Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of the PINNACLE® Dual Mobility Construct
Phase: NA
Conditions: Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
Sponsor: DePuy Orthopaedics



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Table of Contents 
 
1 
Responsible Parties Involved in the Study ...................................................................... 4 
1.1 
Location of Information ...................................................................................... 4 
Investigator and Responsible Party information for this multi-center clinical 
investigation is on file at the operating company ................................................ 4 
2 
Investigator Signature Page ............................................................................................. 5 
3 
STUDY SUMMARY ...................................................................................................... 6 
3.1 
Protocol Synopsis ................................................................................................ 6 
3.2 
TIME AND EVENTS SCHEDULE ................................................................... 10 
4 
INTRODUCTION ........................................................................................................... 11 
4.1 
Background ......................................................................................................... 11 
4.2 
Radiostereometric Analysis (RSA) ..................................................................... 11 
4.3 
Study Article Description .................................................................................... 11 
4.4 
Benefits/Risks ...................................................................................................... 11 
5 
PURPOSE ....................................................................................................................... 13 
5.1 
Primary Objective and Endpoint ......................................................................... 13 
5.2 
Secondary Objectives and Endpoints .................................................................. 13 
5.3 
Exploratory Objectives and Endpoints ................................................................ 13 
5.4 
Safety Endpoints ................................................................................................. 14 
5.5 
Device Description .............................................................................................. 14 
6 
SUBJECT DEFINITION ................................................................................................ 15 
6.1 
Inclusion Criteria ................................................................................................. 15 
6.2 
Exclusion Criteria ................................................................................................ 16 
6.3 
Definition of Subject Enrollment ........................................................................ 17 
7 
STUDY DESIGN ............................................................................................................ 17 
7.1 
Subject Enrollment .............................................................................................. 17 
7.2 
Subject Screening and Informed Consent ........................................................... 17 
8 
STUDY PROCEDURES ................................................................................................. 20 
8.1 
Pre-Operative (-90 days to Day of Surgery) ....................................................... 20 
8.2 
Operative (Day 0) ................................................................................................ 20 
8.3 
Prior to Discharge (Day 1 to Discharge) ............................................................. 21 
8.4 
6 Weeks (Day 28-56) .......................................................................................... 21 
8.5 
3 Month, 6 Month, 1 Year and 2 Year Visits ...................................................... 21 
8.6 
Unscheduled Visit ............................................................................................... 22 
8.7 
Radiostereometric Analysis (RSA) ..................................................................... 23 
9 
ADVERSE EVENT REPORTING ................................................................................. 24 
9.1 
Adverse Events .................................................................................................... 24 
9.2 
Serious Adverse Events ....................................................................................... 24 
9.3 
Duration of Follow-up After Adverse Events ..................................................... 24 
9.4 
Reporting an Adverse Event ............................................................................... 25 
10 
EARLY DISCONTINUATION ...................................................................................... 26 
10.1 
Reasons for Early Discontinuation ...................................................................... 26 

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10.2 
Subject Early Discontinuation ............................................................................. 26 
10.3 
Study Early Discontinuation ............................................................................... 26 
11 
STATISTICAL METHODOLOGY ............................................................................... 27 
11.1 
Study Design ....................................................................................................... 27 
11.2 
Treatment Assignment ........................................................................................ 27 
11.3 
Randomization and Blinding Procedures ............................................................ 27 
11.4 
Interval Windows ................................................................................................ 27 
11.5 
Analysis Sets ....................................................................................................... 28 
11.6 
Primary and Secondary Endpoints and Associated Hypotheses ......................... 28 
11.7 
Levels of Significance ......................................................................................... 29 
11.8 
Sample Size Justification .................................................................................... 29 
11.9 
General Conventions ........................................................................................... 29 
11.10 Disposition of Study Subjects ............................................................................. 29 
11.11 Demographic and Baseline Characteristics ......................................................... 29 
11.12 Primary, Secondary, and Safety Endpoint Analyses ........................................... 30 
11.13 Safety Endpoint Analysis .................................................................................... 31 
11.14 Plans for Interim Analysis ................................................................................... 31 
11.15 Handling of Missing Data ................................................................................... 32 
12 
STUDY MANAGEMENT AND ADMINISTRATION ................................................ 32 
12.1 
Investigator Responsibilities ............................................................................... 32 
12.2 
Good Clinical Practice ........................................................................................ 32 
12.3 
Ethical Considerations ......................................................................................... 32 
12.4 
Subject Information and Informed Consent ........................................................ 33 
12.5 
Subject Confidentiality ........................................................................................ 33 
12.6 
Direct Access to Source Data .............................................................................. 33 
12.7 
Case Report Form Completion ............................................................................ 33 
12.8 
Record Retention ................................................................................................. 34 
12.9 
Investigator agreements and curricula vitae of Investigator(s), Delegation 
Log, and Investigator Reports ............................................................................. 34 
13 
SPONSOR OBLIGATIONS ........................................................................................... 34 
13.1 
Investigator(s) Training ....................................................................................... 34 
14 
RESEARCH ETHICS BOARDS AND REGULATORY REQUIREMENTS .............. 34 
14.1 
REBs .................................................................................................................... 34 
14.2 
Protocol Amendments ......................................................................................... 35 
14.3 
Protocol Deviations ............................................................................................. 35 
15 
PUBLICATION POLICY ............................................................................................... 35 
16 
Appendix A ..................................................................................................................... 36 
17 
Appendix B ..................................................................................................................... 46 
 
 
 
 
 
 
 
 

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1 Responsible Parties Involved in the Study 
1.1 
  Location of Information 
Investigator and Responsible Party information for this multi-center clinical investigation is on 
file at the operating company 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 Investigator Signature Page 
 
Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis  
of the PINNACLE® Dual Mobility Implant 
Document 
Type 
Revision  
Effective Date 
Original 
1 
 
12 November, 2020 
Amendment 
2 
 
25 January, 2022 
Amendment 
3 
 
10 March, 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 and Title 
 
 
-------------------------------------------------------- 
Site Identification Number 
 

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3 STUDY SUMMARY 
3.1 
Protocol Synopsis 
 
Clinical Sponsor 
DePuy Synthes Joint Reconstruction 
Title 
Multi-Center, Non-Controlled, Prospective Radiostereometric 
Analysis of the PINNACLE® Dual Mobility Construct 
 
Short Title 
PINNACLE® DM RSA Study 
Protocol Number 
DSJ 2019 02 
Indication 
Total Hip Arthroplasty (THA) 
Study Article Description 
PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual 
Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility 
Polyethylene Liner, a DePuy femoral stem with a polished femoral 
neck and a DePuy modular, femoral head PINNACLE® Dual 
Mobility Metal Liners and Porous-coated PINNACLE® Acetabular 
Cups are intended for cementless applications. 
 
Study Design 
Multi-Center, Non-randomized, Non-Controlled, Prospective 
Study Population 
Males and Females aged 21 or older, who are undergoing 
primary, unilateral THA or revision THA and who may have, in 
the opinion of the Investigator, a risk of dislocation in the 
operative joint.  
Number of Subjects 
N = a minimum of 30 and up to 45  
Number of Sites 
3 (all Canadian) 
Enrollment Timeframe 
12 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 
x To establish the mean subsidence profile of the 
PINNACLE® Acetabular Shell and Dual Mobility Metal 
Liner construct using model-based RSA over the first two 
years post-implantation 
x To compare study results from this trial to historical 
PINNACLE® data obtained from DSJ 2018 02. 
Endpoints 
Primary: 
x RSA measured mean superior cup migration (subsidence: 
Y translation in mm) at 2 years  
Secondary: 
x Comparison of mean superior cup migration at 2 years to 
historical PINNACLE® data 
x RSA measured subsidence of the PINNACLE® 
Acetabular Shell at 3 months, 6 months and 1 year and 
compare to historical PINNACLE® data 

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x 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 and compare to historical 
PINNACLE® data 
x Linear head penetration at 6 weeks, 1 year and 2 years and 
compare to historical PINNACLE® data 
x Functional and health status as measured with Harris Hip 
Score, HOOS Jr. and Forgotten Joint Score (FJS-12) and 
compare to historical PINNACLE® data at baseline and 3 
months, 6 months and 1 and 2 years post-operative 
 
Exploratory: 
x Subsidence for subset of Subjects where RSA data was 
obtained prior to discharge and compare to historical 
PINNACLE® data 
x Analyses to examine the correlation of functional and 
health status outcomes vs. RSA observations may be 
explored 
x Incidence of intraprosthetic dislocation (IPD) 
x Incidence of intraoperative complications 
 
Safety: 
x The type and frequency of any serious and non-serious 
device or procedure-related AEs across all study intervals 
will be summarized 
Inclusion Criteria 
1. 
Individuals requiring THA for a severely painful and/or 
disabled joint (typically due to non-inflammatory 
degenerative joint disease); failed previous hip surgery; or 
dislocation risks.  
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 who have an active local or systemic infection 

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2. 
Individuals who have loss of musculature, neuromuscular 
compromise or vascular deficiency in the affected limb 
rendering the procedure unjustified. 
3. 
Individuals with poor bone quality, such as osteoporosis, 
where, in the surgeon’s opinion, there could be considerable 
migration of the prosthesis or a significant chance of bone 
fracture 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 
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 6 months following 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 per the Investigators 
determination. 
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. 
16. Individuals who require revision arthroplasty and have a 
well-fixed non-DePuy Synthes femoral stem or a well-fixed 
DePuy Synthes femoral stem that does not have a polished 
neck 

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Safety Assessments 
Type and frequency of device or procedure related Adverse 
Events will be collected. The Site Ethics Committee/Research 
Ethics Board (REB) 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; 
there are no hypotheses in this study.  The standard deviation in 
observed migration 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 comparison with historical PINNACLE® data with a 
margin of error of approximately 2(¥) = 0.073 mm, which 
is deemed to be an adequate level of precision by the Sponsor. Up 
to 45 Subjects may be enrolled to offset pre and post-operative 
attrition. 
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.   Comparisons of 
the primary and secondary endpoints with historical PINNACLE® 
data will be conducted using the t-test and the Fisher’s exact test. 
Those comparisons will only be provided to facilitate clinical 
judgement. 
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 and support 
regulatory submissions.  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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4 INTRODUCTION 
4.1 
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.   
4.2 
Radiostereometric Analysis (RSA) 
Radiostereometric Analysis is an accurate method of determining the migration of orthopaedic 
implants following surgical procedures such as total hip arthroplasties.  RSA is able to measure 
early micromotion of the hip implant which is predictive of long-term fixation. 
 
There are no RSA evaluations of the PINNACLE® Dual Mobility Metal Liner.  Therefore, in order 
to evaluate future dual mobility hip replacement products, baseline migration values for the 
PINNACLE® Dual Mobility Implant will be determined; in addition, PINNACLE® Dual Mobility 
RSA data will allow for comparison with historical RSA data obtained using standard PINNACLE® 
acetabular constructs in study DSJ_2018_02. 
4.3 
Study Article Description 
The PINNACLE® Dual Mobility Metal Liner is intended to be used in total hip arthroplasty with a 
PINNACLE® Acetabular Cup, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a 
DePuy femoral stem with a polished neck and a DePuy modular, femoral head.  The dual mobility 
liner is a CoCr device that forms a modular connection with the acetabular shell and serves an articular 
surface for the polyethylene liner. PINNACLE® Dual Mobility Metal Liners and Porous-coated 
PINNACLE® Acetabular Cups are intended for cementless applications.  All Subjects will receive a 
PINNACLE® Dual Mobility metal liner and a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene 
Liner in this study. 
4.4 
Benefits/Risks 
4.4.1 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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4.4.2 Risks 
As specified in the Instructions For Use (IFU-0902-00-898 and IFU-78410403 included in the 
implant packaging), the following are generally the most frequently encountered adverse events and 
complications in total hip arthroplasty, including the study devices: 
GENERAL 
x Change in position of the prosthetic components 
x Early or late loosening of the prosthetic components 
x Fatigue fracture of the femoral stem 
x Excessive wear or fracture of the bearing components 
x Early or late infection 
x Peripheral neuropathies. Subclinical nerve damage may also occur as a result of surgical 
trauma 
x Tissue reactions, osteolysis, and/or implant loosening caused by metallic corrosion, allergic 
reactions, wear or particulate debris 
x Pain 
 
INTRAOPERATIVE 
x Acetabular fracture 
x Femoral shaft perforation, fissure or fracture, which may require the use of internal fixation 
x Trochanteric fracture 
x Damage to blood vessels 
x Temporary or permanent nerve damage 
x Subluxation or dislocation of the hip joint due to implant size or configuration selection, 
positioning of components and /or muscle and fibrous tissue laxity 
x Lengthening or shortening of the affected extremity 
x Breakage or chipping of the ceramic femoral head 
 
EARLY POSTOPERATIVE 
x Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial 
infarction 
x Hematoma and/or delayed wound healing 
x Subluxation or dislocation 
 
LATE POSTOPERATIVE 
x Trochanteric avulsion from excessive muscular tension, weight-bearing, or inadvertent 
intraoperative weakening of the trochanter 
x Aggravation of problems in the ipsilateral or contralateral knee and ankle joints due to leg 
length discrepancy, femoral medialization and/or muscular deficiencies. 
 

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x Femoral or acetabular fracture due to trauma or excessive loading particularly in the presence 
of poor bone stock caused by severe osteoporosis, bone defects from previous surgery, 
intraoperative reaming procedures, or bone resorption. 
x Bone resorption which may contribute to the deterioration of fixation and eventual loosening 
of the implant 
x Periarticular calcification or ossification which may lead to a decrease in joint mobility and 
range of motion 
x Traumatic arthrosis of the ipsilateral knee secondary to intraoperative positioning of the 
extremity during surgery 
x Subluxation or dislocation 
5 PURPOSE 
5.1 
Primary Objective and Endpoint 
The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual 
Mobility Construct 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. Additionally, the data from this study will be compared to historical 
PINNACLE® data obtained in study DSJ_2018_02.  
5.2 
Secondary Objectives and Endpoints 
Secondary objectives are: 
x To establish the subsidence profile of the PINNACLE® Dual Mobility construct; this will be 
accomplished by determining the mean subsidence at 3 months, 6 months and 1 year as 
measured with RSA. This endpoint will be compared to historical PINNACLE® data. 
x 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. These endpoints will be compared to 
historical PINNACLE® data. 
x Linear head penetration (in mm) at 6 weeks, 1 year and 2 years. This endpoint will be 
compared to historical PINNACLE® data. 
x Functional and health status will be measured with Harris Hip Score, HOOS Jr. and Forgotten 
Joint Score (FJS-12) at baseline and 3 months, 6 months and 1 and 2 years post-operative. 
These endpoints will be compared to historical PINNACLE® data. 
5.3 
Exploratory Objectives and Endpoints 
The following will be summarized as exploratory analyses: 

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x Subsidence for subset of Subjects where RSA data was obtained prior to discharge. This 
endpoint will be compared to historical PINNACLE® data. 
x Analyses to examine the correlation of functional and health status outcomes vs. RSA 
observations may be explored. This endpoint will be compared to historical PINNACLE® 
data. 
x Incidence of intraprosthetic dislocation (IPD) 
x Incidence of intraoperative complications 
5.4 
Safety Endpoints 
The type and frequency of serious, non-serious, and device or procedure related Adverse Events 
across all study intervals will be summarized. 
5.5 
Device Description 
The PINNACLE® Dual Mobility Metal Liner and BI-MENTUM™ ALTRX® Dual Mobility 
Polyethylene Liner are commercially available in Canada. All PINNACLE® Acetabular Cups, 
DePuy femoral stems and DePuy modular, femoral heads used in this clinical investigation are 
commercially available.  The PINNACLE® Dual Mobility Metal Liner and Porous-coated 
PINNACLE Acetabular Cups are intended for cementless applications. Please refer to Table 1 
below for implant compatibility. The part numbers allowed by this protocol are listed in Appendix 
A. 
 
PINNACLE® Acetabular Shell 
The shells are designed to assemble with the PINNACLE® Dual Mobility metal liner insert.   
 
PINNACLE® Dual Mobility Metal Liner 
The dual mobility liner is a CoCr device that forms a modular connection with the acetabular shell 
and serves an articular surface for the polyethylene liner. 
 
BI-MENTUM™ ALTRX® Polyethylene Liner 
The liner is attached to the femoral head and then the liner/head construct is impacted onto the 
femoral stem. The BI-MENTUM™ ALTRX® Polyethylene Liner is then reduced into the dual 
mobility liner.  
 
DePuy Femoral Head 
Ceramic and metal heads are allowed for this clinical investigation.  The inner diameter of the 
polyethylene liner bearing surface must correspond to the femoral head size. Please note the Biolox 
Delta TS femoral head +12 is not intended for use with dual mobility liners. 
 
DePuy Femoral Stem 
A variety of femoral stems may be used in this investigation, however, only those stems with 
polished necks are indicated for use with the PINNACLE® Dual Mobility construct. Please refer to 
Table 1 below for a listing and Appendix A for implant part codes.  

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1. Individuals requiring THA for: 
a. a severely painful and/or disabled joint (typically due to non-inflammatory 
degenerative joint disease).  
b. failed previous hip surgery. 
c. or dislocation risks. 
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. 
6.2 
Exclusion Criteria 
Subjects will be excluded from participation in the study if they meet any of the following criteria: 
 
1. Individuals have active local or systemic infection. 
2. Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency 
in the affected limb rendering the procedure unjustified. 
3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon’s opinion, there 
could be considerable migration of the prosthesis or a significant chance of bone fracture 
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 who are pregnant or lactating. 
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 6 months following 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 per the Investigators determination 
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. 
 

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12. 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. 
13. 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. 
14. Subject has a medical condition with less than 2 years life expectancy. 
15. Individual has a BMI >45 kg/m2. 
16. Individuals who require revision arthroplasty and have a well-fixed non-DePuy Synthes 
femoral stem or a well-fixed DePuy Synthes femoral stem that does not have a polished 
neck 
 
6.3 
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). 
 
7 STUDY DESIGN 
This study is designed as a prospective, multi-center, non-randomized, non-controlled study.  This 
study does not limit the surgical approach involved in the treatment of the Subject as long as the 
protocol specified products are utilized. 
7.1 
Subject Enrollment 
A minimum of 30, and up to 45, Subjects will be enrolled at 3 Investigational sites. No protocol 
specified activities can be completed until written Informed Consent is obtained for a 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. 
7.2 
Subject Screening and Informed Consent 
As patients are being scheduled for primary or revision 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 and confirm the 
Subject understands the following points of the study: 
 

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• 
The purpose of the study 
• 
The potential risks or adverse events that are posed by their treatment 
• 
The potential risks or adverse events related to study participation 
• 
Possibility of failure and the need for subsequent treatment(s)  
• 
Alternative procedures/treatments available to the Subject  
• 
Requirements of the study including rehabilitation and follow-up visits  
• 
All the Subject’s rights as a participant in the clinical investigation  
 
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, or study file.  Screening, consenting and enrollment are illustrated in Figure 7-1. 
 
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 applicable regulations, 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’.  Each enrolled Subject will be 
assigned a unique Subject identification number by the database.  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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8 STUDY PROCEDURES 
8.1 
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: 
x Age, gender, height and weight 
x History of concurrent or previous medical issues 
x History of previous treatment to the index hip 
x Harris Hip Score 
x HOOS Jr. 
x 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 3.2).  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. 
8.2 
Operative (Day 0) 
Each Subject will receive a DePuy femoral stem with a polished neck in combination with a DePuy 
PINNACLE® acetabular cup.  All Subjects will receive a PINNACLE® DM metal liner and a BI-
MENTUM™ ALTRX® Dual Mobility Polyethylene Liner. Either metal or ceramic heads may be 
used; however, compatibilities must align with product labeling. Please note since revisions of 
existing THAs are acceptable to enroll into this study, variations in what is implanted will occur, 
however Subjects must receive the PINNACLE® DM metal liner and a BI-MENTUM™ ALTRX® 
Dual Mobility Polyethylene Liner. If the surgeon determines intraoperatively that there exists 
insufficient bone quality to support the implantation of the construct that Subject will be withdrawn 
from the study. Subjects that are withdrawn pre-operatively or intra-operatively will be replaced in 
order to have a minimum of 30 and up to 45 Subjects implanted with the study devices.   
 
Each surgeon shall perform the surgical approach they are most comfortable with and have the 
greatest expertise.   
 
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 3.2). 
8.3 
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.  Device and 
procedure-related adverse events will be collected. 
 
For clinical sites with the ability to perform immediate post-operative RSA exams, Subjects at these 
sites will undergo a model-based RSA examination prior to discharge from the hospital.  RSA 
radiographs shall be obtained with Subjects in a supine position.  A duplicate RSA exam will be 
conducted at this time to calculate intra-Subject measurement error. 
 
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 3.2). 
8.4 
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.  If not performed earlier, 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: 
 
x Harris Hip Score; ROM optional 
x Hip Evaluation 
x HOOS Jr. 
x Forgotten Joint Score 
x Adverse Events (if applicable) 
x 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 3.2). 
8.5 
3 Month, 6 Month, 1 Year and 2 Year Visits 
The Subject will have the following health and functional status evaluations: 

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x Harris Hip Score 
x Hip Evaluation 
x HOOS Jr. 
x Forgotten Joint Score 
x Adverse Events (if applicable) 
x Radiographs  
o AP Femur 
o Lateral 
x 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 3.2). 
8.6 
Unscheduled Visit 
An unscheduled visit is to be documented on an Unscheduled Visit eCRF/CRF when: 
1. A Subject returns for an additional visit during a study visit interval as described in Table 3.2 
- Time and Events.   
2. A Subject returns between study visit intervals 
 
If a Subject requires an additional visit during a study interval, and is seen by one or more persons 
listed on the Delegation of Authority Log, then the following information shall be repeated: 
 
x Harris Hip Score 
x Hip Evaluation 
x HOOS Jr. 
x Forgotten Joint Score 
x Adverse Events (if applicable) 
 
If a Subject has an unscheduled visit after the 6 week interval (outside defined protocol window), 
with one or more persons listed on the Delegation of Authority Log then the following information 
shall be collected: 
 
x Harris Hip Score 
x Hip Evaluation 
x HOOS Jr. 
x Forgotten Joint Score 
 
 

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x Adverse Events (if applicable) 
x Radiographs  
o AP Femur 
o Lateral 
x 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. 
 
8.7 
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 X, Y and Z translation measurements in mm from baseline;  
x X, Y and Z rotation measurements in degrees from baseline; 
x Maximal total point motion (one measurement in mm of maximal migration). 
 
In a subgroup of Subjects, a second baseline will be defined as the result collected prior to 
discharge. For these Subjects, the translation, rotation and maximal total point motion will be 
reported at 6 weeks, 3 months, 6 months, 1 year and 2 years.  This sub-analysis will determine the 
approximate magnitude of migration that occurs between the time of surgery and 6-weeks post-
operative.  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 the 1 year and 2 year exams.  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’ 
center point. 
 

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9 ADVERSE EVENT REPORTING 
9.1 
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 9.2), 
device and/or procedure related adverse events will be reported to the Sponsor. 
All non-serious 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) as soon 
as possible but no later than two weeks after awareness of the AE having 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.   
9.2 
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 
4. Led to chronic disease 
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 9.3. 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).  
9.3 
 Duration of Follow-up After Adverse Events 

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The Investigator should ensure that adequate medical care is provided to any Subject for any 
adverse events related to the study. 
Only SAEs, 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.  
9.4 
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 
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. 

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For all serious and device/procedure-related adverse events, the Investigator is responsible for 
determining whether the adverse events are anticipated or unanticipated. This determination is 
based on whether the severity, type and frequency of the adverse event is consistent with the 
Instructions for Use (IFU) in the opinion of the Investigator. 
 
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. 
10   EARLY DISCONTINUATION 
10.1 Reasons for Early Discontinuation 
Possible reasons for early discontinuation may include, but are not limited to the following: 
x 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; 
x 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); 
x Revision of any component; 
x Death, and/or 
x Early study termination: DePuy Synthes can decide to discontinue the study prematurely for various 
reasons. 
10.2 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.   
10.3 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 

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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. 
11 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. 
11.1 Study Design 
This is a prospective, multi-center, non-randomized, non-controlled study designed to establish the 
2-year migration profile of the PINNACLE® DM Construct.  
11.2 Treatment Assignment 
Subjects enrolled will undergo THA using the study devices listed in Section 5.5.  
11.3 Randomization and Blinding Procedures 
Not applicable. 
11.4 Interval Windows 
Data collected throughout the study will be assessed for compliance with the protocol-specified visit 
schedule. 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 11-1 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 11-1 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 

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3 Months 
60 to 120 
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 date of surgery (DOS). 
 
11.5 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 
protocol violations that exclude them from analyses, 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.   
11.6 Primary and Secondary Endpoints and Associated Hypotheses 
There are no hypotheses associated with the primary or secondary endpoints; endpoints appear 
below. 
11.6.1 Primary Endpoint 
The primary endpoint is the RSA-measured mean superior cup migration (Y translation in mm) at 2 
years.  
11.6.2 Secondary Endpoints 
The secondary endpoints are the following: 
 
x RSA measured subsidence (superior cup migration) at 3 months, 6 months and 1 year. 
x 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 
x Linear head penetration at 6 weeks, 1 year and 2 years; 
x Harris Hip Score at 6 weeks, 3 months, 6 months, 1 year and 2 years; 
x HOOS Jr. at 6 weeks, 3 months, 6 months, 1 year and 2 years; 
x Forgotten Joint Score (FJS-12) at 6 weeks, 3 months, 6 months, 1 year and 2 years. 
11.6.3 Exploratory Endpoints 
The following will be summarized as exploratory analyses: 

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x Mean subsidence for the subset of Subjects where RSA data was obtained prior to discharge 
at 6 Weeks, 3 months, 6 months and 1 year and 2 years; 
x Correlation of functional and health status outcomes (Harris Hip Score, HOOS Jr, and FJS-
12) vs. RSA observations may be explored. 
x Incidence of intraprosthetic dislocation (IPD) 
x Incidence of intraoperative complications 
 
11.7 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.  
11.8 Sample Size Justification 
This study sample size was established to provide adequate precision on the mean subsidence 
estimate at 2 years. 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 is anticipated to 
have a margin of error equal to approximately 2SE = 2 ×
ୗୈ
ξ௡= 2 ×
଴.ଶ
ξଷ଴ =  0.073 mm. This margin 
of error was deemed to be an adequate level of precision by the Sponsor. 
11.9 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. 
11.10 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.   
11.11 Demographic and Baseline Characteristics 

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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. 
11.12 Primary, Secondary, and Safety Endpoint Analyses 
11.12.1 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.  
 
11.12.2 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 6 weeks, 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) 

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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.  
11.12.3 Exploratory Endpoint Analysis 
Exploratory analyses will include the following: 
x Summaries of RSA measured subsidence at 6 Weeks, 3 months, 6 months and 1 year and 2 
years will be conducted on the subset of Subjects where RSA data was obtained prior to 
discharge.  
x Correlation of functional and health status outcomes (Harris Hip Score, HOOS Jr, and FJS-
12) vs. RSA observations may be explored. 
x Summaries of incidence of intraprosthetic dislocation 
x Summaries of incidence of intraoperative complications 
11.12.4 Comparisons to Historical PINNACLE® Data 
All primary, secondary, and exploratory endpoints will be compared to their counterparts in the 
DSJ_2018_02 (PINNACLE® RSA) study for the visits at which those endpoints are assessed using 
the t-test if the endpoint is continuous or Fisher’s exact if the endpoint is categorical. The mean 
difference (PINNACLE® – PINNACLE® DM), the 2-sided 95% confidence interval for the 
difference, and the p-value for the test of equality will be presented. There are no formal hypotheses 
associated with those tests and the p-values and confidence intervals are only presented to facilitate 
clinical judgment. 
11.13 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 will be presented and will include the number and 
percentage of Subjects having one or more: 
x Serious adverse event (SAE) 
x Device related AEs 
x Procedure related AEs 
x Withdrawals due to AE 
x 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. 
11.14 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 

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year visit in order to support regulatory submissions and give product development an 
understanding of acetabular cup subsidence that might be expected for future product development 
purposes.  
11.15 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.   
 
12 STUDY MANAGEMENT AND ADMINISTRATION 
12.1 Investigator Responsibilities 
In conducting this clinical study, the Investigator is responsible for: 
x Ensuring that the clinical study is conducted according to the Declaration of Helsinki, 
applicable local regulations, the clinical study agreement and the protocol; 
x Protecting the rights, safety and welfare of Subjects under the Investigator’s care; and 
x 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. 
12.2 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. The Investigator Site 
files should be established at the beginning of the study, maintained for the duration of the study 
and retained according to the appropriate regulations.  
12.3 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, ICD, advertisements (if applicable), written information given to 
the Subjects, safety updates (per local policy), annual progress reports (per local policy), 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.  
 
 

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12.4 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: 
x 
The most current, approved ICD is completed by the Subject prior to the start of study 
specific procedures; 
x 
The Subject personally signed and dated the ICD; 
x 
The investigator or designated study personnel has also signed and dated the ICD; 
x 
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 ICD; and 
x 
The signed ICD(s) are retained by the investigator and are available for inspection. 
12.5 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 
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.  
12.6 Direct Access to Source Data  
The study will be monitored by DePuy Synthes or its designee. Monitoring procedures and 
frequency will be conducted throughout the course of the study according to the Clinical 
Monitoring Plan.  Qualified site personnel are expected to meet with the clinical monitor to resolve 
queries and review action items at any onsite monitoring visits.  During any monitoring visit the 
Sponsor and authorized Sponsor representatives shall be given access to all study records, including 
the medical records.  
12.7 Case Report Form Completion  
An electronic data capture system, compliant to applicable regulations, 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.  

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12.8 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.  
 
Study documentation includes, but is not limited to, the following:  
• 
Source data/medical records, informed consents and completed Patient Reported Outcome 
tools 
• 
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 
12.9 Investigator agreements and curricula vitae of Investigator(s), Delegation Log, and 
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. Protocol Deviations –Any departures from the protocol must be fully documented in the eCRF 
and source documentation and reported to the EC/REB per local policy. 
3. Progress Reports – Annual progress reports must be forwarded to the REB and the Sponsor  
4. 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. 
5. Principal Investigator(s) may delegate a qualified associate(s) to complete study 
responsibilities. However, the Principal Investigator retains the overall responsibility for 
Subject safety and proper conduct of the study.  
13   SPONSOR OBLIGATIONS  
13.1 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.  
14   RESEARCH ETHICS BOARDS AND REGULATORY REQUIREMENTS 
14.1 REBs 

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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. 
14.2 Protocol Amendments 
As appropriate, DePuy Synthes will submit changes in the protocol to the investigators and the 
appropriate regulatory authorities.  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: 
x The safety or physical or mental integrity of the Subjects; 
x Scientific value of the trial; 
x Conduct or management of the trial; 
x Quality or safety of an investigational medical product used in the trial. 
14.3 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, improper 
informed consent process) or other GCP requirements. 
Investigators may not deviate from the protocol except where necessary to protect the life or physical 
well-being of a Subject in an emergency.  
Any 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.   
15   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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16 Appendix A 
Part Codes 
 
PINNACLE™ DM Metal Liners 
Liner Size (mm) 
ID mm 
Product Code 
48/41 
35 
1218-48-041 
50/43 
37 
1218-50-043 
52/45 
39 
1218-52-045 
54/47 
41 
1218-54-047 
56/49 
43 
1218-56-049 
58/49 
43 
1218-58-049 
60/51 
45 
1218-60-051 
62/53 
47 
1218-62-053 
64/53 
47 
1218-64-053 
66/55 
49 
1218-66-055 
BI-MENTUM ALTRX® Polyethylene Liners 
Liner Size (mm) 
OD mm 
Product Code 
22 × 41 
35 
1221-22-041 
22 × 43 
37 
1221-22-043 
22 × 45 
39 
1221-22-045 
28 × 47 
41 
1221-28-047 
28 × 49 
43 
1221-28-049 
28 × 51 
45 
1221-28-051 

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13 
3L92503 
14 
3L92504 
15 
3L92505 
16 
3L92506 
18 
3L92508 
20 
3L92521 
Dysplasia 
Collarless 
6 
L20106 
Corail Collarless STD 
Stems 
8 
3L92507 
9 
3L92509 
10 
3L92510 
11 
3L92511 
12 
3L92512 
13 
3L92513 
14 
3L92514 
15 
3L92515 
16 
3L92516 
18 
3L92518 
20 
3L92520 
Corail Coxa Vara (135) 
9 
3L93709 
10 
3L93710 
11 
3L93711 
12 
3L93712 
13 
3L93713 
14 
3L93714 
15 
3L93715 
16 
3L93716 
18 
3L93718 
20 
3L93720 
Corail Collarless High 
Offset 
9 
L20309 
10 
L20310 
11 
L20311 
12 
L20312 
13 
L20313 
14 
L20314 
15 
L20315 
16 
L20316 
18 
L20318 
20 
L20320 

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PINNACLE Primary Cups 
 
 
PINNACLE Revision Cups