A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
 
Triathlon Tritanium Cone Augments Outcomes 
Study  
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center evaluation of the clinical outcomes of the 
Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Triathlon Tritanium Cone Augments 
Protocol Number: 
76 
Clincaltrials.gov ID 
 
NCT02521103 
510(k) Clearance Number: 
K143393 – Triathlon Tritanium Cone Augments 
K190991 – Triathlon Tritanium Central Femoral Cone 
Augment 
 
Version 4.0 
Date:  01 Aug  2024  
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.

 
 
Orthopaedics 
 
 
 
 
 
 
 
Triathlon Tritanium Cone Augments Outcomes 
Study  
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center evaluation of the clinical outcomes of the 
Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Triathlon Tritanium Cone Augments 
Protocol Number: 
76 
510(k) Clearance Number: 
K143393 – Triathlon Tritanium Cone Augments 
K190991 – Triathlon Tritanium Central Femoral Cone 
Augment 
 
Version 4.0 
Date:  01 Aug 2024  
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. 
Page i 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
1 
New 
Danielle Campbell 
2 
Updated: 
• 
Study Synopsis: Inclusion / Exclusion Criteria 
(Exclusion Criteria E.); Study Duration; Number of 
Centers; Number of Cases 
• 
Section 1.3 - Clinical Data to Date 
• 
Section 2.2 - Number of Centers 
• 
Section 2.3 – Number of Subjects 
• 
Section 4.1 – Subject Recruitment and Screening 
• 
Section 4.3 – Early Withdrawal of Subjects 
• 
Section 8.4.2 – Sample Size Justification 
• 
Section 10 – Publication Plan 
• 
Section 13.3 - Subject Stipends or Payments 
Christine Brozyniak 
3 
Updated: 
• 
Study Synopsis: Number of Cases; Study Device 
• 
Section 1.1 – Background 
• 
Section 1.2 – Preclinical Data 
• 
Section 2.3 – Number of Subjects 
• 
Section 3.1 – Study Device 
• 
Section 4.3 – Early Withdrawal of Subjects 
• 
Appendix A – FDA 510(k) Clearance Letters 
• 
Appendix B – Component Listing 
• 
Appendix I – Product Labeling 
 
Ajay Rastogi 

Triathlon Tritanium Cone Augments Outcomes Study  
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page ii 
Version 
Description 
Changed By 
4 
Updated: 
• 
Study Synopsis – Objectives 
• 
Study Synopsis – Additional Data Collection 
• 
Study Synopsis – Number of Cases 
• 
 Study Synopsis - Statistical Methodology 
• 
Study Synopsis - Evaluation Schedule- 
Radiographs: Bilateral AP Images clarification 
6-10 Year column removed; Follow-Up 
Questionnaire requirement removed 
• 
Section 2.3 – Number of Subjects 
• 
Section 5.2- Radiographic Outcomes 
• 
Section 6.3.2- Device Retrieval Process 
• 
Section 8.1.3 – Exploratory Objective Analysis 
• 
Section 8.1.6 – Secondary Efficacy Analyses 
• 
Section 8.1.7 – Exploratory Efficacy Hypothesis 
• 
Section 8.1.8 – Exploratory Efficacy Analysis 
• 
Section 8.4.1 – Data Summary 
• 
Section 8.4.2 – Sample Size Justification 
• 
Appendix B – Component Listing 
• 
Appendix D – Model Informed Patient Consent 
• 
Appendix F- Retrieved Implant Analysis Protocol 
Filesha Haniff 

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Page iii 
Table of Contents 
STUDY SYNOPSIS ....................................................................................................................................... 1 
STUDY DURATION ....................................................................................................................................... 1 
NUMBER OF CENTERS ................................................................................................................................. 1 
OBJECTIVES ............................................................................................................................................... 2 
INCLUSION/EXCLUSION CRITERIA ................................................................................................................. 5 
EVALUATION SCHEDULE .......................................................................................................................... 7 
1 
INTRODUCTION .................................................................................................................................. 8 
1.1 
BACKGROUND ................................................................................................................................ 8 
1.2 
PRECLINICAL DATA ........................................................................................................................ 9 
1.3 
CLINICAL DATA TO DATE............................................................................................................... 11 
2 
CLINICAL STUDY PLAN ................................................................................................................... 15 
2.1 
STUDY DESIGN ............................................................................................................................ 15 
2.2 
STUDY CENTERS .......................................................................................................................... 15 
2.3 
NUMBER OF SUBJECTS ................................................................................................................. 16 
3 
DEVICE DESCRIPTION .................................................................................................................... 16 
3.1 
STUDY DEVICE ............................................................................................................................. 16 
3.2 
ADDITIONAL DEVICES ................................................................................................................... 19 
4 
STUDY PROCEDURES ..................................................................................................................... 20 
4.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 20 
4.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 20 
4.3 
EARLY WITHDRAWAL OF SUBJECTS............................................................................................... 21 
5 
STUDY DETAILS ............................................................................................................................... 23 
5.1 
STUDY OBJECTIVES AND EVALUATION SCHEDULE .......................................................................... 23 
5.2 
RADIOGRAPHIC OUTCOMES .......................................................................................................... 23 
6 
ADVERSE EVENTS ........................................................................................................................... 24 
6.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 24 
6.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 26 
6.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 28 
6.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 28 
6.3.2 
Device Retrieval Process ...................................................................................................... 28 
6.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 29 
6.5 
MEDICAL MONITORING ................................................................................................................. 29 
7 
DATA MANAGEMENT ...................................................................................................................... 29 
7.1 
DATABASE ................................................................................................................................... 29 
7.2 
CONFIDENTIALITY ......................................................................................................................... 29 
7.3 
SOURCE DOCUMENTS .................................................................................................................. 30 
7.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 30 
7.5 
DATA CLARIFICATION REQUESTS .................................................................................................. 30 
7.6 
PROTOCOL DEVIATIONS ............................................................................................................... 31 
7.7 
RECORDS RETENTION .................................................................................................................. 31 
8 
STATISTICAL PLAN ......................................................................................................................... 31 
8.1 
STUDY OBJECTIVES ..................................................................................................................... 31 
8.1.1 
Primary Objective Analysis .................................................................................................... 31 
8.1.2 
Secondary Objective Analyses.............................................................................................. 31 

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8.1.3 
Exploratory Objective Analysis .............................................................................................. 32 
8.1.4 
Primary Efficacy Hypothesis .................................................................................................. 32 
8.1.5 
Primary Efficacy Analysis ...................................................................................................... 32 
8.1.6 
Secondary Efficacy Analyses ................................................................................................ 32 
8.1.7 
Exploratory Efficacy Hypothesis ............................................................................................ 33 
8.1.8 
Exploratory Efficacy Analysis ................................................................................................ 33 
8.2 
SAFETY ....................................................................................................................................... 33 
8.2.1 
Safety Parameters ................................................................................................................. 33 
8.2.2 
Safety Analyses ..................................................................................................................... 33 
8.3 
MISSING DATA ............................................................................................................................. 34 
8.4 
STATISTICAL METHODOLOGY ........................................................................................................ 34 
8.4.1 
Data Summary....................................................................................................................... 34 
8.4.2 
Sample Size Justification ...................................................................................................... 35 
8.4.3 
Interim Analyses .................................................................................................................... 36 
8.4.4 
Analysis Population ............................................................................................................... 36 
9 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................. 36 
9.1 
STUDY MONITORING PLAN ............................................................................................................ 36 
9.2 
AUDITING AND INSPECTING ........................................................................................................... 37 
10 
PUBLICATION PLAN ........................................................................................................................ 37 
11 
RISK/BENEFIT ASSESSMENT ......................................................................................................... 38 
11.1 
RISK CATEGORY .......................................................................................................................... 38 
11.2 
POTENTIAL RISK .......................................................................................................................... 38 
11.3 
EXPECTED COMPLICATIONS AND RATES OF OCCURRENCES ........................................................... 39 
11.4 
PROTECTION AGAINST RISKS........................................................................................................ 40 
11.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 40 
12 
ETHICAL CONSIDERATIONS .......................................................................................................... 41 
13 
STUDY FINANCES ............................................................................................................................ 41 
13.1 
FUNDING SOURCE ........................................................................................................................ 41 
13.2 
CONFLICT OF INTEREST ................................................................................................................ 41 
13.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 42 
14 
REFERENCES ................................................................................................................................... 43 
 
 
 

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

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Page vi 
List of Tables and Figures 
TABLE 1.  PUBLICATIONS FROM THE TRIATHLON TS OUTCOMES STUDY .................................... 12 
FIGURE 1. FEMORAL CONE AUGMENT ................................................................................................. 17 
FIGURE 2. CENTRAL FEMORAL CONE AUGMENT ............................................................................... 17 
FIGURE 3. SYMMETRIC TIBIAL CONE AUGMENT ................................................................................ 18 
FIGURE 4. ASYMMETRIC TIBIAL CONE AUGMENT .............................................................................. 19 
FIGURE 5. ADVERSE EVENT DECISION TREE ...................................................................................... 25 
 
 
 
 
 

Triathlon Tritanium Cone Augments Outcomes Study     
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Page vii 
List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CPTi 
Commercially Pure Titanium 
CSM 
Clinical Study Manager 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
International Conference of Harmonisation Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HSS 
Hospital for Special Surgery 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LEAS 
Lower Extremity Activity Scale 
PI 
Principal Investigator 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-12 
Short Form-12 
TKA 
Total Knee Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene
 
 

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Study Synopsis 
 
Title 
A prospective, post-market, multi-center evaluation of the clinical 
outcomes of the Triathlon TS Total Knee System with Triathlon 
Tritanium Cone Augments 
Short Title 
Triathlon Tritanium Cone Augments Outcomes Study 
Protocol Number 
76 
Phase 
Post-market 
Methodology 
This study is a prospective, open-label, post-market, non-randomized, 
multi-center clinical evaluation of the Triathlon TS Total Knee System 
with Triathlon Tritanium Cone Augments for revision total knee 
arthroplasty (TKA) in a consecutive series of patients who meet the 
eligibility criteria.  The total enrollment goal for the study is a minimum 
of 145 cases, all of which will receive the Triathlon TS Total Knee 
System with at least one Triathlon Tritanium Cone Augment.  The 
clinical outcomes of Triathlon Tritanium Cone Augments will be 
compared to published literature and data collected in the Triathlon TS 
Outcomes Study.   
Study Duration 
1. Follow-up of each revision TKA case to 5 years 
2. Enrollment period of 48 months 
3.   Approximate 10-year total duration 
Number of Centers 
8 to 12 investigational centers 
Hypothesis 
The revision rate of the Triathlon Tritanium Cone Augments is expected 
to be less than 2.8% for aseptic loosening1,2 of either the Femoral or the 
Tibial Cone Augments at 2 years postoperative. 

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Objectives 
Primary: 
To evaluate the success rate of the Triathlon Tritanium Cone Augment 
with the Triathlon TS Total Knee System at 2 years postoperative, 
defined as absence of revision of the Femoral Cone Augment or Tibial 
Cone Augment for aseptic loosening. 
Secondary: 
• 
To evaluate unexpected end-of-stem pain with regards to the 
Triathlon Tritanium Cone Augments location and severity and 
compare to published literature3 at 2 years postoperative.  
• 
To evaluate intraoperative bone defects using the Anderson 
Orthopaedic Research Institute (AORI) classification and correlate 
with the size and shape of cone implanted6,7.  
Exploratory: 
• 
To evaluate the mean KSS objective knee scores at 2 years 
postoperative for cases which received the Triathlon TS Total Knee 
System with a Triathlon Tritanium Central Femoral Cone Augment. 
 

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Additional Data 
Collection 
• 
Function and health related quality of life (QOL) will be compared 
between the Triathlon TS with Triathlon Tritanium Cone Augments 
and published results for other revision knee systems with 
metaphyseal augments, as well as the Triathlon TS Outcomes 
Study using the following outcomes measures: 
o 2011 Knee Society Score (KSS)9 
o Short Form-12 (SF-12) 
o Lower Extremity Activity Scale (LEAS) 
o Hospital for Special Surgery (HSS) Patella Score 
o EuroQuol 5D (EQ-5D) 
o Follow-Up Questionnaire 
• 
Data collected at 6-week, 6-month, 1-year, 2-year, and 5-year 
visits will be compared to above mentioned controls with respect to 
improvement from preoperative scores.   
• 
Radiographic stability,  preoperative AORI classification and 
complications will be compared between those implanted with the 
Triathlon TS with Triathlon Tritanium Cone Augments and 
published results for other revision knee systems. 
• 
Surgical details will be compared to data collected as part of the 
Triathlon TS Outcomes Study. 
Number of Cases 
Cases will be enrolled until at least 145 cases have received the 
Triathlon TS Total Knee System with a Triathlon Tritanium Cone 
Augment. 
 
Additionally, between 40-50 cases (within the study population) will 
receive the Triathlon TS Total Knee System with a Triathlon Tritanium 
Central Femoral Cone Augment. 

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Study Device 
Triathlon TS Total Knee System with Triathlon Tritanium Cone 
Augments  
Required Components : 
1. Triathlon TS Femoral Component 
2. Triathlon TS or Triathlon PS Tibial Insert 
3. Triathlon TS Universal Tibial Baseplate 
4. Triathlon TS Tibial Cone Augment and/or Triathlon TS Femoral 
Cone Augment (between 40-50 cases implanted with Triathlon 
TS Central Femoral Cone Augment) 
 
The femoral component and tibial baseplate must be used in a 
cemented application. The cone augments must be used in a 
cemented application with respect to the Triathlon TS Femoral and 
Tibial Components, and a cementless application with respect to the 
prepared bone. 
 
The subject’s patellar component may or may not be revised based 
upon surgeon discretion. If revised, an X3 or N2Vac Triathlon Patellar 
Component must be used in a cemented application.  
 
Additionally, a variety of compatible Triathlon TS device accessories 
may be used, as indicated in the surgical protocol. 

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Inclusion/Exclusion 
Criteria 
Inclusions: 
A. Patient has signed an IRB/EC approved, study specific 
Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female, skeletally mature and 
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) > 45. 
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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Statistical 
Methodology 
Primary Objective: 
• 
2-year success rate of the TS Total Knee System with Triathlon 
Tritanium Cone Augments with an endpoint of revision/removal of 
Femoral Cone Augment or Tibial Cone Augment for aseptic 
loosening will be compared with success of published literature on 
revision TKA with metaphyseal augments, with a 2.5% 
noninferiority margin. 
 
Secondary Objectives: 
• 
The unexpected end-of-stem pain at 2 years will be tabulated 
separately for cases with femoral cone implanted only, tibial cone 
implanted only, both femoral and tibial cone implanted. The two 
way tables will have the level of shin pain as row variable and level 
of thigh pain as column variable.   
• 
A two-way table of intraoperative AORI classification by femoral or 
tibial cone augment size will be presented. 
 
Exploratory Objective: 
• 
The mean of KSS Objective Knee Score at 2 years postoperative 
for cases receive the Triathlon TS Total Knee System with a 
Triathlon Tritanium Central Femoral Cone Augment will be 
compared to 86 points with a 5 points noninferiority margin.  
 

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     Evaluation Schedule 
Evaluation 
Preop 
X-rays (-1 yr) 
CRFs (-4 mos) 
Intraop 
6 weeks 
(+ 2 wks) 
6 months 
((+ 2 wks) 
1 year 
(+ 2 mos) 
2 years 
(+ 2 mos) 
5 years 
(+ 2 mos) 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
Demographics & Medical History 
X 
 
 
 
 
 
 
Preoperative Functional Evaluation 
X 
 
 
 
 
 
 
Previous Implant Information 
 
X 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
Postoperative Functional Evaluation 
 
 
X 
X 
X 
X 
X 
SF-12 
X 
 
X 
X 
X 
X 
X 
LEAS 
X 
 
X 
X 
X 
X 
X 
HSS Patella Score 
X 
 
X 
X 
X 
X 
X 
EQ-5D 
X 
 
X 
X 
X 
X 
X 
Stem Tip Pain Diagram  
*If applicable 
X* 
 
X 
 
 
X 
X 
Radiographs:  
1. Bilateral* Anteroposterior (AP)  
Xa. Long standing at pre-op and 6 weeks 
Xb. Standard at 1 year, 2 years, and 5 
years 
2. Mediolateral (ML) 
3. Merchant (30° flexion) 
*Bilateral AP x-rays are preferred.  Unilateral AP x-
rays may be submitted if bilateral images are not 
available.   
Xa 
 
Xa 
Xb 
Xb 
Xb 
Xb 
 
X: Evaluation is required for all cases. 
Functional Evaluation: The Functional Evaluations include the 2011 KSS, a standardized instrument with both surgeon completed, and patient reported sections that evaluate 
function, satisfaction, pain and motion. 
SF-12:  The SF-12 is a 12-item patient questionnaire that evaluates general health and well-being. 
LEAS: The LEAS is a self-administered patient evaluation designed to reflect patient activity.  
HSS Patella Score: The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint.  
EQ-5D: The EQ-5D is a standardized instrument that evaluates the patient’s current health state.  
Stem Tip Pain Diagram: The Stem Tip Pain Diagram is an anatomic diagram the patient completes to demonstrate the level and location of pain in their femur or tibia.  This 
questionnaire is only applicable preoperative if the patient has a long stem previously implanted.  

Triathlon Tritanium Cone Augments Outcomes Study                                                                                       Page 14  
Stryker Orthopaedics Clinical Study Protocol  
 
 
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This document is a protocol for a human research study.  This study will be conducted in 
compliance with the protocol, Good Clinical Practice (GCP) Standards, associated Federal 
regulations and all applicable research requirements.  
1.1 Background 
Reconstruction of large metaphyseal defects, severe bone loss and achieving lasting 
component fixation in the femur or tibia during revision total knee arthroplasty (TKA) are 
clinically challenging problems2,4. Modern knee systems provide a modular approach to 
reestablishing the femoral and tibial anatomy, and implant selection should be based on the 
complexity of the reconstruction5. Various options are available for the management of small 
bone defects which include bone grafts, metal augments, and extended stems. To address 
larger defects categorized as Type II and Type III based on Anderson Orthopaedic Research 
Institute’s (AORI) classification6,7, metaphyseal cones or sleeves have shown to provide stable 
fixation and early structural support4,8. 
 
There have been a few studies showing early results for revision TKA using either tantalum 
cones or metaphyseal sleeves. In a retrospective study, Lachiewicz et al.2 reported on 27 
revision TKA procedures, including nine femoral cones and 24 tibial cones addressing Type IIB 
and III AORI bone defects. Overall there were two failures, one for infection and the second for 
aseptic loosening (3.7%) by 25 months post-op. All other cone augments showed evidence of 
osseointegration at the latest follow-up (average of 3.3 years). Additionally, Aggarwal et al.1 
retrospectively reviewed 104 revision TKAs in 103 patients needing metaphyseal sleeves. Of all 
the cases included in the analysis, two were revised for aseptic loosening at six months 
postoperatively. With an average follow-up of 43 months, the remaining 102 knees showed 
good evidence of osseointegration.  
 
The Triathlon TS Total Knee System was developed as platform knee technology for Stryker 
Orthopaedics.  The Triathlon TS Total Knee System, cleared for use under FDA 510(k) 
K070095 and K072221, includes femoral components fabricated from cast cobalt-chromium-
molybdenum alloy, distal and posterior femoral augments, fluted stems, stem extenders, offset 
1 Introduction 

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adapters, tibial inserts fabricated from ultra-high molecular weight polyethylene (UHMWPE) and 
a patellar component also made from UHMWPE.   
 
The first-generation Triathlon Tritanium Cone Augments, cleared for use under FDA 510(k) 
K#143393, have been developed to supplement the Triathlon TS Total Knee System, and are 
designed to accommodate voids of various sizes. The Triathlon Tritanium Central Femoral Cone 
Augments serve the same purpose and were created within a larger portfolio project as a 
contemporary and vertically integrated solution within the revision and oncology marketplace. 
They are cleared for use under FDA 510(k) K#190991. All components are compatible with the 
Triathlon TS Femoral Component, the Triathlon Universal Baseplate, the Triathlon TS Stems 
(cemented and cementless), the Triathlon TS augments and limited sizes of the Triathlon TS 
offset adapters as outlined in the surgical protocol. 
1.2  Preclinical Data 
The following bench tests (with test report numbers) were conducted with the Triathlon Tritanium 
Cone Augments: 
  
Mechanical Properties (RD-14-075) 
The following mechanical properties of the LRM-foam and the LRM-solid were tested to verify 
that the materials meet the pre-determined performance criteria.  
 
• 
Tensile Bond Strength (MTP 108.1-03): The average tensile strength of the LRM-foam 
coating was 41.8 MPa. 
• 
Shear Bond Strength (MTP 109.1-03): The average shear bond strength of the LRM-
foam coating was 31.6 MPa. 
• 
Fatigue Strength (MTP 110.0-02): Fatigue strength of the LRM-foam coating was 9.66 
MPa at ten (10) million cycles. 
• 
Ultimate Tensile Strength and 0.2% Offset Yield Strength (MTP 114.0-05): The 
average ultimate tensile strength of the LRM-solid substrate coupons was 67 ksi and the 
mean 0.2% offset yield was 50.3 ksi.  
• 
Rotating Beam Fatigue Strength (MTP 006): The average fatigue strength of the LRM-
solid substrate coupons was 30.66 ksi at ten (10) million cycles.  
 

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Materials Characterization (RD-14-076 and A0043790) 
This testing effort characterized the physical properties of the modified surface of the three 
styles of cone augments. The modified surface, or porous coating, will interface with bone tissue 
or bone cement in the in-situ environment.  The solid substrate for the device is also constructed 
of CPTi material made simultaneously with the LRM-foam by the LRM process. This solid 
substrate provides structural support for the device. In the in-situ environment, the inner surface 
of the device interfaces with the instrumentation for implantation and bone cement. The testing 
established that the porous coating meets the requirements outlined in the FDA guidance 
documents, “Guidance Document for Testing Orthopedic Implants With Modified Metallic 
Surfaces Apposing Bone Or Bone Cement”, April 28, 1994, and FDA Guidance Document, 
“Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial 
Metal/Polymer Porous-Coated Uncemented Prostheses, Guidance for Industry and FDA”, 
January 16, 2003.  This surface is intended to provide biologic fixation.   
 
Micromotion of Triathlon Cone Augment Constructs (RD-14-049 and RD-14-050 and 
A0040475) 
Comparative testing was performed to evaluate the initial stability of the Triathlon Tibial and 
Femoral Cone constructs within the prepared simulated tibial cavity during a simulated stair 
descent activity and simulated femoral cavity during a normal walking profile. Data was 
compared to a predicate device, demonstrating that the Triathlon Cone Augments are at least 
equivalent to the predicate device in resisting micromotion.  
 
Torque of Triathlon Cone Augment Constructs (RD-14-067 and A0043380) 
Comparative testing was performed to evaluate the ability of the Triathlon Femoral Cone 
Augment to remain fixed to the tibial tray under clinically relevant loading. The test was 
completed with fixture of a 3D printed Stratasys Fused Disposition Modeling. All samples ran 
through the test cycle with no disassociation of the cone to the tibial baseplate. In all cases the 
test was stopped with the femoral rotation reached 30° which creates a torque which is beyond 
the capacity of the insert post. This is approximately three times the peak internal rotation 
experienced in the knee.  
 
Additional testing was not needed for the Central Femoral Cone Augment. Analysis showed that 
the various stepped features and pockets, as well as the posterior and anterior cutout features, 

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provided torsional rigidity to the Central Femoral Cone Augment that was no worse than that of 
the first-generation Femoral Cone Augment. 
 
Impaction of Triathlon Cone Augment Constructs (RD-14-013 and A0040158) 
The strength of cone augment upon impaction into the joint was assessed to evaluate for any 
damage or deformation to the device. The cadaveric lab supported the cone augment strength 
via measurements of average force, speed, and energy applied. 
 
The results of the bench top testing conducted for the Triathlon Tritanium Cone Augments 
identified acceptance criteria were met. 
 
Copies of all test reports are available at Stryker Orthopaedics.   
1.3  Clinical Data to Date 
This study is the second Stryker sponsored multi-center prospective data collection on the 
Triathlon TS Total Knee System. This will be the first study collecting data on the Triathlon 
Tritanium Cone Augments. To date, early data from Clinical Protocol #65 Triathlon TS 
Outcomes Study has been presented at the following meetings. The abstracts are summarized 
below in Table 1.  
 
 

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Table 1. Publications from the Triathlon TS Outcomes Study 
Title 
Journal/ 
Conference 
Authors 
Summary 
Anatomic Boss Position 
Decreases the Need for 
Offset in Revision Total 
Knee Arthroplasty 
International 
Congress for 
Joint 
Reconstruction 
2012 
 
Southern 
Orthopaedic 
Association 
2012 
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. 
Recovery of Range of 
Motion, Pain and 
Function Similar in 
Revision and Primary 
Single Radius Knees 
Eastern 
Orthopaedic 
Association 
2013 
 
International 
Society for 
Technology in 
Arthroplasty 
2013 
Stoker, Manoshi; 
Howard, Michael; 
Anthony, 
Danielle; Hitt, 
Kirby; Jacofsky, 
David and Smith, 
Eric 
Clinical outcomes from two multicenter studies 
were analyzed to compare single radius designs: 
posterior stabilized primary TKAs and revision 
TKAs. Improvement was significantly higher in the 
revision group than the primary group, with 
comparable overall KSS scores in function and 
range of motion.The authors concluded that 
revision TKA subjects perform as well as primary 
TKA subjects with a single radius design. 
Use of Augments 
Provides Greater 
Functional Outcomes 
than Augments with 
Offset Adapters 
International 
Society for 
Technology in 
Arthroplasty 
2013 
Anthony, 
Danielle; Howard, 
Michael; Hitt, 
Kirby; Jacofsky, 
David; Smith, 
Eric 
and Orozco, 
Fabio 
Of 125 cases collected in a multicenter study, only 
17.6% of subjects received an offset adapter. 
Cases were divided into two groups: Group 1 with 
femoral and/or tibial augments only and Group 2 
included subjects with femoral and or tibial 
augments and offset adapters. Early clinical 
outcomes show no difference in ROM, but greater 
improvements in overall KSS and PROMs in the 
augments only group. The authors concluded that 
the single radius design decreases the need for 
additional ancillary devices during revision TKA. 
Reason For Revision Of 
Single Radius And Multi-
Radius Total Knee 
Designs 
Eastern 
Orthopaedic 
Association 
2014 
Smith, Eric;  
Hitt, Kirby;  
Orozco, Fabio; 
Campbell, 
Danielle  
and  
Robinson, Kristin 
Among 177 revisions cases, reasons for revision 
were analyzed. Subjects we divided based on 
previous implant design: single radius (SR) TKA 
or multi-radius (MR) TKA. The SR group was 
primarily revised for Infection (23.7%), while the 
MR group was primarily revised for Global 
Instability (31.7%). Further differences between 
the two groups were noted in stability, with the MR 
group showing a higher incidence of instability 
>10mm in the AP plane and 10° in ML plane. The 
authors concluded that infection can be a result of 
improper healing and post-op care, while 
instability is also associated with component 
failures and malalignment.  
 
 

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Table 1. Publications from the Triathlon TS Outcomes Study (cont’d) 
Title 
Journal/ 
Conference 
Authors 
Summary 
Joint Line Restoration in 
a Contemporary 
Revision Knee System 
Journal of Knee 
Surgery 2015; 
28(01): 075-
082 
Hitt, Kirby;  
Stoker, Manoshi; 
Howard, Michael; 
Mittal, Yogesh; 
Heekin, David  
and  
David Jacofsky 
A new revision total knee arthroplasty device and 
associated instrumentation was investigated to 
determine if it could reduce intraoperative 
complexity and restore the joint line through the 
arc of motion. In a prospective multicenter study, 
a total of 95 consecutive patients undergoing a 
revision knee arthroplasty were evaluated.  
Medical history, functional health scores, and 
intraoperative data were collected. The joint line 
was restored to 28mm±5mm in full extension and 
90° flexion. Significant improvements were noted 
in all functional and general health scores.  The 
anatomic boss position may allow for a reduction 
in instrumentation, as the need for femoral offset 
adapters was limited. Joint line restoration with 
proper posterior condylar offset correlated with 
positive functional outcomes. 
Use Of Tibial Augments 
Provides Improved 
Functional Outcomes In 
A Revision Single 
Radius Knee Design 
 
World 
Arthroplasty 
Congress 2015 
 
Smith, Eric; Della 
Valle, Craig; 
Mittal, Yogesh; 
Robinson, Kristin 
and Campbell, 
Danielle 
Among 181 cases collected in a multi-center 
study, surgical details, clinical and patient-
reported outcomes, and radiographic findings 
were evaluated in two groups based on whether a 
tibial augment was used (TA group) or not used 
(NA group).  The study showed patients with tibial 
augments had less pain, better functional 
performance and improved stability at the 1- and 
2-year follow-up visit.   
Decreased Anterior 
Knee Pain with a 
Revision Single Radius 
Knee Design: Clinical 
Outcomes 
 
World 
Arthroplasty 
Congress 2015 
 
Hitt, Kirby; Della 
Valle, Craig; 
Jacofsky, David; 
Robinson, Kristin 
and Campbell, 
Danielle 
Of 181 revision TKA cases studied, 98% of the 
subjects had a resurfaced patella, with only 40% 
of subjects having their patella revised. Objective 
and patient-reported outcomes including the Knee 
Society Score (KSS), Hospital for Special Surgery 
Patella Score (HSS) and radiographic findings 
were reviewed.  The study shows significant 
increases in functionality and decreases in pain at 
the 6-week and 6-month timepoints, with further 
positive results to 2 years follow-up. 
Revision Total Knee 
Arthroplasty: Do 
Postoperative Outcomes 
Vary Depending On The 
Etiology Of The Failed 
Arthroplasty? 
 
World 
Arthroplasty 
Congress 2015 
 
Smith, Eric; Hitt, 
Kirby; Orozco, 
Fabio; Robinson, 
Kristin and 
Campbell, 
Danielle 
Reasons for revision were analyzed among the 
181 cases in this revision TKA study.  These 
included osteolysis, loosening, component failure, 
instability, component malpositioning, infection, 
and pain and/or stiffness. Subjects revised for 
pain or stiffness (pain/stiffness group) realized 
lower mean scores than the overall study 
population at 2 years postoperative and smaller 
score improvements from preoperative to 
postoperative on every measure analyzed except 
the KSS, which was in line with the overall group. 
In contrast, patients revised for infection (infection 
group) achieved greater improvement than the 
overall study population from preoperative to 2 
years on the KSS, LEAS, and SF-36 Mental 
Component Score (MCS). 

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Table 1. Publications from the Triathlon TS Outcomes Study (cont’d) 
Title 
Journal/ 
Conference 
Authors 
Summary 
Preoperative Activity 
Level Does Not Affect 
Postoperative Outcomes 
with a contemporary 
revision TKA 
 
International 
Society for 
Technology in 
Arthroplasty 
2016 
 
American 
Academy of 
Hip and Knee 
Surgeons 2016 
 
European Knee 
Society 2016 
 
Hitt, Kirby; Della 
Valle, Craig; 
Campbell, 
Danielle and 
Brozyniak, 
Christine 
Of the 181 cases in this revision study, subjects 
were divided into groups based on preoperative 
activity level using LEAS. Low activity had an 
LEAS score of 1-7 and High Activity has an LEAS 
score of 8-18. Postoperative improvement in both 
groups were similar in the KSS, but the LA group 
showed larger increases in the KSS Functional 
assessment at 6 weeks and 2 years.  Higher SF-
6D outcomes were also seen in the LA group at 1 
year.   
Ninety Day Readmission 
Rates in Revision Total 
Knee Arthroplasty 
The European 
Federation of 
National 
Associations of 
Orthopaedics 
and 
Traumatology 
2016 
 
International 
Society for 
Technology in 
Arthroplasty 
2016 
 
European Knee 
Society 2016 
 
Della Valle, 
Craig; Hitt, Kirby; 
Campbell, 
Danielle and 
Brozyniak, 
Christine 
The readmission rate was 5% within 30 days and 
9% within 90 days in a study population of 181 
revision TKA cases.  16 readmissions involving 14 
patients were reported within 90 days. More than 
half of the readmissions were related to an 
existing comorbidity or the index reason for 
revision and over one third of readmissions are 
medical in nature. Infection and wound healing 
complications represented more than half of the 
surgical complications. 
Improved Clinical 
Outcomes Following 
Revision Total Knee 
Arthroplasty With or 
Without Patellar 
Revision 
The European 
Federation of 
National 
Associations of 
Orthopaedics 
and 
Traumatology 
2016 
 
Hitt, Kirby; Smith, 
Eric; Della Valle, 
Craig; Robinson, 
Kristin and 
Campbell, 
Danielle 
181 cases were analyzed for anterior knee 
functionality, pain after revision TKA and for 
review of outcomes associated with and without 
patella revision.  The current study shows 
significant increases in functionality and 
decreases in pain at the six week and six month 
timepoints, with further positive results to two 
years. Early improvements may have been 
enhanced by the revision of a failing patellar 
component, although patients with retained 
patellar components display similar results to 
revised patients by one year postoperative. These 
improvements in anterior knee pain and function 
regardless of patellar revision suggest that a well 
fixed patellar component does not need to 
necessarily be revised to alleviate symptoms. 
 
 
 

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Table 1. Publications from the Triathlon TS Outcomes Study (cont’d) 
Title 
Journal/ 
Conference 
Authors 
Summary 
Improved Health Related 
Quality of Life and 
Clinical Outcomes Using 
A Contemporary 
Revision Total Knee 
System  
 
The European 
Federation of 
National 
Associations of 
Orthopaedics 
and 
Traumatology 
2016 
 
Hitt, Kirby; Smith, 
Eric; Della Valle, 
Craig; Campbell, 
Danielle and 
Robinson, Kristin  
Of the study population of 181 cases, the majority 
consisted of primarily first-time revision patients 
(81.2%) with a diagnosis of osteoarthritis. 
Clinically significant results were seen in the 
LEAS, with the average score improving by 1.6 
points and 1.9 points at six months and two years, 
respectively. SF-6D scores indicated moderate 
clinical relevance at each postoperative timepoint, 
with an effect size of 0.65, 0.70, and 0.69 at six 
months, one year, and two years, respectively. 
The KSS Pain/Motion and Functional Scores were 
determined to be highly correlated with the SF-6D 
scores (Pearson’s r > 0.6) at one and two years 
postoperatively. 
 
2 Clinical Study Plan 
2.1 Study Design 
A prospective, post-market, multi-center design will be employed.  Radiographs will be assessed 
by an independent reviewer. 
2.2 Study Centers 
Cases will be enrolled at eight to twelve centers.  For investigators that have not used the Triathlon 
TS Total Knee System previously, enrollment of cases into the study will commence when each 
investigator has completed a learning curve of three cases using the Triathlon TS device.  The 
enrollment goal is approximately 25 cases per investigator utilizing the Triathlon Tritanium Cone 
Augments but will vary dependent upon the number of participating centers.   Although a goal 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 Institutional Review Board (IRB) or Ethics 
Committee (EC) approval.  Non-compliance of a study center may result in termination of the 
center’s participation in the study. 

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2.3  Number of Subjects 
Cases will be enrolled until at least 145 cases have received the Triathlon TS Total Knee System 
with a Triathlon Tritanium Cone Augment.  Additionally, between 40 - 50 cases (within the study 
population) must receive the Triathlon TS Total Knee System with a Triathlon Tritanium Central 
Femoral Cone Augment. 
 
3 Device Description 
3.1 Study Device 
All cases in this post-market study will receive a femoral or tibial Triathlon Tritanium Cone 
Augment.  The Triathlon Tritanium Tibial and Femoral Cone Augments were cleared for use in 
the United States under FDA 510(k) K#143393 on January 13, 2015. The Triathlon Tritanium 
Central Femoral Cone Augment was cleared for use in the United States under FDA 510(k) 
K#190991 on August 15, 2019. See Appendix A for the FDA clearance letter. 
 
The Triathlon Tritanium Cone Augments are an extension of the Triathlon TS system, intended to 
be used as an optional accessory component in primary or revision TKA. The Triathlon Tritanium 
Cone Augments are comprised of commercially pure titanium (CPTi) with the outer surface 
incorporating a foam porous coating. The Triathlon Tritanium Cone Augments are designed to 
accommodate voids of various sizes. The components may be placed with or without bone 
cement into the prepared bone, but will be used in a cemented application with respect to the 
Triathlon TS femoral and tibial components. The components are compatible with the Triathlon 
TS femoral components, the Triathlon Universal Baseplate, limited sizes of the Triathlon TS 
Stems (cemented and cementless), the Triathlon TS augments, and limited sizes of the Triathlon 
TS offset adapters.   
 
There are four designs of Triathlon Tritanium Cone Augments: 
• 
Femoral Cone Augments 
• 
Central Femoral Cone Augments 
• 
Symmetric Tibial Cone Augments 
• 
Asymmetric Tibial Cone Augments 
 

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The Femoral Cone Augment (Figure 1) is available in six sizes (Size 1-2, Size 3, 4, 5, 6 and Size 
7-8), in left and right configurations.  The Femoral Cone Augments are intended to be cemented 
to the internal aspect of the appropriate Triathlon TS femoral component.   Previously available 
distal and/or posterior femoral augments may be utilized, as the femoral cone is cemented to the 
femoral component/augment combination. The femoral cone is open on the anterior surface to 
accommodate the TS intercondylar box, any anterior bone that is present, and any stems/stem 
extenders that are intended to be used. The internal aspect of the cone augment has 
normalizations for bone cement bonding, and has a keyed feature to allow the use of an impactor 
during insertion. The outer surface of the femoral cone incorporates a CPTi foam porous coating 
that is designed for biological fixation in cementless applications, or for cement interdigitation in 
cemented applications, as well as solid areas without coating. The Femoral Cone Augment is 
intended to be used to provide support and fill bone voids in the metaphyseal region of the distal 
femur.  
 
Figure 1. Femoral Cone Augment 
 
The Central Femoral Cone Augment (Figure 2) is an extension of the first-generation Femoral 
Cone Augment and is available in five sizes (Size 1-2, 3-4, 5, 6, and 7-8), in left and right 
configurations. This cone also accommodates the TS intercondylar box, and a CPTi porous outer 
surface for biological fixation, or interdigitation with bone cement. This design of the femoral cone 
is compatible with the same devices as the first-generation Femoral Cone Augment and is 
implanted in the same manner.  
 
Figure 2. Central Femoral Cone Augment 

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The Symmetric Tibial Cone Augment (Figure 3) is intended to be used with the Triathlon 
Universal baseplate and will accommodate the use of previously available tibial augments. The 
tibial cones are cemented to the Universal baseplate.  The Symmetric Tibial Cone Augment is 
available in five sizes (A – E). This design features a cone shaped geometry tapering from the 
surface nearest the joint line to a smaller dimension distally. The narrow end of the cone 
provides an opening with a minimum dimension to allow for the use of compatible Triathlon TS 
stems.  Offset adapters may also be used.  There is a keyed feature present on the superior 
aspect of the cone to allow for the use of an impactor.  The internal surface of the cone contains 
normalizations for cement bonding.  The outer surface of cone incorporates a CPTi foam porous 
coating that is designed for biological fixation in cementless applications, or for cement 
interdigitation in cemented applications. The Symmetric Cone Augment is intended to be used 
to provide support and fill bone voids in the metaphyseal area of the tibia.   
 
Figure 3. Symmetric Tibial Cone Augment 
 
The Asymmetric Tibial Cone Augment (Figure 4) is available in four sizes (B, C, D, and E) with 
right medial/left lateral, and left medial/right lateral options.  This design features a lobe at the 
superior aspect of the cone to fill asymmetric bone voids in the tibial metaphysis.  This cone also 
features an internal surface with normalizations for cement interdigitation, and a CPTi porous 
outer surface for biological fixation, or interdigitation with bone cement. This design of tibial cone 
is compatible with the same devices as the Symmetric Tibial Cone and is implanted in the same 
manner.  

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Figure 4. Asymmetric Tibial Cone Augment 
 
The following Triathlon Tritanium Cone Augment catalog numbers are permissible according to 
this study protocol and are in the following format, where ‘XX’ varies by size: 
5549-A-3XX (Femoral Cone Augment) 
5549-A-6XX (Central Femoral Cone Augment) 
5549-A-1XX (Symmetric Tibial Cone Augment) 
5549-A-2XX (Asymmetric Tibial Cone Augment) 
The full listing of permissible Triathlon Tritanium Cone Augment catalog numbers may be found 
in Appendix B. 
3.2 Additional Devices 
Additionally, only the following Stryker compatible devices may be used, according to this study 
protocol: 
Required Additional Components 
5512-F-XXX  
Triathlon TS Femoral Component 
5521-B-XXX 
Triathlon TS Universal Tibial Baseplate 
 
Study Specific Tibial Inserts 
5537-G-XXX 
Triathlon TS Tibial Insert 
5532-G-XXX 
Triathlon PS Tibial Insert, X3 
5532-P-XXX 
Triathlon PS Tibial Insert, N2Vac 
 
Optional Ancillary Devices 
5550-G-XXX 
Triathlon Patellar Component, Symmetric  
X3 
5550-L-XXX 
N2Vac 
5551-G-XXX 
Triathlon Patellar Component, Asymmetric 
X3 
5551-L-XXX 
N2Vac 
5565-S-XXX 
Triathlon Fluted Stem 
100 mm 
5566-S-XXX 
150 mm 
5560-S-XXX 
Triathlon Cemented Stem 
5571-S-XXX 
Triathlon Stem Extender 

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5570-S-XXX 
Triathlon TS Offset Adapter 
5540-A-XXX 
Triathlon Femoral Distal Augment 
5 mm 
5541-A-XXX 
10 mm 
5542-A-XXX 
15 mm 
5543-A-XXX 
Triathlon Femoral Posterior Augment 
5 mm 
5544-A-XXX 
10 mm 
5545-A-XXX 
Triathlon Tibial Half Block Augment 
5 mm 
5546-A-XXX 
10 mm 
5540-A-000 
Triathlon Femoral Augment Locking Screw 
5545-A-000 
 
The compatible Stryker components are listed in the surgical protocol and Appendix B. 
 
 In the case of any uncertainty regarding device compatibility, the current version of the Triathlon TS 
surgical protocol should be reviewed. 
 
4 Study Procedures 
4.1  Subject Recruitment and Screening 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  Advertising for the study at each center will be at the discretion of the investigator.  All 
handouts, brochures, advertisements, etc. must be approved by the IRB/EC prior to the 
dissemination of any recruitment materials to potential subjects.  Study advertisement content 
may be found in Appendix C. 
 
During the preoperative visit, patients that are possible candidates for this study will be screened 
to determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, the 
investigator will propose participation in the study to the patient, according to GCP guidelines.  
Patients must sign an IRB/EC approved Informed Patient Consent Form prior to participation in 
the study, as well as prior to any data collection. 
 
4.2   Patient Informed Consent and Guidelines 
 
All patients for this study will be provided an Informed Patient Consent Form describing this study 
and providing sufficient information for them to make an informed decision about their 
participation.  The Informed Patient Consent Form must contain all elements required by the FDA 

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

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Termination Reason 
 
 
 
Date of Termination 
Death 
 
 
 
 
 
Date of death 
Investigative center termination  
 
Date of study close-out visit 
Lost to follow-up  
 
 
 
Date Stryker termination approval given 
Voluntary withdrawal 
 
 
 
Date subject notified center of withdrawal 
Revision/removal of study device  
 
Date of revision/removal procedure 
Study device not implanted 
 
 
Date of surgery 
Surgery not performed 
 
 
 
Date Stryker termination approval given 
 
 
At the time of study surgery it is required that the following components are implanted to be 
included in the analysis: 
o Triathlon Tritanium Femoral Cone Augment or Central Femoral Cone Augment and/or 
Tibial Cone Augment 
o Triathlon TS Femoral Component 
o Triathlon TS Universal Tibial Baseplate 
o Triathlon TS Tibial Insert or Triathlon PS Tibial Insert 
Revision or removal of the Triathlon Tritanium Cone Augments for aseptic loosening constitutes 
a failure.  Revision or removal of all implanted Triathlon Tritanium Cone Augments for any reason 
requires study termination for the subject. 
 
If revision of the Tibial Insert or the Patellar Component is required during the study, the event 
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 the subject fails to return for his/her follow-up appointments, every effort should be made to 
contact the subject to assess his/her health status.  If, after attempting to contact the subject 
through three documented phone calls and a certified letter, the subject still does not respond, 
he/she will be considered lost to follow-up.  A Study Termination eCRF will be completed only 
after notifying Stryker of the subject’s status and being given approval to terminate.   

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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 
consent, the subject will need to reaffirm participation in the study.  All preoperative data will need 
to be re-collected to be current within 4 months of study surgery.  If the surgery is not to be 
rescheduled or if the subject is no longer considered an appropriate study candidate, a Study 
Termination eCRF 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 eCRF will be completed. 
 
5 Study Details 
5.1 Study Objectives and Evaluation Schedule 
The primary and secondary study objectives, as well as additional data collection are listed on 
page 2. For the evaluation schedule, please reference page 7.  
5.2 Radiographic Outcomes 
Radiographs will be taken and collected in the anteroposterior (AP), mediolateral (ML), and 
merchant or skyline views for the preoperative, 6-week, 6-month, 1-year, 2-year, and 5-year 
intervals. At the preoperative and 6-week follow-up, a long-standing AP view will be taken. The 
suggested radiographic technique for the views required is included in Appendix E. 
 
Radiographs will be evaluated by an independent reviewer throughout the course of the study.  
Parameters for radiographic failures will follow the guidelines that have been set by the Knee 
Society10. Radiographic analysis of the tibial component will employ  nine zones (Zone 1 – Zone 
9) in the AP view and seven zones (Zone 1 – Zone 7) in the lateral view. Radiographic analysis 
of the femoral component will employ five zones (Zone 1 - Zone 5) in the AP view and nine zones 
(Zone 1 – Zone 9) in the lateral view.  Several parameters will be reviewed by zone, including 
mechanical alignment, radiolucency, and osteolysis and migration..  Radiolucency in at least 50% 
of a zone and measuring at least 1 mm in width is defined as radiolucency present.  Cases that 
present with at least 2 mm radiolucency in all zones within a single view will be considered 
radiographic failures.  A migrating or shifting prosthesis with or without disappearance of 

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radiolucent lines or bone-prosthesis or bone-cement interface may be considered as a possible 
radiographic failure. This determination will be made by the independent reviewer.    
 
6 Adverse Events 
6.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
• 
All AEs that meet the definition of serious (see page 27) and occur within the perioperative 
period (intraoperative to hospital discharge) to 90 days following the date of surgery.  
• 
All AEs related to the operative site, regardless of seriousness or time of occurrence. 
 
On postoperative functional evaluations, investigators and SCs will be prompted to question 
subjects as to whether they have seen a doctor for any reason, been hospitalized for any reason 
or have a current impediment to their function. 
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 5. Adverse Event Decision Tree 
 
 
 
No 
Yes 
Yes 
Start 
Site becomes 
aware of 
Adverse Event 
Is the event 
related to the 
operative 
site? 
Does the AE 
meet the 
criteria for 
Seriousness? 
Do NOT report 
to Stryker 
Did the event 
occur within the 
perioperative 
period to 90 
days following 
date of surgery? 
Report AE to 
Stryker via AE 
eCRF 
End 
Yes 
No 
No 

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

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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 6.1, Reporting of Adverse Events, for the AE reporting requirements for this study. 
 
Anticipated Adverse Event 
An anticipated AE is an AE, of which the nature, severity or degree of incidence is known and 
identified in applicable product labeling, published literature or the study protocol. The list of 
anticipated events is provided in Section 11, Risk/Benefit Assessment. 
 
Serious Adverse Event 
A SAE meets one or more of the following definitions: 
• 
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 
 
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. 

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6.3 Study Sponsor 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 Stryker Clinical Research either by telephone/fax/email 
within 24 hours of the site becoming aware of the event if any of the following apply: 
• 
The AE occurs intraoperatively or is related to the surgical procedure. 
• 
The AE is considered by the investigator to be device related or if the investigator 
is uncertain regarding the device related assessment; 
• 
The AE required a reoperation of the study knee or a revision of any study knee 
components. 
 
At the time of the initial report, the following information should be provided: 
• 
Subject number 
• 
A description of the event 
• 
Date of onset 
• 
Current status 
• 
Whether study treatment was 
discontinued 
• 
Investigator assessment of the 
association between the event and 
the study treatment 
 
These reports will be evaluated by Stryker to determine if a Product Inquiry (PI) is required. 
 
It is recommended that all other reportable AEs are submitted through eCRF entry within 2 weeks. 
 
6.3.1  Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the EC or IRB 
according to their specific requirements.  Copies of each report and documentation of 
EC/IRB notification and receipt will be kept with the investigator’s study files. 
 
6.3.2  Device Retrieval Process 
If the study device is removed for any reason, Stryker Orthopaedics will retrieve the 
Triathlon TS system for analysis to help characterize potential device-related 

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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 Retrieved Implant Analysis 
Protocol (Appendix F) should be followed, as allowed by the hospital and institution.  When 
revision of a study subject is scheduled, the study coordinator (SC) should contact the 
Clinical Study Manager (CSM) or other Stryker Clinical Research personnel assigned to 
the project, as soon as possible. 
6.4 Recording of Adverse Events 
All protocol defined AEs occurring during the study period must be recorded; this includes events 
that occur between visit intervals.  The clinical course of each event should be followed until 
resolution or stabilization. 
6.5 Medical Monitoring 
It is the responsibility of the investigator to oversee the safety of the study at his/her center.  This 
safety monitoring will include careful assessment and appropriate reporting of AEs, as previously 
noted.  Stryker will conduct formal investigations via the Product Surveillance Department of those 
AEs which are submitted through our Product Inquiry System.  
 
7 Data Management 
7.1  Database 
Data will be collected at each center and entered into Stryker’s Electronic Data Capture (EDC) 
system.  The system can be accessed remotely by each investigative center and the data entered 
will be managed by Stryker.  Subject data will be processed and monitored according to the 
protocol schedule by Stryker or Stryker representatives.  Draft specifications to support eCRFs 
are provided in Appendix G and patient questionnaires are provided in Appendix H. 
7.2  Confidentiality 
This study will comply with the 2002 HIPAA privacy rule.  As such, Stryker will only collect that 
information which is necessary to support the objectives of the clinical study.  Stryker will take 
precautions to ensure that data received is as de-identified as possible.  In the case that some 
identified information is received, Stryker will ensure that any identifying information is not 
reported.  Study subjects will authorize Stryker to use their health information in support of the 
clinical study during the informed consent process.  Should a subject choose to withdraw 

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authorization, Stryker may use data collected prior to the withdrawal of authorization in order to 
maintain data integrity.  
7.3  Source Documents 
Source data include 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, clinical and office charts, study worksheets, laboratory notes, 
memoranda, subject questionnaires, pharmacy dispensing records, recorded data from 
automated instruments, radiographs, subject files, and records kept at the pharmacy, at the 
laboratories and at medico-technical departments involved in the clinical study. 
All data points collected during preoperative and follow-up visits must be documented in the 
subject’s chart.  This includes range of motion values, pain and function as well as AEs and 
additional comments.  The informed consent process should also be documented in the patient 
chart.  Monitors, defined further in Section 9, will be comparing the eCRFs against source 
documents for adequacy.  The monitors will seek to draw a reference between each data point 
on the eCRF and the subject’s chart.  Thus, one cannot derive pain, ROM or function based on a 
chart note that reads “Patient doing well.”  Every effort should be made to ensure complete source 
documentation.  
Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
7.4  Electronic Case Report Forms 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be documented.  All missing data must be explained.  It is recommended that 
eCRFs be completed and electronically signed by the investigator within 2 weeks of the evaluation 
date. 
7.5  Data Clarification Requests 
If errors or omissions are noted by Stryker upon review of the data entered into the eCRFs, a 
query will be sent to the center within the EDC system.  Queries should be answered in a clear 
and comprehensible manner.  If the query requires a change to study data, the EDC system will 
update the eCRF automatically with the data captured in the query response.  The investigative 
center will be required to reapply their electronic signature to the modified eCRF.  Modified eCRFs 
need not be printed and included in conjunction to answered queries. 

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7.6  Protocol Deviations 
Any major deviation from this protocol will be recorded in Stryker’s Clinical Trial Management 
System and must be reported to the EC/IRB by the investigational site according to their reporting 
procedures.  Major protocol deviations for this study may include the following; this list may not 
be all-inclusive:  
• 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
• 
Patient enrolled does not meet the inclusion/exclusion criteria 
• 
Protocol specified study component(s) not implanted 
• 
Visit deviations, including: 
o Unavailable primary endpoint 
 
If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
7.7  Records Retention 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or 2 years after the date of investigative center termination. These documents 
should be retained for a longer period if required by an agreement with Stryker. 
 
8 Statistical Plan 
8.1 Study Objectives 
8.1.1   Primary Objective Analysis 
The primary efficacy parameter is the revision/removal of femoral cone augment or tibial 
cone augment for aseptic loosening at 2 years postoperative.  
 
8.1.2   Secondary Objective Analyses 
The secondary efficacy parameters include:  
• 
The end-of-stem pain – shin pain and thigh pain at 2 years 
• 
The intraoperative AORI classification, size, and shape of the femoral or tibial cone 
augment 

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8.1.3   Exploratory Objective Analysis  
       The exploratory efficacy parameter is the  KSS objective knee score at 2  years   
postoperative for cases which received the Triathlon TS Total Knee System with a 
Triathlon Tritanium Central Femoral Cone Augment. 
8.1.4  Primary Efficacy Hypothesis  
The primary hypothesis to be tested will be that the success rate at 2 years 
postoperative with the Triathlon Tritanium Cone Augments is not worse than 97.2% with 
a non-inferiority margin of 2.5%.  That is, the following hypothesis will be tested: 
 
H0:  Pt <= 97.2% - 2.5%  HA:  Pt > 97.2%- 2.5%  
 
Here, Pt is the success rate at 2 years postoperative with the Triathlon Tritanium Cone 
Augments. A case success at 2 years is defined as no incidence of revision/removal of 
femoral or tibial cone augment for aseptic loosening within 2 years. 
 
8.1.5   Primary Efficacy Analysis 
A 90% two-sided confidence interval will be computed for the success rate at 2 years. If 
the lower bound of the confidence interval is greater than 94.7%, then the non-inferiority 
hypothesis will be supported; that is the 2 year success rate is non-inferior to 97.2% with 
a margin of 2.5%.  If the lower bound of the confidence interval is greater than 97.2% then 
it is supported that the 2 year success rate is superior to 97.2%.  
 
The Kaplan-Meier survival curve of revision/removal of femoral or tibial cone augment will 
be displayed using SAS/PROC LIFETEST. 
 
8.1.6 Secondary Efficacy Analyses 
A two by two table of shin pain by thigh pain at 2 years will be created separately for cases 
with femoral cone augment implanted only; tibial cone augment implanted only; and both 
femoral cone augment and tibial cone augment implanted. 
 

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The intraoperative AORI classification and the size of the femoral or tibial cone augment 
will be tabulated. 
 
8.1.7 Exploratory Efficacy Hypothesis 
For cases which received the Triathlon TS Total Knee System with a Triathlon Tritanium 
Central Femoral Cone Augment, the exploratory hypothesis to be tested will be that the 
mean of  KSS Objective Knee Score at 2 years postoperative is no worse than 86 with a 
non-inferiority margin of 5. The performance goal for 2-year KSS Objective Knee Score 
was calculated as 86 - 5 to give 81. That is, the following hypothesis will be tested: 
 
H01:  u <=81   HA1:  u >81 
 
Here, u is the mean KSS Objective Knee Score at 2 years postoperative. 
 
 
      
8.1.8 Exploratory Efficacy Analysis 
For cases which received the Triathlon TS Total Knee System with a Triathlon Tritanium 
Central Femoral Cone Augment, A 95% two-sided confidence interval for the mean of 
KSS Objective Knee Score at 2 years will be computed.  If the lower bound of the 
confidence interval is greater than 81, then it is supported that KSS Objective Knee Score 
at 2 years is no worse than 86 with a non-inferiority margin of 5. If the lower bound of the 
confidence interval is greater than 86, then it is supported that KSS Objective Knee Score 
at 2 years is better than 86. 
 
The analysis for the additional data collection is in 8.4.1 Data Summary.  
 
8.2 Safety 
8.2.1  Safety Parameters 
Safety parameters include all protocol-defined adverse events as well as revision and/or 
removal rates.  For details regarding protocol-defined adverse events, see Section 6.1. 
 
8.2.2  Safety Analyses 
The frequency and percentage of all protocol-defined adverse events will be tabulated. 

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The all cause revision/removal rates for the Triathlon TS Total Knee System with Triathlon 
Tritanium Cone Augments will be calculated.  
 
The Kaplan-Meier survival curve of all cause revision/removal will be displayed using 
SAS/PROC LIFETEST. 
 
For details regarding protocol-defined adverse events, see Section 6.1. 
 
8.3 Missing Data 
No missing data will be imputed. 
 
8.4 Statistical Methodology 
8.4.1  Data Summary 
Descriptive statistics will be computed for all baseline conditions and demographic 
parameters.  That is, for continuous data, the N, mean, median, standard deviation, 
minimum and maximum will be computed.  For categorical data, the frequency will be 
computed. The data will be presented by appropriate subgroups (e.g., center). 
 
For all additional data collected that are not required for direct support of a study objective, 
data will be summarized according to visit.  For parameters represented by continuous 
variables (e.g., ROM), the summaries will consist of the N, mean, median, standard 
deviation, minimum, and maximum values. For categorical variables (e.g.,gender ), the 
frequency and percentage in each category will be presented.  
 
A two way table of preoperative AORI classification by femoral or tibial cone augment size 
will be presented.  
 
A table of shin pain by thigh pain  will be created separately for cases with femoral cone 
augment implanted only, tibial cone augment implanted only, and both femoral cone 
augment and tibial cone augment implanted at preoperative,  6 weeks, 2 years, and 5 
years. 
 

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LEAS at 2 years will be compared to the Triathlon TS Outcomes Study as reported at 2 
years postoperative, adjusted by preoperative LEAS, age, gender, and BMI, if applicable. 
The improvement from preoperative visit to postoperative visits will be compared with the 
Triathlon TS Outcomes Study, if applicable. 
 
The HSS Patella Score at 2 years postoperative will be compared to the Triathlon TS   
Outcomes Study as reported at 2 years postoperative, adjusted by preoperative HSS 
Patella Score, age, gender, and BMI, if applicable. The improvement from preoperative 
visit to postoperative visits will be compared with the Triathlon TS Outcomes Study if 
applicable. 
 
Statistical analyses including T-test, Wilcoxon test or Chi-square tests will be utilized for 
comparing the applicable surgical data collected from Triathlon TS Outcomes Study. 
 
For radiographic data, data will be presented according to visits for available parameters.  
Frequency and percentage will be computed for radiolucency according to visit.  Lists will 
be generated for migration over time.  Radiographic failure will be evaluated, where 
radiographic failure is defined as at least 2 mm radiolucency in all zones within a single 
view.  Radiographic failure due to device migration will be evaluated by the independent 
reviewer.  Documentation of statistical analyses utilizing SAS® software version 9.1.3 or 
higher. 
 
8.4.2  Sample Size Justification 
For primary efficacy objective, based on the literature review1,2, it is reasonable to have a 
reference value of 97.2% for success rate at 2 years. A case success at 2 years is defined 
as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening 
within 2 years.  
 
Based on Triathlon TS Outcome Study, it is reasonable to assume the expected success 
rate at 2 years is 98.8%, 100 cases will be needed to have a power of 80% to detect that 
the 2 year success rate is non-inferior to 97.2% with a margin of 2.5% at 5% significance 
level. After factoring a 30% lost to follow-up rate, a total of 145 cases will be needed. 
 

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For exploratory efficacy objective among cases receive the Triathlon TS Total Knee 
System with a Triathlon Tritanium Central Femoral Cone Augment, based on the existing 
data of this study for non-femoral central cone, it is reasonable to have a reference value 
of 86 for the mean of KSS Objective Knee Score at 2 years postoperative, with a standard 
deviation of 10, 32 cases will be needed to have a power of 80% to identify the mean of 
KSS Objective Knee Score at 2 years postoperative is Non-Inferior to 86 with a non-
inferiority margin of 5 at 2.5% significance level. After factoring a 30% attrition rate, a total 
of 46 cases will be needed. 
 
8.4.3  Interim Analyses 
No interim analysis is planned. 
 
8.4.4  Analysis Population 
Per Protocol Population: The study population for analysis will include all non-
censored subjects who receive a Triathlon TS with Triathlon Tritanium Cone Augment 
and are available for efficacy evaluation at the 2-year primary endpoint. The primary and 
secondary efficacy analyses will be based on the per protocol population.   
 
Safety Population: The safety population will include all non-censored subjects who 
received Triathlon TS with Triathlon Tritanium Cone Augment. The safety analysis will 
be based on the safety population. 
 
9  Study Monitoring, Auditing, and Inspecting 
9.1  Study Monitoring Plan 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects 
involved in a clinical investigation and the quality and integrity of data submitted as a result of the 
investigation. 
 
Each investigational site conducting this study will be monitored at least once per year, with 
additional monitoring as necessary. The investigator will allocate adequate time for such 

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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, as applicable, and has adequate space to conduct the monitoring visit, when applicable.  
The monitor will review all source documents and compare them to the data contained in the 
eCRFs, in addition to performing a periodic review of regulatory documents such as EC/IRB 
approvals.  The monitors will need the following: 
• 
An area where they can review study data, when monitoring is conducted on site 
• 
Access to eCRF data for all cases 
• 
Access to source documentation 
• 
Regulatory documents 
• 
Time to discuss findings with the SC and the investigator  
9.2  Auditing and Inspecting 
A quality assurance audit is a form of review that provides additional confidence to the sponsor 
concerning the validity and accuracy of clinical study data that 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 the sponsor’s protocol and standard operating 
procedures and in compliance with FDA regulations. 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, 
Stryker and/or government regulatory bodies of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data).  The investigator will 
ensure the capability for inspections of applicable study-related facilities. 
 
10 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted to 
a peer-reviewed journal at the time the study cohort reaches 2 years and 5 years of follow-up.  
Early results with regard to surgical information and postoperative biomechanics may be 
published prior to the 2-year time point.  Additional publication proposals may also be made by 
investigators at any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 

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At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 2- and 5-year multi-center publications are submitted.  Although Stryker will 
not be involved in coordinating these independent manuscripts, all publications of the data shall 
be submitted to Stryker for review prior to submission for publication.  Stryker shall not edit or 
otherwise influence the publications other than to ensure that confidential information is not 
disclosed, that no off-label use of Stryker devices is promoted and that the data is accurately 
represented.  Any publications resulting from this study must be submitted to Stryker for review 
at least 60 days prior to submission of publication. 
 
11  Risk/Benefit Assessment 
11.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of the 
revision TKA procedure.  
11.2  Potential Risk 
The study involves the routine assessment of a revision TKA procedure.  The Triathlon Tritanium 
Cone Augments have been cleared for use by the FDA and will be used according to their labeling, 
included in Appendix I.  Assessment involves questionnaires, patient and physician assessments 
as well as routine radiographs.  The information collected will be kept confidential and will comply 
with the HIPAA privacy rule. 
 
While the expected life of TKA components is difficult to estimate, it is finite.  These components 
are made of foreign materials, which are placed within the body for the potential restoration of 
mobility or reduction of pain.  However, due to the many biological, mechanical and 
physiochemical factors which affect these devices but cannot be evaluated in vivo, the 
components cannot be expected to indefinitely withstand the activity level and loads of normal 
healthy bone. 
 
Adverse effects associated with revision TKA include the following: 
 

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This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Serious complications may be associated with any total joint replacement surgery.  These 
complications include, but are not limited to:  infection; genitourinary disorders; gastrointestinal 
disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; 
myocardial infarction or death. 
 
With all implanted devices, asymptomatic, localized progressive bone resorption (osteolysis) may 
occur around the prosthetic components as a consequence of foreign-body reaction to the 
particulate matter of metal and UHMWPE.  Particulate is generated by interaction between 
components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can be 
generated by third body wear.  Osteolysis can lead to future complications, including loosening, 
necessitating the removal and replacement of prosthetic components. 
 
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 and/or 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. 
11.3  Expected Complications and Rates of Occurrences 
Complications associated with TKA procedures, such as those performed with the Triathlon TS 
Total Knee System with Triathlon Tritanium Cone Augments, 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 re-operation, revision, arthrodesis of the involved joint, or amputation of the limb.  The safety 

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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
objective will compare the complication rates of the Triathlon TS Total Knee System to published 
rates.   
11.4  Protection Against Risks 
Subjects will be treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or wellbeing 
of the subject, this deviation will be promptly reported to both the EC/IRB and Stryker.   
11.5  Potential Benefits to the Subject 
There is no guarantee that subjects will personally benefit from inclusion in this study.  Subjects 
may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance.  This study seeks to provide clinicians information about this 
device by comparing it to published results for other similar devices.  Information gathered in this 
study may benefit others undergoing this procedure in the future. 
 
 
 

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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
12 Ethical Considerations 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56 as well as 45 CFR Parts 160 and 164. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
EC/IRB for formal approval of the study conduct.  The decision of the EC/IRB concerning the 
conduct of the study will be made in writing to the investigator and a copy of this decision will be 
provided to Stryker before commencement of this study.  The investigator may be asked to 
provide a list of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided an Informed Patient Consent Form 
describing this study and providing sufficient information for patients to make an informed decision 
about their participation.  This Informed Patient Consent Form must be modified to contain center 
specific information and submitted with the protocol for review and approval by the EC/IRB for the 
study.  The formal consent of a patient, using the EC/IRB approved Informed Patient Consent 
Form, must be obtained before that patient is submitted to any study procedure.  This Informed 
Patient Consent Form must be signed by the patient or legally acceptable surrogate and the 
investigator-designated research professional obtaining the consent.  
 
13 Study Finances 
13.1  Funding Source 
This study is financed by Stryker Orthopaedics. 
13.2  Conflict of Interest 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 
Committee-sanctioned conflict management plan that has been reviewed and approved by 
Stryker prior to participation in this study.   

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

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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
 
1. Agarwal S, Azam A, Morgan-Jones R. Metal Metaphyseal sleeves in revision total knee 
replacement. Bone Joint J. 2013; 95-B:1640-1644.   
2. Lachiewicz PF, Bolognesi MP, Henderson RA, Soileau ES, Vail TP. Can tantalum cones 
provide fixation in complex revision knee arthroplasty? Clin Orthop and Relat Res. 2012; 
470:199-204. 
3. Barrack R, Rorabeck C, Burt M, Sawhney J. Pain at the end of the stem after revision total 
knee arthoplasty. Clin Orthop and Relat Res. 1999; 367:216-225. 
4.  Rao BM, Kamal TT, Vafaye J, Moss M. Tantalum cones for major osteolysis in revision knee 
replacement. Bone Joint J. 2013; 95-B:1069-1074. 
5. Radnay CS, Scuderi GR. Management of bone loss: augments, cones, offset stems. Clin 
Orthop and Relat Res. 2006; 446: 83-92. 
6.  Engh GA, Ammeen DJ. Bone loss with revision total knee arthroplasty: defect classification 
and alternatives for reconstruction. Instr Course Lect. 1999; 48: 167-175. 
7. Qiu YY, Yan CH, Chiu KY, Ng FY. 2011.  Review article: Bone defect classifications in revision 
total knee arthroplasty. Journal of Orthopaedic Surgery. 2011; 19: 238-243. 
8. Meneghini RM, Lewallen DG, Hanssen AD. Use of porous tantalum metaphyseal cones for 
severe tibial bone loss during revision total knee replacement. J Bone Joint Surg. 2008; 90-A: 
78-84. 
9. Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The new Knee Society 
knee scoring system. Clin Orthop and Relat Res. 2012; 470: 3-19. 
10. Ewald  FC. The Knee Society Total Knee Arthroplasty Roentgenographic 
Evaluation and Scoring System. Clin Orthop and Relat Res. 1989; 248: 9-12. 
 
14 References 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix A 
 
FDA 510(k) Clearance Letters 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix B 
 
Component Listing 

 
Appendix B 
 Triathlon Tritanium Cone Augments and 
 Triathlon TS Total Knee System Protocol-Specified Component List: 
 
Catalog Number 
Triathlon Tritanium Femoral Cone Augment 
5549-A-321 
5549-A-322 
5549-A-331 
5549-A-332 
5549-A-341 
5549-A-342 
5549-A-351 
5549-A-352 
5549-A-361 
5549-A-362 
5549-A-371 
5549-A-372 
Triathlon Tritanium Central Femoral Cone Augment 
5549-A-621 
5549-A-622 
5549-A-641 
5549-A-642 
5549-A-651 
5549-A-652 
5549-A-661 
5549-A-662 
5549-A-671 
5549-A-672 
Triathlon Tritanium Symmetric Tibial Cone Augment 
5549-A-110 
5549-A-120 
5549-A-130 
5549-A-140 
5549-A-150 
Triathlon Tritanium Asymmetric Tibial Cone Augment 
5549-A-221 
5549-A-222 
5549-A-231 
5549-A-232 
5549-A-241 
5549-A-242 
5549-A-251 
5549-A-252 
Triathlon TS Femoral Component 
5512-F-101 
5512-F-102 
5512-F-201 
5512-F-202 
5512-F-301 
5512-F-302 
5512-F-401 
5512-F-402 
5512-F-501 
5512-F-502 
5512-F-601 
5512-F-602 
5512-F-701 
5512-F-702 
5512-F-801 
5512-F-802 
Triathlon TS Tibial Baseplate 
5521-B-100 
5521-B-200 
5521-B-300 
5521-B-400 
5521-B-500 
5521-B-600 
5521-B-700 
5521-B-800 
 
 
 

 
Appendix B 
 
Catalog Number 
 
Triathlon TS  Plus Tibial Insert 
 
5537-G-109 
5537-G-109-E 
5537-G-509 
5537-G-509-E 
5537-G-111 
5537-G-111-E 
5537-G-511 
5537-G-511-E 
5537-G-113 
5537-G-113-E 
5537-G-513 
5537-G-513-E 
5537-G-116 
5537-G-116-E 
5537-G-516 
5537-G-516-E 
5537-G-119 
5537-G-119-E 
5537-G-519 
5537-G-519-E 
5537-G-122 
5537-G-122-E 
5537-G-522 
5537-G-522-E 
5537-G-125 
5537-G-125-E 
5537-G-525 
5537-G-525-E 
5537-G-128 
5537-G-128-E 
5537-G-528 
5537-G-528-E 
5537-G-131 
5537-G-131-E 
5537-G-531 
5537-G-531-E 
5537-G-209 
5537-G-209-E 
5537-G-609 
5537-G-609-E 
5537-G-211 
5537-G-211-E 
5537-G-611 
5537-G-611-E 
5537-G-213 
5537-G-213-E 
5537-G-613 
5537-G-613-E 
5537-G-216 
5537-G-216-E 
5537-G-616 
5537-G-616-E 
5537-G-219 
5537-G-219-E 
5537-G-619 
5537-G-619-E 
5537-G-222 
5537-G-222-E 
5537-G-622 
5537-G-622-E 
5537-G-225 
5537-G-225-E 
5537-G-625 
5537-G-625-E 
5537-G-228 
5537-G-228-E 
5537-G-628 
5537-G-628-E 
5537-G-231 
5537-G-231-E 
5537-G-631 
5537-G-631-E 
5537-G-309 
5537-G-309-E 
5537-G-709 
5537-G-709-E 
5537-G-311 
5537-G-311-E 
5537-G-711 
5537-G-711-E 
5537-G-313 
5537-G-313-E 
5537-G-713 
5537-G-713-E 
5537-G-316 
5537-G-316-E 
5537-G-716 
5537-G-716-E 
5537-G-319 
5537-G-319-E 
5537-G-719 
5537-G-719-E 
5537-G-322 
5537-G-322-E 
5537-G-722 
5537-G-722-E 
5537-G-325 
5537-G-325-E 
5537-G-725 
5537-G-725-E 
5537-G-328 
5537-G-328-E 
5537-G-728 
5537-G-728-E 
5537-G-331 
5537-G-331-E 
5537-G-731 
5537-G-731-E 
5537-G-409 
5537-G-409-E 
5537-G-809 
5537-G-809-E 
5537-G-411 
5537-G-411-E 
5537-G-811 
5537-G-811-E 
5537-G-413 
5537-G-413-E 
5537-G-813 
5537-G-813-E 
5537-G-416 
5537-G-416-E 
5537-G-816 
5537-G-816-E 
5537-G-419 
5537-G-419-E 
5537-G-819 
5537-G-819-E 
5537-G-422 
5537-G-422-E 
5537-G-822 
5537-G-822-E 
5537-G-425 
5537-G-425-E 
5537-G-825 
5537-G-825-E 
5537-G-428 
5537-G-428-E 
5537-G-828 
5537-G-828-E 
5537-G-431 
5537-G-431-E 
5537-G-831 
5537-G-831-E 
 
 
 

 
Appendix B 
Catalog Number 
 
Triathlon PS  Tibial Insert 
 
5532-G-109 
5532-G-109-E 
5532-P-109 
5532-P-109-E 
5532-G-209 
5532-G-209-E 
5532-P-209 
5532-P-209-E 
5532-G-309 
5532-G-309-E 
5532-P-309 
5532-P-309-E 
5532-G-409 
5532-G-409-E 
5532-P-409 
5532-P-409-E 
5532-G-509 
5532-G-509-E 
5532-P-509 
5532-P-509-E 
5532-G-609 
5532-G-609-E 
5532-P-609 
5532-P-609-E 
5532-G-709 
5532-G-709-E 
5532-P-709 
5532-P-709-E 
5532-G-809 
5532-G-809-E 
5532-P-809 
5532-P-809-E 
5532-G-111 
5532-G-111-E 
5532-P-111 
5532-P-111-E 
5532-G-211 
5532-G-211-E 
5532-P-211 
5532-P-211-E 
5532-G-311 
5532-G-311-E 
5532-P-311 
5532-P-311-E 
5532-G-411 
5532-G-411-E 
5532-P-411 
5532-P-411-E 
5532-G-511 
5532-G-511-E 
5532-P-511 
5532-P-511-E 
5532-G-611 
5532-G-611-E 
5532-P-611 
5532-P-611-E 
5532-G-711 
5532-G-711-E 
5532-P-711 
5532-P-711-E 
5532-G-811 
5532-G-811-E 
5532-P-811 
5532-P-811-E 
5532-G-113 
5532-G-113-E 
5532-P-113 
5532-P-113-E 
5532-G-213 
5532-G-213-E 
5532-P-213 
5532-P-213-E 
5532-G-313 
5532-G-313-E 
5532-P-313 
5532-P-313-E 
5532-G-413 
5532-G-413-E 
5532-P-413 
5532-P-413-E 
5532-G-513 
5532-G-513-E 
5532-P-513 
5532-P-513-E 
5532-G-613 
5532-G-613-E 
5532-P-613 
5532-P-613-E 
5532-G-713 
5532-G-713-E 
5532-P-713 
5532-P-713-E 
5532-G-813 
5532-G-813-E 
5532-P-813 
5532-P-813-E 
5532-G-116 
5532-G-116-E 
5532-P-116 
5532-P-116-E 
5532-G-216 
5532-G-216-E 
5532-P-216 
5532-P-216-E 
5532-G-316 
5532-G-316-E 
5532-P-316 
5532-P-316-E 
5532-G-416 
5532-G-416-E 
5532-P-416 
5532-P-416-E 
5532-G-516 
5532-G-516-E 
5532-P-516 
5532-P-516-E 
5532-G-716 
5532-G-716-E 
5532-P-716 
5532-P-716-E 
5532-G-816 
5532-G-816-E 
5532-P-816 
5532-P-816-E 
5532-G-119 
5532-G-119-E 
5532-P-119 
5532-P-119-E 
5532-G-219 
5532-G-219-E 
5532-P-219 
5532-P-219-E 
5532-G-319 
5532-G-319-E 
5532-P-319 
5532-P-319-E 
5532-G-419 
5532-G-419-E 
5532-P-419 
5532-P-419-E 
5532-G-519 
5532-G-519-E 
5532-P-519 
5532-P-519-E 
5532-G-619 
5532-G-619-E 
5532-P-619 
5532-P-619-E 
5532-G-719 
5532-G-719-E 
5532-P-719 
5532-P-719-E 
5532-G-819 
5532-G-819-E 
5532-P-819 
5532-P-819-E 
5532-G-122 
5532-G-122-E 
5532-P-122 
5532-P-122-E 
5532-G-222 
5532-G-222-E 
5532-P-222 
5532-P-222-E 
5532-G-322 
5532-G-322-E 
5532-P-322 
5532-P-322-E 
5532-G-422 
5532-G-422-E 
5532-P-422 
5532-P-422-E 
5532-G-522 
5532-G-522-E 
5532-P-522 
5532-P-522-E 
5532-G-622 
5532-G-622-E 
5532-P-622 
5532-P-622-E 
5532-G-722 
5532-G-722-E 
5532-P-722 
5532-P-722-E 
5532-G-822 
5532-G-822-E 
5532-P-822 
5532-P-822-E 
5532-G-125 
5532-G-125-E 
5532-P-125 
5532-P-125-E 
5532-G-225 
5532-G-225-E 
5532-P-225 
5532-P-225-E 
5532-G-325 
5532-G-325-E 
5532-P-325 
5532-P-325-E 
5532-G-425 
5532-G-425-E 
5532-P-425 
5532-P-425-E 
5532-G-525 
5532-G-525-E 
5532-P-525 
5532-P-525-E 
5532-G-625 
5532-G-625-E 
5532-P-625 
5532-P-625-E 
5532-G-725 
5532-G-725-E 
5532-P-725 
5532-P-725-E 
5532-G-825 
5532-G-825-E 
5532-P-825 
5532-P-825-E 

 
Appendix B 
 
Catalog Number 
 
Triathlon Patellar Component 
 
5550-G-278 
5550-G-278-E 
5550-L-278 
5550-L-278-E 
5550-G-298 
5550-G-298-E 
5550-L-298 
5550-L-298-E 
5550-G-319 
5550-G-319-E 
5550-L-319 
5550-L-319-E 
5550-G-339 
5550-G-339-E 
5550-L-339 
5550-L-339-E 
5550-G-360 
5550-G-360-E 
5550-L-360 
5550-L-360-E 
5550-G-391 
5550-G-391-E 
5550-L-391 
5550-L-391-E 
5551-G-299 
5551-G-299-E 
5551-L-299 
5551-L-299-E 
5551-G-320 
5551-G-320-E 
5551-L-320 
5551-L-320-E 
5551-G-350 
5551-G-350-E 
5551-L-350 
5551-L-350-E 
5551-G-381 
5551-G-381-E 
5551-L-381 
5551-L-381-E 
5551-G-401 
5551-G-401-E 
5551-L-401 
5551-L-401-E 
 
Triathlon TS Stems - Cemented 
 
5560-S-109 
5560-S-112 
5560-S-115 
5560-S-209 
5560-S-212 
5560-S-215 
5560-S-309 
5560-S-312 
5560-S-315 
 
Triathlon TS Stems- Cementless 
 
5565-S-010 
5566-S-010 
5565-S-011 
5566-S-011 
5565-S-012 
5566-S-012 
5565-S-013 
5566-S-013 
5565-S-014 
5566-S-014 
5565-S-015 
5566-S-015 
5565-S-016 
5566-S-016 
5565-S-017 
5566-S-017 
5565-S-018 
5566-S-018 
5565-S-019 
5566-S-019 
5565-S-020 
5566-S-020 
5565-S-021 
5566-S-021 
5565-S-022 
5566-S-022 
5565-S-023 
5566-S-023 
5565-S-024 
5566-S-024 
5565-S-025 
5566-S-025 
Triathlon Stem Extender 
5571-S-025 
5571-S-050 
Triathlon TS Offset Adapter 
5570-S-020 
5570-S-040 
5570-S-060 
5570-S-080 
 
 
 

 
Appendix B 
 
Catalog Number 
Triathlon TS Femoral Distal Augments 
5540-A-101 
5541-A-101 
5542-A-101 
5540-A-201 
5541-A-201 
5542-A-201 
5540-A-301 
5541-A-301 
5542-A-301 
5540-A-401 
5541-A-401 
5542-A-401 
5540-A-501 
5541-A-501 
5542-A-501 
5540-A-601 
5541-A-601 
5542-A-601 
5540-A-701 
5541-A-701 
5542-A-701 
5540-A-801 
5541-A-801 
5542-A-801 
5540-A-102 
5541-A-102 
5542-A-102 
5540-A-202 
5541-A-202 
5542-A-202 
5540-A-302 
5541-A-302 
5542-A-302 
5540-A-402 
5541-A-402 
5542-A-402 
5540-A-502 
5541-A-502 
5542-A-502 
5540-A-602 
5541-A-602 
5542-A-602 
5540-A-702 
5541-A-702 
5542-A-702 
5540-A-802 
5541-A-802 
5542-A-802 
Triathlon TS Femoral Posterior Augments 
5543-A-100 
5544-A-100 
5543-A-200 
5544-A-200 
5543-A-300 
5544-A-300 
5543-A-400 
5544-A-400 
5543-A-500 
5544-A-500 
5543-A-600 
5544-A-600 
5543-A-700 
5544-A-700 
5543-A-800 
5544-A-800 
Triathlon Femoral Augment Locking Screws 
5540-A-000 
5545-A-000 
Triathlon TS Tibial Augments 
5545-A-101 
5546-A-101 
5545-A-201 
5546-A-201 
5545-A-301 
5546-A-301 
5545-A-401 
5546-A-401 
5545-A-501 
5546-A-501 
5545-A-601 
5546-A-601 
5545-A-701 
5546-A-701 
5545-A-801 
5546-A-801 
5545-A-102 
5546-A-102 
5545-A-202 
5546-A-202 
5545-A-302 
5546-A-302 
5545-A-402 
5546-A-402 
5545-A-502 
5546-A-502 
5545-A-602 
5546-A-602 
5545-A-702 
5546-A-702 
5545-A-802 
5546-A-802 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix C 
 
Study Advertisements 

 
Clinical Trial with the Triathlon Tritanium Cone Augments 
 
 
Dr. (name) of (practice) is participating in a clinical study evaluating a revision 
knee replacement with a new ancillary device in patients who are eligible for a 
revision total knee replacement.   
 
The Triathlon Tritanium Cone Augments are intended for cemented use 
respective to the femoral and tibial components, and cementless use with 
respect to the prepared bone.  They are compatible with other Stryker 
components as well.  These augments are currently being sold in the United 
States and are implanted in patients who need revision knee surgery. 
 
Dr. (name) is one of 5 to 8 surgeons nationwide selected to enroll qualifying 
patients into this clinical study. The data collected will be used to evaluate short-
term (5-year) performance of the components following surgery.  
 
The study includes males and non-pregnant females between 18 and 75 years of 
age.  These patients must be candidates for a revision knee replacement.  These 
patients must also be able to comply with requirements following surgery 
including weight bearing restrictions and self-evaluation questionnaires.  Enrolled 
patients will be required to come in for an evaluation and x-rays before surgery 
and follow-up evaluations and x-rays at 6 weeks, 6 months, 1 year, 2 years, and 
5 years after surgery.     
 
Meeting all of the above criteria does not guarantee participation in the study.  
Further consultation and a screening evaluation with the physician are necessary 
to ensure this is the right study for you.  Study personnel at the site will explain all 
the details of the study to you so you can make an informed decision as to 
whether or not you would like to participate.   
 
 If you are interested in participating in this study, please contact Dr. (name) or 
(study coordinator name) at the numbers listed below for further details.  
  
Your request for information about this study in no way commits you to 
participate.  In order to participate, you will have to meet specific criteria and sign 
a consent form that details all aspects of the study, the device and the risks 
associated with revision knee surgery.     
 
Dr. (name) 
 
 
 
 
 
Study Coordinator Name  
 
Practice Name 
 
 
 
 
Title 
Telephone Number   
 
 
 
Telephone Number 

 
 
 
 
 
 
 
 
 
 
 
Appendix D  
 
Model Informed Patient Consent

Triathlon Tritanium Cone Augments Outcomes Study 
Confidential 
 
Patient’s Initials: ______ 
 
   Page 1 of 6 
Version:  ____________ 
Informed Patient Consent 
 
I. 
Study Title:  A prospective, post-market, multi-center evaluation of the clinical outcomes 
of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments. 
II. 
Description of the Study  
You have been asked to be in this research study because your doctor thinks you need 
surgery to replace your knee joint.  About 145 people from up to 12 different hospitals 
will be in this study.   
The reason this study is being done is to see how successful a knee replacement using 
parts called the Triathlon TS Total Knee System and Triathlon Tritanium Cone Augments 
will be. Some of these parts will be put in using bone cement. The study will be able to 
tell how the knee replacement parts are performing by looking at whether there is a need 
to remove or replace the femoral component or baseplate due to the parts getting loose 
near the bone, and not because of an infection. This will be compared with how much 
this happens to patients who have a knee replacement with a similar cone augment.   
This study is being done by Stryker Orthopaedics (the maker of the knee replacement, 
also called the Sponsor) and your doctor. We are doing this study to review the 
performance of the Stryker Orthopaedics Triathlon TS Total Knee System with Triathlon 
Tritanium Cone Augments knee replacement. 
Your doctor and his staff will ask you some questions during this visit. Based on the 
requirements of the study, you may or may not be chosen to be in the study. 
Fitting all of these requirements does not mean you will be in the study. The doctor also 
has to examine you to make sure the study is right for you.  The staff at the doctor’s 
office will tell you everything about the study. Then you can decide if you want to be in 
the study or not. 
Your participation in the study will last for 10 years following your study surgery.  Your 
doctor will examine you before surgery and during surgery.  You will have surgery and 
your doctor will tell us the details of your surgery. During the visit before surgery you will 
need to fill out forms about your health. Your doctor will also collect other information 
and x-rays that would be collected at a normal visit.  
He will then examine you for the study after your surgery. During your visits to the doctor 
after surgery, your doctor will figure out how your knee is performing and take x-rays. 
These x-rays are the same kind you would have if you were not in the study.  
At your visits to the doctor after surgery, your doctor will ask you to fill out questionnaire 
forms. These forms will be about your health. These visits will follow the evaluation 
schedule below: 
 
 

Triathlon Tritanium Cone Augments Outcomes Study 
Confidential 
 
Patient’s Initials: ______ 
 
   Page 2 of 6 
Version:  ____________ 
Surgeon Evaluations 
Before 
Surgery 
6 Weeks 
6 Months 
1 Year 
2 Years 
5 Years 
Annually
6 Years -
10 Years 
Demographics and Current 
Medical Conditions 
X 
 
 
 
 
 
 
2011 Knee Society Score 
X 
X 
X 
X 
X 
X 
 
AP X-ray* 
X 
X 
X 
X 
X 
X 
 
ML X-ray 
X 
X 
X 
X 
X 
X 
 
Merchant view X-ray 
X 
X 
X 
X 
X 
X 
 
Patient Questionnaires 
 
SF-12 
X 
X 
X 
X 
X 
X 
 
LEAS 
X 
X 
X 
X 
X 
X 
 
HSS Patella Score 
X 
X 
X 
X 
X 
X 
 
EQ-5D 
X 
X 
X 
X 
X 
X 
 
Stem Tip Pain Diagram 
X 
X 
 
 
X 
X 
 
Follow-Up Questionnaire 
 
 
 
 
 
 
X 
*Bilateral Anteroposterior (AP) X-ray: A Long-standing AP x-ray will be taken before surgery and at 6 weeks after surgery.  At 6 months,       1 
year, 2 years and 5 years after surgery, a standard AP x-ray will be taken. 
(Bilateral AP x-rays are preferred.  However, unilateral AP x-rays may be submitted at these timepoints, if bilateral images are not available)   
Mediolateral (ML) X-ray: A standard ML x-ray will be taken before surgery and at 6 weeks, 6 months, 1 year, 2 years and 5 years after 
surgery. 
Merchant view X-ray: A standard Merchant view x-ray will be taken before surgery and at 6 weeks, 6 months, 1 year, 2 years and 5 years after 
surgery. 
Short Form-12 (SF-12):  The SF-12 is a 12-item patient questionnaire that evaluates general health and well-being. 
Lower Extremity Activity Scale (LEAS): The LEAS is a patient questionnaire designed to reflect patient activity.  
Hospital for Special Surgery Patella Score: The HSS Patella Score incorporates both patient reported symptoms and surgeon reported data 
specific to the front of the knee.  
EuroQol-5D (EQ-5D): The EQ-5D is a standardized instrument that evaluates the patient’s current health state.  
Stem Tip Pain Diagram: The Stem Tip Pain Diagram is an anatomic diagram the patient completes to demonstrate the level and location of 
pain in their thigh or shin.  This questionnaire is only applicable preoperative if the patient has a long stem previously implanted.  
Follow-Up Questionnaire: The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, 
pain, whether the study device is in place and reportable complications. 
III.   
Condition and Care after Surgery 
Your doctor will tell you what to do to get better after your surgery.  Like with any 
surgery, your body takes time to heal.  That amount of time will be related to the surgery 
and your health.  While you are healing, you may experience pain because of the 
surgery. This pain might last a few months after the surgery. 
Your doctor will tell you to use crutches, a walker, or a cane after your surgery.  This will 
take some weight off of your knee. This can help your knee replacement last longer. You 
must follow your doctor’s orders on using a cane, crutches, or walker.   
The goal of this surgery is to lessen pain and improve your knee performance.  You will 
need to see your doctor at the scheduled follow-up visits after your surgery for an 
evaluation of your knee replacement. 
 

Triathlon Tritanium Cone Augments Outcomes Study 
Confidential 
 
Patient’s Initials: ______ 
 
   Page 3 of 6 
Version:  ____________ 
IV. 
Possible Risks 
This study looks at how your knee replacement is performing. The Food and Drug 
Administration (FDA) already allows this knee replacement to be sold in the United 
States.  There are no extra risks for you because you are in this study, just the normal 
risks of knee replacement surgery.  You may need to spend a little more time in the 
doctor’s office to fill out paperwork.  If the doctors and scientists find out any new 
information during this study that might make you change your mind about being in the 
study, you will get that new information. 
There are some risks in knee surgery.  These might be:  moderate to severe pain; 
breaking the knee replacement parts or the surrounding bones; movement of parts of the 
replacement inside your body; parts of the replacement sinking; parts of the replacement 
moving out of their normal position; allergies to the metal parts of the replacement; 
removal of one or more of the parts; loosening and infection; rubbing of parts of the 
replacement which might lead to losing part of the bone; disorders of the nerves 
involving your legs; damage to the nerves;  abnormal building up of bone; changes in 
movement of your blood related to your heart, blood and lymph vessels; problems with 
urinating; problems with your stomach or intestines; problems with blood vessels like 
blood clots; lung problems like pneumonia; a clogged blood vessel; or a heart attack. 
V.  
Potential Benefits 
You might not benefit personally from being in the study, but the results might help out 
others that have knee replacement surgery in the future. 
VI. 
Other Types of Treatment 
You have talked about other possible treatments with your doctor. These treatments 
might be conservative treatment that is not surgery or no treatment at all. 
You can say no to being a part of this study.  This will not change any part of your knee 
surgery.  Your doctor can tell you detailed facts about this treatment and the benefits of 
other types of treatment you can have. You should feel free to talk with your doctor 
about other options.  
VII. 
Making Financial Information Known 
Your doctor and/or the hospital can be paid money from the company that made the 
knee replacement. This money would be to pay for the cost of doing the study or for 
other reasons. If you want to know more about this, you can ask your doctor or his staff.  
VIII. 
Privacy 
If you say yes to being a part of this study, your medical records and identity will be kept 
private. They will be kept private based on the law. The records will not be given to 
anyone unless you give written permission.   
If you sign this consent form, you allow Stryker Orthopaedics employees to see your 
medical records. You also allow people to see your records who look at how safe and 
effective medical products are. These people also make sure that medical treatment and 
research studies are safe. Your name and identity will not be in those records. 
 
 

Triathlon Tritanium Cone Augments Outcomes Study 
Confidential 
 
Patient’s Initials: ______ 
 
   Page 4 of 6 
Version:  ____________ 
IX.  
Cost to Be in the Study 
Your procedure is a routine revision knee surgery should be covered by your insurance 
carrier.  
Additionally, you will be offered a stipend in the form of a debit card for various follow-up 
visits held in your doctor’s office. You must complete all of the applicable questionnaires 
and evaluations in order to receive the stipend per visit.  You can learn more about the 
program from your study doctor and his staff.  
 
X. 
Device Retrieval Analysis Study 
If [Investigators’ Names] finds it medically necessary to perform a knee revision because 
of device failure, Stryker Orthopaedics has a procedure to test the parts. 
I understand that Stryker Orthopaedics Corporation makes the implant and runs the 
study. I understand that Stryker Orthopaedics will ask my doctor to send any removed 
knee replacement parts to them. My doctor will send them to the Product Surveillance 
department at Stryker Orthopaedics. They will test these parts, and this can be a part of 
being in the study.  
I allow my doctor and to give Stryker Orthopaedics (the Sponsor) any knee implant parts 
that have been removed. I also allow my doctor to give Stryker Orthopaedics other 
information. This other information is my name, birth date, and details about my knee 
surgery. Then they can test the knee replacement parts that have been taken out. They 
can give the company and the doctor the results of those tests.  
My doctor will get the results of this testing. I understand that I will not get these parts 
back. I also understand that I will not get the results of any tests that are done on those 
parts. 
I understand that nobody outside of the Sponsor will see my removed knee replacement 
parts.  
I understand that I will let my doctors and the Sponsor see information about my identity. 
I also understand that nobody else will see that information. I understand that if I want to 
see this information, I can ask my doctor for it. 
I understand that I can I decide I do not want to let these knee replacement parts to be 
used anymore. I can also decide if I do not want my identity information to be used 
anymore. I understand that I will need to say this in writing. I understand that any 
information from before that is still allowed to be used. 
Records about me will be kept private.  I can choose whether I want to allow my knee 
replacement parts to be studied if they are taken out. I understand I am allowed to say 
no to having my knee replacement parts studied. I also understand that I can stop being 
in the study whenever I want. If I choose to stop being in the study, my doctor will not 
change my care or treatment.  
I have signed below and have read and understood what is written above. I allow for 
information about my identity to be released.  My signature shows that I have had a 
chance to ask questions about this removed knee replacement parts study. My doctor 
has answered these questions. I have been given a copy of the consent form.   
 

Triathlon Tritanium Cone Augments Outcomes Study 
Confidential 
 
Patient’s Initials: ______ 
 
   Page 5 of 6 
Version:  ____________ 
Please check one of the boxes below: 
 
 I agree to allow the Sponsor to study any knee replacement parts removed from me. 
 
 I do not want to allow the Sponsor to study any knee replacement parts removed from 
me. 
 
           
                                                       _____     
 
_____________                                             
Signature of Subject/Legal Representative  
 
Date 
XI. 
Clinical Trial Website Posting 
 
A description of this clinical trial will be on the website http://www.Clinical Trials.gov. The   
U.S. law says it has to be posted on that website. This Web site will not have any 
information that can tell other people who you are. The Web site will show some of the 
results, or maybe even less than that. You can search this Web site whenever you want. 
XII. 
Payment and Medical Treatment Related to Injury 
The Sponsor will not give you any money if you have a medical problem related to 
surgery. Stryker Orthopaedics will not give you free medical treatment. If you have a 
medical problem related to your surgery, you should call [Investigators’ Names] as soon 
as you can at [Phone Number].  
[Institution Name] will not give any money back or free treatment to you either. 
[Investigators’ Names] should tell you about what the hospital does if you have a 
complication. By signing this consent form, you are not getting rid of any of your rights. 
Your doctor is still responsible if he does something wrong. 
XIII.   Access to Data and Privacy 
By being part of this study, you are letting your doctor and his staff give the Sponsor 
information about your health. You also allow people to see your records who look at 
how safe and effective medical products are. These people also make sure that medical 
treatment and research studies are safe. This is required by the law.  This health 
information includes all information from the study.  It may also include other health 
information in your medical records. Some of this health information might be from 
before you joined the study. 
The Sponsor will only collect information that they need for the study. They will make 
sure that the information they get does not have your name or address on it. They will 
make sure that no one else will see information about your identity. 
The Sponsor will use information about your health to do the study. They will use the 
results of the study to evaluate the performance of the knee replacement parts. They will 
also use the results to improve the parts that they make. They might also use the 
information to design new parts.  
This permission to use your information does not have an ending date. You can take 
back this permission to release your health information at any time. You can do this by 

Triathlon Tritanium Cone Augments Outcomes Study 
Confidential 
 
Patient’s Initials: ______ 
 
   Page 6 of 6 
Version:  ____________ 
telling your doctor in writing. If you say you do not want to be in the study anymore it will 
not change the work that has already been done in the study. You have to sign this 
consent form to be in the study. This form also lets your health information be seen by 
those groups mentioned before. If you take back this consent you cannot be in the study 
anymore. At the end of the study information about your identity cannot be used 
anymore.  
XIIV. 
People to Contact 
If you have any questions you can call [IRB Name] IRB at [IRB Phone Number]. You can 
also ask them if you want to know your rights as part of the study.  You should contact 
Dr. [Investigators’ Names] as soon as you can at [Phone Number] if you have an injury 
that is related to the study. 
 
XV.  
Being in the Study 
Being part of this study is your choice.  If you do not choose to be in the study, you will 
not lose any benefits that you are supposed to have.  You can decide you do not want to 
be in the study anymore and will not lose the benefits you are supposed to have.   
By signing and dating this form below, you are saying you have read and looked over all 
sections of this Informed Consent Form. You are also saying someone has answered all 
of your questions. You are also saying voluntarily consent to be in this research study.  If 
you do not sign this form, you will not be allowed to be in the research study. 
 
_______________________________________ 
Printed name of Subject/Legal Representative 
 
_______________________________________ 
__________       
Signature of Subject/Legal Representative                                     Date Signed     
 
 
 
_______________________________________ 
 
          __________ 
Signature of Person conducting the consent process                     Date Signed 
 
_______________________________________ 
 
__________       
 
Signature of Investigator 
                             Date Signed 
 
 
A signed and dated copy of this consent form must be given to the patient.   

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix E 
 
Suggested Radiographic Technique 

Suggested Radiographic Techniquei 
The following views are required preoperatively and at each postoperative interval specified 
according to the evaluation schedule to enable evaluation of the bone-prosthesis interfaces. 
 
Long Standing AP 
 
AP 
 
ML 
 
Merchant (30° of flexion) 
General Requirements 
A. Appropriate corrections in radiological exposure setting are needed for obese subjects. 
B. At least a 14”x17” sized film should be used. 
C. If the subject is bilateral and a view showing both knees is submitted, two copies of that 
view are required. 
D. Both digital and film radiographs are acceptable.  Digital films must be in uncompressed 
DICOM format. 
E. A view capturing the complete prosthesis must be submitted to Stryker.  Radiographs 
incompletely displaying components will be rejected. 
F. Each image must have: 
a. Subject’s identification number 
b. Subject’s initials 
c. Date of radiograph 
d. Indication of operative side in the study 
e. Markers for right and left sides, as applicable 
f. Visit interval 
AP 
A. Long Standing techniqueii 
a. The subject should be standing with the study knee in 10° flexion. Both knees should 
be in the view. 
b. The x-ray beam should be directed vertically to the study knee with 5° to 7° 
angulation toward the subject’s head. 
c. The entire lower extremity, including the ipsilateral and contralateral hip must 
be visible on the film as shown in Figure 1. The femoral component, the medial 

and lateral femoral epicondyles, tibial component and an unobstructed view of the 
polyethylene tibial insert must be visible on film as well.  
B. Standard technique 
d. The subject should be supine with the knee in full extension and the leg positioned 
neutrally. Both knees should be in the view. 
e. The x-ray beam should be directed vertically to the study knee with 5° to 7° 
angulation toward the subject’s head. 
f. The femoral component, the medial and lateral femoral epicondyles, tibial 
component and an unobstructed view of the polyethylene tibial insert must be 
visible on film as shown below (Figure 2).  
Refer to Figure 1 and 2 for an acceptable AP radiographs.                 
 
Figure 1.  Long Standing AP View - Acceptable 

 
Figure 2.  Standard AP View - Acceptable 
ML 
A. Standard technique 
a. The subject should be lying flat on the same side as the study knee.  The knee 
should be flexed 25° to 30°. 
b. The x-ray beam should be directed vertically toward the medial aspect of the knee 
joint perpendicular to the plane of the extremity. 
c. The patella, the patellar component, overlapping posterior condyles of the 
femoral component and tibial component, all in profile, must be visible in this 
radiograph. 
Refer to Figure 2 for an acceptable ML radiograph. 
 
Figure 2.  ML View - Acceptable 

Merchant (30° of flexion) 
A. Standard technique 
a. The subject should be supine with his/her knee flexed about 30° at the table’s edge. 
b. A device should be use to maintain flexion at this angle, to which the film cassette 
should be attached. 
c. The x-ray beam should be directed through the patella at 60° from the vertical axis. 
d. The articular surface of the patella and femur must be visible. 
Refer to Figure 3 for an acceptable Merchant (30° of flexion) radiograph. 
 
Figure 3.  Merchant (30° of Flexion) View – Acceptable 
                                                 
i Greenspan, A. (1992). Orthopedic radiology: A practical approach (2nd ed.). New York: Gower Medical 
Publishing. 
iiSabharwal S. Assessment of Lower Limb Alignment: Supine Fluoroscopy compared with a standing full-
length radiograph. J Bone Joint Surg AM.2008; 90: 43-51.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix F 
 
Retrieved Implant Analysis Protocol 

 
RETRIEVED IMPLANT ANALYSIS PROTOCOL 
Triathlon Tritanium Cone Augments Outcomes Study 
PURPOSE: 
To evaluate retrieved Stryker Orthopaedics Triathlon TS Tibial Baseplates, Triathlon TS 
Femoral Components, Triathlon TS Tibial Inserts, Triathlon Tritanium Cone Augments, 
and other ancillary components in order to help characterize patterns of wear and 
potential device-related complications. 
 
METHODS: 
A. Subject Selection: 
Surgeons participating in the Stryker Orthopaedics Triathlon Tritanium Cone 
Augments Outcomes Study [510(k) clearance #K070095 – June 1, 2007, 510(k) 
clearance #K072221 – October 15, 2007, and 510(k) clearance #K143393 – 
January 13, 2015] will be asked to comply with the Retrieved Implant Analysis 
Protocol.  Whenever possible, subjects who undergo revision/removal of the 
Stryker Orthopaedics Triathlon TS Total Knee System and/or other ancillary 
components will be included in this analysis.  Subjects will be asked to consent to 
having their implants analyzed.  A sample Informed Patient Consent Form, 
including a section for implant analysis, is attached to this protocol as Appendix 
D. 
This study protocol will comply with the 2002 HIPAA privacy rule.  As such, 
Stryker will only collect that information which is necessary to support the 
objectives of the study protocol.  Stryker will take precautions to ensure that data 
received is as de-identified as possible.  In the case that some identified 
information is received, Stryker will ensure that any identifying information is not 
reported.  Study subjects will authorize Stryker to use their retrieved implant(s) 
and health information in support of the study protocol by completing and signing 
the Informed Patient Consent Form.  A subject also has the option to sign the 
Informed Patient Consent Form for study participation but decline participation in 
the Retrieved Implant Analysis Protocol by checking off the appropriate selection 
in that section of the consent.  Should a subject choose to withdraw 
authorization, Stryker may use data collected prior to the withdrawal of 
authorization in order to maintain data integrity.  
B. Specimen Handling: 
The Stryker Orthopaedics Triathlon TS Tibial Baseplates, Triathlon TS Femoral 
Components, Triathlon TS Tibial Inserts, Triathlon Tritanium Cone Augments, 
and/or ancillary component(s) obtained at the time of revision/removal should be 
placed in neutral buffered formalin.  Each specimen container should be carefully 
labeled with subject initials, operative side, surgeon name and the component(s) 
included for analysis.  Whenever possible, relevant radiographic studies and a 
clinical summary should be placed on the outside of the shipping container along 
with the specimen.   
All specimens should be placed into a sufficient quantity of 10% formalin for a 
minimum of 24 hours prior to shipping.  

 
After the specimens have been immersed in 10% formalin for a minimum of 24 
hours, they should be transferred to a leak proof container with a quantity of 10% 
formalin sufficient to keep the specimens moist. 
C. Recommendations for Packing and Shipping Explants To Stryker Orthopaedics 
Please contact the Triathlon Tritanium Cone Augments Outcomes Study CSM, 
identified on the Stryker Orthopaedics Contact Sheet, via phone or email once 
the scheduled revision/removal surgery has been performed in order to notify the 
study team of the intended revision/removal.   
A confirmation with the Product Inquiry (PI) number, including shipping 
instructions, will be provided by Stryker once the event is reported to Stryker. 
Please ensure that the provided PI number is marked on the outside of the 
shipping container.   
 
RESULTS 
A report suitable for routine patient care will be provided to each surgeon by request.   

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix G 
 
Draft Specifications for Electronic Case Report Forms  
 

Annotated Study Book for Study Design: TriathCone
Study Design Version: 1.4
Sponsor: Stryker
Protocol: TriathCone
A prospective, post-market, multi-center evaluation of the clinical outcomes of the Triathlon TS Total Knee 
System with Triathlon Tritanium Cone Augments
Generated by Central Designer TM
May 8, 2015 5:20PM
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Annotated Study Book - TriathCone
5/8/2015
file:///C:/Users/mhipolit/AppData/Local/Apps/2.0/P04J85LY.DDK/QZ9Q1AZE.NQW/orac..74.7_bd27f2385a501...

Time and Events Schedule For Study Design: TriathCone
Element
System
Assessment
CRF
System 
Screening
(SCR)
[S]
System 
Enrollment
(ENR)
[S]
Baseline / Pre-
Op
(BASE/PREOP)
[S]
Surgical 
Details
(INTRAOP)
[S]
6WK
(6WK)
[S/D]
6MO
(6MO)
[S/D]
1YR
(1YR)
[S/D]
2YR
(2YR)
[S/D]
5YR
(5YR)
[S/D]
Adverse 
Event
(AE)
[S]
Study 
Completion
(STUDYCOMP)
[S]
Visit Start Hours
0
0
0
1
1009
5041
9409
18169
18170
18171
18172
1 
System Screening
SCR
1
2 
System Enrollment
ENR
1
3 
Date of Visit
DOV
1
1
1
1
1
1
1
4 
Inclusion / Exclusion
IE
2
5 
Demographics
DM
3
6 
CENSOR
CENSOR
4
7 
Knee Society Score: Pre-Op
PREKSS2011
5
8 
SF-12v2 Health Survey
SF12
6
4
4
4
4
4
9 
Lower Extremity Activity Scale
LEAS
7
5
5
5
5
5
10 HSS Patella Score
HSSPAT
8
6
6
6
6
6
11 EQ-5D Health Questionnaire
EQ5D
9
7
7
7
7
7
12 End of Stem Pain
ESP
10
8
8
8
13 Previous Implant Information
PIF
2
14 Surgical Details
SURG
3
15 Surgical Prostheses
SP
4
16 Knee Society Score: Post-Op
POSTKSS2011
2
2
2
2
2
17 Post-Op Events
POEVENT
3-DF
3-DF
3-DF
3-DF
3-DF
18 Adverse Event TriathCone
AE
1-RF
19 Study Termination
TERM
1
Key:    [S] = Scheduled Visit    [D] = Dynamic Visit    [U] = Unscheduled Visit    [R] = Repeating Visit
C = Common Form    DF = Dynamic Form    RF = Repeating Form
Page 2 of 37
Annotated Study Book - TriathCone
5/8/2015
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TriathCone: System Screening (SCR) [SCR]
1.*

Subject Initials
[Subj Initials] 
[SCRINIT] 
Enter "-", if subject does not have a middle initial.
A3
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TriathCone: System Enrollment (ENR) [ENR]
1.
Subject Number [read-only]
[Subj Number] 
[SUBID] 
A10
2.*

Scheduled Surgery Date
[Scheduled Surgery Date] 
[SCHDSURG] 
Req
/ Req
/ Req
(2015-2025)
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TriathCone: DOV (DOV) [DOV]
1.* Date of Visit
[Date of Visit] 
[DOVDT] 
Req
/ Req
/ Req
(2015-2025)
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TriathCone: Inclusion / Exclusion (IE) [IE]
General Information [IE_S1]
1.*

Operative Side
[Operative Side] 
[OPSIDE] 
Right
Left 
2.*

Informed Consent Date Signed
[Informed Consent Date Signed] 
[CONSENT] 
Req
/ Req
/ Req
(2015-2025)
Inclusion Criteria [IE_S2]
**All of the below must be answered "Yes" for the patient to be included in the study.
3.*

Patient has signed an IRB/EC approved study specific Informed 
Patient Consent Form.
[INCLUSION 1] 
[IEINC1] 
Yes
No
4.*

Patient is a male or non-pregnant female age 18 or older at time of 
study device implantation.
[INCLUSION 2] 
[IEINC2] 
Yes
No
5.*

Patient is a candidate for revision of all femoral and tibial 
components of a total knee replacement.
[INCLUSION 3] 
[IEINC3] 
Yes
No
6.*

Patient is willing and able to comply with postoperative scheduled 
clinical and radiographic evaluations and rehabilitation.
[INCLUSION 4] 
[IEINC4] 
Yes
No
Exclusion Criteria [IE_S3]
**All of the below must be answered "No" for the patient to be included in the study.
7.*

Patient has a Body Mass Index (BMI) > 40.
[EXCLUSION 1] 
[IEEXC1] 
Yes
No
8.*

Patient has an active or suspected latent infection in or about the 
affected knee joint at time of study device implantation.
[EXCLUSION 2] 
[IEEXC2] 
Yes
No
9.*

Patient has a neuromuscular or neurosensory deficiency, which limits 
the ability to evaluate the safety and efficacy of the device.
[EXCLUSION 3] 
[IEEXC3] 
Yes
No
10.*

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.
[EXCLUSION 4] 
[IEEXC4] 
Yes
No
11.*

Patient is immunologically suppressed or receiving steroids in excess 
of normal physiological requirements (e.g. > 30 days).
[EXCLUSION 5] 
[IEEXC5] 
Yes
No
12.*

Patient has a failed unicondylar knee prosthesis
[EXCLUSION 6] 
[IEEXC6] 
Yes
No
13.*

Patient has a known sensitivity to device materials.
[EXCLUSION 7] 
[IEEXC7] 
Yes
No
14.*

Patient is a prisoner.
[EXCLUSION 8] 
[IEEXC8] 
Yes
No
COMMENTS [IE_S4]
15.

Comments
[Comments] 
[IECMT] 
A200
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TriathCone: Demographics (DM) [DM]
Demographics [DM]
1.*

Date of Assessment
[Date of Assessment] 
[DOA] 
Req
/ Req
/ Req
 (2015-2025)
2.
Subject Number [read-only]
[Subj Number] 
[SUBID] 
A10
3.*

Subject Initials
[Subj Initials] 
[INITIALS] 
A3
4.*

Education Level
[Education Level] 
[EDU] 
Less Than High School
High School Diploma
Greater Than High School
5.*

Annual household income (Please choose one)
[Annual household income] 
[INCOME] 
<= $24,999
$25,000-$49,999
$50,000-$74,999
$75,000-$99,999
$100,000-$149,999
>= $150,000
6.*

Employment Status
[Employment Status] 
[EMPLOY] 
Working
Not Working
7.*

Ethnicity
[Ethnicity] 
[ETH] 
Hispanic or Latino origin
Not Hispanic or Latino origin
8.*

Race
[Race] 
[RACE] 
American Indian or Alaskan Native
Asian
Black or African
Native Hawaiian or other Pacific Islander
White
If the subject is a current or past cigar and /or pipe smoker, please select "Non-smoker" and enter a comment below.
9.*

Cigarette Use
[Cigarette Use] 
[CIGUSE] 
Non-smoker
[cmpCURSMOK] 
Current cigarette smoker
[KNPACK] 
Does the subject know the number of packs/day?
[PACKS] 
#Packs/Day
xxx.
Unknown
[KNYRSMOK] 
Does the subject know the number of years he/she has been smoking?
[YRSMOK] 
#Years
xxx.
Unknown
[cmpEXSMOK] 
Ex-cigarette smoker
[KNEXPACK] 
Does the subject know the number of packs/day?
[EXPACKS] 
#Packs/Day
xxx.
Unknown
[KNEXYRSM] 
Does the subject know the number of years he/she had been smoking?
[EXYRSMOK] 
#Years
xxx.
Unknown
[STOPSM] 
Date Stopped
Req/Unk
/ Req/Unk
/ Req
 (1900-2025)
10.*

Alcohol Use
[Alcohol Use] 
[ALUSE] 
Have never had alcohol
Have not had alcohol in the last year
Less than 3 drinks a week
3 - 7 drinks a week
8 - 14 drinks a week
15+ drinks a week
11.*

Date of Birth
[Date of Birth] 
[BRTHDAT] 
Req
 / Req
 / Req
 (1900-2010)
12.* Gender
[GENDER] 
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[Gender] 
Male
Female
13.*

Height
[Height] 
[HT] 
xxxxx.
inches
centimeters
14.*

Weight
[Weight] 
[WT] 
xxxxx.
lbs
kg
15.
BMI [read-only]
[BMI] 
[BMI] 
xxxxxxx.
16.*

Primary Orthopedic diagnosis
[Primary Orthopedic diagnosis] 
[INDX] 
Osteoarthritis
Traumatic Arthritis
Avascular Necrosis
[cmpOTHDX] 
Other
[OTHDX] 
(Specify)
A100
17.*

Does the subject have any of the following conditions
[Does subject have conditions] 
[MORBIDYN] 
[cmpCMORBID] 
Yes
[COMORBID] 
Myocardial infarction
Congestive heart failure
Peripheral vascular disease
Cerebrovascular disease
Dementia
Chronic pulmonary disease
Connective tissue disease
Peptic ulcer disease
Mild liver disease
Diabetes without organ damage
Diabetes with organ damage
Hemiplegia or paraplegia
Moderate or severe renal disease
Malignant tumor (any)
Leukemia
Lymphoma
Moderate or severe liver disease
Metastatic solid tumor
HIV
No
18.*

Concurrent Medical Conditions
[Concurrent Medical Conditions] 
[CMCYN] 
[cmpCMC] 
Yes
[CMC] 
[cmpCA] 
Cancer
[CANCER] 
A200
[cmpCARD] 
Cardiovascular
[CARDIO] 
A200
[cmpDERM] 
Dermatologic
[DERM] 
A200
[cmpDIG] 
Digestive
[DIGEST] 
A200
[cmpENDO] 
Endocrine / Metabolic
[ENDO] 
A200
 [b] 
[b] 
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[cmpIMM] 
Immunologic / Lymphatic
[IMM] 
A200
[cmpMUS] 
Musculoskeletal
[MUS] 
A200
[cmpNEUR] 
Neurologic
[NEUR] 
A200
[cmpPSYC] 
Psychologic
[PSYC] 
A200
[cmpRESP] 
Respiratory
[RESP] 
A200
[cmpSUBD] 
Substance Dependence
[SUBD] 
A200
[cmpUROG] 
Urogenital
[URO] 
A200
[cmpOTCMC] 
Other
[OTCM] 
(Specify)
A200
No
Comments [DM_S5]
19.

Comments
[Comments] 
[DMCOM] 
A200
20.
Charlson-Deyo Comorbidity Index [read-only]
[CCI] 
[CCI] 
N2
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TriathCone: CENSOR (CENSOR) [CENSOR]
CENSOR [CENSOR]
1. Censor from Analysis [hidden]
[Censor from Analysis] 
[CENSORFA] 
[cmpCENSOR] 
Yes
[CNSRDT] 
Date Censored
Req
 / Req
/ Req
(2015-2025)
[CNSREASN] 
Censor Reason
A200
No
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TriathCone: Knee Society Score: Pre-Op (PREKSS2011) [PREKSS2011]
1.*

Visit Date
[Visit Date] 
[KSSDOV] 
Req
/ Req
/ Req
(2015-2025)
2.*

Charnley Functional Classification
[Charnley Functional Classification] 
[CHARNLY] 
A Unilateral Knee Arthritis
B1 Unilateral TKA, opposite knee arthritic
B2 Bilateral TKA
C1 TKR, but remote arthritis affecting ambulation
C2 TKR, but medical condition affecting ambulation
C3 Unilateral or Bilateral TKA with Unilateral or Bilateral THR
Objective Knee Indicators [PREKSS_S2]
3.*

Alignment: measured on AP standing Xray (Anatomic Alignment)
[Alignment] 
[ALIGNMSR] 
Neutral: 2-10 degrees valgus
Varus: < 2 degrees valgus
Valgus: > 10 degrees valgus
4.*

Medial / Lateral instability: measured in full extension
[Medial / Lateral instability] 
[INSTML] 
None
Little or < 5 mm
Moderate or 5 mm
Severe or > 5 mm
5.*

Anterior / Posterior Instability: measured at 90 degrees
[Anterior / Posterior Instability] 
[INSTAP] 
None
Moderate < 5 mm
Severe > 5 mm
6.*

Range of motion
[Range of motion] 
[ROM] 
N3
7.*

Flexion Contracture
[Flexion Contracture] 
[FLEXC] 
None
1-5 degrees
6-10 degrees
11-15 degrees
> 15 degrees
8.*

Extensor Lag
[Extensor Lag] 
[EXTLAG] 
None
< 10 degrees
10-20 degrees
> 20 degrees
Symptoms [PREKSS_S3]
9.*

Pain with level walking
[Pain with level walking] 
[PNLVLWLK] 
0 - None
1
2
3
4
5
6
7
8
9
10 - Severe
10.*

Pain with stairs or inclines
[Pain with stairs or inclines] 
[PNSTAIR] 
0 - None
1
2
3
4
5
6
7
8
9
10 - Severe
11.*

Does this knee feel "Normal" to you?
[Knee feels Normal] 
[FEELNORM] 
Always
Sometimes
Never
Subject Satisfaction [PREKSS_S4]
12.*

Currently, how satisfied are you with the pain level of your knee 
while sitting?
[Satisfied with pain level of knee while sitting] 
[SIT] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
13.*

Currently, how satisfied are you with the pain level of your knee 
while lying in bed?
[Satisfied with pain level of knee while lying in bed] 
[INBED] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
14.*

Currently, how satisfied are you with your knee function while 
getting out of bed?
[Satisfied with your knee function while getting out of bed] 
[OUTBED] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
15.*

Currently, how satisfied are you with your knee function while 
performing light household duties?
[Satisfied with your knee function while performing light household 
duties] 
[HSEHLD] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
16.*

Currently, how satisfied are you with your knee function while 
performing leisure recreational activities?
[Satisfied with your knee function while performing leisure 
recreational activities] 
[RECACT] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
Subject Expectations [PREKSS_S5]
What do you expect to accomplish with your knee replacement:
17.*

Do you expect your knee joint replacement surgery will relieve your 
knee pain?
[Expect knee joint replacement surgery will relieve knee pain] 
[JNTRPLC] 
No, not at all
Yes, a little bit
Yes, somewhat
Yes, a moderate amount
Yes, a lot
18.*

Do you expect your surgery will help you carry out your normal 
activities of daily living?
[Expect surgery will help you carry out normal activities of daily 
living] 
[DAILYACT] 
No, not at all
Yes, a little bit
Yes, somewhat
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Yes, a moderate amount
Yes, a lot
19.*

Do you expect your surgery will help you perform leisure, 
recreational or sports activities?
[Expect surgery will help you perform leisure, recreational or sports 
activities] 
[LSRACT] 
No, not at all
Yes, a little bit
Yes, somewhat
Yes, a moderate amount
Yes, a lot
Functional Activities [PREKSS_S6]
20.*

Can you walk without any aids (such as a cane, crutches or 
wheelchair)?
[Walk without any aids?] 
[WALKAID] 
Yes
[cmpWALKAID] 
No
[OTWLKAID] 
If no, which of the following aid(s) do you use?
Wheelchair
Walker
Crutches
Two canes
One crutch
One cane
Knee sleeve / brace
[KNEEAIDS] 
Do you use these aid(s) because of your knees?
Yes
No
21.*

For how long can you stand (with or without aid) before sitting due 
to knee discomfort?
[How long stand before sitting?] 
[HLSTAND] 
Cannot stand
0-5 minutes
6-15 minutes
16-30 minutes
31-60 minutes
More than an hour
22.*

For how long can you walk (with or without aid) before stopping due 
to knee discomfort?
[How long walk before stopping?] 
[HLWALK] 
Cannot walk
0-5 minutes
6-15 minutes
16-30 minutes
31-60 minutes
More than an hour
How much does your knee bother you during each of the following activities? [PREKSS_S10]
23.*

Walking on an uneven surface
[Walk on uneven surface] 
[UNEVEN] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
24.*

Turning or pivoting on your leg
[Turn or pivot leg] 
[PIVOT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
25.*

Climbing up or down a flight of stairs
[Climb up down stairs] 
[UPDN] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
26.*

Getting up from a low couch or a chair without arms
[Up from low couch or chair without arms] 
[GETUP] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
27.*

Getting into or out of a car
[Get into or out of a car] 
[CARINOUT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
28.*

Moving laterally (stepping to the side)
[Move laterally] 
[MOVLAT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
29.*

Climbing a ladder or step stool
[Climb ladder or step stool] 
[CLIMB] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
30.*

Carrying a shopping bag for a block
[Carry bag for a block] 
[CARRY] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
31.*

Squatting
[Squatting] 
[SQUAT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
32.*

Kneeling
[Kneeling] 
[KNEELING] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
33.*

Running
[Running] 
[RUNNING] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
Discretionary Knee Activities [PREKSS_S9]
34.*

Discretionary Knee Activity 1
[Discretionary Knee Activity 1] 
[cmpDISCACT1] 
[DISCACT1] 
Discretionary Knee Activities
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[cl_DISCACT]
[BOTHER1] 
How much does your knee bother you during this activity?
No bother
Slight
Moderate
Severe
Very severe
Cannot do (because of knee)
35.*

Discretionary Knee Activity 2
[Discretionary Knee Activity 2] 
[cmpDISCACT2] 
[DISCACT2] 
Discretionary Knee Activities
[cl_DISCACT]
[BOTHER2] 
How much does your knee bother you during this activity?
No bother
Slight
Moderate
Severe
Very severe
Cannot do (because of knee)
36.*

Discretionary Knee Activity 3
[Discretionary Knee Activity 3] 
[cmpDISCACT3] 
[DISCACT3] 
Discretionary Knee Activities
[cl_DISCACT]
[BOTHER3] 
How much does your knee bother you during this activity?
No bother
Slight
Moderate
Severe
Very severe
Cannot do (because of knee)
37.
Alignment [read-only]
[Alignment] 
[ALIGNSC] 
xxxxxxx.
38.
Instability [read-only]
[Instability] 
[INSTSC] 
xxxxxxx.
39.
Joint Motion [read-only]
[Joint Motion] 
[JOINTSC] 
xxxxxxx.
40.
Symptoms [read-only]
[Symptoms] 
[SYMPSC] 
xxxxxxx.
41.
Subject Satisfaction Score [read-only]
[Subject Satisfaction Score] 
[SATSC] 
xxxxxxx.
42.
Subject Expectations [read-only]
[Subject Expectations] 
[EXPSC] 
xxxxxxx.
43.
Walking and Standing [read-only]
[Walking and Standing] 
[WLKSTSC] 
xxxxxxx.
44.
Standard Activities [read-only]
[Standard Activities] 
[STDACTSC] 
xxxxxxx.
45.
Advanced Activities [read-only]
[Advanced Activities] 
[ADVACTSC] 
xxxxxxx.
46.
Discretionary Knee Activities [read-only]
[Discretionary Knee Activities] 
[DISC] 
xxxxxxx.
47.
Objective Knee Score [read-only]
[Objective Knee Score] 
[OBJKSC] 
xxxxxxx.
48.
Functional Knee Score [read-only]
[Functional Knee Score] 
[FUNKSC] 
xxxxxxx.
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TriathCone: SF-12v2 Health Survey (SF12) [SF12]
This survey asks for your views about your health. This information will help you keep track of how you feel and how well you are able to do your usual 
activities. Thank you for completing this survey! 
For each of the following questions, please mark the circle that best describes your answer.
1.*

Date of Assessment
[Date of Assessment] 
[DOA] 
Req
 / Req
 / Req
(2015-2025)
1) In general, would you say your health is: [SF12new_S1]
2.*

In general, would you say your health is:
[In general, would you say your health is] 
[SFHEALTH] 
Excellent
Very Good
Good
Fair
Poor
2) The following questions are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? 
[SF12new_S2]
3.*

a. Moderate activities, such as moving a table, 
pushing a vacuum cleaner, bowling, or playing golf
[Moderate activities] 
[MOD] 
Yes, limited a lot
Yes, limited a little
No, not limited at all
4.*

b. Climbing several flights of stairs
[Climbing stairs] 
[STAIR] 
Yes, limited a lot
Yes, limited a little
No, not limited at all
3) During the past 4 weeks, how much of the time have you had any of the following problems with your work or other regular daily activities as a result of your 
physical health? [SF12new_S3]
5.*

a. Accomplished less than you would like
[Accomplished less] 
[SFACCOM] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
6.*

b. Were limited in the kind of work or other 
activities
[Limited in kind of work or activities] 
[SFKIND] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
4) During the past 4 weeks, how much of the time have you had any of the following problems with your work or other regular daily activities as a result of any 
emotional problems (such as feeling depressed or anxious)? [SF12new_S4]
7.*

a. Accomplished less than you would like
[Accomplished less] 
[SFACCLESS] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
8.*

b. Did work or activities less carefully than usual
[Did work or activities less carefully] 
[SFUSUAL] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
5) During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? [SF12new_S5]
9.*

During the past 4 weeks, how much did pain
interfere with your normal work (including both 
work outside the home and housework)?
[Pain affect normal work] 
[SFPAIN] 
Not at all
A little bit
Moderately
Quite a bit
Extremely
6) These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that 
comes closest to the way you have been feeling. How much of the time during the past 4 weeks... [SF12new_S6]
10.*

a. Have you felt calm and peaceful?
[Felt calm peaceful] 
[SFPEACE] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
11.*

b. Did you have a lot of energy?
[Have a lot of energy] 
[SFENRGY] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
12.*

c. Have you felt downhearted and depressed?
[Felt downhearted and depressed?] 
[SFDEPRES] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
7) During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting friends, 
relatives, etc.)? [SF12new_S7]
13.*

During the past 4 weeks, how much of the time 
has your physical health or emotional problems
interfered with your social activities (like visiting 
friends, relatives, etc.)?
[Physical health or emotion interfer social] 
[SFPHYHLTH] 
All of the time
Most of the time
Some of the time
A little of the time
None of the time
14.
PHYSICAL COMPONENT SCORE [read-only]
[PHYSICAL COMPONENT SCORE] 
[SF12PCS] 
xxxxxxxxxxx.
15.
MENTAL COMPONENT SCORE [read-only]
[MENTAL COMPONENT SCORE] 
[SF12MCS] 
xxxxxxxxxxx.
16.
Physical Functioning [read-only]
[Physical Functioning] 
[PF] 
xxxxxxxxxxx.
17.
Role Physical [read-only]
[Role Physical] 
[RP] 
xxxxxxxxxxx.
18.
Bodily Pain [read-only]
[Bodily Pain] 
[BP] 
xxxxxxxxxxx.
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19.
General Health [read-only]
[General Health] 
[GH] 
xxxxxxxxxxx.
20.
Vitality [read-only]
[Vitality] 
[VT] 
xxxxxxxxxxx.
21.
Social Functioning [read-only]
[Social Functioning] 
[SF] 
xxxxxxxxxxx.
22.
Role Emotional [read-only]
[Role Emotional] 
[RE] 
xxxxxxxxxxx.
23.
Mental Health [read-only]
[Mental Health] 
[MH] 
xxxxxxxxxxx.
   Key:  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
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TriathCone: Lower Extremity Activity Scale (LEAS) [LEAS]
Please read through each description given below, pick the ONE description that best describes your regular daily activity and select that one circle.
1.*

Lower Extremity Activity Scale
[Lower Extremity Activity Scale] 
[LEASCALE] 
1. I am confined to bed all day
2. I am confined to bed most of the day except for minimal transfer activities (going to the 
bathroom, etc.).
3. I am either in bed or sitting in a chair most of the day.
4. I sit most of the day, except for minimal transfer activities, no walking or standing.
5. I sit most of the day, but I stand occasionally and walk a minimal amount in my house. (I may 
rarely leave the house for an appointment and may require the use of a wheelchair or scooter for 
transportation.)
6. I walk around my house to a moderate degree but I don't leave the house on a regular basis. I 
may leave the house occasionally for an appointment.
7. I walk around my house and go outside at will, walking one or two blocks at a time.
8. I walk around my house, go outside at will and walk several blocks at a time without any 
assistance (weather permitting).
9. I am up and about at will in my house and can go out and walk as much as I would like with no 
restrictions (weather permitting).
10a. I am up and about at will in my house and outside. I also work outside the house in a minimally 
active job.
10b. I am up and about at will in my house and outside. I also work outside the house in a 
moderately active job.
10c. I am up and about at will in my house and outside. I also work outside the house in a 
extremely active job.
11a. I am up and about at will in my house and outside. I also participate in relaxed physical activity 
such as jogging, dancing, cycling, swimming occasionally (2-3 times per month).
11b. I am up and about at will in my house and outside. I also participate in relaxed physical activity 
such as jogging, dancing, cycling, swimming 2-3 times per week.
11c. I am up and about at will in my house and outside. I also participate in relaxed physical activity 
such as jogging, dancing, cycling, swimming daily.
12a. I am up and about at will in my house and outside. I also participate in vigorous physical 
activity such as competitive level sports occasionally (2-3 times per month).
12b. I am up and about at will in my house and outside. I also participate in vigorous physical 
activity such as competitive level sports 2-3 times per week.
12c. I am up and about at will in my house and outside. I also participate in vigorous physical 
activity such as competitive level sports daily.
2.
LEAS SCORE [read-only]
[LEAS SCORE] 
[LEASCOR] 
N2
3.*

Date of Assessment
[Date of Assessment] 
[DOA] 
Req
/ Req
/ Req
 (2015-2025)
4.

Comments
[Comments] 
[LEASCMT] 
A200
   Key:  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
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TriathCone: HSS Patella Score (HSSPAT) [HSSPAT]
Patient Questionnaire [HSSPAT_S1]
1.*

Date of Assessment
[Date of Assessment] 
[DOA] 
Req
/ Req
/ Req
 (2015-2025)
2.*

Rate the pain you experience on the front of your knee while rising 
from a low chair
[Pain front of knee rising from low chair] 
[RATEPAIN] 
N2
(0 - 10)
Do you feel that the anterior (front) part of your knee is limiting you while [HSSPAT_S2]
3.*

Climbing stairs?
[Climbing stairs] 
[CLIMSTAIR] 
Yes
No
4.*

Descending stairs?
[Descending stairs] 
[DESSTAIR] 
Yes
No
5.*

Sitting for prolonged time (30 minutes at 90 degrees)?
[Prolonged sitting] 
[LONGSIT] 
Yes
No
For Surgeon's Use Only [HSSPAT_S3]
6.*

Tenderness with palpation of medial and/or lateral patellar 
retinaculum-facet?
[Tenderness with palpation] 
[TENDER] 
Absent
Present
7.*

Crepitus during active range of motion (ROM)?
[Crepitus] 
[CREP] 
None
Mild (for a limited ROM)
Moderate (through entire ROM)
Severe (catching/clunk)
8.*

Quadriceps Strength
[Quadriceps Strength] 
[QUAD] 
Normal (5/5)
Reduced (3-4/5)
Deficient (1-2/5)
9.

Comments
[Comments] 
[HSSPATCM] 
A200
10. HSS Patella Score [read-only]
[HSS Patella Score] 
[PATSCOR]
N3
   Key:  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
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TriathCone: EQ-5D Health Questionnaire (EQ5D) [EQ5D]
By placing a checkmark in one box in each group below, please indicate which statements best describe your own health state today.
1.*

Mobility
[Mobility] 
[MOBIL] 
I have no problems in walking about
I have some problems in walking about
I am confined to bed
2.*

Self-Care
[SelfCare] 
[SELFCARE] 
I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself
3.*

Usual Activities (e.g. work, study, housework, family or leisure 
activities)
[Usual Activities ] 
[UNACT] 
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities
4.*

Pain/Discomfort
[PainDiscomfort] 
[EQ5DPD] 
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort
5.*

Anxiety/Depression
[AnxietyDepression] 
[EQ5DAD] 
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed
6.*

EQ VAS SCORE
[EQ VAS SCORE] 
[EQVAS]
N3
7.
TTO Score [read-only]
[TTO Score] 
[EQ5DTTO] 
xxxxxxx.
8.*

Date of Assessment
[Date of Assessment] 
[DOA] 
Req
/ Req
/ Req
(2015-2025)
9.

Comments
[Comments] 
[EQ5DCMT] 
A200
   Key:  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
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TriathCone: End of Stem Pain (ESP) [ESP]
1.*

Date of Assessment
[Date of Assessment] 
[DOA] 
Req
/ Req
/ Req
(2015-2025)
2.*

Shin Pain
[Shin Pain] 
[SHINPAIN] 
No Pain
[cmpSHIN1] 
Pain with Extreme Activity Only
[SHINLOC1] 
Proximal
Mid-Shaft
Distal
[cmpSHIN2] 
Pain with Moderate Activity
[SHINLOC2] 
Proximal
Mid-Shaft
Distal
[cmpSHIN3] 
Pain with Normal Activity
[SHINLOC3] 
Proximal
Mid-Shaft
Distal
[cmpSHIN4] 
Pain at Rest
[SHINLOC4] 
Proximal
Mid-Shaft
Distal
3.*

Thigh Pain
[Thigh Pain] 
[THIPAIN] 
No Pain
[cmpTHI1] 
Pain with Extreme Activity Only
[THILOC1] 
Proximal
Distal
[cmpTHI2] 
Pain with Moderate Activity
[THILOC2] 
Proximal
Distal
[cmpTHI3] 
Pain with Normal Activity
[THILOC3] 
Proximal
Distal
[cmpTHI4] 
Pain at Rest
[THILOC4] 
Proximal
Distal
4.*

Does pain pertain to the operative side?
[Pain pertain to operative side] 
[PAINOPS]
Yes
No
5.

Comments
[Comments] 
[ESPCMT] 
A200
   Key:  [] = Source verification required   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
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TriathCone: Previous Implant Information (PIF) [PIF]
Diagnosis [PIF_S1]
1.*

Visit Date
[Visit Date] 
[PIFDOV] 
Req
/ Req
/ Req
 (2015-2025)
2.*

For the TKR being revised, provide Date of Implant
[TKR Date of Implant] 
[IMPDT] 
Req/Unk
 / Req/Unk
 / Req
(1980-2025)
3.*

Type of existent implant
[Type of existent implant] 
[IMPTYP] 
Posterior Cruciate Retaining
Posterior Cruciate Substituting
Constrained Condylar
Rotating Hinge
4.*

Number of previous total joint surgeries to operative knee
[Num previous total joint surgeries to operative knee] 
[NUMSURG] 
1
2
3
[cmpSURGSP] 
> 3 [SURGSP] 
Specify N1
Prosthesis [PIF_S2]
5.*

Tibial Baseplate
[Tibial Baseplate] 
[BASEPL] 
Cemented
Cementless
6.*

Femoral Component
[Femoral Component] 
[FCOMP] 
Cemented
Cementless
7.*

Implant Manufacturer of tibial & femoral components
[Implant Manufacturer of tibial & femoral components] 
[TFMANU] 
Biomet
Depuy / J&J
Smith & Nephew
Stryker
Wright
Zimmer
[cmpTFMANU] 
Other
[OTFMANU] 
Specify A30
8.*

Patellar Component
[Patellar Component] 
[PCOMP] 
[cmpPMANU1] 
Cemented
[PMANU1] 
Patellar Implant 
Manufacturer
Biomet
Depuy / J&J
Smith & Nephew
Stryker
Wright
Zimmer
[cmpOTPCOMP1] 
Other
[OTPCOMP1] 
Specify A30
[cmpPMANU2] 
Cementless
[PMANU2] 
Patellar Implant 
Manufacturer
Biomet
Depuy / J&J
Smith & Nephew
Stryker
Wright
Zimmer
[cmpOTPCOMP2] 
Other
[OTPCOMP2] 
Specify A30
Not Revised
Reason for Revision [PIF_S3]
9.*

Type of Failure
[Type of Failure] 
[FAILTYP] 
Aseptic failure of the knee
Septic failure of the knee
Reason for Revision [PIF_S4]
10.*

Reason for Revision
[Reason for Revision] 
[REVREAS] 
[cmpFALIKNEE] 
Failed Total Knee
[FAILKNEE] 
Failed femoral component
Failed tibial component
Failed patellar component
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Failed polyethylene insert
Polyethylene wear
Global instability
Extension instability
Mid-Flexion instability
Flexion instability
Infection
[cmpOTFAIL] 
Other Implant Failure
[OTFAIL] 
Ingrowth bead shedding
Ingrowth pad dissociation
Breakage of wires / screws
Breakage of implant
Modular component dissociation
Metal wear
Malalignment
Pain
Arthrofibrosis
[cmpMIGRA] 
Implant Migration, Loosening
[MIGRA] 
Implant migration, loosening, femoral
Implant migration, loosening, tibial
Implant migration, loosening, patellar
[cmpLYSIS] 
Bone Lysis
[LYSIS] 
Bone lysis, femoral
Bone lysis, tibial
Bone lysis, patellar
[cmpGRFAIL] 
Bone Graft Failure
[GRFAIL] 
Bone graft, non-union
Bone graft, collapse / extrusion
Bone graft, resorption
Bone graft, fracture
[cmpOTREV] 
Other
[OTREV] 
Specify
A200
11.

Comments
[Comments] 
[PIFCMT] 
A200
   Key:  [] = Source verification required   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
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TriathCone: Surgical Details (SURG) [SURG]
1.*

Surgery Date
[Surgery Date] 
[SURGDT] 
Req
 / Req
 / Req
(2015-2025)
2.*

Type of Anesthesia Used
[Type of Anesthesia Used] 
[ANESTYP] 
General
Spinal
Epidural
Femoral Block
3.*

Surgical Approach
[Surgical Approach] 
[APPROACH] 
Medial Parapatellar
Lateral Parapatellar
Sub Vastus
Mid Vastus
4.*

Joint Line Position Prior to Implant Removal: Full Extension
[Joint Line Position Prior to Implant Removal: Full Extension] 
[PRIORFULL] 
N4
mm
5.*

Joint Line Position Prior to Implant Removal: 90 degree Flexion
[Joint Line Position Prior to Implant Removal: 90 degree Flexion] 
[PRIOR90] 
N4
mm
6.*

Joint Line Position Final Triathlon Cone implanted: Full Extension
[Joint Line Position Final Triathlon Cone implanted: Full Extension] 
[FINALFULL] 
N4
mm
7.*

Joint Line Position Final Triathlon Cone implanted: 90 degree 
Flexion
[Joint Line Position Final Triathlon Cone implanted: 90 degree 
Flexion] 
[FINAL90] 
N4
mm
8.*

Tibial AORI Classification
[Tibial AORI] 
[TAORI] 
Type I
Type IIa
Type IIb
Type III
9.*

Femoral AORI Classification
[Femoral AORI] 
[FAORI] 
Type I
Type IIa
Type IIb
Type III
10.*

Navigation Used
[Navigation Used] 
[NAVIGATION] 
Yes
No
11.*

Estimated blood loss
[Estimated blood loss] 
[BLOSS] 
N4
cc's
12.*

Units of blood transfused
[Units of blood transfused] 
[UNITRANS] 
N4
cc's
13.*

Skin to skin time
[Skin to skin time] 
[SKTOSK] 
N3
minutes
14.*

Tourniquet time
[Tourniquet time] 
[TOURN] 
N3
minutes
15.*

Tibio-Femoral Gap, Full Extension: Medial
[Tibio-Femoral Gap, Full Extension: Medial] 
[GAPFLMED] 
N2
 mm
16.*

Tibio-Femoral Gap, Full Extension: Lateral
[Tibio-Femoral Gap, Full Extension: Lateral] 
[GAPFLLAT] 
N2
 mm
17.*

Tibio-Femoral Gap, 90 degree Flexion: Medial
[Tibio-Femoral Gap, 90 degree Flexion: Medial] 
[GAP90MED] 
N2
 mm
18.*

Tibio-Femoral Gap, 90 degree Flexion: Lateral
[Tibio-Femoral Gap, 90 degree Flexion: Lateral] 
[GAP90LAT] 
N2
 mm
19.*

Tibial Bone Loss?
[Tibial Bone Loss?] 
[BLOSSTIB] 
[cmpTIBLOC] 
Yes
[TIBLOC] 
[cmpA] 
Anterior
[ACONTAIN] 
Anterior defect contained
Yes
No
[cmpP] 
Posterior
[PCONTAIN] 
Posterior defect contained
Yes
No
[cmpM] 
Medial
[MCONTAIN] 
Medial defect contained
Yes
No
[cmpL] 
Lateral
[LCONTAIN] 
Lateral defect contained
Yes
No
No
[b]
[b]
[b]
[b]
[b]
[b]
[b]
[b]
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20.*

Femoral Bone Loss?
[Femoral Bone Loss?] 
[BLOSSFEM] 
[cmpFEMLOC] 
Yes
[FEMLOC] 
[cmpAF] 
Anterior Femur
[AFCONTAIN] 
Anterior femur defect contained?
Yes
No
[cmpCC] 
Central
[CCONTAIN] 
Central defect contained?
Yes
No
[cmpMD] 
Medial Distal Femur
[MDCONTAIN] 
Medial Distal Femur defect contained?
Yes
No
[cmpLD] 
Lateral Distal Femur
[LDCONTAIN] 
Lateral Distal Femur defect contained?
Yes
No
[cmpLP] 
Lateral Posterior Condyle
[LPCONTAIN] 
Lateral Posterior Condyle defect contained?
Yes
No
[cmpMP] 
Medial Posterior Condyle 
[MPCONTAIN] 
Medial Posterior Condyle defect contained?
Yes
No
No
21.*

Bone Removed: Distal Femur
[Bone Removed: Distal Femur] 
[REMOVDF] 
N3
 mm
22.*

Bone Removed: Proximal Femur
[Bone Removed: Proximal Femur] 
[REMOVDPF] 
N3
 mm
23.*

Distal Femoral Coverage
[Distal Femoral Coverage] 
[DISTFMR] 
Complete
[cmpUNSZ] 
Undersized
[UNDERSZ] 
N2
mm
[cmpOVHG] 
Overhang
[OVHANG] 
N2
mm
24.*

Posterior Condyles: Overhanging bone removed prior to final 
implant?
[Posterior Condyles: Overhang bone removed prior to final 
implant] 
[PCONDYL] 
Yes
No
25.*

Proximal Tibia: AP Coverage Complete?
[Proximal Tibia: AP Coverage Complete?] 
[APCOMP] 
Yes
[UNOVAP] 
No
[cmpANTPOS1] 
Undersized
[ANTPOS1] 
[ANT1] 
Anterior N2
mm
[POS1] 
Posterior N2
mm
[cmpANTPOS2] 
Overhang
[ANTPOS2] 
[ANT2] 
Anterior N2
mm
[POS2] 
Posterior N2
mm
26.*

Proximal Tibia: ML Coverage Complete?
[Proximal Tibia: ML Coverage Complete?] 
[MLCOMP] 
Yes
[UNOVML] 
No
[cmpMEDLAT1] 
Undersized
[MEDLAT1] 
[MED1] 
Medial N2
mm
[LAT1] 
Lateral N2
mm
[cmpMEDLAT2] 
Overhang
[MEDLAT2] 
[MED2] 
Medial N2
 mm
[LAT2] 
Lateral N2
mm
[b]
[b]
[b]
[b]
[b]
[b]
[b]
[b]
[b]
[b]
[b]
[b]
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27.*

How satisfied are you with the fit?
[How satisfied with fit] 
[SATFIT] 
Extremely
Quite a bit
Moderately
A little bit
Not at all
28.*

Intraoperative complication? (If yes, complete AE form.)
[Intraoperative complication] 
[COMPL] 
Yes
No
29.*

Post-op plan
[Post-op plan] 
[POSTPLAN] 
Full weight bearing
Partial weight bearing
30.*

Discharge to
[Discharge to] 
[DISCHRG] 
Skilled Nursing Facility
Chronic Care Center
Rehabilitation Unit
Home
[cmpOTDIS] 
Other
[OTDIS] 
Specify
A100
31.*

Discharge Date
[Discharge Date] 
[SDDISDT] 
Req
 / Req
 / Req
(2015-2025)
32.
Length of Hospital Stay [read-only]
[Length of Hospital Stay] 
[STAY] 
N3
Days
33.

Comments
[Surgery Comments] 
[SURGCOM] 
A200
   Key:  [] = Source verification required  [b] = Base Unit   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
[b]
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TriathCone: Surgical Prostheses (SP) [SP]
COMPONENT LISTING [SP_S1]
1.*

Femoral Component 
[Femoral Component ] 
[cmpFC] 
[FEMREF] 
Femoral Component Reference # [clFREF]
[FEMLOT] 
Femoral 
Component Lot #
A50
2.

Femoral Cone Augment
[Femoral Cone Augment] 
[cmpFCA] 
[FCONEREF] 
Femoral Cone Augment Reference # [clFCREF]
[FCONELOT] 
Femoral Cone 
Augment Lot #
A50
3.*

Tibial Component/Metal Tray
[Tibial Component/Metal Tray] 
[cmpTC] 
[TIBIREF] 
Tibial Component/Metal Tray Reference # [clTIBIREF]
[TIBLOT] 
Tibial 
Component/Metal 
Tray Lot #
A50
4.

Tibial Cone Augment
[Tibial Cone Augment] 
[cmpTCA] 
[TCONEREF] 
Tibial Cone Augment Reference # [clTCREF]
[TCONELOT] 
Tibial Cone 
Augment Lot #
A50
5.*

Tibial Insert/UHMWPE Bearing
[Tibial Insert/UHMWPE Bearing] 
[cmpTI] 
[BEARREF] 
Tibial Insert/UHMWPE Bearing Reference # A10
[BERLOT] 
Tibial 
Insert/UHMWPE 
Bearing Lot #
A50
6.*

Patellar Component Revised?
[Patellar Component Revised] 
[REVISED] 
[cmpPC] 
Yes
[PATREF] 
Patellar Component Reference # [clPATREF]
[PATLOT] 
Patellar 
Component 
Lot #
A50
No
PROSTHESIS [SP_PROS]
7.*

Ancillary Devices? (Stem extenders, offset 
adapters)
[Ancillary Devices] 
[ANCILL] 
Yes
No
Ancillary Devices
Reference #
Lot #
8.

Ancillary Devices Entry [SP_ANCIL]
8.1*

Ancillary Devices? (Stem extenders, offset adapters)
[Ancillary Devices] 
[ANCILDEV] 
Stem Extenders
Offset Adapters
8.2*

Reference #
[Reference #] 
[ANCILREF] 
A10
8.3*

Lot #
[Lot #] 
[ANCILLOT] 
A50
9.*

Stem 1
[Stem 1] 
[cmpSTEM1] 
[STEMREF1] 
Stem Reference #1 A10
[STEMLOT1] 
Stem Lot #1 A50
10.

Stem 2
[Stem 2] 
[cmpSTEM2] 
[STEMREF2] 
Stem Reference #2 A10
[STEMLOT2] 
Stem Lot #2 A50
11.

Stem Area Cemented?
[Stem Area Cemented] 
[STEMCEM] 
[cmpSTEMAREA] 
Yes
[STEMAREA] 
Stem Area
Proximal Portion
Distal Tip
Entire Stem
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No
12.

If Tibial Offset Adapters used, complete the 
following
[Tibial offset adapter: magnitude and orientation] 
[cmpOFFADTIB] 
[MAGTIB] 
Magnitude N1
[ORIENTT] 
Orientation N2
13.

If Femoral Offset Adapters used, complete the 
following
[Femoral offset adapters: magnitude and 
orientation] 
[cmpOFFADDFEM]
[MAGFEM] 
Magnitude N1
[ORIENTF] 
Orientation N2
14.*

Augmentation Used? (Non-cone augments, femoral 
locking screws, bone grafts, etc.)
[Augmentation Used] 
[AUGUSEYN] 
Yes
No
Augmentation
Reference #
Lot #
15.

Augmentation Entry [SP_AUG]
15.1*

Augmentation
[Augmentation] 
[AUGMEN] 
Tibial Augment
Femoral Augment
Femoral Locking Screw 
Bone Graft
[cmpOTAUG] 
Other
[OTAUG] 
Specify
A200
15.2*

Reference #
[Reference #] 
[AUGREF] 
A10
15.3*

Lot #
[Lot #] 
[AUGLOT] 
A50
COMMENTS [SP_COM]
16.

Comments
[Surgical Prostheses Comments] 
[SPCOM] 
A200
   Key:  [] = Source verification required   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
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TriathCone: Knee Society Score: Post-Op (POSTKSS2011) [POSTKSS2011]
1.*

Visit Date
[Visit Date] 
[KSSDOV] 
Req
/ Req
/ Req
(2015-2025)
2.*

Height
[Height] 
[HT] 
xxxxx.
inches
centimeters
3.*

Weight
[Weight] 
[WT] 
xxxxx.
lbs
kg
4.
BMI [read-only]
[BMI] 
[BMI] 
xxxxxxx.
5.*

Charnley Functional Classification
[Charnley Functional Classification] 
[CHARNLY] 
A Unilateral Knee Arthritis
B1 Unilateral TKA, opposite knee arthritic
B2 Bilateral TKA
C1 TKR, but remote arthritis affecting ambulation
C2 TKR, but medical condition affecting ambulation
C3 Unilateral or Bilateral TKA with Unilateral or Bilateral THR
Objective Knee Indicators [POSTKSS_S2]
6.*

Alignment: measured on AP standing Xray (Anatomic Alignment)
[Alignment] 
[ALIGN] 
Neutral: 2-10 degrees valgus
Varus: < 2 degrees valgus
Valgus: > 10 degrees valgus
7.*

Medial / Lateral instability: measured in full extension
[Medial / Lateral instability] 
[INSTML] 
None
Little or < 5 mm
Moderate or 5 mm
Severe or > 5 mm
8.*

Anterior / Posterior Instability: measured at 90 degrees
[Anterior / Posterior Instability] 
[INSTAP] 
None
Moderate < 5 mm
Severe > 5 mm
9.*

Range of motion
[Range of motion] 
[ROM] 
N3
10.*

Flexion Contracture
[Flexion Contracture] 
[FLEXC] 
None
1-5 degrees
6-10 degrees
11-15 degrees
> 15 degrees
11.*

Extensor Lag
[Extensor Lag] 
[EXTLAG] 
None
< 10 degrees
10-20 degrees
> 20 degrees
Symptoms [POSTKSS_S3]
12.*

Pain with level walking
[Pain with level walking] 
[PNLVLWLK] 
0 - None
1
2
3
4
5
6
7
8
9
10 - Severe
13.*

Pain with stairs or inclines
[Pain with stairs or inclines] 
[PNSTAIR] 
0 - None
1
2
3
4
5
6
7
8
9
10 - Severe
14.*

Does this knee feel "Normal" to you?
[Knee feels Normal] 
[FEELNORM] 
Always
Sometimes
Never
Subject Satisfaction [POSTKSS_S4]
15.*

Currently, how satisfied are you with the pain level of your knee 
while sitting?
[Satisfied with pain level of knee while sitting] 
[SIT] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
16.*

Currently, how satisfied are you with the pain level of your knee 
while lying in bed?
[Satisfied with pain level of knee while lying in bed] 
[INBED] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
17.*

Currently, how satisfied are you with your knee function while 
getting out of bed?
[Satisfied with your knee function while getting out of bed] 
[OUTBED] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
18.*

Currently, how satisfied are you with your knee function while 
performing light household duties?
[Satisfied with your knee function while performing light household 
duties] 
[HSEHLD] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
19.*

Currently, how satisfied are you with your knee function while 
performing leisure recreational activities?
[Satisfied with your knee function while performing leisure 
recreational activities] 
[RECACT] 
Very Satisfied
Satisfied
Neutral
Dissatisfied
Very Dissatisfied
Subject Expectations [POSTKSS_S5]
Compared to what you expected before your knee replacement:
20.*

My expectations for pain relief were...
[My expectations for pain relief were] 
[EXPPR] 
Too High - "I'm a lot worse than I thought"
Too High - "I'm somewhat worse than I thought"
[b] 
 [b] 
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Just Right - "My expectations were met"
Too Low - "I'm somewhat better than I thought"
Too Low - "I'm a lot better than I thought"
21.*

My expectations for being able to do my normal activities of daily 
living were...
[My expectations for being able to do my normal activities of daily 
living were...] 
[EXPNORM] 
Too High - "I'm a lot worse than I thought"
Too High - "I'm somewhat worse than I thought"
Just Right - "My expectations were met"
Too Low - "I'm somewhat better than I thought"
Too Low - "I'm a lot better than I thought"
22.*

My expectations for being able to do my leisure, recreational or 
sports activities were...
[My expectations for being able to do my leisure, recreational or 
sports activities were...] 
[EXPLSRE] 
Too High - "I'm a lot worse than I thought"
Too High - "I'm somewhat worse than I thought"
Just Right - "My expectations were met"
Too Low - "I'm somewhat better than I thought"
Too Low - "I'm a lot better than I thought"
Functional Activities [POSTKSS_S6]
23.*

Can you walk without any aids (such as a cane, crutches or 
wheelchair)?
[Walk without any aids?] 
[WALKAID] 
Yes
[cmpWALKAID] 
No
[OTWLKAID] 
If no, which of the following aid(s) do you use?
Wheelchair
Walker
Crutches
Two canes
One crutch
One cane
Knee sleeve / brace
[KNEEAIDS] 
Do you use these aid(s) because of your knees?
Yes
No
24.*

For how long can you stand (with or without aid) before sitting due 
to knee discomfort?
[How long stand before sitting?] 
[HLSTAND] 
Cannot stand
0-5 minutes
6-15 minutes
16-30 minutes
31-60 minutes
More than an hour
25.*

For how long can you walk (with or without aid) before stopping due 
to knee discomfort?
[How long walk before stopping?] 
[HLWALK] 
Cannot walk
0-5 minutes
6-15 minutes
16-30 minutes
31-60 minutes
More than an hour
How much does your knee bother you during each of the following activities? [POSTKSS_S10]
26.*

Walking on an uneven surface
[Walk on uneven surface] 
[UNEVEN] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
27.*

Turning or pivoting on your leg
[Turn or pivot leg] 
[PIVOT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
28.*

Climbing up or down a flight of stairs
[Climb up down stairs] 
[UPDN] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
29.*

Getting up from a low couch or a chair without arms
[Up from low couch or chair without arms] 
[GETUP] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
30.*

Getting into or out of a car
[Get into or out of a car] 
[CARINOUT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
31.*

Moving laterally (stepping to the side)
[Move laterally] 
[MOVLAT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
32.*

Climbing a ladder or step stool
[Climb ladder or step stool] 
[CLIMB] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
33.*

Carrying a shopping bag for a block
[Carry bag for a block] 
[CARRY] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
34.*

Squatting
[Squatting] 
[SQUAT] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
35.*

Kneeling
[Kneeling] 
[KNEELING] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
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36.*

Running
[Running] 
[RUNNING] 
No 
bother
Slight
Moderate
Severe
Very 
severe
Cannot do (because 
of knee)
I never do 
this
Discretionary Knee Activities [POSTKSS_S9]
37.*

Discretionary Knee Activity 1
[Discretionary Knee Activity 1] 
[cmpDISCACT1] 
[DISCACT1] 
Discretionary Knee Activities
[cl_DISCACT]
[BOTHER1] 
How much does your knee bother you during this activity?
No bother
Slight
Moderate
Severe
Very severe
Cannot do (because of knee)
38.*

Discretionary Knee Activity 2
[Discretionary Knee Activity 2] 
[cmpDISCACT2] 
[DISCACT2] 
Discretionary Knee Activities
[cl_DISCACT]
[BOTHER2] 
How much does your knee bother you during this activity?
No bother
Slight
Moderate
Severe
Very severe
Cannot do (because of knee)
39.*

Discretionary Knee Activity 3
[Discretionary Knee Activity 3] 
[cmpDISCACT3] 
[DISCACT3] 
Discretionary Knee Activities
[cl_DISCACT]
[BOTHER3] 
How much does your knee bother you during this activity?
No bother
Slight
Moderate
Severe
Very severe
Cannot do (because of knee)
40.

Comments
[Comments] 
[KSSCOM] 
A200
41.
Alignment [read-only]
[Alignment] 
[ALIGNSC] 
xxxxxxx.
42.
Instability [read-only]
[Instability] 
[INSTSC] 
xxxxxxx.
43.
Joint Motion [read-only]
[Joint Motion] 
[JOINTSC] 
xxxxxxx.
44.
Symptoms [read-only]
[Symptoms] 
[SYMPSC] 
xxxxxxx.
45.
Subject Satisfaction Score [read-only]
[Subject Satisfaction Score] 
[SATSC] 
xxxxxxx.
46.
Subject Expectations [read-only]
[Subject Expectations] 
[EXPSC] 
xxxxxxx.
47.
Walking and Standing [read-only]
[Walking and Standing] 
[WLKSTSC] 
xxxxxxx.
48.
Standard Activities [read-only]
[Standard Activities] 
[STDACTSC] 
xxxxxxx.
49.
Advanced Activities [read-only]
[Advanced Activities] 
[ADVACTSC] 
xxxxxxx.
50.
Discretionary Knee Activities [read-only]
[Discretionary Knee Activities] 
[DISC] 
xxxxxxx.
51.
Objective Knee Score [read-only]
[Objective Knee Score] 
[OBJKSC] 
xxxxxxx.
52.
Functional Knee Score [read-only]
[Functional Knee Score] 
[FUNKSC] 
xxxxxxx.
   Key:  [] = Source verification required  [b] = Base Unit   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
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TriathCone: Post-Op Events (POEVENT) [POEVENT]
1.*

Visit Date
[Visit Date] 
[VSDT] 
Req
 / Req
 / Req
(2015-2025)
2.*

Have there been any protocol defined Adverse Events since 
the last visit?
*If Yes, complete an AE form for each event.
[Protocol defined Adverse Events] 
[PROTAE]
Yes
No
3.*

Has the subject seen a doctor for any medical event since 
the last visit?
[Seen doctor for medical event since last visit] 
[SEEDOC] 
[cmpSEEDOC] 
Yes
[SEEDOCY] 
If Yes, specify
A1000
No
4.*

Has the subject been hospitalized for any elective surgery 
since the last visit?
[Subject hospitalized for elective surgery since last visit] 
[HOSP] 
[cmpHOSPY] 
Yes
[ELECSURG] 
Elective Surgery
Contralateral knee
Contralateral hip
Ipsilateral hip
Contralateral shoulder
Ipsilateral shoulder
Cataract
[cmpHOSPOT] 
Other
[HOSPOT] 
(Specify)
A200
[DETAILS] 
Provide 
Details
A1000
No
5.*

Is anything currently affecting the subject's function?
[Is anything currently affecting the subjects function] 
[AFFUNC] 
[cmpAFFUNC] 
Yes
[AFUNCY] 
Specify
A1000
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No
6.

Comments
[Comments] 
[POCMT] 
A200
   Key:  [] = Source verification required   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
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TriathCone: Adverse Event TriathCone (AE) - Repeating Form [AE]
#
Seq 
No
Onset 
Date
When did 
event occur?
Adverse 
Event
System 
Organ Class
Describe 
circumstances
Device 
Related
Meet protocol definition 
of seriousness
Treatment Resolution of 
event
Comments
Other 
Treatments
1
Adverse Event TriathCone [AE]
1.
Seq No. [read-only]
[Seq No] 
[AESEQNO]
N2
2.*

Onset Date
[Onset Date] 
[AESTDAT] 
Req
/ Req
/ Req
 (2015-2025)
3.*

When did event occur?
[When did event occur?] 
[AEWHEN] 
Preoperative
Perioperative (intra-operative to hospital discharge)
Postoperative
4.*

Adverse Event
[Adverse Event] 
[ALLAE] 
Arthrofibrosis
Deep Joint Infection
Excessive Knee Pain
Femoral Fracture
[cmpLOOSFC] 
Loosening Femoral Component
[LOOSFC] 
Septic
Aseptic
[cmpLOOSPC] 
Loosening Patellar Component
[LOOSPC] 
Septic
Aseptic
[cmpLOOSTB] 
Loosening Tibial Component
[LOOSTB] 
Septic
Aseptic
Myositis Ossificans
Patellar Component Dislocation
Patellar Fracture
Patellar Subluxation
Patellar Tendon Rupture
Peroneal Nerve Palsy
Prosthesis Fracture / Femoral Component
Prosthesis Fracture / Patellar Component
Prosthesis Fracture / Tibial Component
Prosthesis Fracture / Tibial Insert
Reflex Sympathetic Dystrophy (RSD)
Soft Tissue Trauma
Superficial Wound Infection
Supracondylar Fracture
Tibial Component Subsidence
Tibial Fracture
Wound Hematoma
[cmpWOUND] 
Wound Related
[AEWOUND] 
(Specify)
A200
[cmpOPSITEOT] 
Operative Site Other
[OPSITEOT] 
(Specify)
A200
[cmpAERESP] 
Bronchopulmonary
[AERESP] 
(Specify)
A200
[cmpAECA] 
Carcinoma
[AECA] 
(Specify)
A200
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[cmpAECARD] 
Cardiovascular
[AECARD] 
(Specify)
A200
DVT
[cmpAEDERM] 
Dermatological
[AEDERM] 
(Specify)
A200
[cmpAEGASTRO] 
Gastrointestinal
[AEGASTRO] 
(Specify)
A200
[cmpAEURO] 
Genitourinary
[AEURO] 
(Specify)
A200
[cmpAENEURO] 
Neurosensory
[AENEURO] 
(Specify)
A200
Pulmonary Embolism
Thrombophlebitis
[cmpAETRAUMA] 
Trauma
[AETRAUMA] 
(Specify)
A200
[cmpOTSYS] 
Systemic Other
[OTSYS] 
(Specify)
A200
5.*

System Organ Class
[System Organ Class] 
[SOC] 
[clSOC]
6.*

Describe circumstances, including history or causative event, 
specify signs, symptoms and diseases
[Describe circumstances] 
[AECIRCUM] 
A1000
7.*

Device Related?
[Device Related] 
[DVREL] 
[cmpDEVY] 
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Yes
[DEVRELY] 
If Yes or Uncertain, specify below, contact Stryker within 24 hours and send de-identified source 
documentation.
A1000
No
[cmpDEVU] 
Uncertain
[DEVRELU] 
If Yes or Uncertain, specify below, contact Stryker within 24 hours and send de-identified source 
documentation.
A1000
8.*

Seriousness - Does this event meet the protocol definition of 
seriousness?
[Meet protocol definition of seriousness] 
[AESER] 
[cmpAESER] 
Yes
[AESERY] 
If Yes, check all that apply
Resulted in inpatient 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 subject death
[AESERDT] 
Specify when Adverse Event became Serious. If Serious date is the 
same as Onset Date, enter Onset Date
Req
 / Req
/ Req
(2015-
2025)
No
9.*

Treatment
Contact Stryker within 24 hours if the treatment is 
Revision/Removal or Re-Operation
For Stryker Implants, submit PER form and implant(s) to 
Stryker.
Reoperations are for study knee only and include open 
manipulation/reduction. Do not include revision/removals or 
operations unrelated to the study knee.
Other Treatments: Diagnostic tests are not considered 
Treatments (i.e. X-rays and MRIs should NOT be included)
[Treatment] 
[AETX] 
[TXTYPE] 
Yes
[REVREM] 
Revisions/Removals
[FEMDT] 
Femoral Component Date
Req
/ Req
/ Req
(2015-2025)
[FCAUGDT] 
Femoral Cone Augment Date
Req
/ Req
/ Req
 (2015-2025)
[TIBDT] 
Tibial Baseplate Date
Req
/ Req
/ Req
 (2015-2025)
[TCAUGDT] 
Tibial Cone Augment Date
Req
/ Req
/ Req
(2015-2025)
[INSRTDT] 
Tibial Insert Date
Req
 / Req
 / Req
(2015-2025)
[PATDT] 
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Patellar Component Date
Req
 / Req
 / Req
(2015-2025)
[REOPERS] 
Reoperations
[cmpREOP1] 
Reoperation 1
[REOP1DT] 
Date
Req
/ Req
/ Req
(2015-2025)
[REOP1SP] 
Specify
A200
[cmpREOP2] 
Reoperation 2
[REOP2DT] 
Date
Req
 / Req
 / Req
(2015-2025)
[REOP2SP] 
Specify
A200
[cmpREOP3] 
Reoperation 3
[REOP3DT] 
Date
Req
/ Req
/ Req
 (2015-2025)
[REOP3SP] 
Specify
A200
Other Treatments
No
10.*

Resolution of event
[Resolution of event] 
[RESOL] 
[cmpUNRESDT] 
Unresolved
[UNRESDT] 
Unresolved Status Date (Update the resolution if the Event has been resolved)
Req
/ Req
/ Req
 (2015-2025)
[cmpRESDT] 
Resolved
[RESDT] 
Resolution status date
Req
 / Req
 / Req
(2015-2025)
11.

Comments
[Comments] 
[AECOMMNT] 
A200
Other Treatments
Other Treatment Date
12.

Other Treatments Entry [AE_S5]
12.1*

Other Treatments
[Other Treatments] 
[OTTX] 
A200
12.2*

Date
[Other Treatment Date] 
[OTXDT] 
Req
/ Req
/ Req
(2015-2025)
   Key:  [*] = Item is required  [] = Source verification required   [
] = Item is collapsible   [
] = Key item
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
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TriathCone: Study Termination (TERM) [TERM]
GENERAL INFORMATION [TERM_S1]
1.*

TERMINATION DATE
[TERMINATION DATE] 
[TERMDT] 
Req
/ Req
/ Req
 (2015-2025)
STUDY TERMINATION [TERM_S2]
2.*

DID SUBJECT COMPLETE STUDY ACCORDING TO 
PROTOCOL?
Click for eHelp
[Subject complete study] 
[COMPLET] 
Yes
No
3.

CHECK ONE PRIMARY REASON
Click for eHelp
[Reason subject did not complete study] 
[REASON] 
Screen Failure
Death
Investigative site terminated
[cmpLOSTFUP] 
Lost to follow-up
[STLE] 
List efforts to contact subject: [STD1] 
1st phone call:
Req
/ Req
/ Req
(2015-2025)
[STD2] 
2nd phone call:
Req
/ Req
/ Req
(2015-2025)
[STD3] 
3rd phone call:
Req
/ Req
/ Req
(2015-2025)
[STD4] 
Certified letter sent:
Req
/ Req
/ Req
(2015-2025)
[STAE] 
Additional 
efforts:
A1000
Revision/Removal of all implanted cone augments
[cmpNOTIMPL] 
Study Device Not implanted
[STSDO] 
(Specify)
A1000
Subject Withdrawal
[cmpSURGNOT] 
Surgery Not Performed
[STSNO] 
(Specify)
A1000
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Annotated Study Book - TriathCone
5/8/2015
file:///C:/Users/mhipolit/AppData/Local/Apps/2.0/P04J85LY.DDK/QZ9Q1AZE.NQW/orac..74.7_bd27f2385a501...

[cmpOTREAS] 
Other
[STOTH] 
(Specify)
A1000
4.*

WAS STUDY DEVICE IN PLACE AT DATE OF LAST 
CONTACT?
[WAS STUDY DEVICE IN PLACE AT DATE OF LAST 
CONTACT] 
[DEVICE] 
Yes
No
COMMENTS [TERM_S3]
5.

Comments
[Comments] 
[TERMCOM] 
A200
   Key:  [] = Source verification required   [
] = Item is collapsible
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
   Note: Collapsible settings are only available to users who have the rights to edit the item.
Page 37 of 37
Annotated Study Book - TriathCone
5/8/2015
file:///C:/Users/mhipolit/AppData/Local/Apps/2.0/P04J85LY.DDK/QZ9Q1AZE.NQW/orac..74.7_bd27f2385a501...

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix H 
 
Specifications for Patient Questionnaires  
 

Appendix I 
Product Labeling  

FORM FDA 3881 (8/14)
Page 1 of 2
PSC Publishing Services (301) 443-6740       EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known)
K143393
Device Name
Triathlon® Tritanium® Cone Augments
Indications for Use (Describe)
General Total Knee Arthroplasty (TKR) Indications: 
• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including 
osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. 
• Post-traumatic loss of knee joint configuration and function. 
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function 
and stability. 
• Revision of previous unsuccessful knee replacement or other procedure. 
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques. 
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use. 
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use 
only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: 
• Ligamentous instability requiring implant bearing surface geometries with increased constraint. 
• Absent or non-functioning posterior cruciate ligament. 
• Severe anteroposterior instability of the knee joint. 
Additional Indications for Total Stabilizer (TS) Components: 
• Severe instability of the knee secondary to compromised collateral ligament integrity or function. 
Indications for Bone Augments: 
• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic 
arthritis, complicated by the presence of bone loss. 
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. 
Additional Indications for Cone Augments: 
• Severe degeneration or trauma requiring extensive resection and replacement 
• Femoral and Tibial bone voids 
• Metaphyseal reconstruction 
The Triathlon TS Cone Augment components are intended for cemented or cementless use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) 
Over-The-Counter Use (21 CFR 801 Subpart C) 
CONTINUE ON A SEPARATE PAGE IF NEEDED. 
K143393 Page 1 of 2

FORM FDA 3881 (8/14)
Page 2 of 2
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the 
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB number.”
K143393 Page 2 of 2

Device Name 
Triathlon Total Knee System 
Indications for Use (Describe) 
General Total Knee Arthroplasty (TKR) Indications: 
x
Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including 
osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. 
x
Post-traumatic loss of knee joint configuration and function. 
x
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate 
function and stability. 
x
Revision of previous unsuccessful knee replacement or other procedure. 
x
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management 
techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use. 
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use 
only. 
The Triathlon® All Polyethylene tibial components are indicated for cemented use only. 
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: 
x
Ligamentous instability requiring implant bearing surface geometries with increased constraint. 
x
Absent or non-functioning posterior cruciate ligament. 
x
Severe anteroposterior instability of the knee joint. 
Additional Indications for Total Stabilizer (TS) Components: 
x
Severe instability of the knee secondary to compromised collateral ligament integrity or function. 
Indications for Bone Augments: 
x
Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-
traumatic arthritis, complicated by the presence of bone loss. 
x
Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments: 
x
Severe degeneration or trauma requiring extensive resection and replacement 
x
Femoral and Tibial bone voids 
x
Metaphyseal reconstruction 
The Triathlon Tritanium® Cone Augment components are intended for cemented or cementless use. 
Type of Use (Select one or both, as applicable) 
Prescription Use (Part 21 CFR 801 Subpart D) 
Over-The-Counter Use (21 CFR 801 Subpart C) 
CONTINUE ON A SEPARATE PAGE IF NEEDED. 
This section applies only to requirements of the Paperwork Reduction Act of 1995. 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration 
Indications for Use 
Form Approved: OMB No. 0910-0120 
Expiration Date: 06/30/2020 
See PRA Statement below. 
Page 4-2
510(k) Number (if known) 
K190991

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* 
The burden time for this collection of information is estimated to average 79 hours per response, including the 
time to review instructions, search existing data sources, gather and maintain the data needed and complete 
and review the collection of information. Send comments regarding this burden estimate or any other aspect 
of this information collection, including suggestions for reducing this burden, to: 
Department of Health and Human Services 
Food and Drug Administration 
Office of Chief Information Officer 
Paperwork Reduction Act (PRA) Staff 
PRAStaff@fda.hhs.gov 
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB number.” 
FORM FDA 3881 (7/17) 
3DJHRI
PSC Publishing Services (301) 443-6740 EF
Page 4-3