knee prosthesis. 
K. Patient has a known sensitivity to device materials. 

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L. Patient is a prisoner. 
 
Exclusion Criterion F states that an infection cannot exist at the time of study surgery.  It should 
be noted that revision for infection is not excluded.  It is expected, however, that for septic 
failures the infection will be cleared prior to implantation of the Triathlon TS Total Knee System. 
For example, two-stage exchange may be performed in combination with intravenous antibiotics 
to clear the infection prior to implantation.16  Regardless of the method used, Exclusion Criterion 
F indicates that the infection must be cleared prior to implantation of the Triathlon TS study 
components. 
 
5 Subject Enrollment 
 
5.1 Treatment Assignment 
All subjects enrolled in this study will be assigned to receive the Triathlon TS Total Knee 
System.   
5.2 Randomization 
This study will enroll under a non-randomized study design. 
 
6 Device Description 
6.1 Study Device 
The Triathlon TS Total Knee System has been cleared for marketing in the United States, and, 
therefore, this study is considered a post-market assessment.  All cases in this study will 
receive, at a minimum, the Triathlon TS Femoral Component, either the Triathlon TS Plus Tibial 
Insert or the Triathlon PS Tibial Insert, and the Triathlon TS Universal Tibial Baseplate.   
 
The Triathlon TS Femoral Component and the Triathlon TS Universal Tibial Baseplate must be 
used in a cemented application.  The subject’s patellar component may or may not be revised, 
based upon surgeon discretion.  If revised, a Triathlon Patellar Component must be used, and in 
a cemented application.  Additionally, a variety of device accessories may be used. 
 

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Device Description: 
The Triathlon TS Total Knee System includes femoral components, distal and posterior femoral 
augments, fluted stems, cemented stems, stem extenders and offset adapters.  When mated 
with the Triathlon TS Universal Tibial Baseplate, tibial inserts and tibial augments, the parts 
provide a total stabilizing knee replacement. 
 
Figure 1 demonstrates the Triathlon TS Total Knee System excluding the Triathlon tibial 
augments, cemented stems, stem extenders and offset adapters.  Appendix C lists all 
components permissible according to this study protocol. 
 

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Figure 1. Triathlon TS Total Knee System 
 
 
 
 
 
 
 
 
FEMORAL COMPONENTS 
The Triathlon TS Femoral Component is intended for use in a cemented application.  The root 
catalog number for the Triathlon TS Femoral Component is: 
 
5512-F-XXX –Triathlon TS Femoral Component 
 
Fluted Stem  
Locking Screw 
Femoral Distal Augment 
Femoral 
Component 
Tibial Insert 
Support Pin 
Tibial Insert 
Locking Wire 
Universal Tibial 
Baseplate 
Femoral Posterior 
Augment 
Fluted Stem  

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The femoral component is available in right and left configurations, and eight proportional sizes 
(1 – 8) to accommodate differences in patient anatomy.  The femoral component is 
manufactured from cobalt chrome.  This component features an intercondylar box that engages 
the mating tibial insert eminence at approximately 40°, depending upon the size of the implant.  
The interior surface (except for the interior surface of the TS box) is grit-blasted to increase the 
surface roughness.  This is intended to promote interdigitation of the polymethylmethacrylate 
(PMMA) bone cement with the surface texture and apposing bone.  The superior portion of the 
box has a boss to allow for modular stem and offset attachments.  There are threaded 
attachment features on the distal and posterior aspects of the femoral component to be used for 
distal and posterior augments.  The threaded attachment on the distal aspect of the component 
also allows for the use of modular pegs. 
 
 
TIBIAL TRAY: 
The Triathlon TS Total Knee System is compatible with the Triathlon TS Universal Tibial 
Baseplate, which is intended for use in a cemented application. The root catalog number for the 
Triathlon TS Universal Tibial Baseplate is: 
 
5521-B-XXX – Triathlon TS Universal Tibial Baseplate 
 
The Triathlon TS Universal Tibial Baseplate, or tibial tray, is available in sizes 1 – 8, is 
fabricated from cast cobalt-chromium-molybdenum alloy and is neutral in configuration.  The 
undersurface of the tibial tray and keel are grit blasted for interdigitation with PMMA bone 
cement.  The keel of the tibial tray is designed with normalizations for rotational stability and 
cement interdigitation.   The superior aspect of the tibial tray has a rim that contains tabs that 
mate with the outer periphery of the tibial insert, along with the locking wire used on the tibial 
insert.  This locking feature is designed to provide secure attachment of the tibial insert to the 
tray, and is designed to reduce micromotion of the tibial insert on the tray. 
 
TIBIAL INSERTS 
A total stabilizing tibial insert has been developed for use with the Triathlon TS Total Knee 
System, in sequentially cross-linked UHMWPE (X3) and N2Vac.   The Triathlon TS Plus Tibial 
Insert is available in sizes 1 – 8, with thicknesses ranging from 9 mm to 31 mm.  Each insert 
size is provided in nine thicknesses to vary the resection gap.   
 

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The tibial insert design is intended to provide ± 2° of varus/valgus constraint when mated with 
the Triathlon TS Femoral Components.   
 
The Triathlon TS Plus Tibial Insert features a preassembled cobalt chrome locking wire that 
secures the tibial insert in the groove of the Triathlon TS Universal Tibial Baseplate.  The 
Triathlon TS Plus Tibial Insert also features a support post that accommodates a cobalt chrome 
tibial support pin, assembled intraoperatively.  The tibial insert support pin is intended to provide 
additional strength and structural integrity of the knee construct compared to other systems 
without a support post. 
 
The Triathlon PS Tibial Insert is also compatible with the Triathlon TS Total Knee System and 
may be used in this study.  The root catalog numbers for the tibial inserts permissible according 
to this study protocol are: 
 
5537-G-XXX – Triathlon TS Plus Tibial Insert 
5532-G-XXX – Triathlon PS Tibial Insert, X3 
5532-P-XXX – Triathlon PS Tibial Insert, N2Vac 
 
X3 polyethylene is a highly cross-linked polyethylene manufactured through a proprietary 
process where the polyethylene receives 30 kiloGrays of gamma radiation, which generates 
free radicals and cross-linking in UHMWPE prior to machining.  The polyethylene is then 
annealed below melting point to promote cross-linking and maintains mechanical strengtha, 
crystallinityb and densityc.  This also stabilizes the free radicalsd.  This process is repeated twice. 
 
a X3 UHMWPE maintains mechanical properties for Tensile Yield Strength and Ultimate Tensile Strength 
of N2Vac gamma sterilized UHMWPE as measured by ASTM D638.  Tensile Yield Strength was 23.2  
0.4 MPa and 23.5  0.3 MPa for N2Vac UHMWPE and X3 UHMWPE, respectively.  Ultimate Tensile 
Strength was 54.8  2.5 MPa and 56.7  2.1 MPa for N2Vac UHMWPE and X3 UHMWPE, respectively. 
 
b X3 UHMWPE has similar crystalline and lamellar structure as N2Vac gamma sterilized UHMWPE as 
measured by Small Angle X-ray Scattering (SAXS) and Differential Scanning Calorimetry (DSC) analysis.  
DSC determined crystallinity was 61.3  0.8% and 61.7  0.6% for N2Vac UHMWPE and X3 UHMWPE, 
respectively.  Lamellar crystal thickness was 23.0 and 23.6 nanometers for N2Vac UHMWPE and X3 
UHMWPE, respectively. 
 
c X3 UHMWPE increases cross-link density over N2Vac gamma sterilized UHMWPE by 87%, as 
measured by swell ratio, per ASTM F2214.  Cross-link density, as measured by swell ratio, was 0.08  
0.00 mol/dl and 0.15  0.01 mol/dl for N2Vac UHMWPE and X3 UHMWPE, respectively. 
 

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PATELLAR COMPONENTS: 
Triathlon Patellar Components for use with the Triathlon TS Total Knee System are available in 
symmetric and asymmetric styles.  The components are intended for use in a cemented 
application for the purposes of this study protocol.  The cementless (metal-backed) option in the 
asymmetric patellar component design is not permissible. 
 
The root catalog numbers for the Triathlon Patellar Components are: 
 
5550-G-XXX – Triathlon Patellar Component, Symmetric, X3 
5550-L-XXX – Triathlon Patellar Component, Symmetric, N2Vac 
5551-G-XXX – Triathlon Patellar Component, Asymmetric, X3 
5551-L-XXX – Triathlon Patellar Component, Asymmetric, N2Vac 
 
The symmetric design is available in six diameters (27 mm, 29 mm, 31 mm, 33 mm, 36 mm and 
39 mm) and four thicknesses (8 mm, 9 mm, 10 mm and 11 mm).  The symmetric design 
features a central cement recess and three pegs on the bone interface surface.  The Triathlon 
Symmetric Patellar Component is intended to be implanted via a resurfacing or inset surgical 
technique.  The asymmetric design is available in five superior/inferior dimensions (29 mm,  
32 mm, 35 mm, 38 mm and 40 mm) and three thicknesses (9 mm, 10 mm and 11 mm).  The 
asymmetric design features a flare in the lateral aspect of the component.  The asymmetric 
patellar component also has a central recess with three pegs for cement fixation.  The Triathlon 
Asymmetric Patellar Component is intended to be implanted using a resurfacing surgical 
technique.  
 
ACCESSORIES: 
Stems 
Fluted stems, manufactured from titanium alloy, are offered in diameters of 10-25 mm (in 1 mm 
increments) and lengths of 100 mm and 150 mm.  The fluted stems are designed to attach to 
both the femoral and tibial components of the Triathlon TS Total Knee System.  One end of the 
 
d X3 UHMWPE virtually eliminates free radicals, as measured by Electron Spin Resonance (ESR).  A 
very low (noise level, near instrument detection limit) concentration of residual free radicals was detected 
in the X3 UHMWPE.  A 99% reduction of free radicals (14  2 x 1014 spins/gram versus 1550  32 x 1014 
spins/gram) was found when compared to N2Vac gamma sterilized UHMWPE. 
 

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fluted stems is threaded and locks into the threaded boss of the femoral and tibial components.   
The stems are tapered and have a 16 mm diameter at the base, which corresponds to the boss 
diameter of the Triathlon TS Universal Tibial Baseplate and the Triathlon TS Femoral 
Component.  The stems are intended for use when additional length and stability are required in 
the tibia or femur.  The fluted stems are intended to be implanted without the use of bone 
cement.  The root catalog numbers for the Triathlon Fluted Stems are: 
 
5565-S-XXX – Triathlon Fluted Stem, 100 mm 
5566-S-XXX – Triathlon Fluted Stem, 150 mm 
 
In the event a cemented stem is needed, the components are offered in diameters of 9 mm, 
12 mm and 15 mm, with lengths of 50 mm, 100 mm or 150 mm. 
 
The root catalog number for the Triathlon Cemented Stem is: 
 
5560-S-XXX – Triathlon Cemented Stem 
 
Stem Extenders and Offset Adapters 
Stem extenders and offset adapters will be available for use with the Triathlon TS Total Knee 
System.  The Triathlon Stem Extenders provide additional stem length options for the system 
(25 mm and 50 mm), while the Triathlon TS Offset Adapters allow for varying stem placement 
within the femoral and tibial canals.  
 
Each component is manufactured from cobalt chrome and is designed to attach to the Triathlon 
TS Femoral Component, Triathlon TS Universal Baseplate and stems.  Additionally, the stem 
extenders can be attached to the offset adapters.  The Triathlon Stem Extenders and Triathlon 
TS Offset Adapters have the male thread of the stems and the female thread of the tibial tray 
and femoral component stem bosses.  
 
The root catalog numbers for the stem extenders and offset adapters permissible for use 
according to this study protocol are: 
 
5571-S-XXX – Triathlon Stem Extender 
5570-S-XXX – Triathlon TS Offset Adapter 

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Femoral Augments 
For cases with severely inadequate medial or lateral femoral bone stock requiring additional 
fixation of the femoral components, femoral augments are included in this system.  Posterior 
and distal femoral augment components are available for attachment to the Triathlon TS 
Femoral Component with a locking screw.  The Triathlon TS Femoral Components feature a 
threaded hole that accepts the locking screws.  
 
The femoral distal augments are made from cobalt chrome and are grit-blasted.  The augments 
are offered in sizes 1 – 8 and are available in 5 mm, 10 mm and 15 mm thicknesses with right 
and left options.  The posterior femoral augments are also made from cobalt chrome and are 
grit-blasted.  The posterior augments are provided in sizes 1 – 8 with 5 mm and 10 mm 
thicknesses.  The femoral augments have a threaded hole that accommodates a cobalt chrome 
locking screw, packaged with the augment.  The Triathlon Femoral Augments can be cemented 
to the Triathlon TS Femoral Component. 
 
The root catalog numbers for the femoral augments and accompanying locking screw 
permissible according to this study protocol are: 
 
5540-A-XXX – Triathlon Femoral Distal Augment, 5 mm 
5541-A-XXX – Triathlon Femoral Distal Augment, 10 mm 
5542-A-XXX – Triathlon Femoral Distal Augment, 15 mm 
 
5543-A-XXX – Triathlon Femoral Posterior Augment, 5 mm 
5544-A-XXX – Triathlon Femoral Posterior Augment, 10 mm 
 
5540-A-000 – Triathlon Femoral Augment Locking Screw 
5545-A-000 – Triathlon Femoral Augment Locking Screw 
 
Tibial Augments 
Medial and lateral tibial augment components are available in right and left configurations for 
mechanical attachment to the Triathlon TS Universal Tibial Baseplate.  The tibial augments are 
attached to the baseplate and a pre-assembled setscrew is then rotated to engage with a slot 
machined into the outer edge of the baseplate keel.  This allows the tibial augment to lock 

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securely onto the baseplate.  The tibial augments are made from cobalt chrome and are offered 
in sizes 1 – 8, in 5 and 10 mm thicknesses. 
 
The root catalog numbers for the tibial augments permissible according to this study protocol 
are: 
5545-A-XXX – Triathlon Tibial Half Block, 5 mm Augment 
5546-A-XXX – Triathlon Tibial Half Block, 10 mm Augment 
6.2 Device Retrieval Process 
 
Stryker Orthopaedics will retrieve any Triathlon TS Total Knee System components and/or 
adjacent tissues for analysis to help characterize potential device-related complications. 
In the event that any portion of the Triathlon TS Total Knee System is removed from a study 
subject, the procedure outlined in the Retrieval Analysis Protocol (Appendix I) should be 
followed.  In addition: 
 
1. When revision of a study subject is scheduled, the study coordinator (SC) should contact 
the Clinical Study Manager (CSM) or Clinical Study Associate (CSA) assigned to the 
project, as soon as possible. 
2. The CSM or CSA 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 I. 
4. The SC, an identified field representative or the CSM/CSA will complete a Product 
Experience Report (PER). 
5. If not completed by the CSM or CSA, the PER should be faxed to Stryker Product 
Surveillance at 201-831-6775, as well as to Stryker Clinical Research at 201-831-6454. 
6. The PER should be attached to the retrieval container and sent to Product Surveillance.  
A de-identified operative report should be included, when available. 
7. The CSM or CSA will follow up with Product Surveillance to obtain a PER number. 
8. A summary of results will be provided to the investigator upon his/her request. 
 
 

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7 Evaluations 
7.1 Preoperative Visit 
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 approved study consent form prior to participating in any 
study related activities.  Consent must be obtained within four months of surgery. 
 
Once the subject has been consented, preoperative data will be collected including: 
demographics, medical history, KSS, AP, ML and Merchant (30° of flexion) radiographs, SF-36, 
KOOS, HSS Patella Score, and LEAS.  All information collected preoperatively will be used to 
quantify the sample population and compare postoperative progress. 
7.2 Surgery 
Surgical details will be collected from the operative notes and at the time of surgery.  Additional 
information, other than standard operative notes, includes the following measurements:  study-
specific surgical times; navigation data, if applicable; flexion-extension gap measurements and 
component fit.   Measurements, in millimeters, of the thickness of the flexion and extension 
space between the ME and the JL will also be collected. 
7.3 6-week Visit 
During the 6-week visit (± 2 weeks), the following evaluations will be collected:  KSS, AP, ML 
and Merchant (30° of flexion) radiographs. 
7.4 6-month Interval 
During the 6-month interval (± 2 weeks), completion of the following evaluations is required:  
SF-36, KOOS, HSS Patella Score and LEAS. 
7.5 Annual Follow-up Visits 
Clinical data will be collected via office visit by the investigator at the following annual 
postoperative intervals:  1-year, 2-year and 5-year.  Tools for postoperative evaluation will be 
the KSS, AP, ML and Merchant (30° of flexion) radiographs.  

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Patient outcomes data will also be collected via patient questionnaires.  At each of the 1-year, 2-
year and 5-year follow-up visits, the SF-36, KOOS, HSS Patella Score and LEAS are required.  
Patient questionnaires may be given to subjects in the office during intervals that require clinical 
data collection. 
 
8 Adverse Events 
8.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
• 
All AEs that meet the definition of serious, excluding elective procedures 
 
• 
All AEs related to the operative site, regardless of seriousness 
 
Elective procedures meeting the definition of an SAE do not need to be reported as AEs 
according to this study protocol.  Examples of such elective procedures include, but are not 
limited to, the following commonly seen events: 
• 
Contralateral TKR 
• 
Total Hip Replacement 
• 
Rotator Cuff Surgery 
• 
Cataract Surgery 
Such events will not be captured on the AE CRF but rather will be captured on the postoperative 
functional evaluation at the 6-week, 1-year, 2-year and 5-year time points.  On these 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. 
 
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 

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Figure 2. Adverse Event Decision Tree 
 
Start
Site becomes 
aware of Adverse 
Event
Is the event related to the 
operative site? 
Report AE to 
Stryker via AE 
Form
Yes
Does the AE meet the 
criteria for Seriousness?
No
Report AE to 
Stryker via AE 
Form
Do NOT report to 
Stryker
No
End
Is the event an 
elective surgery? 
No
Yes
Yes
 
 

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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 CRF.  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 
CRF.  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.   
8.2 General Adverse Event Definitions 
Following is a list of general AE definitions.  For the purposes of this study, only SAEs, 
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 disease, whether or not related to the study device (AEs may also be referred to as 
complications).  See Section 8.1, 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 study protocol.  The list of 
anticipated events is provided in Section 12, Risk/Benefit Assessment. 

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Serious Adverse Event 
A SAE meets one or more of the following definitions: 
• 
Resulted in in-patient hospitalization 
• 
Resulted in prolonged existing hospitalization 
• 
Resulted in persistent or significant disability/incapacity 
• 
Resulted in permanent impairment of a body function or permanent damage to a body 
structure 
• 
Necessitated medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body structure 
• 
Was a life-threatening situation 
• 
Resulted in patient death 
 
Elective procedures meeting the definition of a SAE do not need to be reported as AEs 
according to this study protocol.   
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. 
8.3 Study Sponsor Fax Notification by Investigator 
Of reportable AEs, certain events must be submitted to Stryker within 24 hours for timely 
notification: 
 
Adverse events that require time sensitive reporting: 
An adverse event should be reported to the study sponsor (CSM or CSA) either by 
telephone/fax/email within 24 hours of the site’s becoming aware of the event if any of the 
following apply: 

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• 
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. 
     
An AE CRF must be completed by the investigator and submitted to Stryker within 24 hours. 
The investigator will keep a copy of this AE CRF on file at the study center and submit the hard 
copy as per CRF data submission procedures.   If a SAE occurs, the de-identified source 
documentation must be submitted within 24 hours of the investigative center’s SAE awareness.  
These reports will be evaluated by Stryker to determine if a Product Experience Report (PER) is 
required. Report SAEs to: 
 
Michael Howard 
 
 
 
Danielle Anthony 
Phone:  201-831-5807 
 
 
Phone: 201-831-5498 
Fax:  201-831-6807 
 
 
 
Fax: 201-831-6498 
michael.howard@stryker.com 
 
danielle.anthony@stryker.com 
 
It is recommended that all other reportable adverse events are reported on eCRFs and 
submitted to Stryker within 2 weeks. 
 
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 
 
8.3.1 Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the Ethics 
Committee (EC) or Institutional Review Board (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. 

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8.4 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. 
8.5 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 
noted above.  Stryker will conduct formal investigations via the Product Surveillance Department 
of those AEs which are submitted through our PER System.  
 
9 Statistical Plan 
9.1 Efficacy 
9.1.1 Primary Efficacy Parameters  
The primary efficacy parameters will be total KSS, KSS pain score and KSS functional 
score, recorded at 2 years postoperative.  
9.1.2 Secondary Efficacy Parameters 
The secondary efficacy parameters will include: 
• 
KSS pain and function score changes from preoperative at 1, 2 and 5-year visits 
• 
SF-36 changes from preoperative at 1, 2 and 5-year visits 
• 
KOOS changes from preoperative at 1, 2 and 5-year visits 
• 
HSS Patella Score changes from preoperative at 1, 2 and 5-year visits 
• 
LEAS score changes from preoperative at 1, 2 and 5-year visits 
9.1.3 Primary Efficacy Hypothesis 
For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 
years postoperative will be less than or equal to .  The alternative hypothesis, H1a, will 
be that the total KSS change from preoperative to 2 years postoperative is greater than 
.  When =63 (see explanation in Section 9.4.2, Sample Size Calculation), the 
hypothesis will test for non-inferiority.  When =70, the hypothesis will test for superiority. 
H0: 2-year  - preop   
Ha: 2-year  - preop >  

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9.1.4 Primary Efficacy Analysis 
A one-sided 95% confidence interval of the total KSS change from preoperative to 2 
years postoperative (2 years - preoperative) will be computed at 2 years postoperative.  
For the non-inferiority comparison, the lower bound of this confidence interval will be 
compared with 63.  For the superiority comparison, the lower bound of this confidence 
interval will be compared with 70.  
9.1.5 Secondary Efficacy Analysis 
A two-sided 0.05 alpha level will be used. 
 
For the secondary efficacy parameters when data is available, comparisons of numerical 
variables between subgroups (e.g. JL groups) will be made by a paired t-test or 
Wilcoxon rank sum test; comparisons of categorical variables between subgroups will be 
made by a Fisher’s exact test.  
 
One-way analysis of covariance (ANCOVA) may be used as a supportive analysis to 
determine if the score change from preoperative is significantly different between the 
subgroups after adjusting the preoperative covariates (e.g. age, gender, BMI), if 
appropriate.  
 
The mean score improvement from the preoperative time point within the Triathlon® TS 
Outcomes Study will be summarized in tables at each nominal visit.  A p-value will be 
presented to determine if the mean score improvement from the preoperative time point 
is non-zero, if appropriate.  
9.2 Safety Parameters 
9.2.1 Safety Parameters 
Safety parameters will include all AEs reported, radiographic stability at 1, 2 and 5-year 
visits and revision rates. 
9.2.2 Safety Analysis 
All AEs will be listed, tabulated and summarized by event, number and percent of 
cases/subjects.  AE rates and 95% confidence intervals will be presented.  In addition, 
a Fisher’s exact test will be used to compare the AE rates between the subgroups or 
cohorts, if appropriate. 

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For categorical variables, such as radiographic stability, revision rates and 
complications, the number and percent in each category will be presented.  
9.3 Missing Data 
No missing data will be imputed for the primary analysis and secondary analyses.   
9.4 Statistical Methodology 
9.4.1 Data Summary 
The following is a detailed proposal of statistical analyses planned for data collected 
during the study. 
 
Descriptive statistics will be computed for all preoperative conditions and demographic 
parameters.  That is, for continuous data (e.g. KSS) the N, mean, median, standard 
deviation, minimum and maximum will be computed.  For categorical data (e.g. gender) 
the frequency will be computed.  If appropriate, the data will be presented by appropriate 
subgroups (e.g. center). 
 
Descriptive statistics and statistical comparisons for important demographic, efficacy and 
safety variables will be provided in tables.   
 
Statistical analyses will use SAS® software version 9.1 or higher. 
9.4.2 Sample Size Calculation 
A total of 181 cases implanted with the Triathlon TS Total Knee System will be enrolled 
in the study.  The mean total KSS improvement expected, as compared from 
preoperative to 2 years postoperative, is 70 points.17   It is assumed that the mean total 
KSS improvement from preoperative to 2 years postoperative for cases implanted with 
the Triathlon TS Total Knee System will be comparable to the expected rates (not 10% 
or 7 points worse), above 63 points.  Given a standard deviation of 35 for the 
improvement in scores, 80% power, and a one-sided 0.05 alpha level to test the 10% (7 
points) non-inferiority hypothesis, a sample size of 154 subjects will be required to meet 
the primary efficacy objective.  By factoring in a 15% lost to follow-up rate within 2 years, 
a total enrollment of 181 subjects will be needed.  

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9.4.3 Interim Analyses and Early Stopping Considerations 
No interim analysis is planned.  
9.4.4 Efficacy Patient Populations 
9.4.4.1  Efficacy  
Per Protocol Population:  The study population for analysis will include all 
subjects who receive the Triathlon TS Total Knee System.  This does not include 
cases censored from analysis for a reason that may have a significant impact on 
outcome.   
 
The primary and secondary efficacy analyses will be based on the per protocol 
population. 
9.4.4.2 Safety  
Safety Population:  The study population for analysis will include all subjects who 
receive the Triathlon TS Total Knee System.  This does not include cases 
censored from analysis for a reason that may have a significant impact on 
outcome. 
 
9.4.4.3 Survival Analysis 
Modified intent to treat population:  Subjects enrolled in the study who received 
the Triathlon TS Total Knee System will be included in the survival analysis. 
 
9.4.4.4 Censored Cases 
In the event that a protocol deviation occurs which could affect subject outcome, 
the data for the affected subject will be censored from the Efficacy and Safety 
Subject Populations.  All cases that fall into this category will be reported 
separately.   
 
 
 

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10  Study Procedures 
10.1   Subject Recruitment and Screening 
 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  All patients recruited for this study will have the capacity to give informed consent.  
Advertising for the study at each center will be at the discretion of the investigator.  See 
Appendix D for samples of study advertisements.  All handouts, brochures, advertisements, etc. 
must be approved by the IRB prior to the dissemination of any recruitment materials to potential 
subjects. 
10.2   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 
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 E 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 before having them sign. 

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• 
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 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. 
10.3  Early Withdrawal of Subjects 
 
When and How to Withdraw Subjects 
In the event that a subject is discontinued by the investigative center prior to the final study 
evaluation, the subject will be notified by the center that they are no longer in the study and a 
Study Termination CRF 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 CRF in each situation.  This list is not 
all inclusive: 
 
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: 
• 
Triathlon TS Femoral Component  
• 
Triathlon TS Universal Tibial Baseplate 
• 
Triathlon TS Plus Tibial Insert or 
Triathlon PS Tibial Insert 
 

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Revision or removal of a femoral component or tibial baseplate constitutes a failure and study 
termination for the subject. 
 
If tibial insert exchange is required during the study, the event is considered a reoperation and 
does not constitute a failure or study termination. 
 
Patellar component revision at the time of study surgery is optional.  However, if the subject 
requires patellar component revision a Triathlon Patellar Component must be used. 
 
If the patellar component is not revised at the time of study surgery and is later revised, it must 
be revised to a Triathlon Patellar Component.  This event is considered a reoperation and does 
not constitute a failure or study termination. 
 
If a Triathlon Patellar Component is implanted at the time of study surgery and is revised again 
during the course of the study, the event is considered a reoperation and does not constitute a 
failure or study termination.  A Triathlon Patellar Component must be used. 
 
Use of ancillary devices at the time of study surgery is optional.  However, if the patient requires 
ancillary devices, the protocol-specified components must be used. 
 
If ancillary devices are not used at the time of study surgery and are needed at a later date 
during the course of the study, protocol-specified components must be used.  This event is 
considered a reoperation and does not constitute a failure or study termination. 
 
If any protocol-specified ancillary devices implanted are revised or removed at a later date, this 
would constitute a removal but would not result in failure or termination. 
 
If the subject fails to return for their 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 CRF will be completed only 
after notifying Stryker of the subject’s status and being given approval to terminate.   
 

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In the event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  If the surgery is rescheduled more than 4 months from the date of 
preoperative data collection, the subject will need to be re-consented, all preoperative data will 
need to be re-collected and all original preoperative data will need to be removed from the 
database.  If the surgery is not to be rescheduled or if the subject is no longer considered an 
appropriate study candidate, a Study Termination CRF may be completed only after notifying 
Stryker of the subject’s status and being given approval to terminate. 
 
When a subject completes the study according to protocol, including the final study evaluation, a 
Study Termination CRF will be completed. 
 
11  Data Management 
11.1  Database 
Data will be collected at each center and sent to Stryker for entry into a database which will 
reside at Stryker.  Subject data will be collected, processed and monitored according to the 
protocol schedule by Stryker or Stryker representatives.  Final CRFs are provided in Appendix 
F.   
11.2  Confidentiality 
This study will comply with the 2002 privacy rule of the Health Insurance Portability and 
Accountability Act (HIPAA).  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 will not be 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 withdrawal of authorization in order to maintain data integrity.  
11.3  Source Documents 
Source data is all information, original records of clinical findings, observations or other activities 
in a clinical study necessary for the reconstruction and evaluation of the study.  Source data are 
contained in source documents.  Examples of these original documents and data records 
include:  hospital records, clinic and office charts, study worksheets, laboratory notes, 
memoranda, subject questionnaires, pharmacy dispensing records, recorded data from 

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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 follow-up visits must be documented in the subject’s chart.  This 
includes ROM values, pain and function, AEs and additional comments.  The informed consent 
process should also be documented in the patient chart.  Monitors, defined further in Section 13, 
will be comparing the CRFs against source documents for adequacy.  The monitors will seek to 
draw a reference between each data point on the CRF 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. 
Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
11.4  Case Report Forms 
The study CRFs are the primary data collection instrument for the study.  All data requested on 
the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is left 
blank because the procedure was not done or the question was not asked, write “N/D.”  If the 
item is not applicable to the individual case, write “N/A.”  All entries should be printed legibly in 
blue or black ink.  If any entry error has been made, to correct such an error draw a single 
straight line through the incorrect entry and enter the correct data above it.  All such changes 
must be initialed and dated.  Do not erase or white out errors.  For clarification of illegible or 
uncertain entries, print the clarification above the item, initial and date it. 
For specific instructions on CRF completion, please consult the Guide to Case Report Forms 
provided under separate cover.  It is recommended that CRFs be completed, signed by the 
investigator and returned to Stryker within 2 weeks of the evaluation date. 
11.5  Data Clarification Forms 
If errors or omissions are noted by Stryker upon receipt of the forms, a data clarification form 
(DCF) will be sent to the center.  DCFs should be answered in a clear and comprehensible 
manner.  If the DCF requires a change to data captured on a CRF, the CRF should be modified 
accordingly.  The DCF should clearly document changes independent of the CRF to which it 
refers.  DCFs must be signed and dated by the investigator.  It is recommended that completed 
DCFs be returned to Stryker within 2 weeks of receipt.  Modified CRFs need not be included in 
conjunction to answered DCFs. 

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11.6  Protocol Deviations 
Any deviation from this protocol will be reported to or identified by Stryker and will be reported to 
the EC/IRB according to their required reporting procedures.  Protocol Deviations for this study 
include, but are not limited to, the following:  
• 
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 
• 
Unavailable primary endpoint 
11.7 Records Retention 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or in the case of non-compliance, 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. 
 
12  Risk/Benefit Assessment 
12.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of 
the revision TKR procedure.  
12.2  Potential Risk 
The study involves the routine assessment of a revision TKR. The device under study has been 
cleared for marketing by the FDA and will be used according to its labeling.  Assessment 
involves questionnaires, patient and physician assessments and routine radiographs.  The 
information collected will be kept confidential and will comply with the HIPAA. 
 
Adverse effects associated with revision TKR include the following: 
 

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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 and 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 or UHMWPE.  Particulate is generated by interaction between 
components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can also be 
generated by third body wear.  Osteolysis can lead to future complications, including loosening, 
necessitating the removal and replacement of prosthetic components. 
 
Early and late loosening of total knee components can occur.  Early biomechanical loosening 
may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or 
trauma.  Late loosening may result from trauma, infection, biological complications including 
osteolysis or mechanical problems, with the subsequent possibility of bone erosion/pain. 
 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
 
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. 
 
Metal sensitivity reactions have been reported following joint replacement. 
 
AEs may necessitate reoperation, revision, arthrodesis of the involved joint or amputation of the 
limb.     
12.3  Expected Complications and Rates of Occurrences 
Complications associated with revision TKA procedures, such as those performed with the 
Triathlon TS Total Knee System, have been reported. These include the potential for: injury to 
the knee’s neurovascular structures, loosening of the components, heterotopic bone formation, 
infection, deep vein thrombosis, pulmonary embolism, metal sensitivity reactions, intraoperative 
or postoperative fracture of the femur or tibia, and the need for reoperation, revision, arthrodesis 

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of the involved joint or amputation of the limb.  The safety objective will compare the Triathlon 
TS Total Knee System complication rates to published rates.   
12.4 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 well 
being of the subject, this deviation will be promptly reported to both the EC/IRB and Stryker.   
12.5 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 
system/device by comparing this treatment/device to published results for other 
treatments/devices.  Information gathered in this study may benefit others undergoing this 
procedure in the future. 
 
Subjects will have incentives to return for follow-up visits through a retention program.  Subjects 
will earn points for completing each follow-up visit within the windows outlined in the protocol 
and without protocol deviations.  They will then have the opportunity to redeem their points for a 
gift (See Appendix G, Patient Retention Program).  Use of this retention program by centers is 
optional. 
 
The monetary value of the gifts to the subjects is modest and should not unduly coerce them to 
participate in the study.  
 
13  Study Monitoring, Auditing, and Inspecting 
13.1  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. 
 

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This study will be monitored at least once a year, with additional visits as necessary. The 
investigator will allocate adequate time for such monitoring activities.  The investigator will also 
ensure that the monitor or other compliance or quality assurance reviewer is given access to all 
study-related documents and study related facilities and has adequate space to conduct the 
monitoring visit.  The monitor will review all source documents and compare them to the data 
contained in the CRFs, in addition to performing a periodic review of regulatory documents such 
as EC/IRB approvals.  The monitors will need the following when they visit: 
• 
An area where they can review study data 
• 
Subject case books 
• 
Patient charts pulled at the center 
• 
Regulatory documents 
• 
Time to meet with the SC and the investigator  
13.2  Auditing and Inspecting 
A quality assurance audit is a form of review that provides additional confidence to a sponsor 
concerning the validity and accuracy of clinical study data that must 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 a 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. 
 
14  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. 
 
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 

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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 should provide a list 
of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided a consent form describing this study and 
providing sufficient information for patients to make an informed decision about their 
participation.  See Appendix E for a copy of the Model Informed Patient Consent.  This 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 IRB 
approved consent form, must be obtained before that patient is submitted to any study 
procedure.  This consent form must be signed by the patient or legally acceptable surrogate and 
the investigator-designated research professional obtaining the consent.  
 
15 Study Finances 
15.1  Funding Source 
This study is financed by Stryker Orthopaedics. 
15.2  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.   
15.3  Subject Stipends or Payments 
Subjects will have incentives to return for follow-up visits through an optional patient retention 
program.  Subjects will earn points for completing each follow-up visit within the windows 
outlined in the protocol and without protocol deviations.  They will then have the opportunity to 
redeem their points for a gift (See Appendix G, Patient Retention Program).  Use of this 
retention program by centers is optional.   
 
The monetary value of the gifts to the subjects is modest and should not unduly coerce them to 
participate in the study.  

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Subject attrition can occur for a variety of reasons, including a subject’s loss of health insurance 
coverage.  In a case where a subject 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. an 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  
Under extreme circumstances, and with prior approval, Stryker may reimburse a subject for the 
cost of transportation to and from the investigator’s office for a protocol-required office visit. 
 
This policy is the same for all participating study subjects and does not bias against any 
particular subject or study cohort.   
 
16 Publication Plan 
 
It is anticipated that publications of the multi-center study results will be compiled and submitted 
to a peer-reviewed journal at the time the study cohort reaches 2 and 5 years of follow-up.  
Additional publication proposals may 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. 
 
Publications will be facilitated by the Chair and the primary investigator (PI) of the study, as 
applicable.  Both individuals will be chosen by Stryker. 

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The PI is solely focused on the multi-center publications and progress towards those 
publications, including recurring updates to centers, center motivation as well as authorship.  If 
the PI does not produce a draft of a publication within 90 days of receiving the results data, 
Stryker will delegate the responsibility to other investigators in the study at its discretion. 
 
The Chair reviews all additional publications proposed by participating investigators based upon 
the study results prior to study completion, on an ongoing basis.  This review includes whether 
or not a proposal will be pursued, as well as imposition of guidelines as to publication 
completion and criteria.  The following summarizes the roles of these parallel positions: 
Chair 
PI 
Contributes to study design 
Contributes to study design 
Assists with study questions requiring expert 
clinical opinion 
Assists with study questions requiring expert 
clinical opinion 
Assists with identification of investigators 
Assists with identification of investigators and 
maintains performance 
Reviews additional publication proposals 
submitted by investigators 
Updates investigators on progress towards 
multi-center results 
Contributing author, if ICMJE guidelines met 
Primary author, multi-center publication of 
primary endpoint data 
 
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 5-year multi-center publication is submitted.  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 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. 

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17 References 
 
 
1 Saleh, K. J., Dykes, D. C., Tweedie, R. L., Mohamed, K., Ravichandran, A., Saleh, R. M., et al. (2002). 
Functional outcome after total knee arthroplasty revision. The Journal of Arthroplasty, 17(8), 967-977. 
2 National Institutes of Health consensus statement on total knee replacement. (2003). Department of 
Health and Human Services, 20(1), 1-32. 
3 Ibid. 
4 Sheng, P., Lehto, M., Kataja, M., Halonen, P., Moilanen, T., & Pajamaki, J. (2003). Patient outcome 
following revision total knee arthroplasty: A meta-analysis. International Orthopaedics, 28, 78-81. 
5 Ibid. 
6 Figgie, H. E., Goldberg, V. M., Heiple, K. G., Moller, H. S., & Gordon, N. H. (1986). The influence of 
tibial-patellofemoral location on function of the knee in patients with the posterior stabilized condylar knee 
prosthesis. The Journal of Bone and Joint Surgery, 68, 1035-1040. 
7 Mason, M., Belisle, A., Bonutti, P., Kolisek, F. R., Malkani, A., & Masini, M. (2006). An accurate and 
reproducible method for locating the joint line during a revision total knee arthroplasty. The Journal of 
Arthroplasty, 21(8), 1147-53. 
8 Ibid. 
9 Mahoney, O. M., & Kinsey, T. L. (2006). Modular femoral offset stems facilitate joint line restoration in 
revision knee arthroplasty. Clinical Orthopaedics and Related Research, 446, 93-98. 
10 Mason, M., Belisle, A., Bonutti, P., Kolisek, F. R., Malkani, A., & Masini, M., 1148. 
11 Roos, E. M., Roos, H. P., Lohmander, L. S., Ekdahl, C., & Beynnon, B. D. (1998). Knee injury and 
osteoarthritis outcome score (KOOS): Development of a self-administered outcome measure. Journal of 
Orthopaedic & Sports Physical Therapy, 78(2), 88-96. 
12 Baldini, A., Anderson, J. A., Zampetti, P., Pavlov, H., & Sculco, T. P. (2006). A new patellofemoral 
scoring system for total knee arthroplasty. Clinical Orthopaedics and Related Research, 452, 150-154. 
13 Saleh, K. J., Mulhall, K. J., Bershadsky, B., Ghomrawi, H. M., White, L. E., Buyea, C. M., et al. (2005). 
Development and validation of a lower-extremity activity scale. The Journal of Bone and Joint Surgery, 
87(9), 1985-1994. 
14 Ewald, F. C. (1989). The Knee Society total knee arthroplasty roentgenographic evaluation and scoring 
system. Clinical Orthopaedics and Related Research, 248, 9-12. 
15 Ibid. 
16 Ghanem, E., Restrepo, C., Joshi, A., Hozack, W., Sharkey, P., & Parvizi, J. (2007). Periprosthetic 
infection does not preclude good outcome for revision arthroplasty. Clinical Orthopaedics and Related 
Research, 461, 54-59. 
17 Saleh, K. J., Dykes, D. C., Tweedie, R. L., Mohamed, K., Ravichandran, A., Saleh, R. M., et al., 967-
977.