Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell
Phase: NA
Conditions: Osteoarthritis, Degenerative Arthritis
Sponsor: DePuy Orthopaedics

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Multi-Center, Non-Controlled, Prospective Radiostereometric 
Analysis of the Pinnacle Acetabular Shell 
 
 
 
 
 
 
SHORT TITLE: Pinnacle RSA Study 
 
Protocol Number: DSJ_2018_02 
 
 
 
Version Rev 5: 25 March 2022 
 
 
 
Clinical Sponsor: 
 
DePuy Synthes Joint Reconstruction 
700 Orthopaedic Drive 
Warsaw, IN 46581 
 
 
 
 
 
 
__________________________ 
, Vice President, Clinical and External Research 
 
 
PPD
PPD

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Investigator Signature Page 
 
Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis  
of the Pinnacle Acetabular Shell 
Document 
Type 
Revision  
Effective Date 
Original 
1 
 
March 27, 2019 
Administrative 
2 
 
July 2, 2019 
Administrative 
3 
 
October 16, 2019 
Amendment 
Amendment 
4 
5 
 
April 17, 2020 
March 25, 2022 
 
I have read this protocol and agree to conduct this clinical investigation in accordance with the design and 
specific provisions outlined herein.  I understand the protocol and I understand I am solely responsible to 
ensure the investigation is conducted in accordance with Good Clinical Practices (GCP), applicable country 
regulations, the Declaration of Helsinki, the signed clinical study contract with the Sponsor and with the 
protocol outlined herein.  I will conduct this study as outlined therein and will make reasonable effort to 
complete the study within the time period designated by the Sponsor. 
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who 
will assist in the conduct of this study.  I will discuss this material with them to ensure they are fully 
informed regarding the device and the conduct of the study. 
 
I will fulfill the requirements of my Research Ethics Board (REB)/Ethics Committee (EC), or other oversight 
committee(s), to ensure complete and continual oversight of this clinical investigation.  I will use an 
Informed Consent Document approved by the Sponsor and my reviewing REB/EC (where required). 
 
I agree to report all information or data in accordance with the protocol and, in particular, I agree to report 
any serious adverse events, device related adverse events, or procedure related adverse events as defined in 
this protocol to the Sponsor, and comply with all adverse event reporting requirements of my reviewing 
REB/EC.  I agree to permit he Sponsor, its authorized representatives, my reviewing REB/EC, and any 
regulatory authority/body access to all records relating to the clinical investigation. 
 
The below signature confirms I have read and understood this protocol and its associated amendments or 
attachments and will accept respective revisions or amendments provided by the Sponsor. 
 
 
 
--------------------------------------------------------  
--------------------------------------------- 
Signature of Principal Investigator:  
 
Date 
 
 
 
-------------------------------------------------------- 
 
Printed Name 
 
 

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Table of Contents 
 
1 
STUDY SUMMARY ...................................................................................................... 5 
1.1 
TIME AND EVENTS SCHEDULE ................................................................... 9 
2 
INTRODUCTION ........................................................................................................... 10 
2.1 
Background ......................................................................................................... 10 
2.2 
Radiostereometric Analysis (RSA) ..................................................................... 10 
2.3 
Study Article Description .................................................................................... 10 
2.4 
Benefits/Risks ...................................................................................................... 10 
3 
PURPOSE ....................................................................................................................... 12 
3.1 
Primary Objective and Endpoint ......................................................................... 12 
3.2 
Secondary Objectives and Endpoints .................................................................. 12 
3.3 
Exploratory Objectives and Endpoints ................................................................ 12 
3.4 
Safety Endpoints ................................................................................................. 13 
3.5 
Device Description .............................................................................................. 13 
4 
SUBJECT DEFINITION ................................................................................................ 13 
4.1 
Inclusion Criteria ................................................................................................. 14 
4.2 
Exclusion Criteria ................................................................................................ 14 
4.3 
Definition of Subject Enrollment ........................................................................ 15 
5 
STUDY DESIGN ............................................................................................................ 15 
5.1 
Subject Enrollment .............................................................................................. 15 
6 
STUDY PROCEDURES ................................................................................................. 18 
6.1 
Pre-Operative (-90 days to Day of Surgery) ....................................................... 18 
6.2 
Operative (Day 0) ................................................................................................ 18 
6.3 
Prior to Discharge (Day 1 to Discharge) ............................................................. 19 
6.4 
6 Weeks (Day 28-56) .......................................................................................... 19 
6.5 
3 Month, 6 Month, 1 Year and 2 Year Visits ...................................................... 20 
6.6 
Unscheduled Visit ............................................................................................... 20 
6.7 
Radiostereometric Analysis (RSA) ..................................................................... 21 
7 
ADVERSE EVENT REPORTING ................................................................................. 21 
7.1 
Adverse Events .................................................................................................... 21 
7.2 
Serious Adverse Events ....................................................................................... 22 
7.3 
Duration of Follow-up After Adverse Events ..................................................... 22 
7.4 
Reporting an Adverse Event ............................................................................... 22 
8 
EARLY DISCONTINUATION ...................................................................................... 24 
8.1 
Reasons for Early Discontinuation ...................................................................... 24 
8.2 
Subject Early Discontinuation ............................................................................. 24 
8.3 
Study Early Discontinuation ............................................................................... 24 
9 
STATISTICAL METHODOLOGY ............................................................................... 25 
9.1 
Study Design ....................................................................................................... 25 
9.2 
Treatment Assignment ........................................................................................ 25 
9.3 
Randomization and Blinding Procedures ............................................................ 25 
9.4 
Interval Windows ................................................................................................ 25 
9.5 
Analysis Sets ....................................................................................................... 26 
9.6 
Primary and Secondary Endpoints and Associated Hypotheses ......................... 26 

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9.7 
Levels of Significance ......................................................................................... 27 
9.8 
Sample Size Justification .................................................................................... 27 
9.9 
General Conventions ........................................................................................... 27 
9.10 
Disposition of Study Subjects ............................................................................. 27 
9.11 
Demographic and Baseline Characteristics ......................................................... 27 
9.12 
Primary, Secondary, and Safety Endpoint Analyses ........................................... 27 
9.13 
Safety Endpoint Analysis .................................................................................... 29 
9.14 
Plans for Interim Analysis ................................................................................... 29 
9.15 
Handling of Missing Data ................................................................................... 29 
10 
STUDY MANAGEMENT AND ADMINISTRATION ................................................ 29 
10.1 
Investigator Responsibilities ............................................................................... 29 
10.2 
Good Clinical Practice ........................................................................................ 30 
10.3 
Ethical Considerations ......................................................................................... 30 
10.4 
Subject Information and Informed Consent ........................................................ 30 
10.5 
Subject Confidentiality ........................................................................................ 30 
10.6 
Direct Access to Source Data .............................................................................. 31 
10.7 
Case Report Form Completion ............................................................................ 31 
10.8 
Record Retention ................................................................................................. 31 
10.9 
Investigator agreements and curricula vitae of Investigator(s), and the Site 
Signature and Delegation Log Investigator Reports ........................................... 32 
11 
SPONSOR OBLIGATIONS ........................................................................................... 32 
11.1 
Investigator(s) Training ....................................................................................... 32 
11.2 
Study Monitoring ................................................................................................ 32 
12 
RESEARCH ETHICS BOARDS AND REGULATORY REQUIREMENTS .............. 32 
12.1 
REBs .................................................................................................................... 32 
12.2 
Protocol Amendments ......................................................................................... 33 
12.3 
Protocol Deviations ............................................................................................. 33 
13 
PUBLICATION POLICY ............................................................................................... 34 
14 
Appendix A ..................................................................................................................... 35 
15 
Appendix B ..................................................................................................................... 39 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 STUDY SUMMARY 
 
Clinical Sponsor 
DePuy Synthes Joint Reconstruction 
Title 
Multi-Center, Non-Controlled, Prospective Radiostereometric 
Analysis of the Pinnacle Acetabular Shell 
Short Title 
Pinnacle RSA Study 
Protocol Number 
DSJ_2018_02 
IDE/IND Number 
Not Applicable 
Indication 
Total Hip Arthroplasty (THA) 
Study Article Description 
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX 
Polyethylene Liner and Corail Femoral Stem 
Study Design 
Multi-Center, Non-randomized, Non-Controlled, Prospective 
Study Population 
Males and Females, aged 21 or older, who are undergoing 
primary, unilateral THA 
Number of Subjects 
N = 90, with equal enrollment across three approaches: posterior 
(N=30), lateral (N=30) and anterior (N=30) 
Number of Sites 
2 (Canadian) 
Enrollment Timeframe 
9 months 
Subject Follow-Up 
Subjects will be seen at the following intervals: 
Preoperative, operative, 6 weeks, 3 months, 6 months, 1 year and 
2 years postoperatively 
Study Objectives 
• To establish the mean subsidence profile of the Pinnacle 
Acetabular Shell using model-based RSA over the first 
two years post-implantation 
Endpoints 
Primary: 
• RSA measured mean superior cup migration (subsidence: 
Y translation in mm) at 2 years for each surgical approach 
separately, as well as combined 
 
Secondary: 
• RSA measured subsidence of the Pinnacle Acetabular 
Shell at 3 months, 6 months and 1 year 
• Other RSA measurements (X and Z translations in mm, X, 
Y, and Z rotations in degrees, and maximal total point 
motion in mm) at all time points 
• Linear head penetration at 1 year and 2 years for each 
surgical approach separately, as well as combined 
• Functional and health status as measured with Harris Hip 
Score, HOOS Jr. and Forgotten Joint Score (FJS-12) 
 
Exploratory: 

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• Analyses to examine the correlation of functional and 
health status outcomes vs. RSA observations may be 
explored 
 
Safety: 
• The type and frequency of serious, non-serious and device 
or procedure related AEs across all study intervals will be 
summarized 
Inclusion Criteria 
1. 
Individuals requiring primary THA for a severely painful 
and/or disabled joint from osteoarthritis, traumatic arthritis, 
rheumatoid arthritis, or congenital hip dysplasia, AVN of the 
femoral head or acute traumatic fracture of the femoral head 
or neck 
2. 
Individuals who are able to speak, read and comprehend the 
informed patient consent document and willing and able to 
provide informed patient consent for participation in the 
study and have authorized the transfer of his/her information 
to DePuy Synthes 
3. 
Individuals who are willing and able to return for follow-up 
as specified by the study protocol 
4. 
Individuals who are a minimum age of 21 years at the time 
of consent 
5. 
Individuals who are willing and able to complete the Subject 
Hip Outcomes questionnaires as specified by the study 
protocol 
Exclusion Criteria 
1. 
Individuals have active local or systemic infection 
2. 
Individuals who have loss of musculature, neuromuscular 
compromise or vascular compromise that would impact 
rehabilitation following surgery 
3. 
Individuals with poor bone quality, such as osteoporosis, 
where in the surgeon’s opinion, there could be considerable 
migration of the prosthesis or require additional acetabular 
cup fixation using screws, or a significant chance of fracture 
of the femoral shaft and/or the lack of adequate bone to 
support the implant(s) 
4. 
Individuals with Charcot’s or Paget’s disease 
5. 
Individuals who, in the judgement of the investigator, would 
not be a candidate for protocol allowable components to be 
used for their THA 
6. 
Women that are pregnant or lactating 

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7. 
Individuals who have had a contralateral hip that was 
implanted less than 6 months prior to the time of consent into 
this study or individuals that expect to have a contralateral 
hip implanted in the following 6 months at the time of 
consent into this study 
8. 
Individuals that have amputations in either leg that would 
impact rehabilitation following surgery 
9. 
Individuals who are bedridden. 
10. Individuals that have participated in a clinical investigation 
with an investigational product (drug or device) in the last 
three months 
11. Individuals currently involved in any personal injury 
litigation, medical-legal or worker’s compensation claims 
12. Individuals, in the opinion of the Investigator, who are drug 
or alcohol abusers or have psychological disorders that could 
affect their ability to complete patient reported 
questionnaires or be compliant with follow-up requirements 
13. Individuals diagnosed and taking prescription medications to 
treat a muscular disorder that limits mobility due to severe 
stiffness and pain such as fibromyalgia or polymyalgia 
14. Subject has a medical condition with less than 2 years life 
expectancy 
15. Individual has a BMI >45 kg/m2. 
Safety Assessments 
Type and frequency of device or procedure related Adverse 
Events will be collected. Site Ethics Committees/REBs will 
provide oversight for study subject safety. 
Sample Size 
The purpose of this study is to summarize the mean subsidence 
(superior cup migration) of the acetabular shell as measured with 
RSA.  Mean subsidence will be summarized at all time points 
with 95% confidence intervals, for each surgical approach 
separately, as well as combined; there are no hypotheses in this 
study.  The standard deviation in observed subsidence values at 2 
years post-op is anticipated to be approximately 0.2 mm.  Based 
upon this standard deviation, a sample size of N=30 is anticipated 
to provide a 95% confidence interval for each surgical approach 
separately with a margin of error of approximately 2(0.2/√30) = 
0.073 mm for each, which is deemed to be an adequate level of 
precision by the Sponsor. 
Statistical Analysis 
There are no formal hypothesis tests for this study.  Summary 
statistics of primary, secondary and exploratory outcomes will be 
provided, along with 95% confidence intervals.  Summaries will 

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be provided for each surgical approach separately, as well as 
combined. 
Interim Analysis 
An interim analysis will be conducted when all subjects have 
reached 1-year post-op in order to give product development an 
understanding of acetabular cup subsidence that might be 
expected for future product development purposes.  There is no 
intention to utilize this interim analysis as a means to justify 
stopping the study early. 
Determination if DMC/CEC 
required 
Not Required 
Time and Events Schedule 
See below 
 
 
 
 
 
 
 
 
 

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1.1 
TIME AND EVENTS SCHEDULE 
Event / Visit 
Pre-op 
Operative 
Prior to 
Discharge 
6 Weeks 
3 
Months 
6 
Months 
1 Year 
2 Years 
-270 to 
DOS 
-90 to 
DOS 
 
Day 0 
 
Day 1 to 
Discharge 
 
28-56 d 
 
60-120 d 
 
135-225 d 
 
275-455 d 
 
640-820 d 
Complete Screening Log 
 
 
 
 
 
 
 
 
 
Obtain Informed Subject 
Consent 
 
 
 
 
 
 
 
 
 
Verify Inclusion / Exclusion 
Criteria 
 
 
 
 
 
 
 
 
 
Subject History 
 
 
 
 
 
 
 
 
 
Harris Hip 
 
 
 
 
* 
 
 
 
 
Hip Evaluation 
 
 
 
 
 
 
 
 
 
HOOS Jr. 
 
 
 
 
 
 
 
 
 
Forgotten Joint Score (FJS-
12) 
 
 
 
 
 
 
 
 
 
Operative Details   
 
 
 
 
 
 
 
 
 
Device Log 
 
 
 
 
 
 
 
 
 
Unscheduled Visit Report ** 
(Interim Visit) 
 
 
 
 
 
 
 
 
 
Adverse Event 
 
 
 
 
 
 
 
 
 
End of Study (Withdrawal 
(W/D)) Form*** 
 
 
 
 
If W/D 
If W/D 
If W/D 
If W/D 
If W/D 
AP View 
 
 
 
 
 
 
 
 
Lateral View 
 
 
 
 
 
 
 
 
RSA Exam (supine) 
 
 
 
  
(dbl exam)  
 
 
 
 
 * ROM optional at 6 weeks only 
 ** As Needed 
 
 
 
  *** As Applicable  
 
 

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2 INTRODUCTION 
2.1 
Background 
Hip replacement, or arthroplasty, is a surgical procedure in which the diseased or damaged parts of 
the hip or hip joint are removed and replaced with prosthetic implants in the proximal femur (stem) 
and the acetabulum (cup or shell). The most common reason that people have hip replacement 
surgery is the wearing out of the hip joint as a result of osteoarthritis. Other conditions, such as 
rheumatoid arthritis (a chronic inflammatory disease that causes joint pain, stiffness and swelling), 
avascular necrosis (loss of bone caused by insufficient blood supply), injury (such as fracture), and 
bone tumors also may lead to breakdown of the hip joint and the need for hip replacement surgery.   
2.2 
Radiostereometric Analysis (RSA) 
Radiostereometric Analysis is an accurate method of determining the migration of orthopaedic 
implants such as total hip arthroplasties.  RSA is able to measure micromotion of the hip implant 
and this information can determine the early fixation of the implant in a short period of time. 
To date, there are no known publications on RSA data evaluating migration of the Pinnacle 
Acetabular Shell.  Therefore, in order to evaluate future hip replacement products, a baseline value 
for the Pinnacle Acetabular Shell must be determined. 
 
2.3 
Study Article Description 
Pinnacle Acetabular Shells come in several configurations based on the number of screw holes 
available in the implant.  The shells also are available in different fixation surfaces.  In this study, 
the Sector style cup with Gription Porous Coating (Pinnacle Acetabular Shell) will be evaluated for 
micromotion.  Gription Porous Coating combines macrotexture and microtexture topographies 
allowing cell adhesion and proliferation. 
 
2.4 
Benefits/Risks 
2.4.1 Benefits 
The primary goal of total hip arthroplasty is the anatomic reconstruction of the hip joint, resulting in 
favorable prosthetic joint load and function.  Mechanically, the goals are to create a stable 
articulation with an optimized range of motion, restore biomechanics for muscular efficiency and 
equalize limb lengths. 
 
 
 
 
 

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2.4.2 Risks 
The most commonly reported adverse events related to the study device are: 
 
• Trochanteric bursitis 
• Wound problems 
• Musculoskeletal problems 
• Dermatological problems 
• Pain 
The following may occur with any hip arthroplasty, including the study device: 
GENERAL 
• Change in position of the prosthetic components 
• Early or late loosening of the prosthetic components 
• Fatigue fracture of the femoral stem 
• Excessive wear or fracture of the bearing components 
• Early or late infection 
• Peripheral neuropathies. Subclinical nerve damage may also occur as a result of surgical 
trauma 
• Tissue reactions, osteolysis, and/or implant loosening caused by metallic corrosion, allergic 
reactions, wear or particulate debris 
INTRAOPERATIVE 
• Acetabular perforation 
• Femoral shaft perforation, fissure or fracture, which may require the use of internal fixation 
• Trochanteric fracture 
• Damage to blood vessels 
• Temporary or permanent nerve damage 
• Subluxation or dislocation of the hip joint due to implant size or configuration selection, 
positioning of components and /or muscle and fibrous tissue laxity 
• Lengthening or shortening of the affected extremity 
EARLY POSTOPERATIVE 
• Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial 
infarction 
• Hematoma and/or delayed wound healing 
• Pneumonia and/or atelectasis 
• Subluxation or dislocation 
 
 
 
 
 
 
 
 
 
 

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LATE POSTOPERATIVE 
 
• Trochanteric avulsion from excessive muscular tension, weight-bearing, or inadvertent 
intraoperative weakening of the trochanter 
• Aggravation of problems in the ipsilateral or contralateral knee and ankle joints 
• Femoral or acetabular fracture due to trauma or excessive loading 
• Bone resorption which may contribute to the deterioration of fixation and eventual loosening 
of the implant 
• Periarticular calcification or ossification which may lead to a decrease in joint mobility and 
range of motion 
• Traumatic arthrosis of the ipsilateral knee secondary to intraoperative positioning of the 
extremity during surgery 
• Subluxation or dislocation 
3 PURPOSE 
3.1 
Primary Objective and Endpoint 
The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular 
Shell using model-based RSA over the first two years post-implantation.  The primary endpoint is 
the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as 
measured with RSA.  This will be summarized for each surgical approach separately, as well as 
combined.  
 
3.2 
Secondary Objectives and Endpoints 
Secondary objectives are: 
• To establish the subsidence profile of the Pinnacle Acetabular Shell; this will be accomplished 
by determining the mean subsidence at 3 months, 6 months and 1 year as measured with RSA.  
• Other RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and 
maximal total point motion in mm) at all time points. 
• Linear head penetration (in mm) at 1 year and 2 years.  This will be summarized for each 
surgical approach separately, as well as combined. 
• Functional and health status will be measured with Harris Hip Score, HOOS Jr. and Forgotten 
Joint Score (FJS-12). 
3.3 
Exploratory Objectives and Endpoints 
The following will be summarized as exploratory analyses: 
•  
• Analyses to examine the correlation of functional and health status outcomes vs. RSA 
observations may be explored. 
 
 
 

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3.4 
Safety Endpoints 
The type and frequency of serious, non-serious, and device or procedure related AEs across all 
study intervals will be summarized. 
3.5 
Device Description 
All components involved in this clinical investigation are commercially available.  The part 
numbers allowed by this protocol are listed in Appendix A. 
 
Pinnacle Acetabular Shell 
The shells are designed to assemble with the polyethylene insert.  The style utilized in this clinical 
investigation are the Gription-coated, Sector Series shells. 
 
AltrX Polyethylene Liner 
The liners are available as several options: Neutral, +4 Neutral, +4 10°, and Lipped.  It is at the 
surgeon’s discretion as to which version is most appropriate for the individual study subject. 
 
Femoral Head 
Only Articul/eze 12/14 metal heads are allowed for this clinical investigation.  Suggested head size 
will be 32 mm diameter for acetabular cup sizes of 48-54 mm, and 36 mm diameter for sizes 56-66 
mm; other on-label combinations are allowable for this protocol. 
 
Corail Femoral Stem 
The Corail femoral stem is an HA coated stem available in several sizes.  Three offset options are 
available and is at the surgeon’s discretion as to which size and offset is most appropriate for the 
individual study subject.   
 
4 SUBJECT DEFINITION 
This study will include subjects aged 21 or older who are scheduled to undergo unilateral joint 
replacement.  Subjects who do not meet all inclusion criteria or who meet any of the exclusion 
criteria will be excluded from study consideration and participation.  Subjects who meet all entry 
criteria and are properly consented may be excluded from further participation due to study 
withdrawal, see Section 8 for details. 
 
 
 
 
 
 
 
 
 
 

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4.1 
Inclusion Criteria 
Subjects meeting all the following specific criteria will be considered for participation in the study: 
a) Individuals requiring primary THA for a severely painful and/or disabled joint from 
osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of 
the femoral head or acute traumatic fracture of the femoral head or neck. 
b) Individuals who are able to speak, read and comprehend the informed patient consent 
document and willing and able to provide informed patient consent for participation in the 
study and have authorized the transfer of his/her information to DePuy Synthes. 
c) Individuals who are willing and able to return for follow-up as specified by the study protocol. 
d) Individuals who are a minimum age of 21 years at the time of consent. 
e) Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as 
specified by the study protocol. 
4.2 
Exclusion Criteria 
Subjects will be excluded from participation in the study if they meet any of the following criteria: 
 
a) Individuals have active local or systemic infection. 
b) Individuals who have loss of musculature, neuromuscular compromise or vascular 
compromise that would impact rehabilitation following surgery. 
c) Individuals with poor bone quality, such as osteoporosis, where in the surgeon’s opinion, there 
could be considerable migration of the prosthesis or require additional acetabular cup fixation 
using screws, or a significant chance of fracture of the femoral shaft and/or the lack of 
adequate bone to support the implant(s). 
d) Individuals with Charcot’s or Paget’s disease. 
e) Individuals who, in the judgement of the investigator, would not be a candidate for protocol 
allowable components to be used for their THA. 
f) Women who are pregnant or lactating. 
g) Individuals who have had a contralateral hip that was implanted less than 6 months prior to 
the time of consent into this study or individuals that expect to have a contralateral hip 
implanted in the following 6 months at the time of consent into this study. 
h) Individuals that have amputations in either leg that would impact rehabilitation following 
surgery. 
i) Individuals who are bedridden 
j) Individuals that have participated in a clinical investigation with an investigational product 
(drug or device) in the last three months. 
k) Individuals currently involved in any personal injury litigation, medical-legal or worker’s 
compensation claims. 
l) Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a 
psychological disorder that could affect their ability to complete patient reported 
questionnaires or be compliant with follow-up requirements. 
 
 

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m) Individuals diagnosed and taking prescription medications to treat a muscular disorder that 
limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia. 
n) Subject has a medical condition with less than 2 years life expectancy. 
o) Individual has a BMI >45 kg/m2. 
4.3 
Definition of Subject Enrollment 
A patient will be considered enrolled when they have provided signed Informed Consent Document 
(ICD) to participate in this Investigation, which includes authorization of the release of his/her 
Protected Health Information (PHI). 
5 STUDY DESIGN 
This study is designed as a prospective, multi-center, non-randomized, non-controlled study.  This 
study does not limit the procedures involved in the treatment of the subject as long as the protocol 
specified products are utilized. 
5.1 
Subject Enrollment 
No protocol specified activities can be completed until written Informed Consent is obtained for 
that Subject.  Standard of care radiographs that have been taken prior to consent may be used for the 
purposes of the protocol as long as they were taken within 270 days of surgery. 
5.1.1 Subject Screening and Informed Consent 
As patients are being scheduled for primary, unilateral THA, the Principal Investigator or a trained 
designee at each of the sites will conduct a preliminary screen to determine if the patient meets 
general requirements for the study.  If a patient appears to be eligible, delegated staff will offer 
study participation to those patients.  Having explained the study purpose to the Subject, the 
Investigator or trained designee shall offer to answer any of the Subject’s questions.  If the Subject 
then agrees to participate, his or her willingness must be documented via his/her name, signature 
and date on the REB’s approved ICD and this document countersigned and dated by the person 
taking consent.  The signed ICD will then be placed into the Subject’s Medical Record.  Screening, 
consenting and enrollment are illustrated in Figure 5.1. 
 
The Principal Investigator is responsible for ensuring that no subject will be included in the study 
without adequate informed consent.  Failure to obtain and properly document this process is in 
violation of 21 CFR Part 50, the Declaration of Helsinki and this study protocol.  All ICDs must 
have approval by the responsible REB.  Consent of a subject needs to come from the Subject 
themselves and be documented on an ICD. 
 
After Informed Consent, study subjects will be defined as ‘enrolled’.  Delegated office research 
staff will then assign a Subject ID number to each enrolled subject.  Each subject will be identified 
by site or surgeon number (e.g. 01, 02) followed by -001 for the first subject, -002 for the second 
subject and so on.  Together the site/surgeon number and the Subject number will comprise the 
unique Subject ID.  This unique identifier will be recorded in the Subject’s ICD, medical record and 
the Screening and Enrollment Log. 
 

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Delegated site research staff should then record the following information into the Screening and 
Enrollment Log: 
• Subject ID; 
• Date of Screening; 
• If applicable, primary reason for not including the patient (e.g., does not satisfy eligibility 
criteria, not interested in participating). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 5-1 Screening and Enrollment Process 
Review Clinical Schedule for 
Pre-op THA patients
Based on Preliminary 
Info, does Patient Meet 
Eligibility?
No Documentation 
Needed
Invite Patient to Participate in 
the Study and document on 
Screening and Enrollment Log
Was Consent 
Successful?
Document Screen 
Failure on Screening 
and Enrollment Log
Subject Enrolled
Assign Subject 
Number
Subject Meets All 
Inclusion and No 
Exclusion?
Withdraw Subject
Proceed with Study 
Requirements
               YES
   YES
                        YES
             YES
NO
NO
NO
             YES
 
 
 
 
 
 

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6 STUDY PROCEDURES 
6.1 
Pre-Operative (-90 days to Day of Surgery) 
Following informed consent and eligibility verification, the subject will have the following pre-
operative health and functional status evaluations: 
 
The subject’s orthopaedic medical history and current diagnoses will be documented. Data collected 
will include but is not be limited to: 
• Age, gender, height and weight 
• History of concurrent or previous medical issues 
• History of previous treatment to the index hip 
• Harris Hip Score 
• HOOS Jr. 
• Radiographs  
o AP Femur* 
o Lateral 
*The AP Femur is the preferred view at all time points, however an AP Pelvis will also be accepted. 
 
The information collected from the ‘Pre-Op’ visit will be populated on the appropriate eCRFs as 
indicated in the Time and Events Table (Section 1.1).  If pre-operative radiographs of sufficient 
quality were obtained within 270 days of surgery, then they do not need to be repeated just for the 
purpose of this study. 
6.2 
Operative (Day 0) 
Each subject will receive an uncemented Corail femoral stem in combination with a Pinnacle Sector 
Acetabular cup.  All subjects will receive a metal femoral head and an AltrX Polyethylene liner.  No 
screw fixation of the Sector cup is allowed by this protocol.  If the surgeon deems that screw 
fixation or any component other than those listed in the protocol is required for that subject, that 
subject will be withdrawn from the study. Subjects that are withdrawn pre-operatively or intra-
operatively will be replaced in order to have 30 subjects in each surgical approach.   
 
Three surgical approaches will be used for the purpose of this study: posterior, anterior, and lateral.  
Each surgeon shall perform the approach they are most comfortable with and have the greatest 
expertise.  In general, subjects enrolled at the Winnipeg site will undergo a posterior approach or 
direct lateral approach.  Subjects enrolled at the London site will undergo a direct anterior approach, 
direct lateral approach or posterior approach.  Enrollment will be closely monitored to ensure a 
minimum of 30 subjects are enrolled in each surgical approach group.  Once a group has reached 30 
implantations, Investigators of that approach group will be informed to halt enrollment of further 
subjects.  If over 30 subjects are enrolled per approach, the additional subjects will be treated as any 
other study subject (i.e. exams, follow-up, analysis). 
 
Implant sizing shall be performed as per the surgeon’s discretion for each individual subject and 
will not be standardized between sites. Approximately 5-10 tantalum beads will be placed into the 

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acetabulum.  Bead placement will be standardized across study sites to reduce the possibility of un-
useable RSA exams resulting from poor bead spacing or bead occlusion. 
 
Any intra-operative adverse events will be captured as well as details of the surgery and 
implants/components used.  The information collected from the ‘Operative’ time-point will be 
populated on the appropriate eCRFs as indicated in the Time and Events Table (Section 1.1). 
6.3 
Prior to Discharge (Day 1 to Discharge) 
Subjects will undergo the standard of care for total hip arthroplasty at the participating sites, 
including bandaging, anti-coagulation, antibiotic and/or physiotherapy protocols.  Adverse events 
and post-operative complications will be collected. 
 
The information collected from the ‘Prior to Discharge’ time-point will be populated on the 
appropriate eCRFs as indicated in the Time and Events Table (Section 1.1). 
6.4 
6 Weeks (Day 28-56) 
All subjects will undergo a model-based RSA examination.  For all sites, the 6-week exam will be 
used as the reference examination.  RSA radiographs will be obtained with subjects in a supine 
position.  A duplicate RSA exam will be conducted at this time-point to calculate the intra-subject 
measurement error.   
 
Additionally, the subject will have the following health and functional status evaluations: 
 
• Harris Hip Score; ROM optional 
• Hip Evaluation 
• HOOS Jr. 
• Forgotten Joint Score 
• Adverse Events (if applicable) 
• Radiographs  
o AP Femur 
o Lateral 
 
The information collected from the ‘6 Week’ visit will be populated on the appropriate eCRFs as 
indicated in the Time and Events Table (Section 1.1). 
NOTE: Any subject that is unable to complete their 6 week visit due to the COVID-19 Pandemic 
can be replaced; as many endpoints use this timepoint as the baseline value.  Subjects unable to 
complete their 6 week visit will not be withdrawn because of this missing visit but continue to be 
followed according to the protocol. 
 
 
 
 
 
 

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6.5 
3 Month, 6 Month, 1 Year and 2 Year Visits 
The subject will have the following health and functional status evaluations: 
 
• Harris Hip Score 
• Hip Evaluation 
• HOOS Jr. 
• Forgotten Joint Score 
• Adverse Events (if applicable) 
• Radiographs  
o AP Femur 
o Lateral 
• RSA Exam (supine position) 
 
The information collected from these visits will be populated on the appropriate eCRFs as indicated 
in the Time and Events Table (Section 1.1). 
6.6 
Unscheduled Visit 
If a subject requires an additional visit during a study interval for their study hip, and is seen by one 
or more person listed on the Delegation of Authority Log, then the following information shall be 
repeated: 
 
• Harris Hip Score 
• Hip Evaluation 
• HOOS Jr. 
• Forgotten Joint Score 
• Adverse Events (if applicable) 
 
If a subject has an unscheduled visit after the 6 week interval (outside defined protocol window) for 
their study hip, with one or more person listed on the Delegation of Authority Log then the 
following information shall be collected: 
• Harris Hip Score 
• Hip Evaluation 
• HOOS Jr. 
• Forgotten Joint Score 
• Adverse Events (if applicable) 
• Radiographs  
o AP Femur 
o Lateral 
• RSA Exam (supine position) if RSA Exam was not conducted in-window for previous visit.  
If subject is seen multiple times outside of the same defined protocol window, only one RSA 
Exam is required. 
 
 
 

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6.7 
Radiostereometric Analysis (RSA) 
The RSA analysis will be the responsibility of the Canadian RSA Network.  In summary, model 
based RSA software (RSAcore, Leiden, Netherlands) will be used for analysis, employing 
computer-models of the DePuy Synthes implants and inserted beads representing the bone rigid 
body.  A central analysis service will be employed to analyze anonymized radiographs in a standard 
manner.  DePuy Synthes will provide production CAD models as required for this analysis.  
 
Three-dimensional migration measurements will be made of the acetabular shell relative to the bone 
beads.  The 6-week examination will be used as reference against which the 3-month, 6-month, 1-
year and 2-year post-operative exams will be compared.  Results obtained from the model based 
RSA software will be changes from the 6-week (baseline) examination and will report the following 
at 3 months, 6 months, 1 year and 2 years:  
• X, Y and Z translation measurements in mm from baseline;  
• X, Y and Z rotation measurements in degrees from baseline; 
• Maximal total point motion (one measurement in mm of maximal migration). 
Three-dimensional migration of the Pinnacle Acetabular Shell shall be determined from the 
software.   
 
Linear head penetration (in mm) will be performed by examining the change in distance between 
the center of the femoral head and the center of the acetabular shell between the 6-week (baseline) 
exam and 1 year and 2 year exam.  The femoral head center is determined by fitting a CAD sphere 
to the articular region of the femoral head (ignoring the trunnion area).  The acetabular shell center 
is determined in a similar manner but also uses the silhouette of the cup face to determine its’ 
centerpoint. 
 
7 ADVERSE EVENT REPORTING 
7.1 
Adverse Events 
An Adverse Event is any untoward medical occurrence in a subject, regardless if there is a 
relationship between the adverse event(s) and the study device(s).  
At each evaluation of the subject enrolled in a clinical investigation, the Investigator determines 
whether any adverse events (AE) have occurred and determines their relationship to the study 
devices or procedure. For the purposes of this study, only serious adverse events (see Section 7.2), 
device and/or procedure related adverse events will be reported to the Sponsor. 
All reportable adverse events, study device malfunctions and other product issues must be recorded 
in the medical records and entered into electronic Case Report Forms (eCRFs) within two weeks of 
awareness the AE occurred.  Upon entry of an AE into the eCRF, designated members of the DePuy 
Synthes clinical team will receive an email alert describing the AE.   
 
 

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7.2 
Serious Adverse Events 
Serious Adverse Events (SAEs) are defined as any adverse event that: 
1. Led to a death, 
2. Led to a serious deterioration in the health of the subject that, 
a. Resulted in life-threatening illness or injury, 
b. Resulted in permanent impairment of a body structure or a body function, 
c. Required in-patient hospitalization or prolongation of existing hospitalization 
d. resulted in medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function, 
3. Led to fetal distress, fetal death or a congenital abnormality or birth defect 
A planned hospitalization and/or medical intervention for pre-existing conditions documented in the 
study records that have not changed in severity, or a procedure required by the protocol, without 
serious deterioration in health, is not considered to be a serious adverse event. 
Investigator must submit to DePuy Synthes any SAEs occurring during the study as soon as possible, 
but within 72 hours, after becoming aware of the event and provide additional information if required 
by DePuy Synthes.  All SAEs need to be followed until the event is resolved (with or without 
sequelae), additional information is located in Section 7.3. The Study Safety Lead of this study will 
decide if more follow-up information is needed (via electronic queries) in case the event is not 
resolved at study completion. 
The Investigator notifies his/her REB of all SAEs as required by REB policy (and any additional 
information as required by REB). All SAEs are to be reported to the Sponsor. 
7.3 
 Duration of Follow-up After Adverse Events 
The Investigator should ensure that adequate medical care is provided to any subject for any adverse 
events related to the study. 
Only SAE, device and/or procedure related Adverse Events will be collected for the purposes of this 
study. All device or procedure adverse events should be followed until the condition has resolved, 
or in the case of permanent impairment until the condition stabilizes and clinical outcome has been 
ascertained, or the study has been completed.  
7.4 
Reporting an Adverse Event 
Adverse events are reported from the time of surgery until the subject’s study participation has 
ended (i.e. completion of study or withdrawal of consent). All reported AEs must be followed until 
the AE has resolved, stabilized, or the study has been completed. Any medical event, that if it had 
occurred post-operatively would be considered a Serious adverse event, that occurs prior to surgery 
is to be reported as history on the Medical History eCRF. 
The Investigator will record the nature, severity, treatment and outcome of the AE, and will 
determine its relationship to the investigational products or any protocol mandated procedures 
involved in the clinical study. 
The determination whether the AE is related to the device and/or procedure will be based upon 
whether a causal relationship between the device and/or procedure and the AE is at least a 

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reasonable possibility, i.e. the relationship cannot be ruled out. A causal relationship cannot be ruled 
out if, in the medical judgment of the Investigator, the effect follows a reasonable temporal 
association with the use of the device and/or is confirmed by the improvement of the effect upon 
discontinuation of the clinical use of the device, and/or the effect is not reasonably explained by the 
Subject’s clinical state.  
Relationship to study device or procedure should be rated as follows:  
1) Not related (definitely not related): there is no relationship between study device and/or 
procedure and the event.  
2) Possibly related (remote possibility, possibly, or probably related): the relationship between 
study device and/or procedure could exist if there is no contradicting evidence that can reasonably 
explain the Subject’s condition.  
3) Definitely related (definitely related): the relationship between study device and/or procedure and 
event does exist and is confirmed upon further investigation by the Investigator.  
 
The following categories of adverse event severity are to be used: 
Mild 
Awareness of sign or symptom that does not interfere with the 
subject’s usual activity or is transient, resolved without 
treatment and with no sequelae, 
Moderate 
Interferes, but does not hinder, the subject’s usual activity and 
may require treatment, 
Severe 
Symptom(s) causing severe discomfort and significant impact 
on the subject’s usual activity and requires treatment or 
intervention. 
 
 
 
Adverse events will be reported by the Investigator to DePuy Synthes via the Adverse Events 
eCRF.   
 
NOTE: Please refer to Appendix B (Anticipated Adverse Events) where a listing of common 
surgical adverse events is listed.  These adverse events are anticipated and assuming the events are 
consistent with the normal postoperative course, then they do not have to be reported as adverse 
events. 
 
 
 
 
 
 
 

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8   EARLY DISCONTINUATION 
8.1 
Reasons for Early Discontinuation 
Possible reasons for early discontinuation may include, but are not limited to the following: 
• 
Withdrawal of consent: Subject decides to withdraw from the study. This decision must be an 
“independent decision” that is documented in the patient study files; 
• 
Adverse event: Adverse event or serious adverse event may not lead to subject discontinuation 
from the study. If the Investigator decides to discontinue further study related procedures, the 
subject must still be followed until the adverse event resolves or until a stable clinical endpoint 
is reached, or the subject withdraws consent (i.e. the subject will continue to be followed for 
safety); 
• 
If the surgeon deems that screw fixation or any component other than those listed in the protocol 
is required for that subject; 
• 
Revision of any component; 
• 
Death, and/or 
• 
Early study termination: DePuy Synthes can decide to discontinue the study prematurely for 
various reasons. 
 
8.2 
Subject Early Discontinuation 
Every subject should be encouraged to remain in the study until they have completed the protocol-
required 2-year follow-up period. If the subject discontinues prematurely from the study, the reason 
for discontinuation must be documented in the source documents and site files and submitted via 
eCRF. 
Data which have been received on subjects who discontinue prematurely will be included in the 
analysis of results. Subjects who discontinue prematurely, excluding those withdrawn pre-
operatively, intra-operatively or those subjects who were unable to complete their 6 week visit due 
to the COVID-19 Pandemic, will not be replaced.   
 
8.3 
Study Early Discontinuation 
DePuy Synthes reserves the right to temporarily suspend or prematurely discontinue this study 
either at a single site, multiple sites, or at all sites at any time for reasons including, but not limited 
to, safety or ethical issues, inaccurate or incomplete data recording, non-compliance, or 
unsatisfactory enrollment with respect to quality or quantity.    
If the study is prematurely terminated or suspended, DePuy Synthes or its representatives will 
inform the Investigators/institutions of the termination or suspension and the reason(s) for the 
termination or suspension, in accordance with applicable regulatory requirement(s). The REB 
should also be informed and provided with reason(s) for the termination or suspension by DePuy 
Synthes or by the Investigator/institution, as specified by the applicable regulatory requirement(s). 
In addition, arrangements will be made for the return of all study material in accordance with 
Sponsor procedure for the study. 

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9 STATISTICAL METHODOLOGY  
The following sections provide a general description of the statistical plan for the analysis of study 
data.  A separate Statistical Analysis Plan (SAP) document that provides greater detail on data 
derivations and the analyses to be performed will be finalized prior to database lock.   The SAP will 
reflect the protocol and any amendments that have been implemented at the time the SAP is 
finalized.  Any deviations from the final SAP will be noted in the final clinical summary report. 
9.1 
Study Design 
This is a prospective, multi-center, non-randomized, non-controlled study designed to establish the 
2-year migration profile of the Pinnacle Acetabular Shell when implanted using 3 different surgical 
approaches: posterior, anterior, and lateral.  
9.2 
Treatment Assignment 
Subjects enrolled will undergo THA using the study devices listed in Section 3.5 and one of the  
surgical approaches under study: posterior, anterior, and lateral. Centers will be selected for their 
expertise in one or more of the surgical approaches. Each surgeon will perform the approach they 
are most comfortable with and have the greatest expertise. In general, subjects enrolled at the 
Winnipeg site will undergo a posterior approach or direct lateral approach. Subjects enrolled at the 
London site will undergo a direct anterior approach, direct lateral approach or posterior approach.  
Enrollment will be closely monitored to ensure a minimum of 30 subjects are enrolled in each 
surgical approach group. Once a group has reached 30 implantations, Investigators of that approach 
group will be informed to halt enrollment of further subjects. 
9.3 
Randomization and Blinding Procedures 
Not applicable. 
9.4 
Interval Windows 
Data collected throughout the study will be assessed for compliance with the protocol-specified visit 
schedule. Error! Reference source not found.Six windows are defined based on the number of 
days prior to or after surgery, Day 0.  Visits conducted within the intervals shown in Table 9-1 will 
be assessed for compliance with the protocol. If multiple visits fall into the pre-operative window, 
or into the 6 Week post-operative window, the result collected most proximate to surgery will be 
utilized.  If multiple measurements fall into the 3 Month, 6 Month, 1 Year, or 2 Year window, the 
last value (furthest from surgery) will be utilized for the analysis.  All safety data will be included in 
the Safety analysis.  
 
Table 9-1 Study Visit Interval Windows per Time and Events Table 
Study Visit 
Study Interval Window (days) 
Pre-Op 
-90 to DOS* 
Operative 
0 
Prior to Discharge 
Day 1 to Discharge 
6 Weeks 
28 to 56 
3 Months 
60 to 120 

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6 Months 
135 to 225 
1 Year 
275 to 455 
2 Years 
640 to 820 
* For radiographs Pre-Op study film window is from -270 days to DOS. 
 
9.5 
Analysis Sets 
 
Safety Analysis Set 
 
The Safety Analysis Set consists of all enrolled subjects who receive THA surgery.  Subjects will be 
analyzed according to the surgical approach applied during of the study.   
 
Per Protocol (PP) Analysis Set  
 
The Per Protocol (PP) Analysis Set will be a subset of Safety Set subjects who have no major 
inclusion/exclusion protocol violations, and who have a baseline RSA exam and at least one post-
baseline RSA exam. Subjects will be analyzed according to the actual treatment (surgical approach) 
received during of the study.   
9.6 
Primary and Secondary Endpoints and Associated Hypotheses 
There are no hypotheses associated with the primary or secondary endpoints; endpoints appear 
below. 
9.6.1 Primary Endpoint 
The primary endpoint is the RSA measured mean superior cup migration (Y translation subsidence 
in mm) at 2 years.  
9.6.2 Secondary Endpoints 
The secondary endpoints are the following: 
• RSA measured subsidence (superior cup migration) at 3 months, 6 months and 1 year. 
• Other RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and 
maximal total point motion in mm) at all time points 
• Linear head penetration at, 1 year and 2 years; 
• Harris Hip Score at 6 weeks, 3 months, 6 months, 1 year and 2 years; 
• HOOS Jr. at 6 weeks, 3 months, 6 months, 1 year and 2 years; 
• Forgotten Joint Score (FJS-12) at 6 weeks, 3 months, 6 months, 1 year and 2 years. 
9.6.3 Exploratory Endpoints 
The following will be summarized as exploratory analyses: 
• Correlation of functional and health status outcomes (Harris Hip Score, HOOS Jr, and FJS-
12) vs. RSA observations may be explored. 
 
 

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9.7 
Levels of Significance 
There are no specific hypotheses being tested in this study. To facilitate clinical interpretation, 
confidence intervals will accompany primary and secondary endpoint estimates and will be 2-sided 
95% confidence intervals; these confidence intervals are considered to be exploratory.  
 
9.8 
Sample Size Justification 
This study sample size was established to provide adequate precision on the mean subsidence 
estimate at 2 years for each surgical approach. A common standard deviation of 0.2 mm is 
anticipated. Based upon this standard deviation and a sample size of N=30, a 2-sided 95% 
confidence interval for each respective surgical approach is anticipated to have a margin of error 
equal to approximately 2SE = 2 ×
SD
√𝑛= 2 ×
0.2
√30 =  0.073 mm. This margin of error was deemed to 
be an adequate level of precision by the Sponsor. 
9.9 
General Conventions 
All statistical analysis will be performed using SAS® Version 9.3 or higher, unless otherwise noted. 
A separate Statistical Analysis Plan (SAP) will provide detail on data derivations and the analyses 
to be performed for the final study report. It will be approved prior to database lock. 
Descriptive statistics for continuous variables will include the number of subjects with an 
observation, mean, standard deviation (SD), median, minimum, and maximum.  Descriptive 
statistics for dichotomous/categorical variables will include the count and percentage of subjects in 
each category.  
Unless specifically stated otherwise, all endpoints will be analyzed by surgical approach and 
overall, pooling all surgical approaches. 
9.10 Disposition of Study Subjects 
An overall summary of the number of subjects in each analysis set (Safety and Per Protocol) who had 
major protocol deviations, who withdrew before study completion, and who completed the study will 
be tabulated for all surgical approaches combined.   
A patient accounting table to present the number of subjects in the Safety Analysis Set at each visit 
interval will be summarized: theoretical due, deaths, withdrawn, and expected due in the interval.   
 
9.11 Demographic and Baseline Characteristics 
Descriptive statistics summarizing demographics and baseline characteristics will be displayed for 
both the Safety Analysis Set and the Per Protocol Analysis Set.  These summaries will include, but 
are not limited to, age, gender, BMI, general medical conditions, Harris Hip Score, Hoos Jr. and 
Forgotten Joint Score. 
9.12 Primary, Secondary, and Safety Endpoint Analyses 

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9.12.1 Primary Endpoint Analysis 
 
RSA Measured Subsidence at 2 years 
The primary endpoint of RSA measured subsidence (Y translation, also known as superior cup 
migration) results in the 2-year visit window will be summarized on the subset of subjects in the Per 
Protocol Analysis Set (primary analysis) who have 6 week and 2 year data for the analysis.  The 
analysis will also be conducted on the subset of subjects in the Safety Analysis Set (supportive 
analysis) who have 6 week and 2 year data for the analysis. Standard continuous summaries will be 
provided along with 95% confidence intervals. These summaries will be provided for each surgical 
approach, as well as combined.  
 
9.12.2 Secondary Endpoint Analysis 
RSA Measured Subsidence at 3 months, 6 months and 1 year 
The analysis for this secondary endpoint will be identical to the analyses described for the primary 
endpoint except conducted on the results in the 3 month, 6 month, and 1 year visit windows, 
respectively, using the Per Protocol Analysis Set and the Safety Set.  
 
 
Linear Head Penetration at 1 year and 2 years 
Linear head penetration will be assessed at 6 weeks, 1 year and 2 years.  Results within each visit 
window will be summarized and changes from baseline will be provided using the Per Protocol 
Analysis Set. 
 
Harris Hip Score at 6 weeks, 3 months, 6 months, 1 year and 2 years 
Harris hip scores are assessed at the Pre-Op visit and at 6 weeks, 3 months, 6 months, 1 year and 2 
years. Results within each visit window will be summarized and changes from baseline will be 
provided using the Per Protocol Analysis Set. Standard continuous summaries will be supplemented 
with 95% confidence intervals. The ROM at 6 weeks is considered optional; the score will be 
missing for subjects for whom ROM was not performed. 
 
HOOS Jr. Score at 6 weeks, 3 months, 6 months, 1 year and 2 years 
HOOS Jr. Score are assessed at the Pre-Op visit and at 6 weeks, 3 months, 6 months, 1 year and 2 
years. Results within each visit window will be summarized and changes from baseline will be 
provided using the Per Protocol Analysis Set. Standard continuous summaries will be supplemented 
with 95% confidence intervals.  
 
Forgotten Joint Score (FJS-12) 
FJS-12 are assessed at the 6 week visit and at  3 months, 6 months, 1 year and 2 years. Results 
within each visit window will be summarized and changes from baseline will be provided using the 
Per Protocol Analysis Set. Standard continuous summaries will be supplemented with 95% 
confidence intervals.  
 

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9.12.3 Exploratory Endpoint Analysis 
Exploratory analyses will include the following: 
• Correlation of functional and health status outcomes (Harris Hip Score, HOOS Jr, and FJS-
12) vs. RSA observations may be explored. 
9.13 Safety Endpoint Analysis 
Adverse Events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA) version 21.1. Analyses will be conducted for all subjects in the Safety Analysis Set.   
An overall summary of the AE incidence within each surgical approach group will be presented and 
will include the number and percentage of subjects having one or more: 
• Serious adverse event (SAE) 
• Device related AEs 
• Procedure related AEs 
• Withdrawals due to AE 
• Deaths 
The number (%) of subjects with adverse events will be presented by MedDRA system organ class 
(SOC) and preferred term (PT) for all device related AEs, procedure related AEs and SAEs. A 
subject-level listing will be provided to display details of all reported AEs. 
9.14 Plans for Interim Analysis 
There are no formal interim analyses that are designed to potentially stop or change the study 
design. A planned interim summary analysis will take place after all subjects have completed the 1 
year visit in order to give product development an understanding of acetabular cup subsidence that 
might be expected for future product development purposes.  There is no intention to utilize this 
interim analysis as a means to justify stopping the study early.  
9.15 Handling of Missing Data 
Only subject data which is collected in the study will be utilized in analyses; there will be no 
imputation of missing data.   
10 STUDY MANAGEMENT AND ADMINISTRATION 
10.1 Investigator Responsibilities 
In conducting this clinical study, the Investigator is responsible for: 
• Ensuring that the clinical study is conducted according to the Declaration of Helsinki, 
applicable local regulations, the clinical study agreement and the protocol; 
• Protecting the rights, safety and welfare of subjects under the Investigator’s care; and 
• Ensuring the integrity of the data. 
 
Prior to the initiation of this clinical study at each site, the responsible Principal Investigator will 
approve this protocol by signing the signature page.  This signature confirms that the clinical study 
will be performed in compliance with the protocol. 
 

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10.2 Good Clinical Practice  
The study will be conducted in accordance with the GCP and the appropriate regulatory 
requirement(s). The Investigator will be thoroughly familiar with the appropriate use of the study 
device as described in the Instructions for Use. Essential clinical documents will be maintained to 
demonstrate the validity of the study and the integrity of the data collected. Master files should be 
established at the beginning of the study, maintained for the duration of the study and retained 
according to the appropriate regulations.  
 
10.3 Ethical Considerations  
The study will be conducted in accordance with ethical principles founded in the Declaration of 
Helsinki.  The REB will review all appropriate study documentation in order to safeguard the rights, 
safety, and well-being of the subjects. The study will only be conducted at sites where initial and 
annual REB approval has been obtained. In addition, a copy of the REB approval letter must be 
filed on site in the Investigator’s study files.  
 
The protocol, Instructions for Use, informed consent form, advertisements (if applicable), written 
information given to the subjects, safety updates, annual progress reports, and any revisions to these 
documents will be provided to the REB by the Investigator. When applicable, amendments to the 
protocol will be submitted for REB review before implementation.  
 
10.4 Subject Information and Informed Consent  
After the study has been fully explained, written informed consent will be obtained from either the 
subject or his/her guardian or legal representative prior to study participation. The method of 
obtaining and documenting the informed consent and the contents of the consent will comply with 
GCP and all applicable regulatory requirement(s), which at a minimum include: 
• 
The most current, approved ICF is completed by the subject prior to the start of study 
specific procedures; 
• 
The subject personally signed and dated the ICF; 
• 
The investigator or designated study personnel has also signed and dated the ICF; 
• 
The subject’s source describes the consent process, including date, by whom, that the 
subject had an opportunity to ask questions, and that they were offered a copy of their 
signed ICF; and 
• 
The signed ICF(s) are retained by the investigator and are available for inspection. 
 
10.5 Subject Confidentiality  
In order to maintain subject privacy, all eCRFs, study device accountability records, study reports 
and communications will identify the subject by the assigned subject number. The Investigator will 
grant monitor(s) and auditor(s) from the Sponsor or its designee and regulatory authority(ies) access 
to the subject’s original medical records for verification of data gathered on the eCRFs and to audit 

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the data collection process. The subject’s confidentiality will be maintained and will not be made 
publicly available to the extent permitted by the applicable laws and regulations.  
 
10.6 Direct Access to Source Data  
The study will be monitored by DePuy Synthes or its designee. Monitoring will be done by personal 
visits from a representative of DePuy Synthes (site monitor) and will include on-site review of the 
eCRFs for completeness and clarity, cross-checking with source documents, and clarification of 
administrative matters will be performed. The review of medical records will be performed in a 
manner to ensure that subject confidentiality is maintained.  
 
The site monitor will ensure that the investigation is conducted according to protocol design and 
regulatory requirements by frequent communications (letter, telephone, e-mail and/or fax).  
Regulatory authorities, the REB, and/or DePuy Synthes quality assurance group may request access 
to all source documents, eCRFs and other study documentation for on-site audit or inspection. 
Direct access to these documents must be guaranteed by the Investigator, who must provide support 
at all times for these activities.  
 
10.7 Case Report Form Completion  
An electronic data capture system, compliant to 21 CFR Part 11, will be used to collect data from 
this study.  
 
eCRFs will be completed for each study subject. It is the Investigator’s responsibility to ensure the 
accuracy, completeness, and timeliness of the data reported in the subject’s eCRF. Source 
documentation supporting the eCRF data should indicate the subject’s participation in the study and 
should document the dates and details of study procedures, adverse events, and subject status.  
The Investigator, or designated representative, should complete the eCRF pages as soon as possible 
after information is collected, preferably on the same day that a study subject is seen for an 
examination, treatment, or any other study procedure. Any outstanding entries must be completed 
immediately after the final examination. An explanation should be given for all missing data.  
10.8 Record Retention  
 
The Investigator will maintain all study records according to GCP and applicable regulatory 
requirement(s). Records will be retained for at least 2 years after the completion of the clinical 
study, according to site procedures or according to applicable regulatory requirement(s) (whichever 
is longest). If the Investigator withdraws from the responsibility of keeping the study records, 
custody must be transferred to a person willing to accept the responsibility. The Sponsor must be 
notified in writing if a custodial change occurs.  
 
 
 
 
 

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Study documentation includes, but is not limited to, the following:  
• 
Source data, informed consents and enrollment logs  
• 
Correspondence with the REB, DePuy Synthes, the site monitor, or other Investigators  
• 
Study protocol and any amendments issued  
• 
Protocol and Informed Consent approvals from the REB 
10.9 Investigator agreements and curricula vitae of Investigator(s), and the Site Signature 
and Delegation Log Investigator Reports  
The Investigator(s) is required to complete the following reports:  
 
1. Withdrawal of REB Approval – Notification must be sent to the Sponsor within 5 working 
days  
2. Informed Consent – A report of any use of the investigational device without a signed 
Informed Consent form must be forwarded to the Sponsor and the REB within 5 working days 
of the occurrence  
3. Investigational Plan Deviations – Emergent deviations must be forwarded to the REB and the 
Sponsor as soon as possible and within 5 working days of the event. Any departures from the 
protocol must be fully documented in the eCRF and source documentation  
4. Progress Reports – Annual progress reports must be forwarded to the REB and the Sponsor  
5. Final Report – A final report/closure submission must be filed with the REB and the Sponsor 
within 3 months of the Investigator’s completion of study site closure. 
6. Principal Investigator(s) may delegate a qualified associate(s) to complete one or more of the 
above functions. However, the Principal Investigator retains the overall responsibility for 
subject safety, proper conduct of the study including obtaining subject consent, compliance 
with this study plan, and the collection of all required data.  
11   SPONSOR OBLIGATIONS  
11.1 Investigator(s) Training  
DePuy Synthes will select only Investigator(s) with extensive experience in THA. The protocol will 
be reviewed with the Investigator(s) and their study personnel at the Site Initiation Visit. 
Furthermore, they will be instructed on how to complete the study documentation.  
11.2 Study Monitoring  
Study monitoring will be carried out in compliance with FDA regulations (21CFR 812) and all GCP 
guidelines and will be consistent with the sponsor’s internal monitoring procedures. 
 
12   RESEARCH ETHICS BOARDS AND REGULATORY REQUIREMENTS 
12.1 REBs 
The protocol, informed consent form and other applicable study-related documents must be submitted 
to the appropriate REB and written approval must be obtained and submitted to DePuy Synthes prior 
to enrolling any subjects. 

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The Investigator will promptly report to the REB any change in the designation of Principal 
Investigator role and all unanticipated problems involving risks to human subjects and will not make 
any changes in the research plan without REB approval, except when necessary to eliminate 
immediate hazards to human subjects. Those amendments involving significant risk or change require 
REB approval and written documentation of this approval must be submitted to the DePuy Synthes. 
The Investigator must report to the REB at least yearly on the progress of the investigation.  A letter 
from the REB should document continuing REB review.  Notification to the REB by the Investigator 
within 3 months after completion, termination, or discontinuation of the study at the specific site must 
be documented. 
 
Other Investigator responsibilities to the REB and DePuy Synthes include the following: 
• During the conduct of the study, submit progress reports to the REB and Sponsor as required 
(Note: the annual progress report to the REB will fulfill the Investigator’s responsibility to 
submit progress reports to the Sponsor.  
• As required, obtain approval from the REB for protocol amendments and for revisions to the 
informed consent or subject recruitment advertisements.  
• Provide REB with any other information it requests before or during the conduct of the study. 
• Maintain a file of study-related information that includes all correspondence with the REB 
and Sponsor. 
• Notify REB within 3 months after study completion, termination or discontinuation. 
• Notify DePuy Synthes, within 5 working days, of withdrawal of approval by the reviewing 
REB.  
 
12.2  Protocol Amendments 
As appropriate, DePuy Synthes will submit changes in the protocol to the investigators, the 
appropriate regulatory authorities and REBs.  REB approval is required for all substantial 
amendments prior to implementation of any changes to study procedures. 
An amendment is regarded substantial when they are likely to have a significant impact on: 
• 
The safety or physical or mental integrity of the subjects; 
• 
Scientific value of the trial; 
• 
Conduct or management of the trial; 
• 
Quality or safety of an investigational medical product used in the trial. 
12.3 Protocol Deviations 
A protocol deviation is defined as a divergence from a specific element of a protocol (e.g., missed 
test or procedure, visit out of window, non-adherence to inclusion/exclusion criteria). 
Investigators may not deviate from the protocol except where necessary to protect the life or physical 
well-being of a subject in an emergency.  

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Deviations shall be reported to DePuy Synthes regardless of whether medically justifiable or taken to 
protect the subject in an emergency. Subject specific deviations will be reported in the eCRFs. 
Investigators will also adhere to procedures for reporting study deviations to their REB in accordance 
with their specific REB reporting policies and procedures.  Regulations require that Investigators 
maintain accurate, complete and current records, including documents showing the dates and reasons 
for each deviation from the protocol. 
 
13   PUBLICATION POLICY 
At the conclusion of the study, a multicenter manuscript will be prepared for publication in a 
reputable scientific journal. The publication of the principal results from any single-site experience 
within the study is not allowed until the preparation and publication of the multi-center results. 
Exceptions to this rule require the prior approval of DePuy Synthes. The analysis of other pre-
specified and non-pre-specified endpoints will be performed by Data Management. Such secondary 
analyses, as well as other proposed investigations, will require the approval of DePuy Synthes. For 
purposes of timely abstract presentation and publication, secondary publications will be delegated to 
the appropriate principal authors, and final analyses and manuscript review for all multi-center data 
will require the approval of DePuy Synthes. 
 
 
 
 
 
 
 

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14 Appendix A 
Part Codes 
 
Sector Gription Acetabular Shell 
Gription 
Code 
Size 
(mm) 
1217-32-048 
48 
1217-32-050 
50 
1217-32-052 
52 
1217-32-054 
54 
1217-32-056 
56 
1217-32-058 
58 
1217-32-060 
60 
1217-32-062 
62 
1217-32-064 
64 
1217-32-066 
66 
 
AltrX Liner 
 
28 mm 
32 mm 
36 mm 
Size 
(mm) 
Neutral 
+4 
Neutral 
+4 10° 
Lipped 
Neutral 
+4 
Neutral 
+4 10° 
Lipped 
Neutral 
+4 
Neutral 
+4 10° 
Lipped 
44 
1221-28-
044 
 
1221-28-
144 
 
 
 
 
 
 
 
 
 
46 
1221-28-
046 
 
1221-28-
146 
 
 
 
 
 
 
 
 
 
48 
1221-28-
048 
1221-28-
448 
1221-28-
148 
1221-28-
248 
1221-32-
048 
1221-32-
448 
1221-32-
148 
 
 
 
 
 
50 
1221-28-
050 
1221-28-
450 
1221-28-
150 
1221-28-
250 
1221-32-
050 
1221-32-
450 
1221-32-
150 
 
 
 
 
 
52 
1221-28-
052 
1221-28-
452 
1221-28-
152 
1221-28-
252 
1221-32-
052 
1221-32-
452 
1221-32-
152 
1221-32-
252 
1221-36-
052 
1221-36-
452 
1221-36-
152 
 
54 
1221-28-
054 
1221-28-
454 
1221-28-
154 
1221-28-
254 
1221-32-
054 
1221-32-
454 
1221-32-
154 
1221-32-
254 
1221-36-
054 
1221-36-
454 
1221-36-
154 
 

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56 
1221-28-
056 
1221-28-
456 
1221-28-
156 
1221-28-
256 
1221-32-
056 
1221-32-
456 
1221-32-
156 
1221-32-
256 
1221-36-
056 
1221-36-
456 
1221-36-
156 
1221-36-
256 
58 
1221-28-
058 
1221-28-
458 
1221-28-
158 
1221-28-
258 
1221-32-
058 
1221-32-
458 
1221-32-
158 
1221-32-
258 
1221-36-
058 
1221-36-
458 
1221-36-
158 
1221-36-
258 
60 
1221-28-
060 
1221-28-
460 
1221-28-
160 
1221-28-
260 
1221-32-
060 
1221-32-
460 
1221-32-
160 
1221-32-
260 
1221-36-
060 
1221-36-
460 
1221-36-
160 
1221-36-
260 
62 
1221-28-
062 
1221-28-
462 
1221-28-
162 
1221-28-
262 
1221-32-
062 
1221-32-
462 
1221-32-
162 
1221-32-
262 
1221-36-
062 
1221-36-
462 
1221-36-
162 
1221-36-
262 
64 
1221-28-
064 
1221-28-
464 
1221-28-
164 
1221-28-
264 
1221-32-
064 
1221-32-
464 
1221-32-
164 
1221-32-
264 
1221-36-
064 
1221-36-
464 
1221-36-
164 
1221-36-
264 
66 
1221-28-
066 
1221-28-
466 
1221-28-
166 
1221-28-
266 
1221-32-
066 
1221-32-
466 
1221-32-
166 
1221-32-
266 
1221-36-
066 
1221-36-
466 
1221-36-
166 
1221-36-
266 
 
 
40 mm 
Size 
(mm) 
Neutral 
+4 
Neutral 
+4 10° 
44 
 
 
 
46 
 
 
 
48 
 
 
 
50 
 
 
 
52 
 
 
 
54 
 
 
 
56 
1221-40-
056 
1221-40-
456 
1221-40-
156 
58 
1221-40-
058 
1221-40-
458 
1221-40-
158 
60 
1221-40-
060 
1221-40-
460 
1221-40-
160 
62 
1221-40-
062 
1221-40-
462 
1221-40-
162 
64 
1221-40-
064 
1221-40-
464 
1221-40-
164 
66 
1221-40-
066 
1221-40-
466 
1221-40-
166 
 
 

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Metal Heads (Articul/Eze 12/14) 
 
Standard Metal 
M-Spec 
 
28 mm 
32 mm 
28 mm 
36 mm 
40 mm 
-2 
 
 
 
1365-50-000 
1365-04-000 
+1 
 
1365-21-000 
 
 
 
+1.5 
1365-11-000 
 
1365-11-500 
1365-51-000 
1365-05-000 
+5 
1365-12-000 
1365-22-000 
1365-12-500 
1365-52-000 
1365-06-000 
+8.5 
1365-13-000 
 
1365-13-500 
1365-53-000 
1365-07-000 
+9 
 
1365-23-000 
 
 
 
+12 
1365-14-000 
 
 
1365-54-000 
1365-08-000 
+13 
 
1365-24-000 
 
 
 
+15.5 
1365-15-000 
 
 
1365-55-000 
1365-09-000 
 
 
 
Corail Femoral Stem 
Standard Collarless 
Standard Collared 
High Offset Collarless 
High Offset Collared 
Coxa Vara Collared 
Code 
Size 
Code 
Size 
Code 
Size 
Code 
Size 
Code 
Size 
L20106 
6 
 
 
 
 
 
 
 
 
3L92507 
8 
3L92498 
8 
 
 
 
 
 
 
3L92509 
9 
3L92499 
9 
L20309 
9 
L971109 
9 
3L93709 
9 
3L92510 
10 
3L92500 
10 
L20310 
10 
L971110 
10 
3L93710 
10 
3L92511 
11 
3L92501 
11 
L20311 
11 
L971111 
11 
3L93711 
11 
3L92512 
12 
3L92502 
12 
L20312 
12 
L971112 
12 
3L93712 
12 
3L92513 
13 
3L92503 
13 
L20313 
13 
L971113 
13 
3L93713 
13 
3L92514 
14 
3L92504 
14 
L20314 
14 
L971114 
14 
3L93714 
14 
3L92515 
15 
3L92505 
15 
L20315 
15 
L971115 
15 
3L93715 
15 
3L92516 
16 
3L92506 
16 
L20316 
16 
L971116 
16 
3L93716 
16 
3L92518 
18 
3L92508 
18 
L20318 
18 
L971118 
18 
3L93718 
18 
 
 
3L92521 
20 
L20320 
20 
L971120 
20 
 
 
 

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125° Standard Offset 
Collarless 
125° Standard Offset 
Collared 
135° Short Neck 
Collarless 
135° Short Neck 
Collared 
Code 
Size 
Code 
Size 
Code 
Size 
Code 
Size 
L981208 
8 
L971208 
8 
L981308 
8 
L971308 
8 
L981209 
9 
L971209 
9 
L981309 
9 
L971309 
9 
L981210 
10 
L971210 
10 
L981310 
10 
L971310 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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15 Appendix B 
Anticipated Adverse Events 
 
In addition to the information provided in the Instructions for Use, included with the packaging for 
all implants, the following surgical adverse events are anticipated.  Assuming the following events 
are consistent with the normal postoperative course, then they do not have to be reported as 
Adverse Events. 
 
UP TO 24 HOURS POSTOPERATIVE 
Genitourinary 
• Urinary retention 
Cardiovascular 
• Hypotension, not requiring treatment 
• Hypertension, not requiring treatment 
• Dysrhythmia (resolving within 36 hours post-op) 
Central Nervous System 
• Incisional pain 
• Post-op consequences of narcotics use 
• Fatigue 
Integumentary 
• Venous congestion without thrombosis (foot swelling alleviated 
with lower limb is raised) 
PRIOR TO DISCHARGE 
Hematological 
• Changes 
in 
lab 
values 
not 
resulting 
in 
clinical 
symptomatology (Electrolytes, CBC, BS, PT/PTT) 
• Anemia, not requiring treatment 
Gastrointestinal 
• Transitory: 
• Nausea 
• Vomiting 
• Constipation 
• Diarrhea 
Central Nervous System 
• Headache 
• Disorientation 
• Confusion 
• Dizziness 
• Incision/operative site pain 
Respiratory 
• Atelectasis, not requiring treatment 
Integumentary 
• Foot swelling, not requiring intervention 
• Surgical site ecchymosis 
• Sanguineous/serosanguinous drainage from incision 
• Skin blisters secondary to tape/adhesive 
• Suture granuloma not involving cellulitis or deeper infection 
(‘spitting suture’, abscess suture) 
Constitutional 
• Elevated temperature (no greater than 101°F) 
 
If you have any questions about potential adverse events (or reporting), please contact DePuy 
Synthes Clinical Research.