A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
 
Tritanium® Primary Acetabular Shell Study 
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center study of the 
Tritanium® Acetabular Shell 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
 
 
Study Product: 
Tritanium® Acetabular Shell 
Protocol Number: 
69 
510(k) Clearance  Number: 
K081171 
 
Version 3.0 
Date:  24 Aug 2020 
CONFIDENTIAL 
 
This document is confidential and the property of Stryker Orthopaedics.  No 
part of it may be transmitted, reproduced, published or used by other persons 
without prior written authorization from Stryker.

 
CONFIDENTIAL 
 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Orthopaedics 
 
 
 
 
 
 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
1.0  9/30/2009 
New 
Kristin L. Given 
1.1  1/26/2011 
Data collection method changed 
from paper case report form to 
electronic data capture.  All 
affected sections have been 
updated to reflect this change. 
Kristin L. Given 
2.0  6/1/2011 
Removed PA-coated product and 
added MDMTM liner.  Added 
background and device information 
for the MDMTM liner and X3® insert.  
Changed enrollment strategy from 
arms to treatment groups.  Added 
EQ-5D and updated eCRF 
specifications to incorporate new 
device and questionnaire.  Added 
Appendices G and H to comply 
with latest protocol template. 
Kristin L. Given 
Michael A. Pelosi 
3.0 8/24/2020 
Removed EDC system, 
NetRegulus reference.  Subject 
retention changed from a points 
accumulation program redeemable 
for a gift (Bennett Brothers), to a 
stipend system.  Appendix F 
revised to now reference Product 
Labeling; Appendix H no longer 
needed.   
Filesha Haniff 

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Table of Contents 
STUDY SYNOPSIS .................................................................................................................................................... 1 
EVALUATION SCHEDULE ...................................................................................................................................... 8 
1 
INTRODUCTION ............................................................................................................................................... 9 
1.1 
BACKGROUND ................................................................................................................................ 9 
1.2 
INVESTIGATIONAL DEVICE ............................................................................................................. 13 
1.3 
PRECLINICAL DATA ...................................................................................................................... 13 
1.4 
CLINICAL DATA TO DATE............................................................................................................... 15 
2 
STUDY OBJECTIVES .................................................................................................................................... 16 
2.1 
EFFICACY .................................................................................................................................... 16 
2.1.1 
Primary .................................................................................................................................. 16 
2.1.2 
Secondary ............................................................................................................................. 16 
2.2 
SAFETY ....................................................................................................................................... 18 
3 
CLINICAL STUDY PLAN .............................................................................................................................. 18 
3.1 
STUDY DESIGN ............................................................................................................................ 18 
3.2 
NUMBER OF CENTERS .................................................................................................................. 18 
3.3 
NUMBER OF SUBJECTS ................................................................................................................. 19 
3.4 
ESTIMATED STUDY DURATION ...................................................................................................... 19 
4 
ELIGIBILITY .................................................................................................................................................... 20 
4.1 
INCLUSION CRITERIA .................................................................................................................... 20 
4.2 
EXCLUSION CRITERIA ................................................................................................................... 20 
5 
SUBJECT ENROLLMENT ............................................................................................................................ 21 
5.1 
TREATMENT ASSIGNMENT ............................................................................................................ 21 
5.2 
RANDOMIZATION .......................................................................................................................... 21 
6 
DEVICE DESCRIPTION ................................................................................................................................ 21 
6.1 
STUDY DEVICE ............................................................................................................................. 21 
6.2 
DEVICE RETRIEVAL PROCESS ....................................................................................................... 25 
7 
EVALUATIONS ............................................................................................................................................... 26 
7.1 
PREOPERATIVE VISIT ................................................................................................................... 26 
7.2 
SURGERY .................................................................................................................................... 27 
7.3 
6-WEEK VISIT ............................................................................................................................... 27 
7.4 
ANNUAL FOLLOW-UP VISITS .......................................................................................................... 27 
8 
ADVERSE EVENTS ....................................................................................................................................... 28 
8.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 28 
8.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 31 
8.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 33 
8.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 34 
8.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 34 
8.5 
MEDICAL MONITORING ................................................................................................................. 34 
9 
STATISTICAL PLAN ...................................................................................................................................... 34 
9.1 
EFFICACY .................................................................................................................................... 34 
9.1.1 
Primary Efficacy Parameters ................................................................................................. 34 
9.1.2 
Secondary Efficacy Parameters ............................................................................................ 34 
9.1.3 
Primary Efficacy Hypothesis .................................................................................................. 35 
9.1.4 
Primary Efficacy Analysis ...................................................................................................... 35 

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9.1.5 
Secondary Efficacy Analysis ................................................................................................. 35 
9.2 
SAFETY PARAMETERS .................................................................................................................. 36 
9.2.1 
Safety Parameters ................................................................................................................. 36 
9.2.2 
Safety Analysis ...................................................................................................................... 36 
9.3 
MISSING DATA ............................................................................................................................. 36 
9.4 
STATISTICAL METHODOLOGY ........................................................................................................ 36 
9.4.1 
Data Summary....................................................................................................................... 36 
9.4.2 
Sample Size Calculation ....................................................................................................... 37 
9.4.3 
Interim Analyses and early Stopping Considerations............................................................ 37 
9.4.4 
Efficacy Patient Populations .................................................................................................. 37 
10 
STUDY PROCEDURES ................................................................................................................................. 38 
10.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 38 
10.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 38 
10.3 
EARLY WITHDRAWAL OF SUBJECTS............................................................................................... 39 
11 
DATA MANAGEMENT .................................................................................................................................. 41 
11.1 
DATABASE ................................................................................................................................... 41 
11.2 
CONFIDENTIALITY ......................................................................................................................... 41 
11.3 
SOURCE DOCUMENTS .................................................................................................................. 41 
11.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 42 
11.5 
DATA CLARIFICATION REQUESTS .................................................................................................. 42 
11.6 
PROTOCOL DEVIATIONS ............................................................................................................... 42 
11.7 
RECORDS RETENTION .................................................................................................................. 43 
12 
RISK/BENEFIT ASSESSMENT ................................................................................................................... 43 
12.1 
RISK CATEGORY .......................................................................................................................... 43 
12.2 
POTENTIAL RISK .......................................................................................................................... 43 
12.3 
EXPECTED COMPLICATIONS AND RATES OF OCCURRENCES ........................................................... 45 
12.4 
PROTECTION AGAINST RISKS........................................................................................................ 45 
12.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 45 
13 
STUDY MONITORING, AUDITING, AND INSPECTING.......................................................................... 45 
13.1 
STUDY MONITORING PLAN ............................................................................................................ 45 
13.2 
AUDITING AND INSPECTING ........................................................................................................... 46 
14 
ETHICAL CONSIDERATIONS ..................................................................................................................... 46 
15 
STUDY FINANCES ......................................................................................................................................... 47 
15.1 
FUNDING SOURCE ........................................................................................................................ 47 
15.2 
CONFLICT OF INTEREST ................................................................................................................ 47 
15.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 47 
16 
PUBLICATION PLAN .................................................................................................................................... 48 
17 
REFERENCES ................................................................................................................................................ 50 
 
 
 

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List of Appendices 
Appendix A 
 
Suggested Radiographic Technique 
Appendix B 
 
Component List 
Appendix C 
 
Study Advertisements 
Appendix D 
 
Model Informed Patient Consent 
Appendix E 
 
Draft Electronic Case Report Form Specifications 
Appendix F 
 
Product Labeling 
Appendix G 
 
FDA 510(k) Clearance Letter 
 

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List of Tables 
Table 1. Tritanium® Acetabular Shell Design Features ..............................................................10 
Table 2. Bench Tests Conducted on the Tritanium® Acetabular Shell .......................................15 
Table 3. Tritanium® Acetabular Shell/Liner/Head Compatibility .................................................23 
Table 4.  MDM™ Liner/Insert/Head Compatibility Chart ............................................................24 
Table 5. MDM™ Liner/Insert/Tritanium® Shell Compatibility Chart ............................................24 
 
 

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List of Figures 
 
Figure 1.  Adverse Event Decision Tree…………………………………………………...27

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List of Abbreviations 
ADE 
Adverse Device Effect 
ADM 
Anatomic Dual Mobility 
AE 
Adverse Event 
AP 
Anteroposterior 
BMI 
Body Mass Index 
CP 
Commercially Pure 
eCRF 
Electronic Case Report Form 
CSA 
Clinical Study Associate 
CSM 
Clinical Study Manager 
DCF 
Data Clarification Form 
DCR 
Data Clarification Request 
EC 
Ethics Committee 
EQ-5D 
EuroQol  
ETA 
Enhanced Tendon Anchor 
GCP 
Good Clinical Practice 
HA 
Hydroxyapatite 
HHS 
Harris Hip Score 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
ID 
Inner Diameter 
IRB 
Institutional Review Board 
LEAS 
Lower Extremity Activity Scale 
MDM 
Modular Dual Mobility 
NIDJD 
Non-Inflammatory Degenerative Joint Disease 
OD 
Outer Diameter 
PER 
Product Experience Report 
PI 
Primary Investigator 
PSF 
Particle Sintered Foam 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-12 
Short Form-12 

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List of Abbreviations 
(continued) 
THA 
Total Hip Arthroplasty 
THR 
Total Hip Replacement 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE Ultra High Molecular Weight Polyethylene 
 
 
 
 
 
 
 
 

Tritanium® Primary Acetabular Shell Study                                                                                                 Page 1 
Stryker Orthopaedics Clinical Study Protocol  
 
 
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Study Synopsis 
 
Title 
A prospective, post-market, multi-center study of the Tritanium® 
Acetabular Shell 
Short Title 
Tritanium® Primary Acetabular Shell Study 
Protocol Number 
69 
Phase 
Post-market 

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Methodology 
This study will be a prospective, non-randomized evaluation of 
the Tritanium® Acetabular Shell for primary total hip 
replacement (THR) with a cementless application in a 
consecutive series of patients who meet the eligibility criteria.  
Half of the cases will use the X3® polyethylene insert alone as 
the bearing surface; the other half will use the MDMTM liner 
coupled with a compatible ADM/MDMTM X3® insert as the 
bearing surface.   Cases receiving the MDMTM liner may be 
coupled with Stryker 22.2 mm or 28 mm LFITTM CoCr, BIOLOX 
delta or alumina ceramic heads.  All cases will be implanted 
with a compatible Stryker femoral stem. 
Data from the Trident® X3® Polyethylene Insert Study will be 
used as a historical control for secondary objectives. This study 
was chosen for the following reasons: 
• 
Similar indication (primary THR) 
• 
The acetabular shell (Trident® HA Hemispherical 
Acetabular Shell) used in this study is a predicate for the 
Tritanium® Acetabular Shell, with similar design 
features. 
• 
The follow-up intervals and data collected in the Trident® 
X3® Study closely match the design of the current study. 
The survivorship value used for development of the statistical 
plan was calculated as a mean of the mid-term results 
published for three studies of similar acetabular shells.  Articles 
presenting long-term results of additional acetabular shells of 
similar design will be used for comparison at the end of the 
study as available.   
Study Duration 
• 
Follow-up of each primary THR case to 10 years 
• 
Enrollment period of 18-24 months  
• 
Approximate 13-year total duration 
Study Center(s) 
7 – 12 centers  

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Hypothesis 
The success rate, defined as freedom from acetabular revision, 
for hips implanted with the Tritanium® Acetabular Shell, is no 
worse than for hips implanted with similar technology as 
reported in the literature and Trident® X3® Study historical 
control at 5 years postoperative. 
Objectives 
Primary: 
To demonstrate, through absence of revision at 5 years 
postoperative, that acetabular replacement with the 
Tritanium® Acetabular Shell provides clinical results 
comparable to similar acetabular components. 
 
Secondary: 
• 
To study rates of screw fixation usage in Tritanium® 
Acetabular Shell (cluster hole) procedures and compare 
with those reported in the Trident® X3® Polyethylene 
Insert Study. 
• 
To compare pain, function and health related quality of 
life (QOL) between the Tritanium® Acetabular Shell 
combined group and the above-referenced historical 
control group.  The following outcomes measures will be 
used for this comparison: 
o Harris Hip Score (HHS) 
o Short Form-12 (SF-12) 
o Lower Extremity Activity Scale (LEAS) 
o EQ-5D 
 
1-year, 3-year, and 5-year HHS, SF-12 and LEAS data 
will be compared to the historical control with respect to 
improvement from preoperative scores.  The EQ-5D 
data will be summarized and presented. 

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Objectives 
• 
An additional Follow-Up Questionnaire will be 
administered annually in postoperative years 6-10 to 
assess patient satisfaction and pain, and to capture 
adverse events.  This questionnaire will provide the 
survivorship information necessary to evaluate the 
primary objective of the study. 
• 
To review radiographic stability and complications 
between those hips implanted with the Tritanium® 
Acetabular Shell and those in the historical control 
group.   
Published complication rates with similar devices, as 
well as complications related to cementless acetabular 
replacement, will be reviewed. 
Number of Subjects 
Cases will be enrolled until 240 cases have received the 
Tritanium® Acetabular Shell 
• 
Treatment 1: 120 cases with X3® polyethylene insert 
• 
Treatment 2: 120 cases with MDMTM liner and 
ADM/MDMTM X3® insert 
Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Inclusions: 
A. Patient has signed an IRB approved, study specific 
Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female age 18 years 
or older at time of study device implantation. 
C. Patient has primary diagnosis of Non-Inflammatory 
Degenerative Joint Disease (NIDJD). 
D. Patient is a candidate for a primary cementless total hip 
replacement. 
E. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations and 
rehabilitation. 

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Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Exclusions: 
F. Patient has a Body Mass Index (BMI) ≥ 40. 
G. Patient has an active or suspected latent infection in or 
about the affected hip joint at time of study device 
implantation. 
H. Patient has a neuromuscular or neurosensory 
deficiency, which limits the ability to evaluate the safety 
and efficacy of the device. 
I. 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. 
J. Patient is immunologically suppressed or receiving 
steroids in excess of normal physiological requirements 
(e.g. > 30 days). 
K. Patient requires revision surgery of a previously 
implanted total hip replacement or hip fusion to the 
affected joint. 
L. Patient has a known sensitivity to device materials. 
M. Patient is a prisoner. 
Study Device 
Required Components: 
• 
Tritanium® Acetabular Shell  
Acetabular components must be used in a cementless 
application. 
Reference Therapy 
Literature control and Trident® HA Hemispherical Shell 

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Ancillary Devices 
The following ancillary devices are permissible: 
• 
Stryker X3® polyethylene inserts (120 cases) 
• 
Stryker MDMTM liners with ADM/MDMTM X3® polyethylene 
inserts (120 cases) 
• 
Stryker LFITTM CoCr, BIOLOX delta and alumina ceramic 
heads (in cases where the MDMTM liner is used, only 22.2 
mm and 28 mm heads are permissible) 
• 
Stryker Universal Adapter Sleeves (for use with BIOLOX 
delta universal ceramic heads) 
• 
Compatible Stryker femoral stems 
• 
Stryker Orthopaedics Torx Bone Screws 

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Statistical 
Methodology 
Primary: 
The 90% confidence interval of the success rate will be 
computed at 5 years postoperative. For the non-inferiority 
comparison, the lower bound of this 90% confidence interval 
will be compared with 94%.  For the superiority comparison, the 
lower bound of this 90% confidence interval will be compared 
with 99%. 
Secondary: 
• 
A Fisher’s exact test or Chi-square test will be used to 
compare the usage of screw fixation between the Tritanium® 
Acetabular Shell and Trident® X3® Polyethylene Insert 
studies.  If there are any statistically significant differences 
in baseline variables (e.g. age, gender, diagnosis) between 
the groups, they will be addressed as covariates and 
ANOVA or ANCOVA will be used. 
• 
A two-sample t-test or Wilcoxon test will be used to 
compare the HHS, SF-12 and LEAS score at 1-year, 3-year, 
and 5-year follow-up between the Tritanium® Acetabular 
Shell and Trident® X3® Polyethylene Insert studies. If there 
are any statistically significant differences in baseline 
variables (e.g. age, gender, diagnosis) between the groups, 
they will be addressed as covariates and ANOVA or 
ANCOVA will be used. 
• 
EQ-5D health states will be converted to numerical results 
using the appropriate value set and presented in table 
format.  
• 
Adverse event (AE) rates will be listed and tabulated, with 
95% confidence intervals presented. 
• 
Radiographic data will be summarized in table format. 

Tritanium® Primary Acetabular Shell Study                                                                                                 Page 8 
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Evaluation Schedule 
Evaluation 
Pre-op 
X-rays 
(-1 yr) 
eCRFs 
(-4 mn) 
Intra-
op 
6-wk 
+ 2 
wks 
1-yr 
+ 2 mn 
2-yr 
+ 2 mn 
3-yr 
+ 3 mn 
4-yr 
+ 4 mn 
5-yr 
+ 4 mn 
6-yr 
+ 4 mn 
7-yr 
+ 4 mn 
8-yr 
+ 4 mn 
9-yr 
+ 4 mn 
10-yr 
+4mn 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics & 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Preoperative 
HHS 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Postoperative 
HHS 
 
 
X 
X 
 
X 
 
X 
 
Optional 
 
 
Optional 
SF-12 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
LEAS 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
EQ-5D 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
Radiographs: 
Antero-posterior 
(AP) pelvis, 
AP femur, 
lateral 
X 
 
X 
X 
 
X 
 
X 
 
Optional 
 
 
Optional 
Follow-up 
Questionnaire 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
 
HHS: The HHS is a subjective outcomes tool completed by the investigator that measures function, pain and motion. 
SF-12:  The SF-12 is a 12-item patient questionnaire that evaluates general health and wellbeing. 
LEAS: The LEAS is a self-administered patient evaluation designed to reflect patient activity. 
EQ-5D: The EQ-5D is a standardized instrument for use as a measure of health outcome.  
Follow-up Questionnaire: The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient 
satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. 

Tritanium® Primary Acetabular Shell Study                                                                                                 Page 9 
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 
Cementless acetabular components for total hip arthroplasty (THA) became popular in the 
United States in the early 1980s, primarily due to poor long-term results with cemented 
cups.  Superior radiographic performance has been reported for cementless cups as 
compared with cemented fixation.1 Cementless acetabular components require initial 
implant stability to allow for bone ingrowth or ongrowth, which provides long-term durability 
of the prosthesis when properly achieved.2  To this end, there are several surface options 
available for cementless acetabular fixation; titanium fibermesh, sintered bead surfaces, and 
plasma spray are some widely used examples, all with good clinical history.3  In a recent 
publication, the 20-year Kaplan-Meier survivorship of a titanium fibermesh cup was reported 
at 96%.4  Similarly positive results have been reported at slightly shorter time points for both 
sintered bead surfaces5 (0.7% revision for aseptic loosening at 9.5 years) and plasma 
sprayed surfaces6 (0% revision for aseptic loosening at 8.5 years). 
 
Tritanium® technology is now available in a primary application and provides a three-
dimensional, commercially pure (CP) Titanium matrix that resembles trabecular bone, 
allowing for enhanced acetabular fixation7 and joint stability.8 Studies have shown the 
superiority of 3-D surfaces when compared to 2-D surfaces9, as well as improved biological 
fixation with CP Ti as compared to alloys.10  An example of the superiority of the Tritanium® 
coating to other coatings can be seen in a pre-clinical study11 examining the canine in vivo 
bone response to six test surfaces.  Bone penetration for Tritanium® surfaces was 
significantly greater than for all other test surfaces (titanium beads with and without PA and 
cobalt chrome beads with and without PA) at 12 weeks.  Mechanically, the failure strength of 
the surface-to-bone attachment for Tritanium® surfaces was significantly greater than that of 
all other test surfaces at the 12-week time point.  Both bone penetration and failure strength 
increased significantly between the 6- and 12-week time points.    
 
1 Introduction 

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Stryker has introduced a porous coated cementless acetabular cup for primary THA, the 
Tritanium® Acetabular Shell.  The basic design of the Tritanium® Acetabular Shell is similar 
to other cementless acetabular cups which are currently commercially distributed.  The 
Tritanium® Acetabular Shell’s design features are based upon the previous success of 
Stryker’s cementless Trident® hemispherical acetabular shells.  
  
Table 1. Tritanium® Acetabular Shell Design Features 
Product 
Identifying Features 
Based upon 
Clinical History of 
the Following 
Existing Shell 
Closest to Same 
Design Features 
Tritanium® 
Acetabular Shell 
 
Hemispherical, solid and cluster 
hole designs 
Ti6Al-4V (Titanium alloy) 
substrate 
CP Titanium porous coating 
Trident® 
Tritanium®Acetabular 
Shell; 
Trident® 
Hemispherical 
Acetabular Shell 
Trident® Tritanium® 
Acetabular Shell 
 
 
The Tritanium® Acetabular Shell shares design similarities with the Trident® Tritanium® and 
Trident® Hemispherical uncemented acetabular shells.  The Trident® Hemispherical shells 
are the design upon which the Tritanium® family of acetabular shells is based; these shells 
are manufactured from a Ti6Al-4V substrate into a hemispherical geometry and have an arc-
deposited coating of CP Ti to increase surface roughness.    The Tritanium® family of shells 
retains the geometry and substrate material of this predecessor design, but replaces the 
arc-deposited CP Ti coating with a three dimensional porous coating of the same CP Ti 
material.   
 
The Tritanium® Acetabular Shell is very similar in design and surface characteristics to the 
Trident® Tritanium® Acetabular Shell that is currently used in revision applications.  A 
prospective, post-market, non-randomized, open-label, multi-center clinical study of the 
Trident® Tritanium® Acetabular Shell (product family 509-02-XXX) is currently in the 
subject enrollment phase. This study evaluates the use of the Trident® Tritanium® 
Acetabular Shell for revision of the acetabular component of a previously failed THR in a 
consecutive series of cases. A total of 244 cases are anticipated. Presently, there are 15 
sites in the United States participating and 239 subjects enrolled. Data collection is on-going 
with the initially enrolled subjects just entering the 3-year follow-up interval.  To date, there 
have been nine reported revisions.  Six of these were reported as related to surgery or 

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infection; two were reported as related to the device; relation to the device in the case of the 
remaining revision is unknown as the revision was discovered at a site close-out visit and 
the investigator was no longer at the institution and therefore not available for consultation. 
 
The Trident® Hemispherical Acetabular Shell is one of the earlier Stryker acetabular devices 
upon which the design of the Tritanium® Acetabular Shell is based. The Exeter® + 
CrossfireTM US Outcomes Study is a prospective, consecutive series of primary THRs of 
Exeter® Femoral Stems with Orthinox Femoral Heads and is a source of clinical data on the 
performance of the Trident® Hemispherical Acetabular Shell. Subjects participating in this 
study were implanted with a cemented Exeter® Femoral Stem and an Orthinox Femoral 
Head, in combination with a cementless Trident® Hemispherical Acetabular Shell (a.k.a. 
Trident® AD Acetabular Shell, product family 540-01-XXX) and a Crossfire™ polyethylene 
insert. Enrollment took place at two sites in the United States and is closed with a total of 
147 cases.  To date, there have been three reported acetabular revisions and one report of 
acetabular loosening.  Two of the acetabular revisions were secondary to infection and one 
was secondary to recurrent dislocation. Mean follow-up is 4.9 years. 
 
   
A review of the data collected suggests that the Trident® Tritanium® Acetabular Shell and the 
Trident® AD Acetabular Shell have performed appropriately for their intended use and 
present no new risks. 
 
Mid-term clinical and radiographic outcomes have been reported for a competitive product 
(Trabecular MetalTM Monoblock Acetabular Component System; Zimmer® Inc, Warsaw, IN) 
of similar design to the subject device.12  In a prospective study, 156 primary THAs in 143 
patients were followed for a minimum of 8 years (maximum of 10 years).  The average HHS 
improved from 44.0 + 13.8 (4-86.75) preoperatively to 97.0 + 6.2 (58.85-100) at the latest 
follow-up evaluation.  Three revisions were reported during the follow-up period; one 
acetabular component was revised for repeated dislocation and two were revised due to late 
hematogenous infection.  All retrieved components were stable at the time of removal. 
 
This clinical study is necessary to compare the success of the Tritanium® Acetabular Shell to 
the reported success of products of similar design.  The objective of the study is to show 
that the study device performs no worse than similar devices at 5 years postoperative with 

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extended follow-up to 10 years.  The study also provides a unique opportunity to collect 
longitudinal data on the performance of the new MDMTM liner. 
 
The MDMTM liner is a highly polished cobalt chrome liner that utilizes a Trident® locking 
mechanism to create a dual mobility bearing when coupled with the Tritanium® acetabular cup 
system, a ADM/MDMTM X3® polyethylene head/insert and a 22.2 mm or 28 mm femoral head. 
 
The concept of dual mobility was first defined by Professor Gilles Bousquet in 1976.  This 
concept combines the advantages of Charnley’s low friction arthroplasty principle and the 
McKee theory of using a large femoral head to maximize stability.12 The modular dual 
mobility (MDM™) liner locks into the Tritanium® acetabular shell using the Trident® locking 
mechanism allowing for the use of the ADM/MDMTM X3® polyethylene insert and femoral 
head to create the dual mobility system. The polyethylene insert freely rotates within the 
MDM™ liner as well as positively captures a prosthetic femoral head.  Thus, there are two 
distinct points of articulation in which range of motion (ROM) is accommodated. 
 
The MDMTM liner introduces the concept of dual articulation to existing, non-dual mobility 
acetabular shells.  Acetabular shell options are important in order to intraoperatively address 
varying bone densities.  The MDMTM liner, coupled with acetabular shells designed with the 
Trident® locking mechanism, such as the Tritanium® Acetabular Shell, combines the 
advanced fixation technology of Tritanium® with the large diameter X3® mobile bearing 
articulation to achieve initial and long-term stability and preserve ROM. By offering this 
unique combination of benefits, the pairing of Tritanium® technologies with the MDM™ 
provides surgeons with options to treat a wide variety of patients.   
 
While the MDM™ liner allows for the introduction of dual mobility in various acetabular shell 
options it is the polyethylene insert which helps accommodate a larger femoral head. X3® 
ultra high molecular weight polyethylene (UHMWPE) is a highly cross-linked polyethylene 
manufactured through a proprietary process to maintain mechanical strength, crystallinity, 
density and stabilize free radicals. X3® UHMWPE was designed to reduce the wear 
characteristics of conventional UHMWPE. Large diameter femoral head sizes have become 
more common as surgeons are looking for additional product solutions to help increase 
patient ROM and stability.  

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1.2 Investigational Device 
The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a 
hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from CP Ti.  
The shell is built upon the design features and clinical history of the existing Trident® 
Tritanium®, Trident® AD, and Trident® HA hemispherical acetabular shells.  The device is 
designed with a roughened surface and high coefficient of friction to resist micromotion and 
promote initial fixation.  The Tritanium® Acetabular Shell, intended for use in a cementless 
application, is available in sizes from 44 mm through 66 mm and is compatible with Trident® 
polyethylene liners and acetabular screws.  This advanced technology is designed to address 
the need for improved initial and biological fixation.  Data in support of these marketing claims 
will be collected in the Tritanium® Primary Acetabular Shell Study. 
 
1.3 Preclinical Data 
The following articles have been published on preclinical studies of the Tritanium® technology: 
 
1. Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. (2004). Bone response to a novel 
highly porous surface in a canine implantable chamber.  J Biomed Mater Res B Appl 
Biomater.,71(2), 387-91. 
 
This study examined the canine in vivo bone response to six test surfaces at 6 and 12 
weeks after implantation.  The surfaces tested were A) titanium (Ti) beads, B) Ti beads 
with PA, C) Cobalt chrome (CoCr) beads, D) CoCr beads with PA, E) Tritanium®, and 
F) Tritanium® with PA.  Bone penetration into the test surfaces was shown to increase 
significantly between 6 and 12 weeks for both the coated and uncoated Tritanium®; 
bone penetration for both Tritanium® surfaces was significantly greater than for all 
other test surfaces at 12 weeks.  Mechanically, the failure strength of the surface-to-
bone attachment again increased significantly between 6 and 12 weeks for both 
Tritanium® surfaces, and was significantly greater than that of all other test surfaces 
at the 12-week time point. 
2. Higuera CA, Inoue N, Lim JS, Zhang R, Dimaano N, Frassica FJ, Chao EY. 
(2005).Tendon reattachment to a metallic implant using an allogenic bone plate 
augmented with rhOP-1 vs. autogenous cancellous bone and marrow in a canine 
model. J Orthop Res.,23(5), 1091-9. 

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In this study, the supraspinous tendon was reattached unilaterally to a modified 
Enhanced Tendon Anchor (ETA) implant with a Tritanium® surface in two canine 
groups.  Allogenic bone plates saturated with rhOP-1-collagen putty were used in the 
first group (OP); plates saturated with autogenous cancellous bone and marrow were 
used in the second group (BM).  At 15 weeks, gait analysis showed 78% and 81% 
recovery of preoperative weight-bearing in the OP and BM groups, respectively.  The 
ultimate tensile strength of the reattachment was 24% and 38% of the intact 
contralateral side in the OP and BM groups, respectively; the difference between the 
two was not significant.  There was evidence of tendon-bone insertion transitional 
zones, tissue ingrowth and adhesion to the metallic surface in both groups.   
3. Zhang R, Brown PR, Dimaano N, Hawkins M. (2003). Enhancement of bone ingrowth 
with a titanium foam surface in a canine intramedullary rod model. Trans Soc for 
Biomat., 327. 
Intramedullary rods of Ti alloy were coated with CP Titanium as either a foam or a 
double layer of beads.  These rods were inserted into the canine femoral 
intramedullary cavity through the osteotomy of the greater trochanter and harvested 
femurs were examined at 4 and 16 weeks.  At 4 weeks, the median average depth of 
bone ingrowth in the Ti foam coating was 82%, compared to 35% for the Ti beads.  At 
16 weeks, the depths were measured at 81% and 51% for the foam and beads, 
respectively.  The bone ingrowth in the Ti foam dramatically increased (15% to 80%) 
from 4 weeks to 16 weeks postoperatively, and was significantly higher than ingrowth 
into the Ti beads (37%) at 16 weeks.  
4. Bobyn JD, Toh KK, Hacking SA, Tanzer M, Krygier JJ. (1999). Tissue response to 
porous tantalum acetabular cups: a canine model.  J Arthroplasty, 14(3), 347-54. 
A total of 22 porous tantalum acetabular cups were implanted without cement in 11 
dogs and studied for 6 months.  Stable bone-implant interfaces were seen in all cases 
upon histological, radiographic and scanning electron microscopic evaluation.  The 
depth of bone ingrowth varied from 0.2 mm to 2 mm (maximum achievable in this 
implant design).  Mean bone ingrowth was 16.8% + 5.7%; in peripheral regions of the 
cup where bone-implant contact was most consistent, this increased to 25.1% + 
10.1%. 
 

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Table 2. Bench Tests Conducted on the Tritanium® Acetabular Shell 
Description of the test 
Report ID 
Evaluation of Bone Response to Porous Surfaces Using a Canine Total 
Hip Model 
RD-08-009 
Particle Sintered Foam (PSF) - The Morphological, Metallurgical, and 
Chemical Properties of the Coating and Substrate Matrices 
RD-08-010 
Particle Sintered Foam (PSF) - A Mechanical Characterization of the 
Coating System and the Underlying Substrate 
RD-08-016 
Evaluation of Press Fit Stability of Tritanium® PSF Acetabular Shells 
with PA coating 
RD-09-021 
In-vitro and In-vivo Biological Evaluation of Particle Sintered Titanium 
Foam 
RD-05-033 
Evaluation of Deformation of Tritanium® PSF Shells for Ease of Liner 
Assembly 
RD-08-046 
Evaluation of Press Fit Stability of Tritanium® PSF Acetabular Shells 
RD-08-049 
Evaluation of Fatigue Strength of Tritanium® Ingrowth Hemispherical 
Acetabular Shell. 
RD-08-092 
 
Copies of all test reports are available at Stryker Orthopaedics. 
 
   
1.4 Clinical Data to Date 
Solid back and cluster hole versions of the Tritanium® Acetabular Shell are currently available 
in the United States.  This study is the first prospective data collection on both versions of the 
device. 
 
 
 
 
 
 
 
 
 
 
 
 

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2 Study Objectives 
 
2.1 Efficacy 
2.1.1 Primary 
The primary objective of this study will be to evaluate the success rate of cementless 
primary THR in hips implanted with the Tritanium® Acetabular Shell, as compared to 
the published results of similar acetabular components.  Success will be defined as 
absence of acetabular shell revision for any reason at 5 years postoperative.  It is 
expected that the survivorship of the Tritanium® Acetabular Shell group will be non-
inferior to the survivorship reported in the literature for similar competitive devices. 
2.1.2 Secondary 
Usage of bone screw fixation will be recorded and compared between the Tritanium® 
Acetabular Shell group and the Trident® HA Hemispherical Shell group (Trident® X3® 
Polyethylene Insert Study). 
 
Additionally, pain, function and health-related QOL data for the Tritanium® Acetabular 
Shell group will be collected at postoperative time points and compared with the 
subjects’ preoperative status, as well as with the historical control group and with 
published literature for similar highly porous acetabular shells.  It is expected that the 
HHS, SF-12 and LEAS outcomes in the study group will be comparable to the historical 
control.  It is expected that the EQ-5D outcomes in the study group will be comparable 
to published results for similar devices. 
 
Lastly, radiographic stability and complications between those implanted with the 
Tritanium® Acetabular Shell and the historical control group will be reviewed. 
  
 
Clinical Outcomes: 
Clinical outcomes will be evaluated via the total HHS, including pain, motion and 
function, preoperatively and at the 6-week, 1, 3, and 5-year visits.  Additional HHS 
data will be obtained at the 7-year and 10-year time points at investigational sites that 
choose to bring their subjects back in for these optional visits.  

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Patient Outcomes: 
Pain, function and health related quality of life (QOL) will be compared between the 
Tritanium® Acetabular Shell combined group, the literature and the above-referenced 
historical control group.  The SF-12 is a 12 item patient self-assessment evaluating 
health and general wellbeing.  The LEAS is a tool that has been developed and 
validated to evaluate the level of patient activity.  The EQ-5D is a standardized 
instrument for use as a measure of health outcome.  These tools will be used to 
assess patient health-related QOL and will be collected preoperatively at the 6-week, 
1, 2, 3, 4 and 5-year visits.  Patient outcomes data will also be obtained at the 7-year 
and 10-year time points at investigational sites that choose to bring their subjects 
back in for these optional visits, in addition to the required Follow-Up Questionnaire 
described below. 
A Follow-Up Questionnaire will be administered annually in postoperative years 6-10 
to assess patient satisfaction and pain, and to capture adverse events.  This 
questionnaire will provide the survivorship information necessary to evaluate the 
primary objective of the study. 
 
Radiographic Outcomes: 
To assess radiographic stability as compared with the historical control, radiographs 
will be taken and collected in the AP pelvis, AP hip and lateral views for the 
preoperative, 6-week, 1, 3 and 5-year intervals.  Additional radiographs will be 
obtained at the 7-year and 10-year time points at investigational sites that choose to 
bring their subjects back in for these optional visits. 
 
The AP pelvis and AP hip views allow for observation of any conditions involving the 
sacral wings, iliac bones, ischium, pubis as well as the femoral head and neck.  The 
lateral view allows for evaluation of the entire hip joint as well as the femoral head, 
neck and proximal shaft.13  Suggested radiographic technique for the views required 
is included in Appendix A. 
 
Radiographs will be evaluated by an independent reviewer throughout the course of 
the study.  Radiographic analysis of the acetabular component will employ three zones 

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(Zone 1 – Zone 3) in the AP views.14,15  Numerous parameters will be reviewed by 
zone, including radiolucency 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 migration of greater than 5 mm in any direction or at least 2 mm 
radiolucency in all zones will be considered radiographic failures. 
2.2 Safety 
All operative site events as well as all serious adverse events (SAEs), excluding 
elective procedures, will be collected and compared to the historical control group and 
to published data.  It is expected that the AE rates reported for hips implanted with the 
Tritanium® Acetabular Shell will be comparable to those reported in the literature for 
similar porous coated cementless acetabular shells and for the historical control group.  
Details regarding AE definitions, recording and reporting are in Section 8 of this 
protocol, Adverse Events. 
 
3 Clinical Study Plan 
3.1 Study Design 
A prospective, post-market, multi-center design will be employed.  Radiographs will be 
assessed by an independent reviewer. 
3.2 Number of Centers 
Cases will be enrolled at 7 to 12 centers.  The enrollment goal ranges from 20 to 34 cases 
implanted with the Tritanium® Acetabular Shell per center.  The enrollment goal range is 
dependent upon the number of participating centers as well as the relative rates of enrollment 
of the two treatment groups.   Although a range is presented, there is no maximum limit to the 
number of cases that a center may enroll.  In the event that a center far exceeds the overall 
enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask 
the center to cease enrollment so as not to skew the data.  All participating centers will comply 
with the federal regulations regarding patient informed consent and IRB approval.  Non-
compliance of a study center may result in termination of the center’s participation in the study. 

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3.3 Number of Subjects 
Cases will be enrolled in this study until a total of 240 receive the Tritanium® Acetabular Shell.  
Half of these cases will use the X3® polyethylene insert alone as the bearing surface; the other 
half will use the MDMTM liner coupled with a compatible ADM/MDMTM X3® insert as the bearing 
surface. These treatment groups will not be separated into arms; instead, investigators will 
use their clinical judgement in determining the appropriate bearing for each case.  If enrollment 
in one of the treatment groups begins to outpace that of the other, centers may be asked to 
enroll only those cases that are candidates for the bearing surface for which enrollment is 
lagging.  Following this plan, cases will not be artificially placed into a treatment group to which 
they may not be best suited on the basis of the timing of their enrollment; consequently, there 
will be fewer opportunities for protocol deviations with regard to treatment. 
 
Only the following ancillary devices may be used according to this study protocol: 
o Stryker X3® polyethylene inserts (120 cases) 
o Stryker MDMTM liners with ADM/MDMTM X3® polyethylene inserts (120 cases) 
o Stryker LFITTM CoCr heads or BIOLOX delta or alumina ceramic heads (in cases 
where the MDMTM liner is used, only 22.2 mm and 28 mm heads are permissible) 
o Stryker Universal Adapter Sleeves (for use with BIOLOX delta universal ceramic 
heads) 
o Compatible Stryker femoral stems 
o Stryker Orthopaedics Torx Bone Screws 
 
The Tritanium® Acetabular Shell is described in detail in Section 6 of this protocol, Device 
Description.   
3.4 Estimated Study Duration  
The enrollment period is estimated to be a maximum of 18 to 24 months; cases will be evaluated 
as per the evaluation schedule until each case reaches 10 years. 
 
 
 
 
 

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4 Eligibility 
 
The following criteria will be used to distinguish patients eligible for enrollment into this study. 
4.1 Inclusion Criteria 
A. Patient has signed an IRB approved, study specific Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female age 18 years or older at time of study device 
implantation. 
C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 
D. Patient is a candidate for a primary cementless total hip replacement. 
E. Patient is willing and able to comply with postoperative scheduled clinical and 
radiographic evaluations and rehabilitation. 
4.2 Exclusion Criteria 
F. Patient has a Body Mass Index (BMI) ≥ 40. 
G. Patient has an active or suspected latent infection in or about the affected hip joint at 
time of study device implantation. 
H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to 
evaluate the safety and efficacy of the device. 
I. 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. 
J. Patient is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements (e.g. > 30 days). 
K. Patient requires revision surgery of a previously implanted total hip replacement or hip 
fusion to the affected joint. 
L. Patient has a known sensitivity to device materials. 
M. Patient is a prisoner. 
 
 
 
 

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5 Subject Enrollment 
 
5.1 Treatment Assignment 
All subjects will receive the Tritanium® Acetabular Shell.  Half of the cases will use the X3® 
polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner coupled 
with a compatible ADM/MDMTM X3® insert as the bearing surface.   Treatment assignment will be 
made based upon the clinical judgment of each investigator and enrollment into each treatment 
group will be monitored by Stryker to ensure equal distribution between the two groups. 
5.2 Randomization 
The study will enroll under a non-randomized study design. 
 
6 Device Description 
6.1 Study Device 
The Tritanium® Acetabular Shell has been cleared for use in the United States; therefore, this 
study is considered a post-market assessment.  All cases in this study will receive the Tritanium® 
Acetabular Shell.  Half of the cases will use the X3® polyethylene insert alone as the bearing 
surface; the other half will use the MDMTM liner coupled with a compatible ADM/MDMTM X3® insert 
as the bearing surface.  Only the following Stryker compatible ancillary devices may be used, 
according to this study protocol: 
o Stryker X3® polyethylene inserts (120 cases) 
o Stryker MDMTM liners with ADM/MDMTM X3® polyethylene inserts (120 cases) 
o Stryker LFITTM CoCr heads or BIOLOX delta and alumina ceramic heads (in cases 
where the MDMTM liner is used, only 22.2 mm and 28 mm heads are permissible)  
o Stryker Universal Adapter Sleeves (for use with BIOLOX delta universal ceramic 
heads) 
o Compatible Stryker femoral stems 
o Stryker Orthopaedics Torx Bone Screws 
 
 
 

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Device Description: 
The Tritanium® Acetabular Shell consists of a porous coated hemispherical cup available in 
solid back and cluster-hole designs, and is similar to other acetabular shells currently 
distributed.  It is intended for cementless application and is designed for use with currently 
available Stryker MDMTM liners and polyethylene inserts.  A description of the Tritanium® 
Acetabular Shell and compatible liner/insert/head combinations follows.    Appendix B gives an 
overview of all protocol-specified components. 
 
The X3® Polyethylene Insert is the next generation of highly cross-linked UHMWPE with 
excellent mechanical and fatigue properties. X3® polyethylene is a highly cross-linked 
polyethylene manufactured through a proprietary, step-wise sequential irradiation and annealing 
process through which the polyethylene receives 30 kiloGrays of gamma radiation and is then 
annealed below melting point to promote cross-linking. This highly cross-linked polyethylene 
has shown reduction in polyethylene wear with approximately the same mechanical properties 
of standard polyethylene. 
 
The Modular Dual Mobility (MDM™) liner, cleared for use under FDA 510(k) K103233, features 
a highly polished cobalt chrome (CoCr) liner with a Trident® locking mechanism which will allow 
for compatibility with the Tritanium® acetabular cup system. The X3® polyethylene insert will 
articulate within the inner surface of the highly polished cobalt chrome liner. The polyethylene 
insert and 22.2 mm or 28 mm femoral head will combine to create the dual mobility bearing. The 
MDM™liner is available in sizes from 36 mm through 58 mm and is compatible with 
ADM/MDMTM X3® Inserts. The MDM™ system is designed to provide stability through the use of 
large diameter dual mobility liners and advanced fixation through the use of ancillary fixation 
and Tritanium® acetabular shells.  
 
Tritanium® Acetabular Shell: 
The catalog numbers for the Tritanium® Acetabular Shell permissible according to this study 
protocol will be in the following format, where ‘XXX’ varies by size: 
 
 
 
 
 
500-03-XXX (solid back) 
 
 
 
 
 
502-03-XXX (cluster hole) 
 
 
 

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X3® Polyethylene insert: 
The catalog numbers for the X3® polyethylene inserts permissible according to this study 
protocol will be in the following format, where ‘XXX’ varies by size: 
623-00-XXX (0o) 
623-10-XXX (10o) 
 
Table 3. Tritanium® Acetabular Shell/Liner/Head Compatibility 
 
Shell Size, Liner Alpha Code and Liner Thickness (mm) 
Tritanium® 
Acetabular 
Shell 
44 
46 
48 
50, 52 
54, 56 
58, 60 
62, 64 
66 
X3® Liner 
Alpha Code 
A 
B 
C 
D 
E 
F 
G 
H 
Anatomic 
Heads 
44mm 
 
 
 
 
 
3.8 
5.4 
7.1 
40mm 
 
 
 
 
3.8 
5.8 
7.4 
9.1 
36mm 
 
 
 
3.9 
5.9 
7.9 
9.4 
11.2 
Femoral 
Heads 
32mm 
 
3.9 
4.9 
5.9 
7.9 
9.9 
11.4 
13.2 
28mm 
4.9 
5.9 
6.9 
7.9 
9.9 
11.9 
13.4 
15.2 
26mm 
 
 
7.9 
8.9 
10.9 
12.9 
14.4 
16.2 
22mm 
7.8 
8.8 
9.8 
10.8 
12.8 
14.8 
16.3 
18.1 
 
MDMTM Liner: 
The catalog numbers for the MDMTM liner permissible according to this study protocol will be in 
the following format, where ‘XXX’ varies by size: 
626-00-XXX 
ADM/MDM™ X3® Polyethylene Insert: 
The catalog numbers for the dual mobility polyethylene inserts permissible with the MDM™ 
Liner according to the study protocol will be in the following format, where ‘XXX’ varies by size: 
1236-2-XXX 
 
 
 
 

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Table 4.  MDM™ Liner/Insert/Head Compatibility Chart 
MDM™ 
Liner 
MDM™ Liner 
Trial 
ADM/MDM™ X3® 
Insert 
ADM/MDM™  
Insert Trial 
Required Femoral  
Head Size (mm) 
626-00-36C 3200-36C 
1236-2-242 
1235-0-242 
22.2mm 
626-00-38D 3200-38D 
1236-2-244  
1235-0-244 
22.2mm 
626-00-42E 3200-42E 
1236-2-848 
1235-0-848 
28mm 
626-00-46F 3200-46F 
1236-2-852 
1235-0-852 
28mm 
626-00-48G 3200-48G 
1236-2-854 
1235-0-854 
28mm 
626-00-52H 3200-52H 
1236-2-858 
1235-0-858 
28mm 
626-00-54I 
3200-54I 
1236-2-860 
1235-0-860 
28mm 
626-00-58J 3200-58J 
1236-2-864 
1235-0-864 
28mm 
 
Table 5. MDM™ Liner/Insert/Tritanium® Shell Compatibility Chart 
Shell Size (mm), Liner Alpha Code 
Tritanium Hemispherical Shell 
48 
50,52 
54,56 
58,60 
62,64 
66 
Liner Alpha Code 
C 
D 
E 
F 
G 
H 
MDM CoCr Liner 
36C 
38D 
42E 
46F 
48G 
52H 
Poly Insert OD (mm) 
36 
38 
42 
46 
48 
52 
Poly Insert ID (mm) 
22.2 
22.2 
28 
28 
28 
28 
Nominal Poly Thickness (mm) 
6.7 
7.7 
6.8 
8.8 
9.8 
11.8 
 
Ancillary Devices: 
Only compatible Stryker femoral stems, Stryker LFITTM CoCr or BIOLOX delta or alumina 
ceramic heads, standard X3® inserts and MDMTM liners with ADM/MDMTM X3® inserts may be 
used as ancillary devices according to this study protocol. 

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The patenteda sequential irradiation and annealing manufacturing process for X3® offers 
increased wear resistance b and virtually eliminates free radicalsc  while preserving mechanical 
propertiesd,e,f,g.  X3® is irradiated by 3 MRads gamma radiation and annealed (heated below 
melting temperature) three times for a total cumulative dose of 9 MRads.    
6.2 Device Retrieval Process 
Stryker Orthopaedics will retrieve any Stryker component removed along with adjacent tissues (if 
applicable) for analysis to help characterize potential device-related complications.  In the event 
that any Stryker component is removed from a study subject, the outlined procedure should be 
followed. 
 
 
a U.S. Patent # 6,174,934 6,372,814 6,664,308 6,818,020 7,517,919 
 
bStryker Orthopaedics Trident Acetabular Inserts made of X3 UHMWPE (unsterilized), 721-00-32E, show a 97% 
reduction in volumetric wear rate versus the same insert fabricated from N 2 \Vac gamma sterilized UHMWPE, 620-
00-32E. The insert tested was 7.5 mm thick with an inner diameter of 32 mm. Testing was conducted under multi-
axial hip joint simulation for 5 million cycles using a 32 mm CoCr articulating counterface and calf serum lubricant. 
X3 UHMWPE Trident acetabular inserts showed a net weight gain due to fluid absorption phenomena but yielded a 
positive slope and wear rate in linear regression analysis. Volumetric wear rates were 46.39 ± 11.42 mm3 /106 
cycles for N2 \Vac gamma sterilized UHMWPE inserts and 1.35 ± 0.68 mm3 /106 cycles for X3 UHMWPE 
(unsterilized) Trident Acetabular Inserts. Although in-vitro hip wear simulation methods have not been shown to 
quantitatively predict clinical wear performance, the current model has been able to reproduce correct wear 
resistance rankings for some materials with documented clinical results.iv, v, vi 
[iv] Wang A, et al. Tribology International, Vol. 31, No. 1-3:17-33, 1998. 
[v] Essner A. et al. 44th Annual Meeting, ORS, New Orleans, Mar. 16-19, 1998:774. 
[vi] Essner A. et al. 47th Annual Meeting, ORS, San Francisco, Feb. 25-28, 2001:1007 
 
c X3 UHMWPE virtually eliminates free radicals, as measured by Electron Spin Resonance (ESR). A very low (noise 
level, near instrument detection limit) concentration of residual free radicals was detected in the X3 UHMWPE. A 
99% reduction of free radicals (14  2 x 1014 spins/gram versus 1550  32 x 1014 spins/gram) was found when 
compared to N2Vac gamma sterilized UHMWPE. 
 
d X3 UHMWPE maintains mechanical properties after accelerated oxidative aging. No statistical difference was found 
for Tensile Yield Strength, Ultimate Tensile Strength and Elongation as measured per ASTM D638 before and after 
exposure to ASTM F2003 accelerated aging (5 Atmospheres (ATM) of oxygen at 70ºC for 14 days). Tensile Yield 
Strength was 23.5 ± 0.3 MPa and 23.6 ± 0.2 MPa, Ultimate Tensile Strength was 56.7 ± 2.1 MPa and 56.3 ± 2.3 
MPa and Elongation was 267 ± 7% and 266 ± 9% before and after accelerated oxidative aging, respectively. 
 
e X3 UHMWPE resists the effects of oxidation. No statistical difference was found for Tensile Yield Strength, Ultimate 
Tensile Strength, Elongation, Crystallinity and Density as measured per ASTM D638, D3417 and D1505 before and 
after ASTM F2003 accelerated aging (5 ATM of oxygen at 70°C for 14 days). Tensile Yield Strength was 23.5 ± 0.3 
MPa and 23.6 ± 0.2 MPa, Ultimate Tensile Strength was 56.7 ± 2.1 MPa and 56.3 ± 2.3 MPa, Elongation was 267 
± 7% and 266 ± 9%, Crystallinity was 61.7 ± 0.6% and 61.0 ± 0.5%, and Density was 939.2 ± 0.1 kg/m3 and 
939.2 ± 0.2 kg/m3 before and after accelerated oxidative aging, respectively. 
 
f “Improved Strength of Cross-linked UHMWPE Without Compromising Oxidation/Fatigue Resistance and Wear”, Yau 
SS; Wang A, Lovell T. 2007 Combined ORS Poster #496. 
 
g “Wear, oxidation and mechanical properties of a sequentially irradiated and annealed UHMWPE in total joint 
replacement”, A.Wang, H.Zeng, S-S Yau, A. Essner, M. Manley and J. Dumbleton, Journal of Physics, D:Appl: Phys 
39 (2006).   

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1. When revision of a study subject is scheduled, the study coordinator (SC) should contact 
the Clinical Study Manager (CSM) or Clinical Study Associate (CSA) assigned to the 
project, as soon as possible. 
2. The CSM or CSA will send a retrieval container to the SC. 
3. After the device is explanted, the SC or an identified Stryker field representative will 
retrieve the device and place it in the retrieval container. 
4. The SC, an identified field representative or the CSM/CSA will complete a Product 
Experience Report (PER). 
5. If not completed by the CSM or CSA, the PER should be faxed to Stryker Product 
Surveillance at 201-831-6775, as well as to Stryker Clinical Research at 201-831-6454. 
6. The PER should be attached to the retrieval container and sent to Product Surveillance.  
A de-identified operative report should be included, when available. 
7. The CSM or CSA will follow up with Product Surveillance to obtain a PER number. 
8. A summary of results will be provided to the investigator upon his/her request. 
 
7 Evaluations 
7.1 Preoperative Visit 
During the preoperative visit, patients that are possible candidates for this study will be screened 
to determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, the 
investigator will propose participation in the study to the patient, according to GCP guidelines.  
Patients must sign an IRB approved study consent form prior to participating in any study related 
activities.  Consent must be obtained within four months of surgery. 
 
Once the subject has been consented, preoperative data will be collected including: 
demographics, medical history, HHS, AP hip, AP pelvis and lateral radiographs, SF-12,  LEAS 
and EQ-5D. 
 
All preoperative data must be collected within 4 months of the scheduled date of surgery, with the 
exception of radiographs, acceptable within 1 year of the scheduled date of surgery.  All 
information collected preoperatively will be used to quantify the sample population and compare 
postoperative progress. 

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7.2 Surgery 
 
Surgical details will be collected from the operative notes and at the time of surgery.  
7.3 6-week Visit 
During the 6-week visit (± 2 weeks), the following evaluations will be collected:  HHS, SF-12, 
LEAS, EQ-5D, AP hip, AP pelvis and lateral radiographs.  
7.4 Annual Follow-up Visits 
Clinical data will be collected via office visit by the investigator at the following annual 
postoperative intervals:  1-year, 3-year and 5-year.  Tools for postoperative evaluation will be the 
HHS, AP hip, AP pelvis and lateral radiographs.   
 
Patient outcomes data will also be collected via patient questionnaires.  At each of the 1-year, 
3-year and 5-year follow-up visits, the SF-12, LEAS and EQ-5D are required.  These same 
questionnaires are also required at 2-year and 4-year intervals, and may be completed during an 
office visit or sent to the subject to be completed, initialed and dated and returned to the 
investigative site. 
 
All clinical data, radiographs, and patient outcomes data must be collected within ± 2 months of 
the 1-year and 2-year anniversary dates.  For remaining annual time points, the window 
expands to ± 3 months of the 3-year anniversary date and ± 4 months of the 4-year and 5-year 
anniversary dates. 
 
The initial phase of the study will continue for 5 years after surgery and include collection of the 
previously described radiographs, HHS, and SF-12, LEAS and EQ-5D patient questionnaires.  
In the second phase of the study, all subjects will complete a brief satisfaction questionnaire 
annually at the 6-year, 7-year, 8-year, 9-year and 10-year follow-up intervals.  This form may be 
completed by the SC during a patient telephone interview, or by the patient either at home or 
during a clinic visit.  The questionnaire will be used to obtain the following information, at a 
minimum: 
• 
Patient satisfaction with the hip replacement 
• 
Presence of any pain in the study hip 
• 
Any surgeries performed on the study hip 

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The questionnaire will also provide information on any revisions and enable calculation of the 
Kaplan-Meier survival curve necessary to meet the primary endpoint of the study. 
 
Additionally, at investigational sites that choose to continue collecting clinical and radiographic 
data during the second phase of the study, subjects will be evaluated again at 7 and 10 years 
after surgery.   
 
 
 
8 Adverse Events 
8.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
• 
All AEs that meet the definition of serious, excluding elective procedures 
 
• 
All AEs related to the operative site, regardless of seriousness 
 
 
Elective procedures meeting the definition of an SAE do not need to be reported as AEs according 
to this study protocol.  Examples of such elective procedures include, but are not limited to, the 
following commonly seen events: 
• 
Contralateral THR 
• 
Total Knee Replacement 
• 
Rotator Cuff Surgery 
• 
Cataract Surgery 
 
Such events will not be captured on the AE electronic Case Report Form (eCRF) but rather will 
be captured on the postoperative functional evaluation at the 6-week, 1-year, 3-year, and 5-year, 
time points.  Additional events of this nature will be captured on the 7-year and 10-year functional 
evaluations if the investigator chooses to bring subjects in for these optional visits.  On these 
functional evaluations, investigators and SCs will be prompted to question subjects as to whether 
they have seen a doctor for any reason, been hospitalized for any reason or have a current 
impediment to their function. 
 

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Additionally, SCs will be responsible for following up with the subjects regarding any questionable 
responses received on the satisfaction questionnaire administered in postoperative years 6 
through 10.  If it is determined upon this further investigation that a protocol-defined adverse event 
has occurred, the SC will be responsible for completing an AE eCRF and submitting the event to 
the sponsor, and reporting to the IRB as required. 
 
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
 
 
Figure 1 
Adverse Event Decision Tree 

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

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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.   
8.2 General Adverse Event Definitions 
Following is a list of general AE definitions.  For the purposes of this study, only SAEs, 
excluding elective procedures, as well as all AEs related to the operative site should be 
reported.   
Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation subject, which changes the 
medical baseline of the subject.  An AE can be an unfavorable and unintended sign, symptom or 
disease, whether or not related to the study device (AEs may also be referred to as complications).  
See Section 8.1, Reporting of Adverse Events, for the AE reporting requirements for this study. 
 

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Anticipated Adverse Event 
An anticipated AE is an AE, of which the nature, severity or degree of incidence is known and 
identified in applicable product labeling, published literature or study protocol. The list of 
anticipated events is provided in Section 12, Risk/Benefit Assessment. 
 
Serious Adverse Event 
A SAE meets one or more of the following definitions: 
• 
Resulted in in-patient hospitalization 
• 
Resulted in prolonged existing hospitalization 
• 
Resulted in persistent or significant disability/incapacity 
• 
Resulted in permanent impairment of a body function or permanent damage to a body 
structure 
• 
Necessitated medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure 
• 
Was a life-threatening situation 
• 
Resulted in patient death 
 
Elective procedures meeting the definition of an SAE do not need to be reported as AEs according 
to this study protocol.   
 
Adverse Device Effect 
An adverse device effect (ADE) is a negative change in the subject’s health that may have been 
caused by, or associated with, the use of the device. 
 
Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) is any serious adverse effect on health, safety 
or any life-threatening problem or death caused by, or associated with, a device if that effect is a 
problem or death not previously identified in nature, severity or degree of incidence, or any other 
unanticipated serious problem associated with a device and related to the rights, safety or welfare 
of subjects. 
 
 

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8.3 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 the study sponsor (CSM or CSA) either by 
telephone/fax/email within 24 hours of the site’s becoming aware of the event if any of the 
following apply: 
• 
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 hip or a revision of any study hip 
components. 
 
An AE eCRF must be completed by the investigator within 24 hours.  If a SAE occurs, the  
de-identified source documentation must be uploaded to the Subject Binder of Stryker’s Electronic 
Data Capture (EDC) system, within 24 hours of the investigative center’s SAE awareness.  See 
Section 11, Data Management, for additional details of Stryker’s EDC system. These reports will 
be evaluated by Stryker to determine if a PER is required. 
 
It is recommended that all other reportable adverse events are reported on eCRFs and 
submitted to Stryker within 2 weeks. 
 
At the time of the initial report, the following information should be provided: 
 
• 
Subject number 
• 
A description of the event 
• 
Date of onset 
• 
Current status 
• 
Whether study treatment was 
discontinued 
• 
Investigator assessment of the 
association between the event and 
the study treatment 
 
 

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8.3.1 Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the Ethics 
Committee (EC) or Institutional Review Board (IRB) according to their specific 
requirements.  Copies of each report and documentation of EC/IRB notification and 
receipt will be kept with the investigator’s study files. 
8.4 Recording of Adverse Events 
All protocol defined AEs occurring during the study period must be recorded; this includes 
events that occur between visit intervals.  The clinical course of each event should be followed 
until resolution or stabilization. 
8.5 Medical Monitoring 
It is the responsibility of the investigator to oversee the safety of the study at his/her center.  This 
safety monitoring will include careful assessment and appropriate reporting of AEs, as previously 
noted.  Stryker will conduct formal investigations via the Product Surveillance Department of those 
AEs which are submitted through our PER System.  
 
9 Statistical Plan 
9.1 Efficacy 
9.1.1 Primary Efficacy Parameters  
The primary efficacy parameter is acetabular component revision for any reason. 
9.1.2 Secondary Efficacy Parameters 
The secondary efficacy parameters include: 
• 
The usage of screw fixation 
• 
HHS at the 1-, 3- and 5-year follow-up visits 
• 
SF-12 scores at the 1-, 3- and 5-year follow-up visits 
• 
LEAS at the 1-, 3- and 5-year follow-up visits 
• 
EQ-5D at the 1-, 2-, 3-, 4- and 5-year follow-up visits 
• 
Follow-Up Questionnaire annually in postoperative years 6-10 

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9.1.3 Primary Efficacy Hypothesis 
The null hypothesis, H0, is that the success rate at 5 years postoperative is less than . 
The alternative hypothesis, Ha, is that the success rate at 5 years postoperative is 
greater than or equal to .   When  = 94%, the hypothesis is a test for non-inferiority.  
When =99%, the hypothesis is a test for superiority. 
H0: p <  
Ha: p ≥  
 
9.1.4 Primary Efficacy Analysis 
A case success is defined as no incidence of revision or removal of the acetabular 
component within 5 years. A 90% confidence interval of the success rate will be 
computed at 5 years postoperative. If the lower bound of this confidence interval is 
greater than 94%, the non-inferiority hypothesis will be supported. If the lower bound of 
this confidence interval is above 99%, the superiority hypothesis will be supported. The 
Kaplan-Meier survival curve of revision or removal of the acetabular component will also 
be displayed using SAS/PROC LIFETEST. 
9.1.5 Secondary Efficacy Analysis 
A two-sided 0.05 alpha level will be used. 
       For comparison of usage of bone screw fixation between the Tritanium® Primary         
      Acetabular Shell Study and the Trident® X3® Polyethylene Insert Study, a Chi-square  
      test or Fisher’s exact test will be used. If there are any statistically significant differences  
      in baseline variables (e.g. age, gender, diagnosis) between the groups, they will be  
       addressed as covariates and ANOVA or ANCOVA will be used. 
For comparison of HHS, and SF-12 and LEAS at 1, 3 and 5 years postoperative 
between the Tritanium® Acetabular Shell and Trident® X3® Polyethylene Insert studies, 
a t-test or Wilcoxon test will be used.  If there are any statistically significant differences 
in baseline variables (e.g. age, gender, diagnosis) between the groups, they will be 
addressed as covariates and ANOVA or ANCOVA will be used. 
EQ-5D values and changes from baseline will be presented for each interval.  Data 
from the Follow-Up Questionnaire will be used as an input to the Kaplan-Meier survival 
curve for postoperative years 6-10; any adverse events collected via the Follow-Up 

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Questionnaire will be reported on a separate Adverse Event eCRF and included in the 
safety analysis. 
9.2 Safety Parameters 
9.2.1 Safety Parameters 
Safety parameters will include:  
• 
All AEs reported 
• 
Radiographic stability at each postoperative visit  
• 
Revision or removal rates 
9.2.2 Safety Analysis 
 
All AEs will be listed, tabulated and summarized by event, number and percent of 
cases/subjects.  AE rates and 95% confidence intervals will be presented.   
 
For categorical variables, such as radiographic stability, the number and percent in each 
category will be presented.  
9.3 Missing Data 
No missing data will be imputed for the primary analysis and secondary analyses.  
9.4 Statistical Methodology 
9.4.1 Data Summary 
The following is a detailed proposal of statistical analyses planned for data collected 
during the study.   
 
Descriptive statistics will be computed for all preoperative conditions and demographic 
parameters.  That is, for continuous data (e.g. HHS), the N, mean, median, standard 
deviation, minimum and maximum will be computed.  For categorical data (e.g. gender), 
the frequency will be computed.  If appropriate, the data will be presented by two cohorts 
in the Tritanium® Primary Acetabular Shell Study. 
 
Descriptive statistics and statistical comparisons for important demographic, efficacy and 
safety variables will be provided in tables.   

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A survival analysis for revision of the acetabular component will be performed.  
 
9.4.2 Sample Size Calculation 
A literature review shows that at 5 years of follow-up there is a 97.9% to 99.6% success 
rate in similar devices using revision or removal of the acetabular component as the 
defining factor.  Based on these results, it should be a reasonable assumption that the 
base success rate of revision or removal of the Tritanium® Acetabular Shell will be 
approximately 99% at 5 years.  Using a base success rate of 99% from the literature 
and a delta of 5%, it was calculated that 142 total cases implanted with the Tritanium® 
Acetabular Shell would be needed to prove non-inferiority with 95% power.  With a 
minimum of 142 cases analyzed, the primary hypothesis of the study will be met if the 
lower bound of the 90% confidence interval for the 5-year success rate is greater than 
94%.  By factoring in a 20% lost to follow-up rate within a 5-year period, the required 
sample size increases to 177 cases.  Cases will continue to be enrolled until a total of 
240 cases are implanted with the Tritanium® Acetabular Shell; half of these cases will 
use the X3® polyethylene insert alone as the bearing surface and the other half will use 
the MDMTM liner coupled with a compatible ADM/MDMTM X3® insert as the bearing 
surface.    
9.4.3 Interim Analyses and early Stopping Considerations 
No interim analysis is planned.  
9.4.4 Efficacy Patient Populations  
 
9.4.4.1 Efficacy 
Per protocol population: 
 
The study population for analysis will include all subjects who receive the Tritanium® 
Acetabular Shell.  This does not include cases censored from analysis or cases that 
are unavailable for evaluation at the 5-year primary endpoint. 
 
The primary and secondary efficacy analyses will be based on the per protocol 
population. 
 

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9.4.4.2 Safety 
      Safety Population: 
The safety population will include all non-censored subjects who received the 
Tritanium® Acetabular Shell. 
9.4.4.3 Survival Analysis 
Modified intent to treat population: 
Subjects enrolled in the study who received the Tritanium® Acetabular Shell will be 
included in the survival analysis.   
9.4.4.4 Censored Cases 
In the event that a protocol deviation occurs which could affect patient outcome, the 
data for the affected patient will be censored from the Efficacy and Safety Patient 
Populations.  All cases that fall into this category will be reported separately.   
 
10  Study Procedures 
10.1   Subject Recruitment and Screening 
 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  All patients recruited for this study will have the capacity to give informed consent.  
Advertising for the study at each center will be at the discretion of the investigator.  See Appendix 
C for samples of study advertisements.  All handouts, brochures, advertisements, etc. must be 
approved by the IRB prior to the dissemination of any recruitment materials to potential subjects. 
10.2   Patient Informed Consent and Guidelines 
 
All patients for this study will be provided a consent form describing this study and providing 
sufficient information for them to make an informed decision about their participation.  The 
informed consent must contain all elements required by the FDA under 21 CFR Part 50, in addition 
to any other elements required by state, local and institutional policies.  See Appendix D for a 
copy of the Model Informed Patient Consent.  This consent form will be submitted with the protocol 
for review and approval by the IRB 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 

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patient, using the IRB approved 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 consent’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 consent form.  The patient or their 
legal representative should receive a signed copy of the consent according to GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
 
• 
Use a current IRB approved copy of the consent form. 
• 
Review the consent thoroughly with the patient before having them sign. 
• 
After the patient has consented to the procedures, ensure he/she signs and dates the 
consent form. 
• 
The person obtaining consent also signs and dates the signature page. 
• 
Provide a copy of the consent to the patient. 
• 
If required, provide the hospital with a copy of the signed consent. 
• 
Maintain the signed original in the patient’s study chart. 
 
10.3 Early Withdrawal of Subjects 
 
When and How to Withdraw Subjects 
In the event that 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: 
 
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 

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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: 
• 
Tritanium® Acetabular Shell 
• 
Stryker X3® polyethylene inserts (120 cases) 
• 
Stryker MDMTM liners with ADM/MDMTM X3® polyethylene inserts (120 
cases) 
• 
Stryker LFITTM CoCr heads, BIOLOX delta or alumina ceramic heads 
• 
Stryker Universal Adapter Sleeves (for use with BIOLOX delta universal 
ceramic heads) 
• 
Compatible Stryker femoral stems 
• 
Stryker Orthopaedics Torx Bone Screws  
Revision or removal of the Tritanium® Acetabular Shell constitutes a failure and study 
termination for the subject. 
 
If MDMTM  liner, acetabular insert (either X3® or ADM/MDMTM X3®) or femoral head exchange is 
required during the study, the event is considered a reoperation and does not constitute a failure 
or study termination. 
 
If femoral stem revision is required during the study, the 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.   
 
In the event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  If the surgery is rescheduled more than 4 months from the date of 
preoperative data collection, the subject will need to be re-consented, all preoperative data will 
need to be re-collected and all original preoperative data will need to be removed from the 
database.  If the surgery is not to be rescheduled or if the subject is no longer considered an 

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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. 
 
11  Data Management 
11.1  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 E. 
11.2 Confidentiality 
This study will comply with the 2002 privacy rule of the Health Insurance Portability and 
Accountability Act (HIPAA).  As such, Stryker will only collect that information which is necessary 
to support the objectives of the clinical study.  Stryker will take precautions to ensure that data 
received is as de-identified as possible.  In the case that some identified information is received, 
Stryker will ensure that any identifying information will not be reported.  Study subjects will 
authorize Stryker to use their health information in support of the clinical study during the informed 
consent process.  Should a subject choose to withdraw authorization, Stryker may use data 
collected prior to the withdrawal of authorization in order to maintain data integrity.  
11.3 Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities 
in a clinical study necessary for the reconstruction and evaluation of the study.  Source data are 
contained in source documents.  Examples of these original documents and data records include:  
hospital records, 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. 

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All data points collected during follow-up visits must be documented in the subject’s chart.  This 
includes ROM 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 13, 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. 
11.4 Electronic Case Report Forms 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be recorded.  All missing data must be explained.   
For specific instructions on eCRF completion, please consult the Guide to Case Report Forms 
provided under separate cover.  It is recommended that eCRFs be completed, signed by the 
investigator and returned to Stryker within 2 weeks of the evaluation date. 
11.5 Data Clarification Requests 
If errors or omissions are noted by Stryker upon receipt of the eCRFs, a data clarification request 
(DCR) will be sent to the center for clarification.  Queries should be answered in a clear and 
comprehensible manner.  If the clarification requires a change to data captured on an eCRF, 
Stryker will modify the eCRF accordingly.  Modified eCRFs need not be printed and included in 
conjunction to answered DCRs. 
11.6 Protocol Deviations 
Any deviation from this protocol will be reported to Stryker as well as to the EC/IRB according to 
their reporting procedures.  Protocol Deviations for this study include, but are not limited to, the 
following:  
• 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
• 
Patient enrolled does not meet the inclusion/exclusion criteria 
• 
Protocol specified study component(s) not implanted 
• 
Visit deviations, including: 
o Unavailable primary endpoint 

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o One or more required eCRFs/radiographs not done 
o Evaluations occurred outside of protocol specified time window 
o Un-evaluable radiographs 
o Missed visit 
If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
11.7 Records Retention 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or in the case of non-compliance, 2 years after the date of investigative center 
termination.  These documents should be retained for a longer period if required by an agreement 
with Stryker. 
 
12  Risk/Benefit Assessment 
12.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of the 
primary THR procedure.  
12.2  Potential Risk 
The study involves the routine assessment of a primary THR procedure. The Tritanium® 
Acetabular Shell has been cleared for use by the FDA and will be used according to its labeling.  
Assessment involves questionnaires, patient and physician assessments, and routine 
radiographs.  The information collected will be kept confidential and will comply with the HIPAA. 
 
While the expected life of THR 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 primary THR include the following: 
 

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Serious complications may be associated with any total joint replacement surgery.  These 
complications include, but are not limited to:  infection; genitourinary disorders; gastrointestinal 
disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; 
myocardial infarction 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, UHMWPE and/or ceramic.  Particulate is generated by interaction 
between components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can 
also be generated by third body wear.  Osteolysis can lead to future complications, including 
loosening, necessitating the removal and replacement of prosthetic components. 
 
Early and late loosening of total hip 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. 
 
Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other 
biomechanical considerations. 
 
Malseating of the acetabular liner can occur during surgery. 
 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
 
Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur 
due to impaction of the component into the prepared femoral canal or acetabulum.  Postoperative 
femoral or acetabular fracture can occur due to trauma, the presence of defects or poor bone 
stock. 
 
If bone screws are used, appropriate selection of bone screw length and location is essential to 
avoid damage to underlying soft tissue structures.  Perforation of the pelvic wall can result in 
internal bleeding and possible damage to vital organs. 
 
Metal sensitivity reactions have been reported following joint replacement. 

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AEs may necessitate reoperation, revision, arthrodesis of the involved joint, girdlestone or 
amputation of the limb. 
12.3  Expected Complications and Rates of Occurrences 
Complications associated with total hip arthroplasty procedures, such as those performed with 
the Tritanium® Acetabular Shell, have been reported. These include the potential for: injury to the 
hip’s neurovascular structures, loosening of the components, malseating of the acetabular liner, 
heterotopic bone formation, infection, deep vein thrombosis, pulmonary embolism, metal 
sensitivity reactions, intraoperative or postoperative fracture of the femur or acetabulum, and the 
need for re-operation, revision, arthrodesis of the involved joint, girdlestone or amputation of the 
limb.  The safety objective will compare the complication rates of the Tritanium® Acetabular Shell 
to published rates.   
12.4 Protection Against Risks 
Subjects will be treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or wellbeing 
of the subject, this deviation will be promptly reported to both the EC/IRB and Stryker.   
12.5  Potential Benefits to the Subject 
There is no guarantee that subjects will personally benefit from inclusion in this study.  Subjects 
may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance.  This study seeks to provide clinicians information about this 
system/device 
by 
comparing 
this 
treatment/device 
to 
published 
results 
for 
other 
treatments/devices.  Information gathered in this study may benefit others undergoing this 
procedure in the future. 
 
13  Study Monitoring, Auditing, and Inspecting 
13.1 Study Monitoring Plan 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects 
involved in a clinical investigation and the quality and integrity of data submitted as a result of the 
investigation. 

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This study will be monitored at least once per year, with additional visits as necessary. The 
investigator will allocate adequate time for such monitoring activities.  The Investigator will also 
ensure that the monitor or other compliance or quality assurance reviewer is given access to all 
study-related documents and study-related facilities and has adequate space to conduct the 
monitoring visit.  The monitor will review all source documents and compare them to the data 
contained in the eCRFs, in addition to performing a periodic review of regulatory documents such 
as EC/IRB approvals.  The monitors will need the following when they visit: 
• 
An area where they can review study data 
• 
Subject binders 
• 
Patient charts pulled at the center, or access to relevant electronic medical records 
• 
Regulatory documents 
• 
Time to meet with the SC and the Investigator  
13.2 Auditing and Inspecting 
A quality assurance audit is a form of review that provides additional confidence to 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. 
 
14 Ethical Considerations 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56 as well as 45 CFR Parts 160 and 164. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
EC/IRB for formal approval of the study conduct.  The decision of the EC/IRB concerning the 

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conduct of the study will be made in writing to the investigator and a copy of this decision will be 
provided to Stryker before commencement of this study.  The investigator 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 a consent form describing this study and 
providing sufficient information for patients to make an informed decision about their participation.  
This consent form must be modified to contain center specific information and submitted with the 
protocol for review and approval by the EC/IRB for the study.  The formal consent of a patient, 
using the IRB approved consent form, must be obtained before that patient is submitted to any 
study procedure.  This consent form must be signed by the patient or legally acceptable surrogate 
and the investigator-designated research professional obtaining the consent.  
 
15  Study Finances 
15.1 Funding Source 
This study is financed by Stryker Orthopaedics. 
15.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 
Committee-sanctioned conflict management plan that has been reviewed and approved by 
Stryker prior to participation in this study.   
15.3 Subject Stipends or Payments 
At pre-determined study visit intervals, Stryker may reimburse subjects with a modest stipend for 
protocol-required data collection. This stipend system and reimbursement amounts must be 
approved by the Institution’s IRB prior to implementation. 
 
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 

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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  
 
Under extreme circumstances, and with prior approval, Stryker may reimburse a subject for the 
cost of transportation to and from the investigator’s office for a protocol-required office visit. 
 
This policy is the same for all participating study subjects and does not bias against any particular 
subject or study cohort.  
 
 
16 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted to 
a peer-reviewed journal at the time the study cohort reaches 3, 5 and 10 years of follow-up.  
Additional publication proposals may be made by investigators at any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 
 
Publications will be facilitated by the Chair and the primary investigator (PI) of the study.  Both 
individuals will be chosen by Stryker.  The PI is solely focused on the multi-center publications 
and progress towards those publications, including recurring updates to centers, center motivation 
as well as authorship.  If the PI does not produce a draft of a publication within 90 days of receiving 
the results data, Stryker will delegate the responsibility to other investigators in the study at its 
discretion.  The Chair reviews all additional publications proposed by participating investigators 
based upon the study results prior to study completion, on an ongoing basis.  This review includes 
whether or not a proposal will be pursued, as well as imposition of guidelines as to publication 
completion and criteria. 

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The following summarizes the possible roles of these parallel positions: 
 
Chair  
 
 
 
 
 
 
PI 
Contributes to study design  
 
 
 
Contributes to study design 
Assists with study questions requiring 
 
 
Assists with study questions requiring 
expert clinical opinion  
 
 
 
 
expert clinical opinion 
Assists with identification of investigators 
 
 
Assists with identification of investigators 
Reviews additional publication proposals submitted  
 
and maintains performance  
 
by investigators 
 
 
 
 
Updates investigators on progress 
Contributing author, if ICMJE guidelines met 
 
 
towards multi-center results 
 
 
 
 
 
 
 
 
Primary author, multi-center publication of  
 
 
 
 
 
 
 
 
 
primary endpoint data 
 
At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 3, 5 and 10-year multi-center publications are submitted.  All publications 
of the data shall be submitted to Stryker for review prior to submission for publication.  Stryker 
shall not edit or otherwise influence the publications other than to ensure that confidential 
information is not disclosed, 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. 
 

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17 References 
 
1 Klika, A.K., Murray, T.G., Darwiche, H., Barsoum, W.K. (2007).  Options for acetabular fixation surfaces.  
Long Term Eff Med Implants, 17(3), 187-92. 
2 Ibid. 
3 Rodriguez, J.A. (2006).  Acetabular Fixation Options: Notes from the Other Side. The Journal of 
Arthroplasty. 21(4), 93-96 (Supplement). 
4 Della Valle, C.J., Mesko, N.W., Quigley, L., Rosenberg, A.G., Jacobs, J.J., Galante, J.O. (2009). 
Primary Total Hip Arthroplasty with a Porous-Coated Acetabular Component. The Journal of Bone and 
Joint Surgery, 91(5), 1130-35. 
5 Engh, C.A., Hopper, R.H. Jr., Engh, C.A. Jr. (2004) Long-term porous –coated cup survivorship using 
spikes, screws, and press-fitting for initial fixation.  The Journal of Arthroplasty, 19(7 suppl 2), 54-60. 
6 Reina, R.J., Rodriguez, J.A., Rasquinha, V.J., Ranawat, C.S. (2007). Fixation and osteolysis in plasma-
sprayed hemispherical cups with hybrid total hip arthroplasty. The Journal of Arthroplasty, 22(4), 531-4.  
7 Stryker Test Report RD-07-077 
8 Klika, 2007. 
9 Ricci J. L., Kauffman J., Jaffe W., et al. (1997) Comparison of Osseointegration and Bone Adhesion 
10 Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. (2004). Bone response to a novel highly porous 
surface in a canine implantable chamber.  J Biomed Mater Res B Appl Biomater.,71(2), 387-91. 
11 Macheras, G., Kateros, K., Kostakos, A., Koutsostathis, S., Danomaras, D., Papagelopoulos, P.J. (2009).  
Eight- to Ten-Year Clinical and Radiographic Outcome of a Porous Tantalum Monoblock Acetabular 
Component.  The Journal of Arthroplasty, 24(5), 705-9. 
12 Philippot, R., Camilleri, J.P., Boyer, B., Adam, P., & Farizon, F. (2008). The use of a dual-articulation 
acetabular cup system to prevent dislocation after primary total hip arthroplasty. International 
Orthopaedics,33, 927-932. 
13 Greenspan, A. (1992). Orthopedic radiology:  A practical approach (2nd ed.). New York:  Gower Medical 
Publishing. 
 
14 Steffen, J.B., Lukoschek, M., Kreutzer, J., Brocai, D., & Gruen, T.A. (2001). Dependency of cement 
mantle thickness on femoral stem design and centralizer. The Journal of Arthroplasty, 16(5), 648-657. 
 
15 Gruen, T.A., McNeice, G.M., & Amstutz, H.C. (1979). Modes of failure of cemented stem-type femoral 
components. Clinical Orthopaedics and Related Research,141, 17-27. 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix D 
 
Model Informed Patient Consent 

Patient’s Initials__________ 
 
 Page 1 of 8 
Version _______________ 
Model Informed Patient Consent 
 
 
I. 
Study Title:  Post-market Study of the Stryker Orthopaedics Tritanium® Acetabular Shell 
II. 
Description of the Study  
You have been asked to take part in this research study because your physician has 
determined that you need surgery to replace your hip joint.  A total of approximately 240 
subjects from 7 - 12 different clinics will be participating in this study.   
The purpose of this study is to evaluate the success rate of cementless primary hip 
replacement with the Tritanium® Acetabular Shell as compared to similar competitive 
devices as reported in scientific journals, through absence of revision of the acetabular 
shell at 5 years postoperative.  We (Stryker Orthopaedics, implant manufacturer and 
sponsor of the study, and your physician) are doing this study to find out if Stryker 
Orthopaedics’ Tritanium® Acetabular Shell is at least as good as hips implanted with 
similar competitive devices.   
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. 
You will be in the study for the next 10 years.  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 well your hip is working 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.  Some of these visits and/or forms may be 
completed remotely (via videoconferencing, telephone or email), if approved by your 
doctor’s Institutional Review Board (IRB).  These visits will follow the evaluation 
schedule below: 
 
 

Patient’s Initials__________ 
 
 Page 2 of 8 
Version _______________ 
Surgeon Evaluations 
Before 
Surgery 
6 Weeks 
1 Year 
2 Years 
3 Years 
4 Years 
5 years 
Demographics and Current 
Medical Conditions 
X 
 
 
 
 
 
 
Harris Hip Score 
X 
X 
X 
 
X 
 
X 
AP Pelvis  X-ray 
X 
X 
X 
 
X 
 
X 
AP Femur X-ray 
X 
X 
X 
 
X 
 
X 
Lateral  X-ray 
X 
X 
X 
 
X 
 
X 
Patient Questionnaires 
 
SF-12 
X 
X 
X 
X 
X 
X 
X 
LEAS 
X 
X 
X 
X 
X 
X 
X 
EQ-5D 
X 
X 
X 
X 
X 
X 
X 
 
Finally, you will be asked to complete a short questionnaire regarding your satisfaction 
with the results of your hip replacement at 6, 7, 8, 9, and 10 years after surgery.  This 
questionnaire may be completed at home and mailed to your doctor, during an office 
visit, or during a telephone call with study personnel. An office visit at 7 and 10 years 
after surgery is optional.  
 III.   
Condition and Care after Surgery 
Your doctor will give you specific instructions regarding your care and rehabilitation after 
your surgery.  As with any surgery, your body takes time to heal.  That amount of time 
will be related to the extent of the surgical procedure and your general physical 
condition.  During this period of healing, you may experience postoperative pain, 
perhaps lasting several months after the operation. 
You will be told to use walking aids (crutches, walker or cane) for a period of time after 
your surgery.  The use of these walking aids will lessen pressure and weight loads on 
your hip, which is thought to increase the chances for a stable implant.  You have been 
informed that you must follow your physician’s orders, including those regarding the use 
of walking aids.   
The goal of this surgery is to lessen pain and increase your hip function.  You will need 
to see your physician at 6 weeks, 1, 3 and 5 years after your surgery for evaluation of 
your artificial hip joint.  Your physician may choose to perform further follow-up 
evaluations and x-rays at 7 years and 10 years.   
IV. 
Possible Risks and Discomforts 
This study involves the routine assessment of a primary hip replacement procedure.  
The Food and Drug Administration (FDA) has cleared the device used in this study for 
sale in the United States.  There are no additional risks associated with participating in 
this study over and above that of the primary hip surgery.  You may need to spend a little 
more time in the doctor’s office to fill out paperwork.  If at any time new information is 
developed during this research study which may affect your willingness to participate, 
the information will be provided to you. 
 

Patient’s Initials__________ 
 
 Page 3 of 8 
Version _______________ 
There are, however, standard risks associated with hip surgery.  These include but are 
not limited to:  moderate to severe pain; crack/fracture (breakage) of femoral (thigh) or 
acetabular (pelvic) bones or components; migration (movement) of components; 
subsidence (sinking) of components; dislocation (to move out of normal position) of 
components; discomfort related to malseating of one of the components; sensitivity to 
metal components (femoral [thigh] and acetabular [pelvic]); revision (removal) of one or 
more of the components; loosening and infection; wear (rubbing) of the components 
which could lead to bone loss; peripheral neuropathies (any disorder of the nerves 
involving your legs); nerve damage; abnormal bone formation; circulatory compromise 
(changes in circulation related to your heart, blood and lymph vessels, to varying 
degrees); genitourinary disorders (related to urination); gastrointestinal disorders (related 
to the stomach and intestines); vascular disorders (related to blood vessels:  including 
thrombus [blood clot]); bronchopulmonary disorders (related to the bronchi tubes and 
lungs, such as pneumonia); emboli (plugged vessel); myocardial infarction (heart attack) 
or death. 
V.  
Potential Benefits 
While there is no guarantee that you will personally benefit from inclusion in this study, 
information gathered in this study may benefit others undergoing primary hip surgery in 
the future. 
You will have incentives to return for annual follow-up visits through a patient retention 
program.  Patients enrolled into the study are encouraged to complete all of their 
required follow-up visits.  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.  This stipend 
should not influence your decision to participate in the study. 
 
VI. 
Other Types of Treatment 
You have discussed alternative treatments with your surgeon, which include but are not 
limited to:  conservative non-surgical treatment, cemented or cementless total hip 
replacement utilizing other commercially available components, hip fusion or no 
treatment at all. 
You may decline to participate in this study.  This will not change any procedures 
associated with your hip surgery.  Your physician can provide detailed information about 
this treatment and the benefits of various treatment options available to you.  You should 
feel free to discuss your alternatives with your physician. 
VII. 
Making Financial Information Known 
Your doctor and/or the research institution may receive compensation from the 
manufacturer of your implant device(s) to cover the time and/or expenses associated 
with this Study or for other services.  If you require any further information please consult 
your doctor or his staff about this issue.   
VIII. 
Privacy 

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If you say yes to participate in this study, your medical records and identity will be kept 
confidential to the extent permitted by law and will not be released without your written 
permission.   
By signing this consent form, you agree to allow representatives from the study sponsor 
to review your medical records.  Some of this information will be provided to the study 
sponsor and its agents and contractors, and as required by law, review boards and other 
people who are required to watch over the safety and effectiveness of medical products 
and therapies and the conduct of research.  Your name and identity will not be revealed 
in those reports. 
IX.  
Cost to Be in the Study 
Your procedure is a routine primary hip surgery and should be covered by your 
insurance carrier.  You will not be paid for participating in this study.   
 
X. 
Device Retrieval Analysis Study 
 
I understand that the Stryker Orthopaedics Tritanium® Primary Acetabular Shell Study 
has a protocol for the analysis of retrieved devices in the event that any study 
component(s) that I have had implanted by Dr. <Investigator’s Name> are removed 
during the course of the investigation. 
 
I understand that Stryker Orthopaedics Corporation (implant manufacturer and Sponsor), 
requests my Physician to send my retrieved study component(s) to the Product 
Surveillance department at Stryker Orthopaedics for evaluation as part of my 
participation in the investigational study.  
 
I hereby authorize my Physician and his staff to provide my retrieved study 
component(s), name, birth date, Patient Information Form and any and all information 
about my hip surgery to Stryker Orthopaedics for the purposes of evaluating my 
retrieved device(s) and reporting the results of the analysis to my Physician and Stryker 
Orthopaedics Corporation.  
 
My Physician will be provided with the results of this analysis. I understand that the 
device(s) will not be returned to me, nor will I receive the results of any tests, analysis, or 
evaluations on the returned device(s).  
 
I understand that, except for sending my retrieved study component(s) to The Cleveland 
Clinic Foundation and Stryker Orthopaedics, my retrieved study component(s) will not be 
released to outside parties.  
 
I understand that, except for providing my individually identifiable information to the 
Physician who performed my surgery, Stryker Orthopaedics Corporation and The 
Cleveland Clinic Foundation, my individually identifiable data will not be released to 
outside parties. I also understand that I may inspect or copy the information by 
requesting said information from my Physician.  
 
I understand that I may revoke this authorization for release of my retrieved study 
component(s) and individually identifiable information at any time by notifying my 
Physician in writing, but I understand that doing so will have no effect on actions taken 
before the receipt of my revocation.   

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I will have confidentiality in all records kept about me.  My agreement to participate in 
this implant retrieval analysis study is completely voluntary. I understand that I have the 
right to not participate and the right to withdraw from the study at any time of my 
choosing and that this will in no way compromise my care, delay my treatment, or affect 
any future medical care. 
 
Please check one of the boxes below: 
 
 I agree to allow the Sponsor to study any hip replacement parts removed from me. 
 
 I do not want to allow the Sponsor to study any hip replacement parts removed from 
me. 
 
           
                                                       _____     
 
_____________                                             
Signature of Subject/Legal Representative  
 
Date 
 
XI. 
Clinical Trial Website Posting 
 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time. 
XII. 
Payment and Medical Treatment Related to Injury 
Stryker Orthopaedics will not provide compensation or free medical treatment if you 
suffer any medical complications related to the surgery.  <Investigator’s name> should 
be contacted immediately at <Investigator’s phone number> if such a complication 
occurs.  No monetary compensation or free medical treatment will be made available by 
<Name of Hospital>.  <Investigator’s name> should inform you of the hospital’s policy in 
such matters.  Signing this consent in no way waives your legal rights or releases the 
investigator, the sponsor, the institution or its agents from liability or negligence. 
XIII.   Access to Data and Privacy 
By participating in this study, you are authorizing your physician and his/her staff to 
provide your health information to the sponsor, its agents and contractors, and as 
required by law, review boards and other people who are required to watch over the 
safety and effectiveness of medical products and therapies and the conduct of research.  
This health information includes all information collected during the research.  It may 
also include relevant health information in your medical records that may have been 
collected prior to your involvement in this research study.     
The sponsor will only collect that information which is necessary to support the 
objectives of the research, and will take precautions to ensure that data received has 
your identifying information (name, address, etc.) removed as much as possible.  
National privacy laws no longer cover use or re-disclosure of your health information, 

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once received by the sponsor.  However, in the case that some identified information is 
received, the sponsor will ensure that any identifying information will not be reported.    
The sponsor will use your health information to conduct the study, as well as for 
additional purposes such as overseeing and improving the performance of its devices, 
proposals for developing new medical products or procedures and other business 
purposes.    
This permission does not have an ending date, but you may take back this permission to 
release your health information at any time by notifying your physician in writing.  
Understand that doing so will have no effect on actions taken before that time.  This 
consent, authorizing that your health information may be provided to those indicated, 
must be signed in order for you to participate in this research study.  If this consent is 
revoked you can no longer participate in this research study.  In any case, your 
authorization to release individually identifiable information will expire at the end of this 
study.   
IV. 
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.   
 
 

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By signing and dating this form below, you are indicating that you have read and 
reviewed all sections of this Informed Consent Form, you have had all your questions 
answered, and you voluntarily consent to participate in this research study.  If you do not 
sign this form, you will not be allowed to participate 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 F 
 
Product Labeling 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix G 
 
510(k) Clearance Letter