A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication
Phase: NA
Conditions: Arthroplasty, Hip Revision
Sponsor: Stryker Orthopaedics

   
 
 
 
 
 
 
 
 
 
Trident II Acetabular Shell Revision Study  
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center evaluation of the clinical outcomes of the 
Trident II Acetabular Shell in a revision indication 
 
 
 
Sponsor: 
Stryker  
Orthopaedics – Joint Replacement 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Trident II Acetabular Shell 
Protocol Number: 
79 
510(k) Clearance  Number: 
K161569 and K171768 
 
Version 1.0 
Date:  October 9, 2019 
CONFIDENTIAL 
 
This document is confidential and the property of Stryker.  No part of it may be 
transmitted, reproduced, published or used by other persons without prior 
written authorization from Stryker.

 
Trident II Acetabular Shell Revision Study 
 
 
Stryker Clinical Study Protocol 
 
 
Version 1.0 
 
CONFIDENTIAL 
This material is the property of Stryker.  Do not disclose or use except as authorized in writing by Stryker. 
Page i 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
A 
New  
Alice Cruz 
1.0 
New 
Janki Shah 

Trident II Acetabular Shell Revision Study 
 
 
Stryker Clinical Study Protocol 
 
 
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Table of Contents 
STUDY SYNOPSIS .................................................................................................................................................... 1 
EVALUATION SCHEDULE ...................................................................................................................................... 5 
1 
INTRODUCTION ............................................................................................................................................... 6 
1.1 
BACKGROUND ................................................................................................................................ 6 
2 
CLINICAL STUDY PLAN ............................................................................................................................... 7 
2.1 
STUDY DESIGN .............................................................................................................................. 7 
2.2 
STUDY CENTERS ............................................................................................................................ 8 
2.2.1 
Centers for Data Collection ..................................................................................................... 8 
2.3 
NUMBER OF SUBJECTS ................................................................................................................... 8 
3 
DEVICE DESCRIPTION .................................................................................................................................. 8 
3.1 
STUDY DEVICE ............................................................................................................................... 8 
3.2 
ANCILLARY DEVICES ...................................................................................................................... 9 
3.3 
DEVICE IMPLANTATION ................................................................................................................. 14 
4 
STUDY PROCEDURES ................................................................................................................................. 14 
4.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 14 
4.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 14 
4.3 
EARLY WITHDRAWAL OR TERMINATION OF SUBJECTS .................................................................... 15 
5 
EVALUATION TOOLS .................................................................................................................................. 16 
5.1 
OBJECTIVE OUTCOMES ................................................................................................................ 16 
5.1.1 
Radiographs and HHS .......................................................................................................... 16 
5.2 
PATIENT REPORTED OUTCOMES ................................................................................................... 17 
6 
ADVERSE EVENTS ....................................................................................................................................... 17 
6.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 17 
6.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 19 
6.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 21 
6.3.1 
Institutional Review Board Notification by Investigator ......................................................... 21 
6.3.2 
Device Retrieval Process ...................................................................................................... 22 
6.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 22 
6.5 
MEDICAL MONITORING ................................................................................................................. 23 
7 
DATA MANAGEMENT .................................................................................................................................. 23 
7.1 
DATABASE ................................................................................................................................... 23 
7.2 
CONFIDENTIALITY ......................................................................................................................... 23 
7.3 
SOURCE DOCUMENTS .................................................................................................................. 24 
7.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 24 
7.5 
DATA QUERIES ............................................................................................................................ 24 
7.6 
PROTOCOL DEVIATIONS ............................................................................................................... 25 
7.7 
RECORDS RETENTION .................................................................................................................. 25 
8 
STATISTICAL PLAN ...................................................................................................................................... 25 
8.1 
STUDY OBJECTIVES ..................................................................................................................... 25 
8.1.1 
Primary Objective Analysis .................................................................................................... 25 
8.1.2 
Secondary Objective Analyses.............................................................................................. 26 
8.2 
SAFETY ....................................................................................................................................... 26 
8.2.1 
Safety Parameters ................................................................................................................. 26 
8.2.2 
Safety Analyses ..................................................................................................................... 27 
8.3 
MISSING DATA ............................................................................................................................. 27 

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8.4 
STATISTICAL METHODOLOGY ........................................................................................................ 27 
8.4.1 
Data Summary....................................................................................................................... 27 
8.4.2 
Sample Size Justification ...................................................................................................... 27 
8.4.3 
Interim Analyses .................................................................................................................... 28 
8.4.4 
Analysis Population ............................................................................................................... 28 
9 
STUDY MONITORING, AUDITING, AND INSPECTING.......................................................................... 28 
9.1 
STUDY MONITORING PLAN ............................................................................................................ 28 
9.2 
AUDITING AND INSPECTING ........................................................................................................... 29 
10 
PUBLICATION PLAN .................................................................................................................................... 29 
11 
RISK/BENEFIT ASSESSMENT ................................................................................................................... 30 
11.1 
RISK CATEGORY .......................................................................................................................... 30 
11.2 
POTENTIAL RISK .......................................................................................................................... 30 
11.3 
EXPECTED COMPLICATIONS .......................................................................................................... 32 
11.4 
PROTECTION AGAINST RISKS........................................................................................................ 32 
11.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 32 
12 
ETHICAL CONSIDERATIONS ..................................................................................................................... 32 
13 
STUDY FINANCES ......................................................................................................................................... 33 
13.1 
FUNDING SOURCE ........................................................................................................................ 33 
13.2 
CONFLICT OF INTEREST ................................................................................................................ 33 
13.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 33 
14 
REFERENCES ................................................................................................................................................ 34 
 
 
 

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List of Appendices 
 
Appendix A 
 
FDA 510(k) Clearance Letters  
Appendix B 
 
Product Labeling  
Appendix C 
 
Component Listing 
Appendix D 
 
Model Informed Patient Consents 
Appendix E 
 
Suggested Radiographic Technique 
Appendix F 
 
Retrieved Implant Analysis Protocol 
Appendix G 
 
Draft eCRF Specifications  
Appendix H 
 
Draft Radiographic Evaluation Form Specifications 
 
 
 

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List of Figures and Tables 
TABLE 1: TRIDENT II TRITANIUM SHELL/FEMORAL HEAD/X3 LINER COMPATIBILITY .................. 10 
TABLE 2: TRIDENT II TRITANIUM SHELL/INSERT COMPATIBILITY ................................................... 11 
TABLE 3: TRIDENT II TRITANIUM SHELL/MDM LINER/INSERT COMPATIBILITY .............................. 11 
TABLE 4: TRIDENT II PSL CLUSTERHOLE HA FEMORAL HEAD/X3 LINER AND SHELL 
COMPATIBILITY……………………………………………………………………………………………...……12 
TABLE 5: TRIDENT II PSL CLUSTERHOLE HA SHELL…………………………………………………….12 
TABLE 6: TRIDENT II PSL CLUSTERHOLE HA SHELL MDM LINER AND INSERT 
COMPATIBLITY……………………………………………………………………………………………………12 
TABLE 7: TRIDENT II CLUSTERHOLE HA: FEMORAL HEAD/X3 LINER AND SHELL 
COMPATIBILITY…………………………………………………………………………………………………...13 
TABLE 8: TRIDENT II CLUSTERHOLE HA SHELL…………………………………………………………..13 
TABLE 9: TRIDENT II CLUSTERHOLE HA MDM LINER AND INSERT 
COMPATIBILITY……………………………………………………………………………………………….…..13 
FIGURE 1: ADVERSE EVENT DECISION TREE ...................................................................................... 18 
 
 
 
 
 
 
 
 
 

 
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List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Anteroposterior 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
fCSM 
Functional Clinical Study Manager 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EQ-5D 
EuroQol Five Dimensions Questionnaire 
FDA 
Food and Drug Administration 
GCP 
International Conference of Harmonisation Good Clinical Practice 
HA 
Hydroxylapatite 
HHS 
Harris Hip Score 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
LEAS 
Lower Extremity Activity Scale 
LRM 
Laser Rapid Manufacturing 
PI 
Product Inquiry 
PSF 
Particle Sintered Foam 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
VR-12 
Veterans RAND-12 
THA 
Total Hip Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
 
 
 
 
 

 
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Study Synopsis 
Title 
A prospective, post-market, multi-center study of the Trident II 
Acetabular Shell in a revision indication 
Short Title 
Trident II Revision Outcomes Study 
Protocol Number 
79 
Phase 
Post-market 
Methodology 
This study will be a prospective, non-randomized evaluation of the 
Trident II Acetabular Shell for revision of the acetabular component 
of a previously failed total hip arthroplasty (THA) with a cementless 
application in a consecutive series of patients who meet the 
eligibility criteria.  
Study Duration 
 
Enrollment period of 60 months  
 
Follow-up of each revision THA case to 10 years 
 
Approximate 15-year total duration 
Study Center(s) 
10-15 centers  
Hypothesis 
The success rate, defined as freedom from acetabular revision for 
aseptic loosening, for hips implanted with the Trident II Acetabular 
Shell, is no worse than for hips implanted with similar technology as 
reported in the literature at five years postoperative. 
Objectives 
Primary: 
 
To demonstrate, through absence of revision for aseptic 
loosening at five years postoperative, that acetabular 
revision with the Trident II Acetabular Shell provides clinical 
results comparable to similar acetabular components for 
revision indications. 
Secondary: 
 
To review radiographic stability of hips implanted with the 
Trident II Acetabular Shell.   

 
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Additional Data 
Collection 
 
To assess pain, function and health related quality of life 
(QOL). The following outcomes measures will be collected: 
o Harris Hip Score (HHS) 
o Veterans RAND-12 (VR-12) 
o Lower Extremity Activity Scale (LEAS) 
o EuroQol-5D (EQ-5D) 
 
An additional Follow-Up Questionnaire will be administered 
in postoperative evaluations 6-week through 10-year to 
assess patient satisfaction and pain, and to capture adverse 
events when the patient is not present to complete the HHS.   
Number of Subjects 
A minimum of 347 cases receiving the Trident II Acetabular Shell 
will be enrolled into the study.  
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 18-85 years of 
age at the time of study device implantation. 
C. Patient is a candidate for a revision of a failed acetabular 
component with a cementless acetabular component.  
D. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations. 

 
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Diagnosis and Main 
Inclusion/Exclusion 
Criteria* 
Exclusions: 
E. Patient has a Body Mass Index (BMI) > 45. 
F. Patient is diagnosed with Inflammatory Arthritis.  
G. Patient has a non-Stryker retained stem.  
H. Patient has an active or suspected latent infection in or 
about the affected hip joint at time of study device 
implantation. 
I. Patient has a mental or neuromuscular disorder which would 
create an unacceptable risk of prosthesis instability, 
prosthesis fixation failure, or complications in postoperative 
care. 
J. Patient has compromised bone stock which cannot provide 
adequate support and/or fixation to the prosthesis.  
K. 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. 
L. Patient is immunologically suppressed or receiving steroids 
in excess of normal physiological requirements 
(e.g. > 30 days). 
M. Patient has a known sensitivity to device materials. 
N. Patient is a prisoner. 
*Although this list is comprehensive from a clinical study patient selection perspective, the Investigator should always review the latest Instructions for Use (IFU) and Surgical Protocol prior 
to choosing subjects and performing surgery as newer versions may become available following study initiation. 

 
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Study Device 
Required Components: 
 
Trident II Tritanium Acetabular Shell: 
o Clusterhole 
o Solidback 
o Multihole 
 
Trident II HA Hemispherical Clusterhole Shell 
 
Trident II HA PSL Clusterhole Shell 
 
Acetabular components must be used in a cementless 
application. 
 
If screws are used, only 6.5 mm Low Profile Hex Screws are 
permissible. 
The following ancillary devices are permissible: 
 
Compatible Stryker Modular Dual Mobility (MDM) acetabular 
liner 
 
Compatible Stryker X3 polyethylene inserts  
 
Compatible Stryker femoral bearing heads 
 
Compatible Stryker femoral stems 
 
Hex Dome Hole Plug 
 
Restoration Acetabular Wedge Augments 
Reference Therapy 
Literature control, based on cementless acetabular revision.   
Statistical 
Methodology 
Primary: 
The 90% confidence interval of the success rate will be computed at 
five years postoperative. For the non-inferiority comparison, the 
lower bound of this 90% confidence interval will be compared with 
90% survival rate.  For the superiority comparison, the lower bound 
of this 90% confidence interval will be compared with 95%. 
 
Secondary: 
 
Radiographic stability will be summarized in table format. 

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Evaluation Schedule 
Evaluation 
Pre-op 
X-rays 
(-1 yr) 
eCRFs 
(-4 mos) 
Intra 
op 
6 week 
(+2 wks) 
3-6 mos 
(+2wks) 
1 year 
(+2 mos) 
2 year 
(+2 mos) 
3 year 
(+3 mos) 
4 year 
(+4 mos) 
5 year 
(+4 mos) 
6 year 
(+4 mos) 
7 year 
(+4 mos) 
8 year 
(+4 mos) 
9 year 
(+4 mos) 
10 year 
(+4 mos) 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Previous 
Implant 
Information 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical 
Details 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
HHS 
X 
 
X 
 
X 
X 
 
 
X 
 
X 
 
 
X 
Postoperative 
Events 
 
 
X 
 
X 
X 
 
 
X 
 
X 
 
 
X 
VR-12 
X 
 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
LEAS 
X 
 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
EQ-5D 
X 
 
X 
 
X 
X 
X 
X 
X 
 
X 
 
 
X 
Radiographs: 
Low AP Pelvis, 
Lateral 
X 
 
X 
X 
X 
X 
 
 
X 
 
X 
 
 
X 
Follow-up 
Questionnaire* 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HHS: The HHS is an assessment that measures function, pain, deformity and motion. 
VR-12:  The VR-12 is a self-administered patient evaluation that evaluates general health and well-being. 
Postoperative Events: The Postoperative Events form is a questionnaire completed by the Investigator intended to provide information on the 
patient’s health status since the last follow-up visit. 
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 questionnaire intended to provide information on patient satisfaction, pain, and 
survivorship. *Only administered when the patient is not present to complete the HHS.  
Low AP Pelvis: Standard radiographic view of the pelvis containing bilateral hips and demonstrating the iliac bone, sacrum, pubis, ischium, femoral 
heads and necks, and greater or lesser trochanters. 
Lateral: Standard radiographic view of the hip joint (can be the Lauenstein lateral, frog leg lateral or cross-table lateral) demonstrating complete 
visualization of the hip joint and femoral neck. 

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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 
Total hip arthroplasty (THA) is one of the most clinically successful and cost-effective 
interventions in health care.1 The use of highly porous metals in cementless THA has yielded 
successful results at mid- to long-term follow-up.2 However, despite the improvements in implant 
designs and surgical techniques, there are cases in which the acetabular component is revised 
due to loosening, wear, or infection. Specifically, as reported in the literature, there is a 2% risk 
of revision for primary THA in the first 18 months after the index procedure and 1% thereafter in 
a 12-year study period.3  
 
Due to the expanding indications and aging population, the demand for THA is projected to 
increase by 174% by 2030, therefore triggering a subsequent rise in revision THA.6,7  
During revision THA surgeons are confronted with greater technical and decision-making 
challenges due to the need to manage acetabular bone loss and poor quality of bone; all the 
while selecting proper implant and fixation strategy.4 As a result of these challenges, this can 
lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. 
However, with advances in cementless acetabular revision there have been improved results 
over the less than optimal cemented fixation.5 
 
In cases utilizing cementless acetabular components there is a required initial implant stability to 
allow for biologic fixation, which provides long-term durability of the prosthesis when properly 
achieved.8 To this end, there are several surface options available for cementless acetabular 
fixation; titanium fibermesh, sintered bead surfaces, plasma spray and trabecular metal are 
some widely used examples, all with good clinical history.9,10 
 
Particularly, the use of porous coated cementless cups in revision THA offers optimal 
biocompatibility therefore offering biological fixation.11 Delanois6 et al. published Kaplan Meier 
survivorship results on highly-porous titanium cups of patients who underwent revision THA, 
1 Introduction 

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reporting 97% survivorship at five years. Similar positive results have been reported at shorter 
time points for both porous-coated anatomic biologic fixation cups (6.6% loosening after 20 
months) and titanium mesh ingrowth cups (1.4% failure after 41-month follow-up).11 
Furthermore, Khatod13 et al. published revision femoral and acetabular rates of 39.43% (248 of 
629 cases), and more specifically re-revision femoral and acetabular rates of 31.74% (20 of 63 
cases) at five years. 
 
Tritanium technology was developed to provide a three-dimensional Titanium matrix that 
resembles cancellous bone, allowing for enhanced acetabular fixation.2,12  
 
The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell indicated for 
cementless application. The Trident II HA Acetabular Shell is a hemispherical hydroxylapatite 
coated acetabular shell indicated for cementless application. Both shells are sterile, single-use 
devices indicated for use in revision total hip arthroplasty. The Trident II Clusterhole HA 
Acetabular Shells are available in both Hemispherical and Peripheral Self-Locking (PSL) outer 
geometry configurations and are compatible with all Trident polyethylene inserts, Trident 
Constrained Acetabular Inserts, and MDM liners.  The Trident II Clusterhole HA Acetabular 
Shells are fabricated from forged Titanium (Ti-6Al-4V) ELI alloy per ASTM F136. The shells 
feature a coarse surface that provides initial fixation for cementless hip arthroplasty.  The outer 
surface is coated with Commercially Pure (CP) Titanium followed by Hydroxylapatite powder 
(PureFix HA), which are each applied separately via a plasma spray process.  The shell is 
subsequently machined to achieve the final product dimensions. The Trident II Tritanium 
Acetabular Shell and its predicate device, the Stryker Tritanium Acetabular Shell, have similar 
properties, with differences noted in material and manufacturing processes. The Trident II 
Tritanium Acetabular Shell is manufactured from Ti-6Al-4V via Laser Rapid Manufacturing 
(LRM) technology, as opposed to the Particle Sintered Foam (PSF) technology used to 
manufacture the Tritanium PSF Acetabular Shell coating from commercially pure titanium.   
 
2 Clinical Study Plan 
2.1 Study Design 
A prospective, post-market, multi-center design will be employed.  Radiographs will be assessed 
by an independent reviewer. 

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2.2 Study Centers 
 
2.2.1 Centers for Data Collection 
 
Cases will be enrolled at ten to fifteen centers.  To allow for a learning curve with the use 
of the device, enrollment of cases into the study will commence when three cases have 
been completed at the center using the Trident II Acetabular Shell.  The enrollment goal 
is a minimum of 25 cases per center utilizing the Trident II Acetabular Shell but will vary 
dependent upon the number of participating centers. Although a goal is presented, there 
is no maximum limit to the number of cases that a center may enroll.  In the event that a 
center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment 
so as not to skew the data.  All participating centers will comply with the federal regulations 
regarding patient informed consent and Institutional Review Board (IRB) approval.  Non-
compliance of a study center may result in termination of the center’s participation in the 
study. 
 
2.3  Number of Subjects 
A minimum of 347 cases receiving the Trident II Tritanium or Trident II HA Acetabular Shell will 
be enrolled into the study.   
 
 
 
3 Device Description 
3.1 Study Device 
The Trident II Tritanium Acetabular Shell is cleared for use in the United States under K161569 
and K171768.  The Trident II HA Shells have been cleared under K171768. See Appendix A for 
the FDA clearance letters.   
 
The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell with a 3D engineered 
porous surface for biological fixation, made of Ti-6Al-4V alloy through additive manufacturing.  
The shell is built upon the design features and clinical history of the existing Tritanium Solid, 
Cluster, Multihole and Trident HA acetabular shells.  Although they do have similar properties, 

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the material and manufacturing processes are different; the Trident II Tritanium hemispherical 
shell is manufactured from Ti-6Al-4V via Laser Rapid Manufacturing (LRM) technology, as 
opposed to the Particle Sintered Foam (PSF) technology used to manufacture the Tritanium PSF 
Acetabular Shell coating from commercially pure titanium.  The Trident II HA Acetabular Shell is 
a hemispherical shell with hydroxylapatite coating and is indicated for cementless application.  
The Trident II HA Shells are an extension of the overall Trident System product line and feature 
the same insert locking mechanism as the current Trident product line. This advanced technology 
is designed to address the need for improved initial and biological fixation. The Trident II Tritanium 
Acetabular Shell, intended for use in a cementless application, is available in sizes from 42 mm 
through 72 mm and is compatible with Trident polyethylene liners, Mobile Dual Mobility (MDM) 
acetabular liners, and Trident II Tritanium acetabular screws.  The Trident II HA Acetabular Shell 
is available in sizes 42 mm through 66 mm.  Data in support of these marketing claims will be 
collected as part of the protocol. 
 
The Trident II Tritanium and Trident II HA Acetabular Shell Product Labeling can be found in 
Appendix B. 
  
The following acetabular component catalog numbers are permissible according to this study 
protocol and are in the following format, where ‘XXY’ varies by size: 
702-04-XXY, 700-04-XXY, 709-04-XXY, 702-11-XXX, 742-11-XXX 
 
The following bone screw catalog numbers are permissible according to this study protocol and 
are in the following format, where ‘XX’ varies by length: 
 7030-65XX 
 
The full listing of permissible acetabular component and bone screw catalog numbers may be 
found in Appendix C. 
 
3.2 Ancillary Devices 
Additionally, only the following Stryker compatible ancillary devices may be used, according to 
this study protocol: 
o Compatible Stryker acetabular inserts 
o Compatible Stryker MDM acetabular liner 

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o Compatible Stryker femoral bearing heads 
o Compatible Stryker femoral stems 
o Restoration Acetabular Wedge Augments 
o 6.5mm Low Profile Hex Screw 
o Hex Dome Hole Plug  
The compatible Stryker acetabular inserts, acetabular liner, and heads are listed in the surgical 
protocol. All compatible ancillary devices will be used on-label only.  
 
For reference, compatible Stryker femoral heads, acetabular liners and inserts are listed in Tables 2-
10 below.  In the case of any uncertainty regarding device compatibility, the current versions of the 
Trident II Acetabular Shell surgical protocols should be reviewed.  
 
 
 
 
Table 1: Trident II Tritanium Shell/Femoral Head/X3 Liner Compatibility 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 2: Trident II Tritanium Shell/Insert Compatibility 
 
 
 
 
Table 3: Trident II Tritanium Shell/MDM Liner/Insert Compatibility 
 
 
 
 
 
 
 
 

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Table 4: Trident II PSL Clusterhole HA Femoral head, X3 Liner and Shell Compatibility 
 
 
 
Table 5: Trident II PSL Clusterhole HA Shell 
 
 
 
Table 6: Trident II PSL Clusterhole HA Shell MDM Liner and Insert Compatibility 
 
 

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Table 7: Trident II Clusterhole HA: Femoral head, X3 Liner and Shell Compatibility  
 
 
Table 8: Trident II Clusterhole HA Shell 
 
 
Table 9: Trident II Clusterhole HA: MDM Liner and Insert Compatibility 
 
 
 
 
 
 
 

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3.3 Device Implantation 
All cases included in the analysis will receive the Trident II Acetabular Shell, in a revision setting, 
using manual instrumentation with an on-label approach.  Only cases using an on-label approach 
in a revision setting may be included in the analysis. 
 
4 Study Procedures 
4.1  Subject Recruitment and Screening 
 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  Advertising for the study at each center will be at the discretion of the investigator.  All 
handouts, brochures, advertisements, etc. must be approved by the IRB prior to the dissemination 
of any recruitment materials to potential subjects.   
During the preoperative visit, patients that are possible candidates for this study will be screened 
to determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, the 
investigator will propose participation in the study to the patient, according to GCP guidelines.  
Patients must sign an IRB approved Informed Patient Consent Form prior to participation in the 
study, as well as prior to any data collection. 
4.2   Patient Informed Consent and Guidelines 
 
All patients for this study will be provided an Informed Patient Consent Form describing this study 
and providing sufficient information for them to make an informed decision about their 
participation.  The Informed Patient Consent Form must contain all elements required by the FDA 
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 applicable Model Informed Patient Consent.  This will 
be submitted with the protocol for review and approval by each institution’s overseeing 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 patient, using the IRB approved Informed 
Patient Consent Form, must be obtained before that patient is submitted to any protocol related 
procedures that are not part of normal care.  Written documentation of consent must be provided 
on the Informed Patient Consent Form’s signature page in addition to a note in the patient medical 
records indicating the date that consent was obtained.  The investigator-designated research 
professional obtaining the consent must also sign this Informed Patient Consent Form.  The 

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patient or his/her legal representative should receive a signed copy of the Informed Patient 
Consent Form, according to GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
 
Use a current IRB approved copy of the Informed Patient Consent Form. 
 
Review the Informed Patient Consent thoroughly with the patient before having them sign. 
 
After the patient has consented to the study procedures, ensure he/she signs and dates 
the Informed Patient Consent Form. 
 
The person obtaining consent also signs and dates the signature page. 
 
Provide a copy of the signed Informed Patient Consent Form to the patient. 
 
If required, provide the hospital with a copy of the signed Informed Patient Consent Form. 
 
Maintain the signed original in the patient’s study chart. 
4.3  Early Withdrawal or Termination of Subjects 
 
When and How to Withdraw Subjects 
In the event that a subject is discontinued by the investigative center prior to the final study 
evaluation, the subject will be notified by the center that he/she is no longer in the study and a 
Study Termination eCRF will be completed.  If the reason for termination involves the study device 
not being implanted or surgery not performed, the subject will also be censored from analysis.    
The following is a list of reasons for which subjects may be terminated from the study 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 
Study device not implanted 
 
 
Date of surgery 
Surgery not performed 
 
 
 
Date Stryker termination approval given 
 
 

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Revision or removal of the Trident II Acetabular Shell for any reason constitutes a failure and a 
study termination for the subject.   
 
If revision of the femoral head, femoral stem, acetabular insert, or acetabular liner is required 
during the study, the event does not constitute a failure or study termination. 
 
If the subject fails to return for his/her follow-up appointments, every effort should be made to 
contact the subject to assess his/her health status.  If, after attempting to contact the subject 
through three documented phone calls and a certified letter, the subject still does not respond, 
he/she will be considered lost to follow-up.  A Study Termination eCRF will be completed only 
after notifying Stryker of the subject’s status and after Stryker has 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 
consent, the subject will need to reaffirm participation in the study.  All preoperative data will 
need to be recollected to be current within 4 months of study surgery.  If the surgery is not to be 
rescheduled or if the subject is no longer considered an appropriate study candidate, a Study 
Termination eCRF may be completed only after notifying Stryker of the subject’s status and 
after Stryker has given approval to terminate. 
When a subject completes the study according to protocol at the final study evaluation, a Study 
Termination eCRF will be completed. 
 
5 Evaluation Tools 
 
5.1 Objective Outcomes 
5.1.1 Radiographs and HHS 
 
To assess radiographic stability, radiographs will be taken and collected in the Low AP 
Pelvis and Lateral views for the preoperative, 6-week, 3-6 months, 1-year, 2-year, 5-
year, 7-year, and 10-year intervals.   
 

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The Low AP Pelvis view allows 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.(14)  Suggested radiographic technique for the views required is included 
in Appendix E. 
 
Radiographs will be evaluated by an independent reviewer throughout the course of 
the study.  Radiographic analysis of the acetabular component will employ three 
zones (Zone 1 – Zone 3) in the AP views. (15), (16) Numerous parameters will be 
reviewed by zone, including radiolucency and migration, in addition to overall 
cup/shell stability.  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. 
 
Clinical outcomes will be evaluated via the HHS including pain, motion and function, 
preoperatively and at the 6-week, 1-year, 2-year, 5-year, 7-year and 10-year intervals. 
5.2 Patient Reported Outcomes 
 
Patient outcomes data will also be collected via patient questionnaires.  During the 
preoperative, 6-week, 1-year, 2-year, 3-year, 4-year, 5-year, 7-year and 10-year 
follow-up visits, the VR-12, LEAS and EQ-5D are required.  In addition, all subjects 
will complete a brief satisfaction questionnaire at the 6-week, 3-6 month, and annually 
through the 10-year follow-up interval when a HHS is not available. 
 
6 Adverse Events 
6.1 Reporting of Adverse Events 
 
The AE reporting requirements for this study are as follows: 
 
 
All AEs that meet the definition of serious and occur from intraoperative to 90 days 
postoperative  
 
 
All AEs related to the operative site, regardless of seriousness or time of occurrence 

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On postoperative functional evaluations, investigators and Study Coordinators (SC) 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. 
Additionally, SCs will be responsible for following up with the subjects regarding any questionable 
responses received on the Follow-up Questionnaire collected in lieu of the completion of a HHS 
at the 6-week through 10-year intervals.  If it is determined upon this further investigation that a 
protocol-defined AE has occurred, the SC will be responsible for completing an AE eCRF, 
submitting the event to Stryker and reporting 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 
 
 
 
Start 
Site becomes 
aware of 
Adverse Event 
Is the event 
related to the 
operative 
site? 
Does the AE 
meet the 
criteria for 
Seriousness? 
 
Do NOT report 
to Stryker 
Did the event 
occur between 
intraop and 90 
days postop? 
Report AE to 
Stryker via AE 
eCRF 
End 
Yes 
Yes 
Yes 
No 
No 
No 

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

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

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6.3 Study Sponsor Notification by Investigator 
Of reportable AEs, certain events must be submitted to Stryker within 24 hours for timely 
notification. 
 
AEs that require time sensitive reporting: 
An AE should be reported to Stryker Clinical Research either by telephone/fax/email within 24 
hours of the site becoming aware of the event if any of the following apply: 
 
The AE occurs intraoperatively or is related to the surgical procedure. 
 
The AE is considered by the investigator to be device related or if the investigator 
is uncertain regarding the device related assessment; 
 
The AE required a reoperation of the study hip or a revision of any study hip 
components. 
 
At the time of the initial report, the following information should be provided: 
 
 
Subject number 
 
A description of the event 
 
Date of onset 
 
Current status 
 
Whether study treatment was 
discontinued 
 
Investigator assessment of the 
association between the event and 
the study treatment 
 
An AE eCRF for an AE meeting the criteria above should be completed within 24 hours of the 
investigative center’s awareness, and the de-identified source documentation should be 
submitted to Stryker within 24 hours of the investigative center’s awareness.  These reports will 
be evaluated by Stryker to determine if a Product Inquiry (PI) is required. 
 
It is recommended that all other reportable AEs are submitted through eCRF entry within 2 
weeks. 
6.3.1 Institutional Review Board Notification by Investigator 
Reports of AEs (including follow-up information) must be submitted to the IRB according 
to each IRB’s specific reporting requirements.  Copies of each report and documentation 
of IRB notification and receipt will be kept with the investigator’s study files. 

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6.3.2 Device Retrieval Process 
If the study device is removed for any reason, Stryker may retrieve the Trident II 
Acetabular Shell and/or adjacent tissues for analysis to help characterize potential device-
related complications.  In the event that the Trident II Acetabular Shell is removed from a 
study subject, the procedure outlined in the Retrieved Implant Analysis Protocol 
(Appendix F) should be followed, as allowed by the patient consent, hospital and 
institution.  In addition: 
 
1. When revision of a study subject is scheduled, the SC should contact the Clinical 
Study Manager (CSM) or other Stryker Clinical Research personnel assigned to 
the project, as soon as possible. 
2. Stryker Clinical Research will send a retrieval container to the SC. 
3. After the device is explanted, the SC or an identified Stryker field representative 
will retrieve the device and place it in the retrieval container, following the 
instructions in Appendix F. 
4. The SC, an identified field representative or Stryker Clinical Research will 
complete a PI. 
5. If not completed by Stryker Clinical Research, the PI should be faxed or emailed 
to Stryker Product Surveillance at 201-831-6775 or 
soprodexreports@stryker.com, as well as to Stryker Clinical Research at 201-
831-6454 or to the Clinical Research email addresses listed on the Sponsor 
Contact Sheet. 
6. The PI should be attached to the retrieval container and sent to Product 
Surveillance.  A de-identified operative report should be included, when 
available. 
7. Stryker Clinical Research will follow up with Product Surveillance to obtain a PI 
number. 
8. A summary of results will be provided to the investigator upon his/her request. 
 
6.4 Recording of Adverse Events 
 
All protocol defined AEs occurring during the study period must be recorded; this includes 
events that occur between visit intervals.  The clinical course of each event should be followed 
until resolution or stabilization. 

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6.5 Medical Monitoring 
 
It is the responsibility of the investigator to oversee the safety of the study at his/her center.  This 
safety monitoring will include careful assessment and appropriate reporting of AEs, as previously 
noted.  Stryker will conduct formal investigations via the Product Surveillance Department of those 
AEs which are submitted through Stryker’s PI System.  
 
7 Data Management 
7.1  Database 
 
Data will be collected at each center and entered into Stryker’s Electronic Data Capture (EDC) 
system.  The system can be accessed remotely by each investigative center and the data entered 
will be managed by Stryker.  Subject data will be processed and monitored according to the 
protocol schedule by Stryker or Stryker representatives.  Draft specifications to support eCRFs 
are provided in Appendix G.   
 
Radiographic images will be collected by each center and uploaded into Stryker’s medical imaging 
platform. This platform allows quick and compliant upload and review of medical images and data 
where they can be accessed by Stryker.  The platform also enables secure sharing of documents 
with and issues queries to, participating sites.  Quality control of the images will be managed by 
designated Stryker personnel.  An independent reviewer will perform review of X-rays and 
transcribe measurements to Stryker radiographic evaluation forms.  Draft specifications to support 
radiographic evaluation forms are provided in Appendix H. 
7.2  Confidentiality 
 
This study will comply with the 2002 HIPAA privacy rule.  As such, Stryker will only collect that 
information which is necessary to support the objectives of the study.   Stryker has a process to 
filter out identifying information in the data received during the course of the study. In the case 
that identifying information is inadvertently received, Stryker will redact and/or return the same in 
order to ensure no further disclosure.  Study subjects will authorize Stryker and its affiliates to 
receive, retain and 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, as described in the patient consent.   

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7.3  Source Documents 
 
Source data include all information, original records of clinical findings, observations or other 
activities in a clinical study necessary for the reconstruction and evaluation of the study.  Source 
data are contained in source documents.  Examples of these original documents and data records 
include:  hospital records, clinical and office charts, study worksheets, laboratory notes, 
memoranda, subject questionnaires, pharmacy dispensing records, recorded data from 
automated instruments, radiographs, subject files, and records kept at the pharmacy, at the 
laboratories and at medico-technical departments involved in the clinical study. 
All data points collected during preoperative and follow-up visits must be documented in the 
subject’s chart.  This includes range of motion values, pain and function as well as AEs and 
additional comments.  The informed consent process should also be documented in the patient 
chart.  Monitors, defined further in Section 9, will be comparing the eCRFs against source 
documents for accuracy.  The monitors will seek to draw a reference between each data point on 
the eCRF and the subject’s chart.  Thus, one cannot derive pain, ROM or function based on a 
chart note that reads “Patient doing well.”  Every effort should be made to ensure complete source 
documentation.  
Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
7.4  Electronic Case Report Forms 
 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be documented.  All missing data must be explained.  It is recommended that 
eCRFs be completed and that any forms requiring signature are electronically signed by the 
investigator within 2 weeks of the evaluation date. 
7.5  Data Queries 
 
If errors or omissions are noted by Stryker upon review of the data entered into the eCRFs, a data 
query will be sent to the center within the EDC system.  Queries should be answered in a clear 
and comprehensible manner.  If the clarification requires a change to study data, the personnel 
delegated to enter EDC data must update the data directly in the EDC system. The query will be 
closed upon an acceptable response.  The investigative center will be required to reapply their 
electronic signature to the modified eCRF.   

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7.6  Protocol Deviations 
 
Any deviation from this protocol categorized as a ‘Major Protocol Deviation’ will be recorded by 
the Sponsor and must be reported to the investigational center’s overseeing IRB according to 
their reporting procedures.  Major protocol deviations for this study may include the following; this 
list may not be all-inclusive:  
 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
 
Patient enrolled does not meet the inclusion/exclusion criteria 
 
Protocol specified study component(s) not implanted 
 
Off label surgical approach 
 
Off label component usage 
o If the stem is not a Stryker device it must be revised to a compatible Stryker 
component or the patient will be censored  
 
If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
7.7  Records Retention 
 
It is the investigator’s responsibility to retain study essential documents for two years after the 
date of the final report, or in the case of non-compliance, two years after the date of 
investigative center termination.  These documents should be retained for a longer period if 
required by an agreement with Stryker. 
 
8 Statistical Plan 
 
8.1 Study Objectives 
 
8.1.1 Primary Objective Analysis 
 

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The primary hypothesis to be tested will be that the success rate at five years 
postoperative with the Trident II Acetabular Shell is not worse than 95% with a non-
inferiority margin of 5%.  That is, the following hypothesis will be tested: 
 
H0:  Pt <= 95% - 5%   HA:  Pt >95 % - 5% 
 
Here, Pt is the success rate at five years postoperative with the Trident II Acetabular Shell. 
Case success at five years is defined as no incidence of revision and removal of Trident 
II Acetabular Shell for aseptic loosening within five years. 
 
A 90% two-sided confidence interval will be computed for the success rate at five years.  
If the lower bound of the confidence interval is greater than a 90% survival rate, then the 
non-inferiority hypothesis will be supported, that is the five-year success rate is non-
inferior to 95% with a margin of 5%.  If the lower bound of the confidence interval is greater 
than 95% then it is supported that the five-year success rate is superior to 95%.  
 
The Kaplan-Meier survival curve of revision and removal of the Trident II Acetabular Shell 
for aseptic loosening will be displayed using SAS/PROC LIFETEST. 
 
8.1.2 Secondary Objective Analyses 
 
 
Radiographic stability will be tabulated for available visits. 
 
The analysis for the additional data collection is in 8.4.1 Data Summary. 
8.2 Safety 
 
8.2.1 Safety Parameters 
 
Safety parameters include all protocol-defined adverse events as well as all-cause 
revision and/or removal of the Trident II Acetabular Shell.  For details regarding protocol-
defined adverse events, see Section 6.1. 

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8.2.2 Safety Analyses 
 
The frequency and percentage of all protocol-defined adverse events will be tabulated.  
All protocol-defined adverse events will be tabulated and 95% confidence interval will be 
presented.  For details regarding protocol-defined adverse events, see Section 6.1. 
 
The Kaplan-Meier survival curve of all cause of revision and removal of the Trident II 
Acetabular Shell at ten years postoperative will be displayed.  
 
8.3 Missing Data 
 
No missing data will be imputed. 
 
8.4 Statistical Methodology 
 
8.4.1 Data Summary 
 
Descriptive statistics will be computed for all baseline conditions and demographic 
parameters.  That is, for continuous data, the N, mean, median, standard deviation, 
minimum and maximum will be computed.  For categorical data, the frequency will be 
computed. The data will be presented by appropriate subgroups (e.g., center). 
For all additional data collected that are not required for direct support of a study objective, 
data will be summarized according to visit.  For parameters represented by continuous 
variables (e.g., ROM), the summaries will consist of the N, mean, median, standard 
deviation, minimum, and maximum values.  For categorical variables (e.g., gender), the 
frequency and percentage in each category will be presented.  
 
For radiographic data, data will be presented according to visits for available parameters.   
Documentation of statistical analyses will be performed utilizing SAS® software version 
9.1.3 or higher. 
 
8.4.2 Sample Size Justification 
 

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Based on the literature review, it is reasonable to have a reference value of 95% of 
success rate at five years, and a case success at five years is defined as no incidence of 
revision and removal of Trident II Acetabular Shell for aseptic loosening within the five-
year follow-up period. With the expectation that the success rate of Trident II Acetabular 
Shell for aseptic loosening within five years will be 94.5%, 277 cases will be needed to 
have a power of 95% to detect that the 5-year success rate is non-inferior to 95% with a 
margin of 5% at 5% significance level. After factoring a 20% lost to follow-up rate, a total 
of 347 cases will be needed.  
 
8.4.3 Interim Analyses 
 
No interim analysis is planned. 
 
8.4.4 Analysis Population 
 
Per Protocol Population: The study population for analysis will include all non-censored 
subjects who received the Trident II Acetabular Shell and are available for efficacy 
evaluation at the 5-year primary endpoint. 
 
The primary and secondary efficacy analyses will be based on the per protocol population.   
 
Safety Population: The safety population will include all non-censored subjects who 
received the Trident II Acetabular Shell. 
 
The safety analysis will be based on the safety population. 
 
9  Study Monitoring, Auditing, and Inspecting 
9.1  Study Monitoring Plan 
 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects 

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involved in a clinical investigation and the quality and integrity of data submitted as a result of the 
investigation. 
 
This study will be monitored at least once per year per site, with additional monitoring as 
necessary. The investigator will allocate adequate time for such monitoring activities.  The 
investigator will also ensure that the monitor or other compliance or quality assurance reviewer is 
given access to all study-related documents and study-related facilities, as applicable, and has 
adequate space to conduct the monitoring visit, when applicable.  The monitor will review all 
source documents and compare them to the data contained in the eCRFs, in addition to 
performing a periodic review of regulatory documents such as IRB approvals.  The monitors will 
need the following: 
 
An area where they can review study data, when monitoring is conducted on site 
 
Access to eCRF data for all cases 
 
Access to source documentation 
 
Regulatory documents 
 
Time to discuss findings with the SC and the investigator  
9.2  Auditing and Inspecting 
 
A quality assurance audit is a form of review that provides additional confidence to the sponsor 
concerning the validity and accuracy of clinical study data that must be submitted to the FDA or 
for publication.  The purpose of investigator audits is to ensure that the investigator has 
maintained all study information according to the sponsor’s protocol and standard operating 
procedures and in compliance with FDA regulations. 
 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, Stryker 
and/or government regulatory bodies of all study related documents (e.g. source documents, 
regulatory documents, data collection instruments, study data).  The investigator will ensure the 
capability for inspections of applicable study-related facilities. 
 
10 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted to 
a peer-reviewed journal at the time the study cohort reaches  5 and 10 years of follow-up.  Early 

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results with regard to surgical information and postoperative functional outcomes may be 
published prior to the 5-year time point.  Additional publication proposals may also be made by 
investigators at any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 
 
At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 5, and 10-year multi-center publications are submitted.  Although Stryker 
will not be involved in coordinating these independent manuscripts, all publications of the data 
shall be submitted to Stryker for review prior to submission for publication.  Stryker shall not edit 
or otherwise influence the publications other than to ensure that confidential information is not 
disclosed, that no off-label use of Stryker devices is promoted and that the data is accurately 
represented.  Any publications resulting from this study must be submitted to Stryker for review 
at least 30 days prior to submission of publication. 
 
11  Risk/Benefit Assessment 
11.1  Risk Category 
 
There are no additional risks associated with participating in this study over and above that of the 
revision THA procedure.  
 
11.2  Potential Risk 
 
The study involves the routine assessment of a revision THA procedure.  The Trident II Acetabular 
Shells have been cleared for use by the FDA and will be used according to its labeling, included 
in Appendix B.  Breach of data privacy is a known risk. All study assessments, patient and 
physician evaluations as well as radiographs will be kept confidential and will comply with the 
HIPAA privacy rule. 
 
While the expected life of THA 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 

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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. 
 
Risks associated with revision THA include the following: 
 
 
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. 
 
 
Asymptomatic, localized progressive bone resorption (osteolysis) may occur around the 
prosthetic components as a consequence of foreign-body reaction to the particulate matter 
of metal, UHMWPE and/or ceramic.  Particulate is generated by interaction between 
components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can be 
generated by third body wear.  Osteolysis can lead to future complications, including 
loosening, necessitating the removal and replacement of prosthetic components. 
 
 
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. 
 
 
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.  

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Postoperative femoral or acetabular fracture can occur due to trauma, the presence of 
defects or poor bone stock. 
 
 
Metal sensitivity reactions have been reported following joint replacement. 
11.3  Expected Complications 
Complications associated with THA procedures, such as those performed with the Trident II 
Acetabular Shells, 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.  Complication rates of the Trident II Acetabular Shells will be reviewed.   
11.4 Protection Against Risks 
 
Subjects will be treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or wellbeing 
of the subject, this deviation will be promptly reported to both the center’s overseeing IRB and 
Stryker.   
11.5  Potential Benefits to the Subject 
 
There is no guarantee that subjects will personally benefit from inclusion in this study.  Subjects 
may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance.  This study seeks to provide clinicians information about this 
device by comparing it to published results for other similar devices.  Information gathered in this 
study may benefit others undergoing this procedure in the future. 
 
12 Ethical Considerations 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56, 45 CFR Parts 160 and 164, as well 
as ISO 14155. 
 

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This protocol and any amendments will be submitted to each investigative center’s properly 
constituted independent IRB for formal approval of the study conduct.  The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator and a copy of this 
decision will be provided to Stryker before commencement of this study.  The investigator may be 
asked to provide a list of IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided an Informed Patient Consent Form 
describing this study and providing sufficient information for patients to make an informed decision 
about their participation.  This Informed Patient Consent Form must be modified to contain center 
specific information and submitted with the protocol for review and approval by the center’s 
overseeing IRB for the study.  The formal consent of a patient, using the IRB approved Informed 
Patient Consent Form, must be obtained before that patient is submitted to any study procedure.  
This Informed Patient Consent Form must be signed by the patient or legally acceptable surrogate 
and the investigator-designated research professional obtaining the consent.  
 
13 Study Finances 
13.1  Funding Source 
 
This study is financed by Stryker. 
13.2  Conflict of Interest 
 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their IRB or a properly constituted Conflict of Interest Committee with a Committee-
sanctioned conflict management plan that has been reviewed and approved by Stryker prior to 
participation in this study.   
13.3  Subject Stipends or Payments 
 
Subject attrition can occur for a variety of reasons, including a subject’s loss of health insurance 
coverage.  In a case where a patient has lost health insurance coverage and no other coverage 
is available, Stryker may, on a case-by-case basis, reimburse investigators for office visits and 
radiographic charges for subjects involved in this study in order to facilitate data retrieval.  The 

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physician or the office staff should contact the fCSM prior to scheduling the subject to discuss this 
possibility and receive pre-approval.  After receipt of the completed data forms, the physician 
must submit either evidence of coverage denial (e.g. explanation of benefits) or a letter explaining 
that the subject does not have insurance.  Other visits, procedures and assessments done other 
than those specified in the protocol will not be reimbursed.  Reimbursement may be provided 
under the following conditions: 
 
Study subjects lose insurance coverage after enrollment into the study 
 
An insurance carrier refuses to pay for a follow-up visit and/or radiographs     
 
An insurance carrier refuses to provide a subject referral to see the investigator for follow-
up  
Additionally, at pre-determined study visit intervals, Stryker may reimburse subjects with a modest 
stipend for protocol-required data collection.  This stipend system must be approved by the 
Institution’s IRB prior to implementation and will be based upon individual IRB approval from each 
site. 
 
 
 
 
 
1 Bozic, K.J.,Ong, K., Lau, E., Kurtz, S., Vail, T.P., Rubash, H.E., Berry, D.J. 56th Annual 
Meeting of the Orthopaedic Research Society. The Comparative Effectiveness of Total Hip 
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2 Naziri, Q., Issa, K., Pivec, R., Harwin, S.F., Delanois, R.E., Mont, M. (2013). Excellent results 
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3 J.N. Katz, E.A. Wright, J. Wright, H.Malchau, N.N. Mahomed, M. Stedman, et al.Twelve-year 
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6 R.E. Delanois, C.U. Gwam, N. Mohamed,et al.Midterm outcomes of revision total hip 
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(2017), p. 2806 
 
14 References 

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7 M.R. Angerame, T.K. Fehring, J.L. Masonis, J.B.Mason, S.M. Odum, B.D. SpringerEarly 
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8 Klika, A.K., Murray, T.G., Darwiche, H., Barsoum, W.K. (2007).  Options for acetabular fixation 
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9 Rodriguez, J.A. (2006).  Acetabular Fixation Options: Notes from the Other Side. The Journal 
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11 L. Pulido, S.R. Rachala, M.E. Cabanela. Cementless acetabular revision: past, present, and 
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12Stryker Test Report RD-07-077 
 
13 Khatod M, Cafri G, Inacio MCS, Schepps AL, Paxton EW, Bini SA (2015) Revision total hip 
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15 Steffen, J.B., Lukoschek, M., Kreutzer, J., Brocai, D., & Gruen, T.A. (2001). Dependency of 
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16 Gruen, T.A., McNeice, G.M., & Amstutz, H.C. (1979). Modes of failure of cemented stem-type 
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