Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
 
Restoration® Anatomic Dual Mobility (ADM) X3® 
Acetabular System Study  
With Long Term Data Collection for the Accolade® II Hip Stem  
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center study of the  
Restoration® ADM X3® Acetabular System  
and the Accolade® II Hip Stem 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Restoration® ADM X3® Acetabular System  
Accolade® II Hip Stem 
Protocol Number: 
70 
510(k) Clearance  Numbers: 
K072020 – October 18, 2007 
K093644 - December 18, 2009 
K103479  – March 21, 2011 
K120578 – March 29, 2012 
 
Version 3.0 
Date:  2020-04-15 
CONFIDENTIAL 
 
This document is confidential and the property of Stryker Orthopaedics.  No 
part of it may be transmitted, reproduced, published or used by other persons 
without prior written authorization from Stryker.

 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Page i 
Orthopaedics 
 
 
 
 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
A 
New 
Veronica Lewis 
B 
Modified evaluation schedule, corrected references, clarified 
inclusion/exclusion criteria, updated statistical analysis, 
modified enrollment period to 24 months, modified Appendix 
B, and created Appendix E. 
Christina Hawley 
1.0 
Removed Draft watermark, Updated Version number.   
Christina Hawley 
2.0 
Added background and device information for the Accolade® II 
Hip Stem.  Enrollment strategy modified as follows: 
• 
Enrollment will continue until 350 cases have received 
the Restoration ADM® X3® System (acetabular shell & 
insert)      
• 
Enrollment will include a minimum of 100 cases 
implanted with the Accolade® II Hip Stem (within the 
study population). 
Additional changes include: 
• 
Added EQ-5D 
• 
AP Femur x-ray view 
• 
Updated eCRF specifications to incorporate new 
device and questionnaire  
Carinna D. Kison 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page ii 
Version 
Description 
Changed By 
3.0 
Updated the following sections and appendix by removing 
language regarding the old patient retention program and 
including information regarding the new patient stipend 
program. 
• 
12.5 Potential Benefits to the Subject 
• 
15.3 Subject Stipends or Payments 
• 
Appendix E 
 
Removed Appendix G as the study is no longer utilizing the 
patient stipend program to which it applied. 
Ajay Rastogi 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page iii 
Table of Contents 
STUDY SYNOPSIS .................................................................................................................................................... 1 
EVALUATION SCHEDULE ...................................................................................................................................... 9 
1 
INTRODUCTION ............................................................................................................................................. 10 
1.1 
BACKGROUND .............................................................................................................................. 10 
1.2 
INVESTIGATIONAL DEVICE ............................................................................................................. 15 
1.3 
PRECLINICAL DATA ...................................................................................................................... 16 
1.4 
CLINICAL DATA TO DATE............................................................................................................... 19 
2 
STUDY OBJECTIVES .................................................................................................................................... 19 
2.1 
EFFICACY .................................................................................................................................... 19 
2.1.1 
Primary .................................................................................................................................. 19 
2.1.2 
Secondary ............................................................................................................................. 19 
2.2 
SAFETY ....................................................................................................................................... 21 
3 
CLINICAL STUDY PLAN ............................................................................................................................. 21 
3.1 
STUDY DESIGN ............................................................................................................................ 21 
3.2 
NUMBER OF CENTERS .................................................................................................................. 21 
3.3 
NUMBER OF SUBJECTS ................................................................................................................. 22 
3.4 
ESTIMATED STUDY DURATION ...................................................................................................... 22 
4 
ELIGIBILITY .................................................................................................................................................... 22 
4.1 
INCLUSION CRITERIA .................................................................................................................... 22 
4.2 
EXCLUSION CRITERIA ................................................................................................................... 23 
5 
SUBJECT ENROLLMENT ............................................................................................................................ 23 
5.1 
TREATMENT ASSIGNMENT ............................................................................................................ 23 
5.2 
RANDOMIZATION .......................................................................................................................... 23 
6 
DEVICE DESCRIPTION ................................................................................................................................ 24 
6.1 
STUDY DEVICE ............................................................................................................................. 24 
6.2 
DEVICE RETRIEVAL PROCESS ....................................................................................................... 26 
7 
EVALUATIONS ............................................................................................................................................... 27 
7.1 
PREOPERATIVE VISIT ................................................................................................................... 27 
7.2 
SURGERY .................................................................................................................................... 28 
7.3 
6-WEEK VISIT ............................................................................................................................... 28 
7.4 
ANNUAL FOLLOW-UP VISITS .......................................................................................................... 28 
8 
ADVERSE EVENTS ....................................................................................................................................... 29 
8.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 29 
8.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 32 
8.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 34 
8.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 35 
8.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 35 
8.5 
MEDICAL MONITORING ................................................................................................................. 35 
9 
STATISTICAL PLAN ...................................................................................................................................... 35 
9.1 
EFFICACY .................................................................................................................................... 35 
9.1.1 
Primary Efficacy Parameters ................................................................................................. 35 
9.1.2 
Secondary Efficacy Parameters ............................................................................................ 35 
9.1.3 
Primary Efficacy Hypothesis .................................................................................................. 36 
9.1.4 
Primary Efficacy Analysis ...................................................................................................... 36 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
 
 
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Page iv 
9.1.5 
Secondary Efficacy Analysis ................................................................................................. 36 
9.2 
SAFETY PARAMETERS .................................................................................................................. 36 
9.2.1 
Safety Parameters ................................................................................................................. 36 
9.2.2 
Safety Analysis ...................................................................................................................... 37 
9.3 
MISSING DATA ............................................................................................................................. 37 
9.4 
STATISTICAL METHODOLOGY ........................................................................................................ 37 
9.4.1 
Data Summary....................................................................................................................... 37 
9.4.2 
Sample Size Calculation ....................................................................................................... 38 
9.4.3 
Interim Analyses and early Stopping Considerations ........................................................... 38 
9.4.4 
Efficacy Patient Populations .................................................................................................. 38 
10 
STUDY PROCEDURES ................................................................................................................................. 39 
10.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 39 
10.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 39 
10.3 
EARLY WITHDRAWAL OF SUBJECTS .............................................................................................. 40 
11 
DATA MANAGEMENT .................................................................................................................................. 41 
11.1 
DATABASE ................................................................................................................................... 41 
11.2 
CONFIDENTIALITY ......................................................................................................................... 42 
11.3 
SOURCE DOCUMENTS .................................................................................................................. 42 
11.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 42 
11.5 
DATA CLARIFICATION REQUESTS .................................................................................................. 43 
11.6 
PROTOCOL DEVIATIONS ............................................................................................................... 43 
11.7 
RECORDS RETENTION .................................................................................................................. 43 
12 
RISK/BENEFIT ASSESSMENT ................................................................................................................... 44 
12.1 
RISK CATEGORY .......................................................................................................................... 44 
12.2 
POTENTIAL RISK .......................................................................................................................... 44 
12.3 
EXPECTED COMPLICATIONS AND RATES OF OCCURRENCES ........................................................... 45 
12.4 
PROTECTION AGAINST RISKS........................................................................................................ 45 
12.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 46 
13 
STUDY MONITORING, AUDITING, AND INSPECTING .......................................................................... 46 
13.1 
STUDY MONITORING PLAN ............................................................................................................ 46 
13.2 
AUDITING AND INSPECTING ........................................................................................................... 47 
14 
ETHICAL CONSIDERATIONS ..................................................................................................................... 47 
15 
STUDY FINANCES ......................................................................................................................................... 48 
15.1 
FUNDING SOURCE ........................................................................................................................ 48 
15.2 
CONFLICT OF INTEREST ................................................................................................................ 48 
15.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 48 
16 
PUBLICATION PLAN .................................................................................................................................... 49 
17 
REFERENCES ................................................................................................................................................ 50 
 
 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page v 
List of Appendices 
 
Appendix A 
 
Suggested Radiographic Technique 
Appendix B 
 
Retrieved Implant Analysis Protocol 
Appendix C 
 
Product Labeling 
Appendix D 
 
FDA 510(k) Clearance Letters 
Appendix E 
 
Model Informed Patient Consent 
Appendix F 
 
Draft Specifications for Electronic Case Report Forms 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page vi 
List of Tables 
Table 1.  Subject Polyethylene Properties .................................................................................. 18 
Table 2.  Restoration® ADM X3® Acetabular System Shell / Insert Thickness / Head 
Compatibility ............................................................................................................................... 25 
 
 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
 
 
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Page vii 
List of Figures 
 
Figure 1.  Schematic of Dual Articulation…………………………………………………..... 9 
 
Figure 2.  Restoration® ADM X3® Acetabular System ……..…………………………….…10 
 
Figure 3.  Accolade® II Hip Stem Size Specific Medial Curvature...…………………….…13 
 
Figure 4.  Adverse Event Decision Tree……………………...………………………….…...30 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
    
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Page viii 
List of Abbreviations 
ADE 
Adverse Device Effect 
ADM 
Anatomic Dual Mobility 
AE 
Adverse Event 
AP 
Anteroposterior 
ASTM 
American Society for Testing Materials 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CP 
Commercially Pure 
CRC 
Clinical Research Coordinator 
CSA 
Clinical Study Associate 
CSM 
Clinical Study Manager 
DCR 
Data Clarification Request 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
International Conference of Harmonisation Good Clinical Practice 
HA 
Hydroxylapatite 
HHS 
Harris Hip Score 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
ID 
Inner Diameter 
IRB 
Institutional Review Board 
LEAS 
Lower Extremity Activity Scale 
NIDJD 
Non-Inflammatory Degenerative Joint Disease 
NIS 
Nationwide Inpatient Sample 
OD  
Outer Diameter 
PER 
Product Experience Report 
PI 
Principal Investigator 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SCFE 
Slipped Capital Femoral Epiphysis  
SF-12 
Short Form-12 
SOMA 
Stryker Orthopaedics Modeling &Analytics 
THA 
Total Hip Arthroplasty 
THR 
Total Hip Replacement 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene

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Stryker Orthopaedics Clinical Study Protocol  
 
 
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Study Synopsis 
 
Title 
A prospective, post-market, multi-center evaluation of the clinical 
outcomes of the Restoration® Anatomic Dual Mobility (ADM) X3® 
Acetabular System with Long Term Data Collection for the Accolade® 
II Hip Stem 
Short Title 
Restoration® ADM X3®  Study 
Protocol Number 
70 
Phase 
Post-market 
Methodology 
This study is a prospective, open-label, post-market, non-
randomized, multi-center, clinical evaluation of the Restoration® ADM 
X3® Acetabular System for primary total hip arthroplasty (THA) with a 
cementless application in a consecutive series of patients who meet 
the eligibility criteria.  The total enrollment goal for the study is 350 
cases, all of which will receive the Restoration® ADM X3® Acetabular 
System.  A minimum of 100 cases (within the study population) will 
receive the Accolade® II Hip Stem.  The remaining cases will receive 
any other compatible Stryker femoral component.   
Data in the literature from other primary hip systems and similar dual 
mobility cups will be used as historical references.   
Study Duration 
1. Follow-up of each primary THA case to 10 years 
2. Enrollment period of 24 months 
3.   Approximate 12-year total duration 
Study Center(s) 
Up to 12 investigational centers 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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Hypothesis 
The success rate, defined as freedom from postoperative femoral 
head dislocation, for hips implanted with the Restoration® ADM X3® 
Acetabular System, is not 3.5% worse than hips implanted with other 
primary hip systems in the literature at 10 years.  The success rate for 
other primary hip systems is approximately 97%.  With a non-inferiority 
margin of 3.5%, the success rate for the Restoration® ADM  X3® 
Acetabular System will be no less than 93.5% at 10 years. 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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Objectives 
Primary: 
• 
To evaluate and determine the success rate, defined as absence 
of postoperative femoral head dislocation, at 10 years with the 
Restoration® ADM X3 ® Acetabular System.  
Secondary: 
• 
To evaluate all-cause revision and removal rates in the 
Restoration® ADM X3 ® Acetabular System and compare with 
those reported for other primary hip systems in the literature. 
• 
To compare function and health related quality of life (QOL) 
between the Restoration® ADM X3® Acetabular System and 
published results for other primary hip systems.  The following 
outcomes measures will be used for this comparison: 
o Harris Hip Score (HHS) 
o Short Form-12 (SF-12) 
o Lower Extremity Activity Scale (LEAS) 
o EQ-5D 
1-year, 2-year, 3-year, 4-year and 5-year HHS, SF-12 and LEAS 
will be compared to literature control with respect to improvement 
from preoperative scores.  The EQ-5D data will be summarized 
and presented. 

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Objectives 
• 
An additional Follow-Up Questionnaire will be administered 
annually in postoperative years 6-10 to assess patient      
satisfaction and pain, and to capture adverse events. This 
questionnaire will provide the survivorship information necessary 
to evaluate the primary objective of the study. 
• 
To review radiographic stability and complications between those 
implanted with the Restoration® ADM X3® Acetabular System and 
published results for other primary hip systems.  Complication 
rates for psoas impingement and associated groin pain will be 
reviewed, as applicable. 
 
Number of Cases 
Cases will be enrolled until 350 cases have received the Restoration 
ADM® X3® Acetabular System.   
Additionally, a minimum of 100 cases (within the study population) 
will receive the Accolade® II Hip Stem.   

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Inclusions: 
A. Patient has signed an IRB/EC approved, study specific 
Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female, skeletally mature 
and age 18-75 years at time of study device implantation. 
C. Patient has a diagnosis of Non-Inflammatory Degenerative 
Joint Disease (NIDJD). 
D. Patient is a candidate for a primary cementless acetabular 
replacement. 
E. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations and 
rehabilitation. 
 

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Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Exclusions: 
F. Patient has a Body Mass Index (BMI) ≥ 40. 
G. Patient has an active or suspected latent infection in or about 
the affected hip joint at time of study device implantation. 
H. Patient has a neuromuscular or neurosensory deficiency, 
which limits the ability to evaluate the safety and efficacy of 
the device. 
I. 
Patient is diagnosed with a systemic disease (e.g. Lupus 
Erythematosus) or a metabolic disorder (e.g. Paget’s disease) 
leading to progressive bone deterioration. 
J. Patient is immunologically suppressed or receiving steroids in 
excess of normal physiological requirements (e.g. > 30 days). 
K. Patient requires revision surgery of a previously implanted 
total hip replacement or hip fusion to the affected joint. 
L. Patient has a known sensitivity to device materials. 
M. Patient is a prisoner. 
 
Proper implant selection must consider design, fixation, and 
environmental variables including: patient weight, age, bone quality 
and size, activity level and pre-operative level of health, as well as 
the surgeon’s experience and familiarity with the device.  For patients 
with poor proximal bone quality, the use of supplemental adjunctive 
proximal fixation/support is advised for implant stability. 

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Study Device 
Restoration® ADM X3® Acetabular System 
Required Components : 
1. Restoration® ADM Acetabular Shell 
2. Restoration® ADM X3® Acetabular Insert 
The acetabular components must be used in a cementless 
application. 
 
Stryker femoral components must be used according to this study 
protocol.  The following ancillary devices are permissible: 
• 
Stryker 28 mm femoral bearing head* 
• 
Stryker compatible femoral stems (minimum 100 cases 
implanted with Accolade® II Hip Stem) 
 
* The Restoration® ADM Acetabular Shell is not intended for use 
with the Stryker LFIT™ Anatomic CoCr femoral bearing head 
larger than 28mm. 
Reference Therapy 
Literature control  

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Statistical 
Methodology 
Primary: 
The 90% confidence interval of the success rate will be computed 
at 10 years postoperative.  For the non-inferiority comparison, the 
lower bound of this 90% confidence interval will be compared 
with 93.5%.  For the superiority comparison, the lower bound of 
this 90% confidence interval will be compared with 97%. 
 
Secondary: 
o The Kaplan-Meier survival curve of revision/removal for 
the Restoration® ADM X3® Acetabular System (acetabular 
shell and insert) will be displayed. 
o A paired t-test will evaluate the changes in clinical and 
patient outcomes (HHS, SF-12, EQ-5D, and LEAS), 
preoperative to 5 years postoperative within the 
Restoration® ADM X3® Acetabular System (acetabular 
shell and insert) group, when data is available.  In 
addition, the mean scores (HHS, SF-12, EQ-5D, and 
LEAS) over time will be tabulated, with standard deviation 
and 95% confidence intervals presented, if applicable. 
o The AE rates and radiographic data will be listed and 
tabulated at 10 years postoperative for the Restoration® 
ADM X3® Acetabular System group, with 95% confidence 
intervals presented, if applicable. 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem                               
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Stryker Orthopaedics Clinical Study Protocol  
 
 
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Evaluation Schedule 
Evaluation 
Preop 
X-rays 
(-1 yr) 
CRFs 
(-4 mos) 
Intraop 
6 weeks 
(+ 3 wks) 
1 year 
(+ 2 mos) 
2 years 
(+ 2 mos) 
3 years 
(+ 3 mos) 
4 years 
(+ 4 mos) 
5 years 
(+ 4 mos) 
6 years 
(+ 4 mos) 
7 years 
(+ 4 mos) 
8 years 
(+ 4 mos) 
9 years 
(+ 4 mos) 
10 years 
(+4 mos) 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics & 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Preoperative 
Functional 
Evaluation 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Postoperative 
Functional 
Evaluation 
 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
SF-12 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
LEAS 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
EQ-5D 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
Radiographs:  
Anteroposterior 
(AP) pelvis, AP 
femur, lateral 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
Follow-up 
Questionnaire 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
Functional Evaluation: The Functional Evaluations include the HHS, a subjective outcomes tool completed by the investigator that measures function, pain and motion. 
SF-12:  The SF-12 is a 12 item patient questionnaire that evaluates general health and well being. 
LEAS: The LEAS is a self-administered patient evaluation designed to reflect patient activity.  
EQ-5D: The EQ-5D is a standardized instrument for use as a measure of health outcome. 
Follow-up Questionnaire: The Follow-up Questionnaire is a short patient questionnaire intended to provide information on dislocation, patient satisfaction, pain and whether 
or not there have been any revisions or removals of the study device since the last follow-up visit.

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem                           Page 10 
Stryker Orthopaedics Clinical Study Protocol  
 
 
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This document is a protocol for a human research study.  This study will be conducted in 
compliance with the protocol, Good Clinical Practice (GCP) Standards, associated Federal 
regulations and all applicable research requirements.  
1.1 Background 
THA is one of the most clinically successful and cost-effective interventions in health care.  
Numerous surgeons have reported excellent long-term results in terms of reducing pain, 
improving function and QOL in patients with debilitating hip disease.1 
 
The concept of dual mobility was first defined by Professor Gilles Bousquet in 1976 at the 
University Hospital of St. Etienne, France.  This concept combines Charnley’s low friction 
principle and the McKee-Farrar theory, implanting a large diameter femoral head to decrease 
the potential for instability.  In the dual mobility system, the outer diameter (OD) of the mobile 
acetabular insert acts as an effective femoral head.  The dual mobility system consists of a 
cementless metallic acetabular shell and a polyethylene insert which freely rotates within the 
shell and positively captures a prosthetic femoral head.  The polyethylene insert functions like a 
bipolar head.  Thus, there are two distinct articulations sharing the same center of motion.2  See 
Figure 1 for a representative schematic. 
 
 
Figure 1.  Schematic of Dual Articulation 
 
 
 
 
 
 
 
 
 
 
 
 
1 Introduction 
1. Acetabular 
Shell 
2. Acetabular Insert 
   “Effective Head” 
3. Femoral Bearing Head 

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Articulation: 
1 → 2:  The first articulation occurs between the metal acetabular component and polyethylene 
acetabular insert.  
2 → 3:  The second articulation occurs between the polyethylene acetabular insert and the femoral 
bearing head. The femoral bearing head can be either metal or ceramic. 
 
In the case of the Restoration® ADM X3® Acetabular System, the Restoration® ADM Acetabular 
Insert is composed of X3 Ultra High Molecular Weight Polyethylene (UHMWPE) which retains 
a femoral head.  The convex surface of the X3 UHMWPE insert articulates on the highly 
polished concave surface of the cobalt chromium acetabular shell.  The outer surface of the 
acetabular shell has a plasma sprayed Commercially Pure (CP) Titanium and Hydroxylapatite 
(HA) coating to establish initial good fixation.  In addition, the rim of the Restoration® ADM 
Acetabular Shell has an anatomic cut-out to prevent conflict with the ilio-psoas tendon.  See 
Figure 2. for a schematic of the Restoration® ADM X3® Acetabular System. 
 
Figure 2.  Restoration® ADM X3® Acetabular System 
 
 
 
 
 
 
Dual mobility systems provide the advantages of the low friction THA with those of large femoral 
head diameters with the goals of increasing implant stability, reducing dislocation, increasing 
ROM and decreasing wear. 
 
Dislocation is one of the most common complications following THA.  Bozic et al.3 used the NIS 
database to analyze clinical, demographic and economic data from 51,345 revision THA 
procedures performed in the United States between October 1, 2005 and December 31, 2006.  
X3® Acetabular Insert 
Acetabular Shell 
Femoral Bearing Head 

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In this series, the most common cause of revision THA was dislocation/instability (22.5%) 
followed by mechanical loosening (19.7%) and infection (14.8%).4  The 2007 Swedish hip 
arthroplasty registry reported that the most common cause for re-operation, aseptic loosening, 
declined by 6.2%, whereas increases were reported for fracture (+16.4%), dislocation (+14.1%) 
and deep infection (+6.6%) as causes for re-operation.5 
 
Dual mobility systems have been successful in maintaining hip stability.  Guyen et al.6 reported 
a success rate of 94.5% in maintaining a stable hip with a dual mobility cup; no dislocation or 
subluxation was reported at 47.5 months.  Philippot et al.7 reported no early or late instability in 
a series of 384 cases who received a dual mobility cup, with a mean follow-up of 15 years.  
 
In a dual mobility system the femoral head rotates within the polyethylene acetabular insert as 
with traditional designs, with the exception that during extended ROM, the UHMWPE insert is 
able to rotate within the cup.  This configuration allows improved ROM before impingement.8  
One reason for groin pain postoperatively is the conflict of the anterior rim of the acetabular cup 
and the ilio-psoas tendon.  Tracol et al.9 evaluated the in vitro depth of the psoas ilio-pubic 
notch and developed the Restoration® ADM cup with a 3.5 mm anterior notch.  The anterior cut-
out is designed to mitigate conflict of the anterior portion of the cup and the psoas tendon.  
 
The polyethylene insert utilized in the Restoration ADM X3 Acetabular System is composed of 
X3 sequentially annealed UHMWPE.  D’Antonio et al.10 presented clinical data from 246 cases 
in a prospective multicenter study (Trident® X3® Acetabular Insert Study) in which all patients 
received X3® polyethylene inserts.  The X3® inserts had a low linear wear rate of 0.008 mm/year 
at 5 years which represents a 58% improvement over a first-generation annealed highly cross-
linked polyethylene.   
 
Cementless acetabular components for THA became popular in the United States in the early 
1980s, primarily due to poor long-term results with cemented cups.  Superior radiographic 
performance has been reported for cementless cups as compared with cemented fixation.11  
The design of the Restoration® ADM Acetabular Shell is based on the Trident® PSL cementless 
cup.  The cup is manufactured from wrought cobalt chromium alloy.  The acetabular shell has a 
CP Titanium plasma sprayed and HA coating to establish initial good fixation.  HA is a naturally 
occurring mineral form of calcium apatite that comprises 70% of human bone.  HA is currently 
used as a biological coating on a variety of orthopaedic implants to stimulate bone ongrowth.  

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HA coating has over 15 years of published clinical history of use on the femoral stem showing 
95.3% survivorship.12  The coating is designed to provide a roughened surface texture.  It is not 
an ingrowth surface but rather provides a surface roughness to the component. 
 
This clinical study is necessary to evaluate the success, defined as freedom from femoral head 
dislocation, of the Restoration® ADM X3® Acetabular System as compared to the reported 
success of other primary total hip systems and with products of similar dual mobility design.  
The objective of the study is to show that the study device performs no worse than similar 
devices at 10 years postoperative. 
 
The study will also collect longitudinal data on the performance of the Accolade® II Hip Stem. 
 
Cemented as well as cementless hip stems have shown good results in THA, even in younger 
patients.13  Implant design may contribute to the success of an implant.  A study conducted by 
Hozack et al.14 showed that the Taperloc’s flat, collarless, and wedge shaped design may have 
contributed to good femoral results.  Additional biomechanical studies have shown excellent 
axial and rotational stability, and similar wedge shaped designs have also shown comparable 
results.15,16,17 
 
A second generation of tapered stems was introduced to address distal fixation by shortening 
their first generation devices or by introducing entirely new stems.  Accolade® II is different from 
other second generation stems in that CT scans were digitally studied in depth prior to 
generating the very first concepts.  This was accomplished though SOMA, the unique Stryker 
Orthopaedics Modeling & Analytics technology. A study of 556 CT scans was conducted using 
SOMA and included a diverse group of men and women of different ethnic backgrounds and 
varying ages.  The data was used to design a stem that would better fit the varying sizes and 
shapes of today’s population18,19.  The medial curvature of the stem was also changed to 
address the bone variations in different people.  Accolade® II’s size-specific medial curvature 
(seen in Figure 1) allows for a correctly proportioned stem that better fits a wider range of 
patients that maximizes the implant to bone surface contact.   Additionally, the Accolade® II 
stem length has been optimized to accommodate all surgical approaches. 
 
 
 

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Figure 3.  Size Specific Medial Curvature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Through micro-motion analysis that compared Accolade® II versus a simply shortened tapered 
wedge stem, it was determined that the size-specific medial curvature and correctly 
proportioned proximal to distal ratio results in an increase in stability.  Contrary to this, if you 
simply shorten a first generation tapered wedge stem, the micro-motion of that stem increases 
or the stability decreases.   
  
The Accolade® II Hip Stem was cleared for use under FDA 510(k) K103479 on March 21, 2011 
and K120578 on March 29, 2012.   The stem neck is designed with a Howmedica Osteonics 
V40 taper on the proximal end similar in design to the previously cleared Accolade® TMZF® Hip 
Stem (K994366, K020572, and K023102). The Accolade® II Hip Stem, like the Restoration® 
Modular Hip Stem (K022549, K051363) will be manufactured from Titanium (Ti-6Al-4V) Alloy 
with a commercially pure Titanium (CP Ti) and hydroxylapatite (HA) coating to establish good 
initial fixation.   
Size Specific Medial Curvature 
Medial radii 
increase with 
each stem size 

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1.2 Investigational Device 
The Restoration® ADM Acetabular System was cleared for use under FDA 510(k) K072020 on 
October 18, 2007.  The Restoration® ADM X3® Acetabular Insert was cleared for use under FDA 
510(k) K093644 on December 18, 2009.  The system consists of two components; an 
acetabular shell and an X3 UHMWPE acetabular insert.  
 
The acetabular shell is manufactured from wrought cobalt chromium alloy with a CP Titanium 
and HA coating and is intended for cementless use.  The inner surface of the cup is highly 
polished.  The outer geometry of the Restoration® ADM Acetabular Shell is based on Stryker’s 
Trident® acetabular cups and has a Peripheral Self Locking (PSL®) design.  The rim of the 
Restoration® ADM Shell has an anatomic cut-out to prevent conflict with the ilio-psoas muscle. 
 
The Restoration® ADM Acetabular Insert is composed of Stryker Orthopaedics sequentially 
annealed UHMWPE, X3®.  The inner diameter (ID) of the acetabular insert is compatible with any 
currently available Stryker 28 mm femoral head (except for the LFIT™ Anatomic CoCr femoral 
bearing head) and a Stryker compatible femoral stem.  
 
The Restoration® ADM X3® Acetabular Shell is available in a left and right configuration and 
ranges in size from 46 to 64 mm, OD.  The shell is coupled with the Restoration® ADM X3® 
Acetabular Insert, ranging in size from 40 to 58 mm, OD.  
 
The Accolade® II Hip Stem is a non-porous coated femoral stem with a flat tapered wedge 
design intended to provide rotational stability. The stem is designed with an anterior and 
posterior groove running along its axis distally up to the mid stem region. The medial curvature 
on the stem is size-specific and increases with stem size to address variations in patients. The 
distal portion of the stem has a lateral relief and satin finish, while the neck region of the stem is 
polished. 
 
The Accolade® II Hip Stem is available in 12 sizes ranging from size 0 through 11.  Stem length 
ranges from 93 mm to 126 mm in 3 mm increments.  The neck lengths of the Accolade® II Hip 
Stem range from 27 mm to 40 mm and are proportional relative to the different body geometry.  
Additionally, the necks are available in two angles (127° and 132°) that provide dual offsets. 
 

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1.3  Preclinical Data 
The following bench tests were conducted with the Restoration® ADM X3® Acetabular System.  In 
some instances, the predicate device, ADM with Duration®, was used as a comparison device:  
 
Wear Testing 
Testing was performed to evaluate the wear performance of the Restoration® ADM System with 
X3® acetabular inserts and compared to the Restoration® ADM System with Duration® 
acetabular inserts.  
 
The Restoration® ADM System with X3® Acetabular Inserts wore at a volumetric rate of 0.6 ± 0.8 
mm3/mc (volume per million cycles) (R2=0.7273) while the Restoration® ADM System with 
Duration acetabular inserts wore at a volumetric rate of 20.9 ± 9.0 mm3/mc (R2=0.999).  This 
corresponds to a 97% reduction in wear rate for the X3® material.a  This reduction rate is 
statistically significant compared to conventional polyethylene materials.  Visual examination 
also showed no signs of mechanical or fatigue damage for both Duration® and X3® materials.   
 
A multi-station hip joint simulator was used for wear testing.  Each station consisted of fixtures 
accommodating the femoral head and acetabular insert, which were aligned along the same 
vertical axis.  Testing was conducted in an anatomical orientation with the insert stationary and 
mounted in a superior position.  Articulation was provided by the femoral head mounted below.  
A specimen chamber surrounded the assembly and allowed for lubrication.  The specimens 
were lubricated with calf serum diluted with deionized water and Ethylenediaminetetraacetic 
acid.  Refer to test report RD-09-079, entitled Hip Simulator Wear Evaluation of The 
 
a Stryker Orthopaedics Restoration® ADM X3® 28 mm ID acetabular inserts made of X3® Gas Plasma Sterilized 
UHMWPE, show a 97% reduction in volumetric wear rate versus 28 mm ID Restoration® ADM Duration Gamma 
Radiation Sterilized UHMWPE. Both ADM constructs utilized a 54mm OD shell and the inserts were 
approximately 9.9 mm thick. Testing was conducted under multi-axial hip joint simulation for 5 million cycles 
using a 28mm CoCr modular femoral head articulating counterface and calf serum lubricant. Volumetric wear 
rates were 109.7±6.0 mm3/106 cycles and -1.03 ± 3.8 mm3/106 cycles for Duration and X3® polyethylene 
insert test samples. Although in-vitro hip wear simulation methods have not been shown to quantitatively 
predict clinical wear performance, the current model has been able to reproduce correct wear resistance 
rankings for some materials with documented clinical results. 1-3   
[1] Wang, A, et. al., Tribology International, Vol. 31, No. 1-3: 17-33, 1998. 
[2] Essner, A. et. al., 44th Annual Meeting, ORS, New Orleans, Mar. 16-19, 1998: 774. 
[3] Essner, A. et. al., 47th Annual Meeting, ORS, San Francisco, Feb. 25-28, 2001: 1007. 

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Restoration® ADM X3® Acetabular System, for detailed methods.  The conclusion of the tests 
was as follows: 
o The Restoration® ADM X3® Acetabular System shows a 100% reduction in total volume 
loss over the Restoration® ADM Duration® Acetabular System after wear testing under 
the same conditions. 
o The Restoration® ADM X3® Acetabular System shows a 97% reduction in wear rate over 
the Restoration® ADM Duration® Acetabular System after wear testing under the same 
conditions.  This level exceeds the 50% level required in the design input, verification 
and validation requirements. 
o The Restoration® ADM Duration® Acetabular System compares favorably in terms of 
wear rate when compared to the same 28 mm ID Stryker Trident® N2VAC® liner.  For 
this reason, this system may outperform a conventional acetabular bearing construct in 
terms of wear. 
o Both X3® and Duration® Restoration ADM Acetabular Inserts showed no signs of 
mechanical or fatigue damage (cracks, etc) after 5 million cycles of testing. 
 
Lever Out/Push Out Testing 
Testing was performed on the worst case component of each material insert to compare the 
dislocation resistance of the inserts by characterizing their lever out and pull out strengths.  The 
following smallest and thinnest available components were identified as the worst case from 
each material:  X3 part number 1236-2-846 (28 mm ID/ 46 mm OD) & Duration® part number 
1235-2-246 (22.2 mm ID/ 46 mm OD).  Seventeen test samples were used for each material in 
both lever-out and pull-out tests.  The results of the testing showed that the lever-out and pull-
out resistance strengths of the worst case X3 Acetabular Insert were not less than the worst 
case Duration® Acetabular Inserts, meeting the test acceptance criteria.  Ease of use with 
instrumentation was also identified to be similar between the X3 and Duration® Acetabular 
Inserts.  Refer to test reports TR09-1014, entitled Comparative Lever-Out & Axial Pull-Out 
Testing of Restoration ADM X3, for detailed methods and results. 
 
Contact Stress Analysis  
The contact stress within the subject Restoration ADM X3 Acetabular Inserts are comparable 
to those of its predicate Trident X3 Acetabular Inserts.  
 
 

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Materials 
The subject X3 and predicate Duration Acetabular Inserts are manufactured from UHMWPE 
meeting American Society for Testing Materials (ASTM) Standard F648.  The predicate 
Duration® Acetabular Insert device is fabricated from GUR 1050 UHMWPE.  The X3 
Acetabular Insert is manufactured from compression molded GUR 1020 polyethylene.  
Manufacturing changes have been made to the processing of the raw material to provide a 
sequentially crosslinked and annealed polyethylene material for use in the manufacturing of the 
inserts.  See Table 1 for a summary of Duration and X3 properties.  Based on the 
comparative results below, the 1020 GUR is acceptable for use in combination with the 
Restoration® ADM Acetabular Shell for THA. 
Table 1.  Subject Polyethylene Properties 
 
Property 
Duration Polyethylene 
1050 GUR 
Mean (Std. Dev.) 
X3® Polyethylene 
1020 GUR 
Mean (Std. Dev.) 
UTS (MPa) 
51.1 (3.3) 
56.7 (2.1) 
Yield Strength (MPa) 
24.3 (0.5) 
23.5 (0.3) 
% Elongation 
404 (16) 
267 (7) 
Density (kg/m3) 
929.2 (0.0) 
939.2 (0.1) 
% Crystallinity 
56.7 
61.7 (0.6) 
 
The results of the bench top testing conducted for the new Restoration® ADM X3 Acetabular 
Inserts identified acceptance criteria was met. 
 
The following bench tests were conducted with the Accolade® II Hip Stem:   
• 
127° Accolade® II  Size 3 Neck Verification Testing (RD-10-095) 
  
• 
127° Accolade® II  Size 0 Distal Body Verification Testing (RD-10-096) 
 
• 
127° Accolade® II Size 2 Neck Verification Testing (RD-11-022) 
  
The results of the bench top testing conducted for the new Accolade® II Hip Stem identified 
acceptance criteria were met. 
 
Copies of all test reports are available at Stryker Orthopaedics.   

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1.4  Clinical Data to Date 
This study is the first Stryker sponsored multi-center prospective data collection on the 
Restoration  ADM X3 Acetabular System and the Accolade® II Hip Stem. 
2 Study Objectives 
 
2.1 
Efficacy 
2.1.1 Primary 
The primary objective of this study is to evaluate the success rate of cementless 
primary total hip replacement (THR) with the Restoration® ADM X3® Acetabular 
System as compared to the published results of primary THR systems.  Success will 
be defined as absence of femoral head dislocation at 10 years postoperative.  It is 
expected that the survivorship of the Restoration® ADM X3® Acetabular System group 
will be non-inferior to the survivorship reported in the literature for other primary THR 
systems. 
 
2.1.2 Secondary 
The secondary objectives of this study will be to evaluate all-cause revision and 
removal rates with the Restoration® ADM X3® Acetabular System and compare with 
those reported for other primary hip systems in the literature. 
 
Additionaly, psoas impingement and associated groin pain, function and health-
related QOL between the Restoration® ADM X3® Acetabular System and those 
reported in the literature for other primary hip systems and similar dual mobility cups 
on the market will be compared at postoperative time points. 
 
Lastly, radiographic stability and complications between those implanted with the 
Restoration® ADM X3® Acetabular System and other primary hip systems in the 
literature will be reviewed. 
 
Clinical Outcomes: 
Clinical outcomes will be evaluated with the total HHS, including pain, motion and 
function, preoperatively and at the 6-week, 1, 2, 3, 4 and 5-year visits.  Additional 

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HHS data will be obtained at the 7-year and 10-year time points at investigational 
sites that choose to bring their subjects in for these optional visits.  
 
Patient Outcomes: 
Pain, function and health related QOL will be compared between the Restoration® 
ADM X3® Acetabular System and reports in the literature for other primary THR 
systems and similar dual mobility cups on the market.  The SF-12 is a 12 item 
patient self-assessment evaluating health and general well being.  The LEAS is a 
tool that has been developed and validated to evaluate the level of patient activity.  
The EQ-5D is a standardized instrument for use as a measure of health outcome.  
These tools will be used to assess patient health-related QOL and will be collected 
preoperatively at the 6-week, 1, 2, 3, 4, and 5-year visits.   
 
A Follow-Up Questionnaire will be administered annually in postoperative years 6-
10 to assess patient satisfaction and pain, and to capture AEs.  This questionnaire 
will provide the survivorship information necessary to evaluate the primary objective 
of the study.  Patient outcomes data will also be obtained at the 7-year and 10-year 
time points at investigational sites that choose to bring their subjects back in for 
these optional visits, in addition to the required Follow-Up Questionnaire described. 
 
Radiographic Outcomes: 
To assess radiographic stability as compared with other primary THR systems and 
similar dual mobility cups, radiographs will be taken and collected in the AP pelvis, 
AP femur and lateral views for the preoperative, 6-week, 1, 2, 3, 4 and 5-year 
intervals.  Additional radiographs will be obtained at the 7-year and 10-year time 
points at investigational sites that choose to bring their subjects back in for these 
optional visits. 
 
The AP pelvis and AP femur view allow for observation of any conditions involving 
the sacral wings, iliac bones, ischium, pubis as well as the femoral head and neck.  
The lateral view allows for evaluation of the entire hip joint as well as the femoral 
head, neck and proximal shaft.20 Suggested radiographic technique for the views 
required is included in Appendix A. 
 

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Radiographs will be evaluated by an independent reviewer throughout the course of 
the study.  Radiographic analysis of the acetabular component will employ three zones 
(Zone 1 – Zone 3) in the AP view.21,22  Radiographic analysis of the femoral component 
will employ seven zones (Zone 1 - Zone 7) in the AP views and seven zones (Zone 8 
– Zone 14) in the  lateral view.  Numerous parameters will be reviewed by zone, 
including radiolucency, hypertrophy, condensation and migration.  Radiolucency in at 
least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency 
present.  Cases that present with migration of greater than  5 mm in any direction or 
at least 2 mm radiolucency in all zones will be considered radiographic failures. 
 
2.2  Safety 
All operative site events as well as all serious adverse events (SAEs), excluding elective 
procedures, will be collected and compared to published data.  It is expected that the AE rates 
reported for the Restoration® ADM X3® Acetabular System will be comparable to those reported 
in the literature for other primary THR systems and similar dual mobility cups on the market.  
Details regarding AE definitions, recording and reporting are in Section 8 of this protocol, Adverse 
Events. 
 
3 Clinical Study Plan 
3.1 Study Design 
A prospective, post-market, multi-center design will be employed.  Radiographs will be assessed 
by an independent reviewer. 
3.2  Number of Centers 
Cases will be enrolled at up to 12 centers.  The enrollment goal is 29 cases per center utilizing 
the Restoration® ADM X3® Acetabular System but will vary dependent upon the number of 
participating centers.   Although a goal is presented, there is no maximum limit to the number of 
cases that a center may enroll.  In the event that a center far exceeds the enrollment goal, Stryker 
may ask the center to cease enrollment so as not to skew the data.  All participating centers will 
comply with the federal regulations regarding patient informed consent and Institutional Review 

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Board (IRB) or Ethics Committee (EC) approval.  Non-compliance of a study center may result in 
termination of the center’s participation in the study. 
3.3  Number of Subjects 
Cases will be enrolled until a total of 350 cases receive the Restoration® ADM X3® Acetabular 
System.  Additionally, a minimum of 100 cases (within the study population) will receive the 
Accolade® II Hip Stem.   
 
Stryker will monitor enrollment to ensure the enrollment goals for the Restoration® ADM X3® 
Acetabular System and the Accolade® II Hip Stem are satisfied. 
 
3.4 
Estimated Study Duration  
The enrollment period is estimated to be a maximum of 24 months; cases will be evaluated as 
per the evaluation schedule until each case reaches 10 years. 
 
To allow for a learning curve with the use of the device, enrollment of cases into the study will 
commence when five cases have been completed at the center using the Restoration® ADM X3® 
Acetabular System. 
4 Eligibility 
 
The following criteria will be used to distinguish patients eligible for enrollment into this study.  
Proper implant selection must consider design, fixation, and environmental variables including: 
patient weight, age, bone quality and size, activity level and pre-operative level of health, as well 
as the surgeon’s experience and familiarity with the device.  For patients with poor proximal 
bone quality, the use of supplemental adjunctive proximal fixation/support is advised for implant 
stability. 
 
4.1 
Inclusion Criteria 
A. Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time 
of study device implantation. 

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C. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 
D. Patient is a candidate for a primary cementless acetabular replacement. 
E. Patient is willing and able to comply with postoperative scheduled clinical and 
radiographic evaluations and rehabilitation. 
 
4.2 
Exclusion Criteria 
F. Patient has a Body Mass Index (BMI) ≥ 40. 
G. Patient has an active or suspected latent infection in or about the affected hip joint at 
time of study device implantation. 
H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to 
evaluate the safety and efficacy of the device. 
I. 
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic 
disorder (e.g. Paget’s disease) leading to progressive bone deterioration. 
J. Patient is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements (e.g. > 30 days). 
K. Patient requires revision surgery of a previously implanted total hip replacement or hip 
fusion to the affected joint. 
L. Patient has a known sensitivity to device materials. 
M. Patient is a prisoner. 
5 Subject Enrollment 
 
5.1 Treatment Assignment 
All subjects will receive the Restoration® ADM X3® Acetabular System with a minimum of 100 
cases (within the study population) that will receive the Accolade® II Hip Stem. 
 
Stryker will monitor enrollment closely to ensure that the enrollment goals of Restoration® ADM 
X3® Acetabular System and the Accolade® II Hip Stem are satisfied. 
5.2 Randomization 
The study will enroll under a non-randomized study design. 
 

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6 Device Description 
6.1 Study Device 
The Restoration® ADM X3® Acetabular System and the Accolade® II Hip Stem have been cleared 
for use in the United States; therefore, this study is considered a post-market assessment.  All 
cases in this study will receive the Restoration® ADM X3® Acetabular System which consists of 
two components, an acetabular cup and an X3 UHMWPE acetabular insert.   
 
Additionally, only the following Stryker compatible ancillary devices may be used, according to 
this study protocol: 
o Compatible Stryker femoral stem (minimum of 100 Accolade® II Hip Stems) 
o 28 mm Stryker femoral head*  
 
The acetabular cup is manufactured from wrought cobalt chromium alloy with a CP Titanium 
and HA coating and is intended for cementless use.  The inner surface of the cup is highly 
polished.  The outer geometry of the Restoration® ADM Acetabular Shell is based on Stryker’s 
Trident® Acetabular Shell and has a PSL® design.  The rim of the Restoration® ADM Acetabular 
Shell has an anatomic cut-out to prevent conflict with the ilio-psoas muscle. 
 
The Restoration® ADM X3® Acetabular Insert is composed of Stryker Orthopaedics sequentially 
annealed UHMWPE, X3®.  The ID is compatible with a 28 mm Stryker femoral bearing head only.  
*The Restoration® ADM Acetabular Shell is not intended for use with the Stryker LFIT™ 
Anatomic CoCr femoral bearing head larger than 28mm. 
 
The Restoration® ADM X3® Acetabular Shell is available in left and right configurations ranging in 
sizes 46 mm – 64 mm OD which are coupled with the polyethylene inserts ranging in sizes 40 
mm - 58 mm OD.  There is a 6 mm difference between cups and inserts and inserts are available 
in 0 degrees only.  
 
The catalog numbers for the Restoration® ADM Acetabular Shell, permissible according to this 
study protocol are in the following format, where ‘XXX’ varies by size: 
 
 
 
 
 
1235-2-XX1 (Right) 
1235-2-XX2 (Left) 

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The catalog numbers for the Restoration® ADM X3® Acetabular Insert, permissible according to 
this study protocol are in the following format, where ‘XX’ varies by size: 
 
 
 
 
 
1236-2-8XX 
 
 
Table 2.  Restoration® ADM X3® Acetabular System Shell/Insert Thickness/Head Compatibility 
 
Restoration® 
ADM Shell 
(OD/mm) 
Restoration® 
ADM X3® Insert 
(OD/mm) 
Insert 
Thickness 
(mm) 
Femoral Head 
Diameter 
(mm) 
46 
40 
5.9 
28 
48 
42 
6.9 
28 
50 
44 
7.9 
28 
52 
46 
8.9 
28 
54 
48 
9.9 
28 
56 
50 
10.9 
28 
58 
52 
11.9 
28 
60 
54 
12.9 
28 
62 
56 
13.9 
28 
64 
58 
14.9 
28 
 
The patentedb sequential irradiation and annealing manufacturing process for X3® offers 
increased wear resistance  and virtually eliminates free radicalsc  while preserving mechanical 
 
b U.S. Patent # 6,174,934 6,372,814 6,664,308 6,818,020 7,517,919 
 
c X3 UHMWPE virtually eliminates free radicals, as measured by Electron Spin Resonance (ESR). A very low (noise 
level, near instrument detection limit) concentration of residual free radicals was detected in the X3 UHMWPE. A 
99% reduction of free radicals (14 ± 2 x 1014 spins/gram versus 1550 ± 32 x 1014 spins/gram) was found when 
compared to N2Vac gamma sterilized UHMWPE. 
 

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propertiesd,e,f,g.  X3® is irradiated by 3 MRads gamma radiation and annealed (heated below 
melting temperature) three times for a total cumulative dose of 9 MRads.       
 
The Accolade® II Hip Stem will be available in 12 sizes ranging from size 0 through 11.  Stem 
length will range from 93 mm to 126 mm in 3 mm increments.  The neck lengths of the 
Accolade® II Hip Stem range from 27 mm to 40 mm and are proportional relative to the different 
body geometry.  Additionally, the necks are available in two angles (127° and 132°) that provide 
dual offsets. 
 
For subjects implanted with the Accolade® II Hip Stem, the following catalog numbers are 
permissible according to this study protocol and are in the following format, where ‘XXXX’ varies 
by size: 
6720-XXXX 
6721-XXXX 
6.2 Device Retrieval Process 
Stryker Orthopaedics will retrieve any Restoration® ADM X3® Acetabular System components and 
the Accolade® II Hip Stem (when applicable) and/or adjacent tissues for analysis to help 
characterize potential device-related complications.  In the event that any portion of the 
Restoration® ADM X3® Acetabular System or the Accolade® II Hip Stem is removed from a study 
subject, the procedure outlined in the Retrieval Analysis Protocol (Appendix B) should be 
followed.  In addition: 
 
 
d X3 UHMWPE maintains mechanical properties after accelerated oxidative aging. No statistical difference was found 
for Tensile Yield Strength, Ultimate Tensile Strength and Elongation as measured per ASTM D638 before and after 
exposure to ASTM F2003 accelerated aging (5 Atmospheres (ATM) of oxygen at 70ºC for 14 days). Tensile Yield 
Strength was 23.5 ± 0.3 MPa and 23.6 ± 0.2 MPa, Ultimate Tensile Strength was 56.7 ± 2.1 MPa and 56.3 ± 2.3 
MPa and Elongation was 267 ± 7% and 266 ± 9% before and after accelerated oxidative aging, respectively. 
 
e X3 UHMWPE resists the effects of oxidation. No statistical difference was found for Tensile Yield Strength, Ultimate 
Tensile Strength, Elongation, Crystallinity and Density as measured per ASTM D638, D3417 and D1505 before and 
after ASTM F2003 accelerated aging (5 ATM of oxygen at 70°C for 14 days). Tensile Yield Strength was 23.5 ± 0.3 
MPa and 23.6 ± 0.2 MPa, Ultimate Tensile Strength was 56.7 ± 2.1 MPa and 56.3 ± 2.3 MPa, Elongation was 267 
± 7% and 266 ± 9%, Crystallinity was 61.7 ± 0.6% and 61.0 ± 0.5%, and Density was 939.2 ± 0.1 kg/m3 and 
939.2 ± 0.2 kg/m3 before and after accelerated oxidative aging, respectively. 
 
f “Improved Strength of Cross-linked UHMWPE Without Compromising Oxidation/Fatigue Resistance and Wear”, Yau 
SS; Wang A, Lovell T. 2007 Combined ORS Poster #496. 
 
g “Wear, oxidation and mechanical properties of a sequentially irradiated and annealed UHMWPE in total joint 
replacement”, A.Wang, H.Zeng, S-S Yau, A. Essner, M. Manley and J. Dumbleton, Journal of Physics, D:Appl: Phys 
39 (2006).   

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

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

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The questionnaire will also provide information on any revisions and enable calculation of the 
Kaplan-Meier Survival Curve necessary to meet the primary endpoint of the study. 
 
Additionally, at investigational sites that choose to continue collecting clinical and radiographic 
data during the second phase of the study, subjects will be evaluated again at 7 and 10 years 
after surgery. 
 
8 Adverse Events 
8.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
• 
All AEs that meet the definition of serious, excluding elective procedures 
 
• 
All AEs related to the operative site, regardless of seriousness 
 
 
Elective procedures meeting the definition of an SAE do not need to be reported as AEs according 
to this study protocol.  Examples of such elective procedures include, but are not limited to, the 
following commonly seen events: 
• 
Contralateral THR 
• 
Total Knee Replacement 
• 
Rotator Cuff Surgery 
• 
Cataract Surgery 
 
Such events will not be captured on the AE electronic Case Report Form (eCRF) but rather will 
be captured on the Postoperative Functional Evaluation at the 6-week, 1-year, 2-year, 3-year,  
4-year and 5-year time points.  Additional events of this nature will be captured on the 7-year and 
10-year functional evaluations if the investigator chooses to bring subjects in for these optional 
visits.  On these functional evaluations, investigators and SCs will be prompted to question 
subjects as to whether they have seen a doctor for any reason, been hospitalized for any reason 
or have a current impediment to their function. 
 
Additionally, SCs will be responsible for following up with the subjects regarding any questionable 
responses received on the Follow-up Questionnaire administered in postoperative years 6 
through 10.  If it is determined upon this further investigation that a protocol-defined AE has 

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occurred, the SC will be responsible for completing an AE eCRF, submitting the event to Stryker 
and reporting to the IRB, as required.   

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The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
 
Figure 4.  Adverse Event Decision Tree 
Start
Site becomes 
aware of Adverse 
Event
Is the event related to the 
operative site? 
Report AE to 
Stryker via AE 
Form
Yes
Does the AE meet the 
criteria for Seriousness?
No
Report AE to 
Stryker via AE 
Form
Do NOT report to 
Stryker
No
End
Is the event an 
elective surgery? 
No
Yes
Yes
 

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General Physical Examination Findings 
At screening for inclusion into the study, any clinically significant abnormality should be recorded 
as a preexisting condition and reported on the Demographics eCRF.  From the time of consent 
forward, any new clinically significant findings or abnormalities that meet the definition of a 
protocol defined AE must also be recorded and documented as an AE. 
Adverse Event Reporting Period 
The study period during which AEs must be reported is normally defined as the period from the 
initiation of any study procedures to the end of the study treatment follow-up.   The start of study 
procedures is considered to be the point of consent.  Any AEs which fit the protocol defined 
reportable events must be reported from the time of consent until study completion. 
 
At each contact with the subject the investigator must seek information on AEs by specific 
questioning and, as appropriate, by examination.  Information on protocol defined AEs should be 
recorded immediately in the source document and also in the appropriate AE module of the eCRF.  
All clearly related signs, symptoms and abnormal diagnostic procedure results should be recorded 
in the source document and grouped under one diagnosis, as appropriate.  The clinical course of 
each event should be followed until resolution or until it is determined at the end of the study that 
the AE will not resolve.   
8.2 General Adverse Event Definitions 
Following is a list of general AE definitions.  For the purposes of this study, only SAEs, 
excluding elective procedures, as well as all AEs related to the operative site should be 
reported.   
Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation subject, which changes the 
medical baseline of the subject.  An AE can be an unfavorable and unintended sign, symptom or 
disease, whether or not related to the study device (AEs may also be referred to as complications).  
See Section 8.1, Reporting of Adverse Events, for the AE reporting requirements for this study. 
 

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

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

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

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9.1.3 Primary Efficacy Hypothesis 
The null hypothesis, H0, is that the success rate, defined as absence of postoperative 
femoral head dislocation, at 10 years postoperative is less than δ.  The alternative 
hypothesis, Ha, is that the success rate at 10 years postoperative is greater than or equal 
to δ.  When δ = 93.5%, the hypothesis is a test for non-inferiority.  When δ=97%, the 
hypothesis is a test for superiority. 
H0:  p < δ 
 
Ha:  p ≥ δ 
9.1.4 Primary Efficacy Analysis 
A case success is defined as no incidence of postoperative femoral head dislocation within 
10 years.  A 90% confidence interval of the success rate will be computed at 10 years 
postoperative.  If the lower bound of this confidence interval is greater than 93.5%, the 
non-inferiority hypothesis will be supported.  If the lower bound of this confidence interval 
is above 97%, the superiority hypothesis will be supported.  The Kaplan-Meier survival 
curve of femoral head dislocation for any reason will also be displayed using SAS/PROC 
LIFETEST. 
9.1.5 Secondary Efficacy Analysis 
A two-sided 0.05 alpha level will be used. 
 
A paired t-test will evaluate the changes in clinical outcomes (HHS, SF-12 and LEAS) 
preoperative to 10 years postoperative within the Restoration® ADM X3® Acetabular 
System group, when data is available.  In addition, the mean scores (HHS, SF-12 and 
LEAS) over time will be tabulated, with standard deviation and 95% confidence intervals 
presented, if applicable. 
9.2 Safety Parameters 
9.2.1 Safety Parameters 
Safety parameters will include  
o All AEs reported 
o Rate of psoas impingement 
o Rate of associated groin pain (derived from the ‘Operative Site – Other’ field on 
the AE form)  

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o Radiographic stability at each postoperative visit  
o Revision or removal of any study component  
o Revision or removal of the Restoration® ADM Acetabular Shell and X3® 
Acetabular Insert 
9.2.2 Safety Analysis 
All AEs will be listed, tabulated and summarized by event, number and percent of 
cases/subjects.  AE rates and 95% confidence intervals will be presented.   
 
For categorical variables, such as radiographic stability, the number and percent in each 
category will be presented.  
 
The Kaplan-Meier survival curve of revision/removal of any study component and the 
Restoration® ADM Acetabular Shell and X3® Acetabular Insert will also be displayed.  
 
9.3 Missing Data 
No missing data will be imputed for the primary analysis and secondary analyses.  
 
9.4 Statistical Methodology 
9.4.1 Data Summary 
The following is a detailed proposal of statistical analyses planned for data collected during 
the study.   
 
Descriptive statistics will be computed for all preoperative conditions and demographic 
parameters.  That is, for continuous data (e.g. HHS), the N, mean, median, standard 
deviation, minimum and maximum will be computed.  For categorical data (e.g. gender), 
the frequency and percentage will be computed. 
 
Descriptive statistics and statistical comparisons for important demographic, efficacy and 
safety variables will be provided in tables.   
 
A survival analysis will be performed.  
 

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9.4.2 Sample Size Calculation 
A literature review shows that at 10 years of follow-up there is an approximate 97% 
success rate using postoperative femoral head dislocation as the defining factor.  Using 
a base success rate of 97% from the literature and a delta of 3.5%, it was calculated that 
274 total cases would be needed to prove non-inferiority with 95% confidence.  With a 
minimum of 274 cases analyzed, the primary hypothesis of the study will be met if the 
lower bound of the one-sided 95% confidence interval for the 10-year success rate is 
greater than 93.5%.  By factoring in a 20% lost to follow-up rate within a 10-year period, 
the required enrollment increases to 343 cases.  A total of 350 cases will be enrolled into 
the study. 
 
9.4.3 Interim Analyses and early Stopping Considerations 
No interim analysis is planned.  
9.4.4 Efficacy Patient Populations  
 
9.4.4.1 Efficacy 
Per protocol population: 
The study population for analysis will include all subjects who receive the 
Restoration® ADM Acetabular Shell and Restoration® ADM X3® Acetabular Insert 
and have the primary efficacy variable measurements available.  This does not 
include cases censored from analysis for a reason that may have a significant 
impact on outcome. 
The primary efficacy analysis will be based on the per protocol population. 
9.4.4.2 Safety 
Safety Population: 
The safety population will include all non-censored subjects who received the 
Restoration® ADM Acetabular Shell and Restoration® ADM X3® Acetabular Insert. 
9.4.4.3 Survival Analysis 
Modified intent to treat population: 
Subjects enrolled in the study who received the Restoration® ADM Acetabular Shell 
and Restoration® ADM X3® Acetabular Insert will be included in the survival analysis. 

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9.4.4.4 Censored Cases 
In the event that a protocol deviation occurs which could affect subject outcome, the 
data for the affected subject will be censored from the Efficacy and Safety Subejct 
Populations.  All cases that fall into this category will be reported separately.   
 
10 Study Procedures 
10.1  Subject Recruitment and Screening 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  All patients recruited for this study will have the capacity to give informed consent.  
Advertising for the study at each center will be at the discretion of the investigator.  All handouts, 
brochures, advertisements, etc. must be approved by the IRB/EC prior to the dissemination of 
any recruitment materials to potential subjects. 
10.2   Patient Informed Consent and Guidelines 
 
All patients for this study will be provided an Informed Patient Consent Form describing this study 
and providing sufficient information for them to make an informed decision about their 
participation.  The Informed Patient Consent Form must contain all elements required by the FDA 
under 21 CFR Part 50, in addition to any other elements required by state, local and institutional 
policies.  For international sites, the applicable country regulations are required.  See Appendix E 
for a copy of the Model Informed Patient Consent.  This will be submitted with the protocol for 
review and approval by the IRB/EC for the study.  All patients must provide written consent after 
having had adequate time to consider their participation in the study.  The formal consent of a 
patient, using the IRB/EC approved Informed Patient Consent Form, must be obtained before that 
patient is submitted to any protocol related procedures that are not part of normal care.  Written 
documentation of consent must be provided on the Informed Patient Consent Form’s signature 
page in addition to a note in the patient medical records indicating the date that consent was 
obtained.  The investigator-designated research professional obtaining the consent must also 
sign this Informed Patient Consent Form.  The patient or his/her legal representative should 
receive a signed copy of the Informed Patient Consent Form, according to GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
• 
Use a current IRB/EC approved copy of the Informed Patient Consent Form. 

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• 
Review thoroughly with the patient before having them sign. 
• 
After the patient has consented to the procedures, ensure he/she signs and dates the 
Informed Patient Consent Form. 
• 
The person obtaining consent also signs and dates the signature page. 
• 
Provide a copy of the Informed Patient Consent Form to the patient. 
• 
If required, provide the hospital with a copy of the signed Informed Patient Consent Form. 
• 
Maintain the signed original in the patient’s study chart. 
 
10.3  Early Withdrawal of Subjects 
 
When and How to Withdraw Subjects 
In the event that the subject is discontinued by the investigative center prior to the final study 
evaluation, the subject will be notified by the center that he/she is no longer in the study and a 
Study Termination eCRF will be completed.   
 
The following is a list of reasons for which subjects may be withdrawn and the date of termination 
that should be used on the Study Termination eCRF in each situation.  This list is not all inclusive: 
 
Termination Reason 
 
 
 
Date of Termination 
Death 
 
 
 
 
 
Date of death 
Investigative center termination  
 
Date of study close-out visit 
Lost to follow-up  
 
 
 
Date Stryker termination approval given 
Voluntary withdrawal 
 
 
 
Date subject notified center of withdrawal 
Revision/removal of study device  
 
Date of revision/removal procedure 
Study device not implanted 
 
 
Date of surgery 
Surgery not performed 
 
 
 
Date Stryker termination approval given 
 
 
 
At the time of study surgery it is required that the following components are implanted for each 
treatment group: 
 
Restoration® ADM X3® System with any compatible Stryker Stem:  
o Restoration® ADM Acetabular Shell 
o Restoration® ADM  X3® Acetabular Insert  

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o 28 mm Stryker femoral head (except for the LFIT™ Anatomic CoCr femoral bearing head) 
o Compatible Stryker femoral stem (with a minimum of 100 Accolade® II Hip Stems) 
 
Revision or removal of the Restoration® ADM X3® Acetabular System (acetabular shell and 
insert) constitutes a failure and study termination for the subject. 
 
If femoral stem or femoral head revision is required during the study, the event is considered a 
reoperation and does not constitute a failure or study termination. 
 
If the subject fails to return for his/her follow-up appointments, every effort should be made to 
contact the subject to assess his/her health status.  If, after attempting to contact the subject 
through three documented phone calls and a certified letter, the subject still does not respond, 
he/she will be considered lost to follow-up.  A Study Termination eCRF will be completed only 
after notifying Stryker of the subject’s status and being given approval to terminate.   
 
In the event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  If the surgery is rescheduled more than 4 months from the date of 
preoperative data collection, the subject will need to be re-consented, all preoperative data will 
need to be re-collected and all original preoperative data will need to be removed from the 
database.  If the surgery is not to be rescheduled or if the subject is no longer considered an 
appropriate study candidate, a Study Termination eCRF may be completed only after notifying 
Stryker of the subject’s status and being given approval to terminate. 
 
When a subject completes the study according to protocol, including the final study evaluation, a 
Study Termination eCRF will be completed. 
 
11 Data Management 
11.1  Database 
Data will be collected at each center and entered into Stryker’s Electronic Data Capture (EDC) 
system, NetRegulus.  The system can be accessed remotely by each investigative center and the 
data entered will be managed by Stryker.  Subject data will be processed and monitored according 
to the protocol schedule by Stryker or Stryker representatives.  Draft specifications to support 
eCRFs are provided in Appendix F. 

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11.2  Confidentiality 
This study will comply with the 2002 HIPAA privacy rule.  As such, Stryker will only collect that 
information which is necessary to support the objectives of the clinical study.  Stryker will take 
precautions to ensure that data received is as de-identified as possible.  In the case that some 
identified information is received, Stryker will ensure that any identifying information is not 
reported.  Study subjects will authorize Stryker to use their health information in support of the 
clinical study during the informed consent process.  Should a subject choose to withdraw 
authorization, Stryker may use data collected prior to the withdrawal of authorization in order to 
maintain data integrity.  
11.3  Source Documents 
Source data is all information, original records of clinical findings, observations or other activities 
in a clinical study necessary for the reconstruction and evaluation of the study.  Source data are 
contained in source documents.  Examples of these original documents and data records include:  
hospital records, clinical and office charts, study worksheets, laboratory notes, memoranda, 
subject questionnaires, pharmacy dispensing records, recorded data from automated 
instruments, radiographs, subject files, and records kept at the pharmacy, at the laboratories and 
at medico-technical departments involved in the clinical study. 
All data points collected during follow-up visits must be documented in the subject’s chart.  This 
includes ROM values, pain and function as well as AEs and additional comments.  The informed 
consent process should also be documented in the patient chart.  Monitors, defined further in 
Section 13, will be comparing the eCRFs against source documents for adequacy.  The monitors 
will seek to draw a reference between each data point on the CRF and the subject’s chart.  Thus, 
one cannot derive pain, ROM or function based on a chart note that reads “Patient doing well.”  
Every effort should be made to ensure complete source documentation.  
Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
11.4  Electronic Case Report Forms 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be documented.  All missing data must be explained.   
For specific instructions on eCRF completion, please consult the Guide to Electronic Case Report 
Forms provided under separate cover.  eCRFs should be completed and electronically signed by 
the investigator within 2 weeks of the evaluation date. 

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11.5  Data Clarification Requests 
If errors or omissions are noted by Stryker upon data entry of the eCRFS, a data clarification 
request (DCR) will be sent to the center via the EDC system.  Queries should be answered in a 
clear and comprehensible manner.  If the clarification requires a change to data captured on an 
eCRF, Stryker will modify the eCRF accordingly.  The investigative center will be required to 
reapply their electronic signature to the modified eCRF.  Modified eCRFs need not be printed and 
included in conjunction to answered DCRs. 
11.6  Protocol Deviations 
Any deviation from this protocol will be reported to Stryker as well as to the EC/IRB according to 
their reporting procedures.  Protocol Deviations for this study include, but are not limited to, the 
following:  
• 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
• 
Patient enrolled does not meet the inclusion/exclusion criteria 
• 
Protocol specified study component(s) not implanted 
• 
Visit deviations, including: 
o Unavailable primary endpoint 
o One or more required eCRFs/radiographs not done 
o Evaluations occurred outside of protocol specified time window 
o Un-evaluable radiographs 
o Missed visit 
If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
11.7  Records Retention 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or in the case of non-compliance, 2 years after the date of investigative center 
termination.  These documents should be retained for a longer period if required by an agreement 
with Stryker. 
 

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12  Risk/Benefit Assessment 
12.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of the 
primary THR procedure.  
12.2  Potential Risk 
The study involves the routine assessment of a primary THR procedure.  The Restoration® ADM 
X3® Acetabular System and Accolade® II Hip Stem have been cleared for use by the FDA and will 
be used according to their labeling, included in Appendix C.  Assessment involves questionnaires, 
patient and physician assessments as well as routine radiographs.  The information collected will 
be kept confidential and will comply with the HIPAA privacy rule. 
 
While the expected life of THR components is difficult to estimate, it is finite.  These components 
are made of foreign materials, which are placed within the body for the potential restoration of 
mobility or reduction of pain.  However, due to the many biological, mechanical and 
physiochemical factors which affect these devices but cannot be evaluated in vivo, the 
components cannot be expected to indefinitely withstand the activity level and loads of normal 
healthy bone. 
 
Adverse effects associated with primary THR include the following: 
 
Serious complications may be associated with any total joint replacement surgery.  These 
complications include, but are not limited to:  infection; genitourinary disorders; gastrointestinal 
disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; 
myocardial infarction or death. 
 
With all implanted devices, asymptomatic, localized progressive bone resorption (osteolysis) may 
occur around the prosthetic components as a consequence of foreign-body reaction to the 
particulate matter of metal, UHMWPE and/or ceramic.  Particulate is generated by interaction 
between components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can 
be generated by third body wear.  Osteolysis can lead to future complications, including loosening, 
necessitating the removal and replacement of prosthetic components. 
 

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Early and late loosening of total hip components can occur.  Early biomechanical loosening may 
result from inadequate initial fixation, latent infection, premature loading of the prosthesis or 
trauma.  Late loosening may result from trauma, infection, biological complications including 
osteolysis or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 
 
Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other 
biomechanical considerations. 
 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
 
Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur 
due to impaction of the component into the prepared femoral canal or acetabulum.  Postoperative 
femoral or acetabular fracture can occur due to trauma, the presence of defects or poor bone 
stock. 
 
Metal sensitivity reactions have been reported following joint replacement. 
 
AEs may necessitate reoperation, revision, arthrodesis of the involved joint, girdlestone or 
amputation of the limb. 
12.3  Expected Complications and Rates of Occurrences 
Complications associated with THA procedures, such as those performed with the Restoration® 
ADM X3® Acetabular System, have been reported. These include the potential for: injury to the 
hip’s neurovascular structures, loosening of the components, malseating of the acetabular liner, 
heterotopic bone formation, infection, deep vein thrombosis, pulmonary embolism, metal 
sensitivity reactions, intraoperative or postoperative fracture of the femur or acetabulum, and the 
need for re-operation, revision, arthrodesis of the involved joint, girdlestone or amputation of the 
limb.  The safety objective will compare the complication rates of the Restoration® ADM X3® 
Acetabular System to published rates.   
12.4 Protection Against Risks 
Subjects will be treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or well 
being of the subject, this deviation will be promptly reported to both the EC/IRB and Stryker.   

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12.5  Potential Benefits to the Subject 
There is no guarantee that subjects will personally benefit from inclusion in this study.  Subjects 
may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance.  This study seeks to provide clinicians information about this 
system/device 
by 
comparing 
this 
treatment/device 
to 
published 
results 
for 
other 
treatments/devices.  Information gathered in this study may benefit others undergoing this 
procedure in the future. 
 
Additionally at pre-determined study visit intervals, Stryker may reimburse subjects with a modest 
stipend for protocol-required data collection. This stipend system must be approved by the 
Institution’s IRB prior to implementation and will be based upon individual IRB approval from each 
site. 
 
The monetary value of the gifts to the subjects is modest and should not unduly coerce them to 
participate in the study.  
 
13 Study Monitoring, Auditing, and Inspecting 
13.1  Study Monitoring Plan 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects 
involved in a clinical investigation and the quality and integrity of data submitted as a result of the 
investigation. 
 
This study will be monitored at least once per year, with additional visits, as necessary. The 
investigator will allocate adequate time for such monitoring activities.  The investigator will also 
ensure that the monitor or other compliance or quality assurance reviewer is given access to all 
study-related documents and study-related facilities and has adequate space to conduct the 
monitoring visit.  The monitor will review all source documents and compare them to the data 
contained in the eCRFs, in addition to performing a periodic review of regulatory documents such 
as EC/IRB approvals.  The monitors will need the following when they visit: 
• 
An area where they can review study data 
• 
Subject case books 

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• 
Patient charts pulled at the center 
• 
Regulatory documents 
• 
Time to meet with the SC and the investigator  
13.2  Auditing and Inspecting 
A quality assurance audit is a form of review that provides additional confidence to the sponsor 
concerning the validity and accuracy of clinical study data that must be submitted to the FDA or 
for publication.  The purpose of investigator audits is to ensure that the investigator has 
maintained all study information according to the sponsor’s protocol and standard operating 
procedures and in compliance with FDA regulations. 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, 
Stryker and/or government regulatory bodies of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data).  The investigator will 
ensure the capability for inspections of applicable study-related facilities. 
 
14 Ethical Considerations 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56 as well as 45 CFR Parts 160 and 164. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
EC/IRB for formal approval of the study conduct.  The decision of the EC/IRB concerning the 
conduct of the study will be made in writing to the investigator and a copy of this decision will be 
provided to Stryker before commencement of this study.  The investigator may be asked to 
provide a list of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided an Informed Patient Consent Form 
describing this study and providing sufficient information for patients to make an informed decision 
about their participation.  This Informed Patient Consent Form must be modified to contain center 
specific information and submitted with the protocol for review and approval by the EC/IRB for the 
study.  The formal consent of a patient, using the EC/IRB approved Informed Patient Consent 
Form, must be obtained before that patient is submitted to any study procedure.  This Informed 

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Patient Consent Form must be signed by the patient or legally acceptable surrogate and the 
investigator-designated research professional obtaining the consent.  
 
15 Study Finances 
15.1  Funding Source 
This study is financed by Stryker Orthopaedics. 
15.2  Conflict of Interest 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 
Committee-sanctioned conflict management plan that has been reviewed and approved by 
Stryker prior to participation in this study.   
15.3  Subject Stipends or Payments 
Subject attrition can occur for a variety of reasons, including a subject’s loss of health insurance 
coverage.  In a case where a patient has lost health insurance coverage and no other coverage 
is available, Stryker may, on a case-by-case basis, reimburse investigators for office visits and 
radiographic charges for subjects involved in this study in order to facilitate data retrieval.  The 
physician or the office staff should contact the CSM prior to scheduling the subject to discuss this 
possibility and receive pre-approval.  After receipt of the completed data forms, the physician 
must submit either evidence of coverage denial (e.g. explanation of benefits) or a letter explaining 
that the subject does not have insurance.  Other visits, procedures and assessments done other 
than those specified in the protocol will not be reimbursed.  Reimbursement may be provided 
under the following conditions: 
• 
Study subjects lose insurance coverage after enrollment into the study 
• 
An insurance carrier refuses to pay for a follow-up visit and/or radiographs     
• 
An insurance carrier refuses to provide a subject referral to see the investigator for follow-
up  
Additionally at pre-determined study visit intervals, Stryker may reimburse subjects with a modest 
stipend for protocol-required data collection. This stipend system must be approved by the 
Institution’s IRB prior to implementation and will be based upon individual IRB approval from each 
site. 

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16 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted to 
a peer-reviewed journal at the time the study cohort reaches 2, 5 and 10 years of follow-up.  
Additional publication proposals may be made by investigators at any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 
 
Publications will be facilitated by the Chair and the primary investigator (PI) of the study.  Both 
individuals will be chosen by Stryker. 
 
The PI is solely focused on the multi-center publications and progress towards those publications, 
including recurring updates to centers, center motivation as well as authorship.  If the PI does not 
produce a draft of a publication within 90 days of receiving the results data, Stryker will delegate 
the responsibility to other investigators in the study at its discretion. 
 
The Chair reviews all additional publications proposed by participating investigators based upon 
the study results prior to study completion, on an ongoing basis.  This review includes whether or 
not a proposal will be pursued, as well as imposition of guidelines as to publication completion 
and criteria. 
 
The following summarizes the possible roles of these parallel positions: 
Chair 
PI 
Contributes to study design 
Contributes to study design 
Assists with study questions requiring expert 
clinical opinion 
Assists with study questions requiring expert 
clinical opinion 
Assists with identification of investigators 
Assists with identification of investigators and 
maintains performance 
Reviews additional publication proposals 
submitted by investigators 
Updates investigators on progress towards 
multi-center results 
Contributing author, if ICMJE guidelines met 
Primary author, multi-center publication of 
primary endpoint data 

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At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 2, 5 and 10-year multi-center publications are submitted.  All publications 
of the data shall be submitted to Stryker for review prior to submission for publication.  Stryker 
shall not edit or otherwise influence the publications other than to ensure that confidential 
information is not disclosed, that no off-label use of Stryker devices is promoted and that the data 
is accurately represented.  Any publications resulting from this study must be submitted to Stryker 
for review at least 60 days prior to submission of publication. 
 
17 References 
1. 
 
1 Huo, M.H., Parvizi, J., Bal, B.S. & Mont, M.A. (2009).  What’s New in Total Hip Arthroplasty.  The Journal of 
Bone and Joint Surgery, 91(10), 2522-2534.  
2 Phillippot, R., Camilleri, J.P, Boyer, B., Adam, P. & Farizon, F.  (2009). The use of a dual-articulation acetabular 
cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 
15 years.  International Orthopaedics, 33(4), 927-932.  
3 Bozic, K.J., Kurtz, S.M., Lau, E., Ong, K., Vail, T.P. & Berry, D.J, 128-133.  
4 Ibid. 
5 2007 Swedish Arthroplasty Registry 
6 Guyen, O., Pibarot, V., Vaz, G., Chevillotte, C. & Béjui-Hugues, J. (2009). Use of a dual mobility socket to 
manage total hip arthroplasty instability. Clinical Orthopaedics and Related Research, 467(2), 465-472. 
7 Phillippot, R., Camilleri, J.P, Boyer, B., Adam, P. & Farizon, F.  (2009). The use of a dual-articulation acetabular 
cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 
15 years.  International Orthopaedics, 33(4), 927-932. 
8 Ibid. 
9 Tracol, P., Vandenbussche, E., Deloeg, N. et al “Navigation Acetabular Anatomic Study Application in the 
Development of a New Implant” EFORT Poster May 2007.  
10 D’Antonio, J.A., Capello, W.N., Ramakrishnan, R.  (2011).  Second-generation Annealed Highly Cross-linked 
Polyethylene Exhibits Low Wear.  Clinical Orthopaedics and Related Research (published online), DOI 
10.1007/s11999-011-2177-3 
11 Klika, A.K., Murray, T.G., Darwiche, H., Barsoum, W.K. (2007).  Options for acetabular fixation surfaces.  Long 
Term Eff Med Implants, 17(3), 187-92. 
 

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12 Capello, W.N., D’Antonio, J.A., Jaffe, W.L., Geesink, R.G., Manley, M.T. & Feinberg, J.R.  (2006).  
Hydroxyapatite-coated femoral components: 15-year minimum followup.  Clinical Orthopaedics and Related 
Research, 453, 75-80.  
13 Langdon IJ, Bannister GC (1999). Cemented hip replacement in patients younger than 50 years: 16-24 year 
results. Hip International, 9: 151-153. 
14 Hozack, W.J., Rothman, R.H., Eng, Kenneth, Mesa, J (1996). Primary Cementless Hip Arthroplasty With a 
Titanium Plasma Sprayed Prosthesis. Clinical Orthopaedics and Related Research, 333, 217-225. 
15 Hozack WJ,(1990). Clinical and radiographic results with the trilock femoral component—a wedge fit porous 
ingrowth stem design. Seminars in Arthoplasty, 1, 64-69 
16 Pellegrini VD, Hughes SS, McCollister-Evarts, C (1992). A collarless cobalt-chrome femoral component in 
uncemented total hip arthroplasty. Journal of Bone and Joint Surgery, 74B, 814-821. 
17 Sharkey PF, Albert TJ, Hume EL, Rothman RH (1990). Initial stability of collarless wedge-shaped prosthesis in 
the femoral canal. Seminars in Arthorplasty, 1, 87-90. 
18 Wuestemann T, Bastian A, Schmidt W, et al. A novel technique for studying proximal femoral bone morphology 
for hip implant design. 56th ORS Annual Meeting, New Orleans, LA, USA, March 6–9, 2010. Poster# 2217.  
19 Wuestemann T, Bastian A, Parvizi J, et al. A novel tapered hip stem design optimized for femoral fit in a wide 
array of bone types. 12th EFORT Congress, Copenhagen, Denmark, 1–4 June 2011. Presentation. 
20 Greenspan, A. (1992).  Orthopedic radiology: A practical approach (2nd ed.) New York: Gower Medical 
Publishing. 
21 Breusch, S.J., Lukoschek, M., Kreutzer, J., Brocai, D., & Gruen, T.A. (2001). Dependency of cement mantle 
thickness on femoral stem design and centralizer. Journal of Arthroplasty, 16(5), 648-657. 
22 Gruen, T.A., McNeice, G.M., & Amstutz, H.C. (1979). Modes of failure of cemented stem-type femoral 
components. Clinical Orthopaedics and Related Research, 141, 17-27. 

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Appendix A 
 
 
Suggested Radiographic Technique 

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Suggested Radiographic Techniquei
 
 
The following views are required preoperatively and at each postoperative interval specified 
according to the evaluation schedule to enable evaluation of the implant-bone interface. 
• 
AP pelvis 
• 
AP femur 
• 
Lateral femur 
 
General Requirements 
A. Appropriate corrections in radiological exposure setting are needed for obese subjects. 
B. At least a 14”x17” sized film should be used. 
C. If the subject is bilateral and a view showing both hips is submitted, two copies of that 
view are required. 
D. Both digital and film radiographs are acceptable.  Digital films must be in uncompressed 
DICOM format. 
E. Each image must have: 
a. Subject’s identification number 
b. Subject’s initials 
c. Date of radiograph 
d. Indication of operative side in the study 
e. Markers for right and left sides, as applicable 
f. Visit interval 
AP Pelvis 
If the subject is bilateral, two copies of the AP pelvis radiograph are needed. 
 
A. Standard technique 
a. 100 cm tube to film distance. 
b. The subject should be supine with his/her sacrum flat against the table and legs in 
full extension, internally rotated 15°, compensating for the normal anteversion of the 
femoral neck. 
c. The x-ray beam should be directed perpendicular to the film cassette and must be 
centered on the pubic ramus. 

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d. The iliac bones, sacrum, pubis, ischium, femoral heads, femoral necks and 
both the greater and lesser trochanter must be visible on film as shown below. 
 
Refer to Figure 1 for an acceptable AP pelvis radiograph. 
 
        
          
 
 
                                                        Figure 1.  AP Pelvis View – 
 
Acceptable 
Refer to Figure 2 for AP subject positioning. 
 
 Figure 2.  AP Positioning 
 
AP Femur  
A. Standard technique. 
a. 100 cm tube to film distance. 
b. The patient should be supine with their sacrum flat against the table and legs should 
be in full extension and internally rotated with toes touching. 
c. The film cassette should be placed immediately below the table, parallel to the 
subject’s frontal plane. 
d. The x-ray beam should be directed perpendicular to the film cassette and should be 
centered toward the center of the involved hip. 

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e. The distal tip of the femoral stem, femoral head and neck, greater and lesser 
trochanter, and the acetabulum must be included in this x-ray. 
 
Refer to Figure 2 for AP pelvis and AP femur subject positioning. 
 
Lateral Femurii,iii
A. Standard technique 
 
a. The subject should be supine with the involved leg flat against the table. 
b. The knee of the involved leg should be flexed 90° and the thigh drawn up to at least 
a 45° angle. 
c. The x-ray beam should be directed over the lesser trochanter, perpendicular to the 
proximal femur. 
d. The entire hip joint must be visible. 
 
Refer to Figure 3 for an acceptable lateral radiograph. 
 
 
                                           Figure 3. Lateral View – 
 
Acceptable 
Refer to Figure 4 for subject positioning. 
 
 
                                                   Figure 4. Lateral Positioning 

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i Greenspan, A. (1992). Orthopedic radiology:  A practical approach (2nd ed.). New York:  Gower Medical 
Publishing. 
ii Callaghan, J. J., Rosenberg, A. G., & Rubash, H. E. (Eds.). (1998). The adult hip. Lippincott Williams & 
Wilkins. 
iii Bono, J. V., McCarthy, J. C., Thornhill, T. S., Bierbaum, B. E., & Turner, R. H. (Eds.). (1999). Revision 
total hip arthroplasty. New York:  Spring-Verlag. 

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Appendix B 
 
 
Retrieved Implant Analysis Protocol 

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RETRIEVED IMPLANT ANALYSIS PROTOCOL 
Restoration® Anatomic Dual Mobility (ADM) X3®
With Long Term Data Collection for the Accolade
 Acetabular System 
®
 
 II Hip Stem 
 
PURPOSE: 
To evaluate retrieved Stryker Orthopaedics Restoration® ADM X3® Acetabular System 
components, the Accolade®
 
 II Hip Stem, other ancillary components and/or adjacent tissues in 
order to help characterize patterns of wear and potential device-related complications. 
METHODS: 
A. 
Subject Selection: 
Surgeons participating in the Stryker Orthopaedics Restoration® ADM X3® Study [510(k) 
clearance # K093644 - December 18, 2009] will be asked to comply with the Retrieved 
Implant Analysis Protocol.  Whenever possible, subjects who undergo revision/removal 
of the acetabular cup or acetabular insert component of the Stryker Orthopaedics 
Restoration® ADM X3® Acetabular System or revision of the Accolade®
 
 II Femoral Stem 
and/or other ancillary components will be included in this analysis.  Subjects will be 
asked to consent to having their implants analyzed.  A sample Informed Patient Consent 
Form for implant analysis is attached to this protocol as Appendix E. 
This study protocol will comply with the 2002 privacy rule of the Health Insurance 
Portability and Accountability Act (HIPAA).  As such, Stryker will only collect that 
information which is necessary to support the objectives of the study protocol.  Stryker 
will take precautions to ensure that data received is as de-identified as possible.  In the 
case that some identified information is received, Stryker will ensure that any identifying 
information is not reported.  Study subjects will authorize Stryker to use their retrieved 
implant(s) and health information in support of the study protocol by completing and 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
  
 
 
 
 
 
signing the Informed Patient Consent Form for implant analysis.  Should a subject 
choose to withdraw authorization, Stryker may use data collected prior to the withdrawal 
of authorization in order to maintain data integrity.  
 
B. 
Specimen Handling: 
The Stryker Orthopaedics Restoration® ADM X3® Acetabular System, Accolade®
 
 II Hip 
Stem and/or ancillary component(s) obtained at the time of revision/removal should be 
placed in neutral buffered formalin.  Any tissue samples submitted along with the implant 
must have been fixed in 10% formalin.  Each specimen container should be carefully 
labeled with subject initials, operative side, surgeon name and the component(s) 
included for analysis.  Whenever possible, relevant radiographic studies and a clinical 
summary should be submitted along with the specimen.   
A sample Specimen Information Form is attached to this protocol.  Specimens should be 
carefully sealed and mailed by express mail to: 
Stryker Orthopaedics 
Product Surveillance 
325 Corporate Drive 
Mahwah, NJ  07430 
 
 Recommendations for packing and shipping explants are attached to this protocol. 
 
C. 
Specimen Evaluation: 
Devices will be evaluated with particular attention to documenting potential device-
related complications.  Explanted devices will be viewed with a dissecting microscope 
and examined for evidence of wear, deformation, corrosion or fracture. Modular 
interfaces will be similarly evaluated for evidence of corrosion or wear.  Tissue samples 
will be decalcified if necessary, embedded, sectioned and the resulting microscope 
slides evaluated by a board certified pathologist with expertise in orthopedic pathology 
and biomaterials.  Histologic evaluation will focus on the presence or absence of visible 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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wear debris particles, the biologic response to debris and any other relevant findings 
(e.g. evidence of infection, unusual inflammatory or foreign body reaction, etc.).     
 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
  
 
 
 
 
 
 
Implant Retrieval Study 
Specimen Information Form 
 
1.  Subject Initials:  
 
  ID #:  70 - __ __ - __ __ __ __ 
 
Brief Subject History
 
: 
2. Hip (circle one):  Left      Right 
 
3. Primary diagnosis made prior to total hip surgery:   
 
 
 
 
 
 
4. Radiographic findings prior to total hip surgery:   
 
 
 
 
 
5. Date of implantation of this device:  ____ / ____ / ____ 
 
6.  Name of implanting physician (study investigator):   
 
 
 
 
 
 
 
7. Relevant postoperative clinical and radiographic findings:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recent Subject History
 
: 
8. Describe reason for explant, including any patient symptoms/conditions experienced prior to 
the explant surgery:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. Radiographic findings prior to explant surgery:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. Date of explant surgery: ____ / ____ / ____ 
 
11. Name of explant surgeon:   
 
 
 
 
 
 
 
 
 
 
12. Location of explant surgery:   
 
 
 
 
 
 
 
 
 
 
13. Surgical findings during explant surgery:   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14. Were there any difficulties encountered while explanting the device(s) that may have 
damaged any of the explanted components?  (circle one):    Yes    /    No 
If Yes, describe what occurred:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
___________ 
15. Other relevant medical history:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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16. Name and Address for Interpretive Report:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please enclose this form and relevant attachments with the specimen(s).   
 
Please send a copy of this form to the Restoration® ADM X3®
 
 Study CSM, identified on the 
Stryker Orthopaedics Contact Sheet at the following address:  Clinical Research Department, 
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 
 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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Recommendations for Packing and Shipping Explants  
To Stryker Orthopaedics 
 
 
Please contact the Restoration® ADM X3®
1 week prior to scheduled revision/removal surgery.  
 Study CSM identified on the Stryker Orthopaedics 
Contact Sheet via phone to obtain an Exakt Pack Retrieval Shipping Container at least  
 
All specimens should be placed into a sufficient quantity of 10% formalin for a minimum of  
24 hours prior to shipping.  
 
After the specimens have been immersed in 10% formalin for a minimum of 24 hours, they 
should be transferred to a leak proof container with a quantity of 10% formalin sufficient to keep 
the specimens moist. 
 
Using the Exakt Pack container as directed in the detailed Instructions For Use also acts to 
insulate any leakage from the shipping handlers. 
 
Seal the shipping container securely.  Send via express mail to: 
 
Stryker Orthopaedics 
Product Surveillance 
325 Corporate Drive 
Mahwah, NJ  07430 
 
 
RESULTS 
A report suitable for routine patient care will be provided to each surgeon by request.   
 
 
 
 
 
 
 
 
 
 
I acknowledge this retrieval analysis protocol and will enforce it once IRB approval is obtained. 
 
 
_______________________________________________ 
_______________________ 
Investigator Signature 
 
 
 
 
 
Date 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix E 
 
Model Informed Patient Consent 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
 
Patient’s Initials ______ 
 
   Page 1 of 6 
Version: ____________ 
Model Informed Patient Consent 
 
 
I. 
Study Title:  Post-market Study of the Stryker Orthopaedics Restoration® Anatomic Dual 
Mobility (ADM) X3® Acetabular System with Long Term Data Collection for the 
Accolade® II Hip Stem. 
II. 
Description of the Study  
You have been asked to take part in this research study because your physician has 
determined that you need surgery to replace your hip joint.  A total of approximately 350 
subjects from up to 12 different clinics will be participating in this study.   
The purpose of this study is to evaluate the success rate of cementless primary hip 
replacement with the Restoration® ADM X3® Acetabular System as compared to other 
primary hip systems in the literature, through absence of femoral head dislocation at 10 
years postoperative.  We (Stryker Orthopaedics, implant manufacturer and sponsor of 
the study, and your physician) are doing this study to find out if Stryker Orthopaedics 
Restoration® ADM X3® Acetabular System is at least as good as other primary hip 
implants.   
You will be asked some questions during this visit and based on study specific criteria, 
you may or may not be selected to participate in the study.  
Meeting all of the above criteria does not guarantee participation in the study. Further 
consideration and a screening evaluation with the physician are necessary to ensure this 
is the right study for you.  Study personnel at the site will explain all the details of the 
study to you so you can make an informed decision as to whether you would like to 
participate. 
If selected, your participation in the study will last 10 years.  You will be evaluated for 
this study during a preoperative visit, during surgery, as well as 6 weeks, 1 year, 2 years, 
3 years, 4 years, 5 years, 7 years and 10 years after surgery. 
During the preoperative visit you will be asked to complete three general health 
assessment questionnaires in addition to the standard information and x-rays that your 
doctor will collect during your office visit. 
You will undergo surgery and your doctor will also provide us with the details of your 
surgery. 
During your 6-week, 1, 2, 3, 4 and 5-year follow-up visits, and optionally at your 7 and 
10-year follow-up visits, your doctor will assess the function of your hip and take three x-
rays.  This set of x-rays is part of the standard care following hip surgery, and would be 
performed in the same manner if you were not involved in the study. Your doctor will 
inform you where the x-rays will be done.  In addition, your doctor will ask you to fill out 
the two general health assessment questionnaires at your 6 week, 1, 2, 3, 4 and 5-year 
follow-up visits, and optionally at your 7 and 10-year visits.  
Finally, you will be asked to complete a short questionnaire regarding your satisfaction 
with the results of your hip replacement at 6, 7, 8, 9, and 10 years after surgery. 
III.   
Postoperative Condition and Care 

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Patient’s Initials ______ 
 
   Page 2 of 6 
Version: ____________ 
Your doctor will give you specific instructions regarding your care and rehabilitation after 
your surgery.  As with any surgery, your body takes time to heal.  That amount of time 
will be related to the extent of the surgical procedure and your general physical 
condition.  During this period of healing, you may experience postoperative pain, 
perhaps lasting several months after the operation. 
You will be told to use walking aids (crutches, walker or cane) for a period of time after 
your surgery.  The use of these walking aids will lessen pressure and weight loads on 
your hip, which is thought to increase the chances for a stable implant.  You have been 
informed that you must follow your physician’s orders, including those regarding the use 
of walking aids.   
The goal of this surgery is to lessen pain and increase your hip function.  You will need 
to see your physician at 6 weeks, 1, 2, 3, 4 and 5 years after your surgery, and optionally 
at 7 and 10 years after your surgery, for evaluation of your artificial hip joint.   
IV. 
Foreseeable Risks and Discomforts 
This study involves the routine assessment of a primary hip replacement procedure.  
The Food and Drug Administration (FDA) has cleared the device used in this study for 
sale in the United States.  There are no additional risks associated with participating in 
this study over and above that of the primary hip surgery.  You may need to spend a little 
more time in the doctor’s office to fill out paperwork.  If at any time new information is 
developed during this research study which may affect your willingness to participate, 
the information will be provided to you. 
 
There are, however, standard risks associated with hip surgery.  These include but are 
not limited to:  moderate to severe pain; crack/fracture (breakage) of femoral (thigh) or 
acetabular (pelvic) bones or components; migration (movement) of components; 
subsidence (sinking) of components; dislocation (to move out of normal position) of 
components; sensitivity to metal components (femoral [thigh] and acetabular [pelvic]); 
revision (removal) of one or more of the components; loosening and infection; wear 
(rubbing) of the components which could lead to bone loss; peripheral neuropathies (any 
disorder of the nerves involving your legs); nerve damage; abnormal bone formation; 
circulatory compromise (changes in circulation related to your heart, blood and lymph 
vessels, to varying degrees); genitourinary disorders (related to urination); 
gastrointestinal disorders (related to the stomach and intestines); vascular disorders 
(related to blood vessels:  including thrombus [blood clot]); bronchopulmonary disorders 
(related to the bronchi tubes and lungs, such as pneumonia); emboli (plugged vessel); 
myocardial infarction (heart attack) or death. 
V.  
Potential Benefits 
While there is no guarantee that you will personally benefit from inclusion in this study, 
information gathered in this study may benefit others undergoing primary hip surgery in 
the future. 
 
 
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
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Patient’s Initials ______ 
 
   Page 3 of 6 
Version: ____________ 
VI. 
Alternate Treatment 
You have discussed alternative treatments with your surgeon which include but are not 
limited to:  conservative non-surgical treatment, cemented total hip replacement utilizing 
commercially available components, hip fusion or no treatment at all. 
You may decline to participate in this study.  This will not change any procedures 
associated with your hip surgery.  Your physician can provide detailed information about 
this treatment and the benefits of various treatment options available to you.  You should 
feel free to discuss your alternatives with your physician.  
VII. 
Financial Disclosure 
Your doctor and/or the research institution may receive compensation from the 
manufacturer of your implant device(s) to cover the time and/or expenses associated 
with this Study or for other services.  If you require any further information please consult 
your doctor or his staff about this issue.   
VIII. 
Confidentiality 
If you consent to participate in this study, your medical records and identity will be kept 
confidential to the extent permitted by law and will not be released without your written 
permission.  By signing this consent form, you agree to allow representatives from the 
study sponsor to review your medical records.  Some of this information will be provided 
to the study sponsor and its agents and contractors, and as required by law, review 
boards and other people who are required to watch over the safety and effectiveness of 
medical products and therapies and the conduct of research.  Your name and identity 
will not be revealed in those reports. 
IX.  
Cost to Participate in Study 
Your procedure is a routine primary hip surgery and should be covered by your 
insurance carrier.  You will not be paid for participating in this study.   
Additionally, you may be offered a stipend in the form of a debit card for various follow-
up visits held in your doctor’s office. You must complete all of the applicable 
questionnaires and evaluations in order to receive the stipend per visit.  You can learn 
more about the program from your study doctor and his staff.  
 
X. 
Device Retrieval Analysis Study 
 
I understand that the Stryker Orthopaedics Restoration® ADM X3® Acetabular System 
Study has a protocol for the analysis of retrieved devices in the event that any study 
component(s) that I have had implanted by Dr. <Investigator’s Name> are removed 
during the course of the investigation. 
 
I understand that Stryker Orthopaedics Corporation (implant manufacturer and Sponsor), 
requests my Physician to send my retrieved study component(s) to the Product 
Surveillance department at Stryker Orthopaedics for evaluation as part of my 
participation in the investigational study.  
 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
 
Patient’s Initials ______ 
 
   Page 4 of 6 
Version: ____________ 
I hereby authorize my Physician and his staff to provide my retrieved study 
component(s), name, birth date, Patient Information Form and any and all information 
about my hip surgery to Stryker Orthopaedics for the purposes of evaluating my 
retrieved device(s) and reporting the results of the analysis to my Physician and Stryker 
Orthopaedics Corporation.  
 
My Physician will be provided with the results of this analysis. I understand that the 
device(s) will not be returned to me, nor will I receive the results of any tests, analysis, or 
evaluations on the returned device(s).  
 
I understand that, except for sending my retrieved study component(s) to The Cleveland 
Clinic Foundation and Stryker Orthopaedics, my retrieved study component(s) will not be 
released to outside parties.  
 
I understand that, except for providing my individually identifiable information to the 
Physician who performed my surgery, Stryker Orthopaedics Corporation and The 
Cleveland Clinic Foundation, my individually identifiable data will not be released to 
outside parties. I also understand that I may inspect or copy the information by 
requesting said information from my Physician.  
 
I understand that I may revoke this authorization for release of my retrieved study 
component(s) and individually identifiable information at any time by notifying my 
Physician in writing, but I understand that doing so will have no effect on actions taken 
before the receipt of my revocation.   
 
I will have confidentiality in all records kept about me.  My agreement to participate in 
this implant retrieval analysis study is completely voluntary. I understand that I have the 
right to not participate and the right to withdraw from the study at any time of my 
choosing and that this will in no way compromise my care, delay my treatment, or affect 
any future medical care. 
 
I, the undersigned have read and understood the above and agree to participate in the 
implant retrieval analysis study, and I hereby consent to the release of my retrieved 
study component(s) and my individually identifiable information under the conditions 
stated above. My signature indicates that I have had the opportunity to ask questions 
about the device retrieval study, have had my questions answered to my satisfaction and 
that I have received a copy of the consent form.   
 
           
                                                       _____     
 
_____________                                             
Signature of Subject/Legal Representative  
 
Date 
XI. 
Clinical Trial Website Posting 
 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time. 

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
 
Patient’s Initials ______ 
 
   Page 5 of 6 
Version: ____________ 
XII. 
Injury Related Compensation and Medical Treatment 
Stryker Orthopaedics will not provide compensation or free medical treatment if you 
suffer any medical complications related to the surgery.  <Investigator’s name> should 
be contacted immediately at <Investigator’s phone number> if such a complication 
occurs.  No monetary compensation or free medical treatment will be made available by 
<Name of Hospital>.  <Investigator’s name> should inform you of the hospital’s policy in 
such matters.  Signing this consent in no way waives your legal rights or releases the 
investigator, the sponsor, the institution or its agents from liability or negligence. 
XIII.   Access to Data and Confidentiality 
By participating in this study, you are authorizing your physician and his/her staff to 
provide your health information to the sponsor, its agents and contractors, and as 
required by law, review boards and other people who are required to watch over the 
safety and effectiveness of medical products and therapies and the conduct of research.  
This health information includes all information collected during the research.  It may 
also include relevant health information in your medical records that may have been 
collected prior to your involvement in this research study.     
The sponsor will only collect that information which is necessary to support the 
objectives of the research, and will take precautions to ensure that data received has 
your identifying information (name, address, etc.) removed as much as possible.  
National privacy laws no longer cover use or re-disclosure of your health information, 
once received by the sponsor.  However, in the case that some identified information is 
received, the sponsor will ensure that any identifying information will not be reported.    
The sponsor will use your health information to conduct the study, as well as for 
additional purposes such as overseeing and improving the performance of its devices, 
proposals for developing new medical products or procedures and other business 
purposes.    
This permission does not have an ending date, but you may take back this permission to 
release your health information at any time by notifying your physician in writing.  
Understand that doing so will have no effect on actions taken before that time.  This 
consent, authorizing that your health information may be provided to those indicated, 
must be signed in order for you to participate in this research study.  If this consent is 
revoked you can no longer participate in this research study.  In any case, your 
authorization to release individually identifiable information will expire at the end of this 
study.   
XIIV. 
Contact People 
If you have any questions about this study or about your rights as a research subject, 
please contact: <names and phone numbers>.  If you have a research-related injury, 
you should immediately contact <names and phone numbers>. 
 
XV.  
Participation 
Your participation in this study is strictly voluntary.  Refusal to participate in the study will 
not result in any penalty or loss of benefits to which you are otherwise entitled.  You may 

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Confidential 
 
Patient’s Initials ______ 
 
   Page 6 of 6 
Version: ____________ 
also withdraw from the study at any time without penalty or loss of benefits to which you 
are otherwise entitled.   
By signing and dating this form below, you are indicating that you have read and 
reviewed all sections of this Informed Consent Form, you have had all your questions 
answered, and you voluntarily consent to participate in this research study.  If you do not 
sign this form, you will not be allowed to participate in the research study. 
 
_______________________________________ 
Printed name of Subject/Legal Representative 
 
_______________________________________ 
__________       
Signature of Subject/Legal Representative                                     Date Signed     
 
(additional signatures that may be required): 
 
 
_______________________________________ 
 
          __________ 
Signature of Person conducting the consent process                     Date Signed 
 
_______________________________________ 
 
__________       
 
Signature of Investigator 
                             Date Signed 
 
A signed and dated copy of this consent form must be given to the patient.   

Restoration® ADM X3® Study with Long Term Data Collection for the Accolade® II Hip Stem 
Confidential 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix F 
 
 
Specifications for Electronic Case Report Forms 

Right
Left
INCLUSION / EXCLUSION
SUBJECT IDENTIFIER:
SUBJECT INITIALS:
(DD-MMM-YYYY)
OPERATIVE SIDE:
DATE INFORMED CONSENT SIGNED:
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. INCLUSION CRITERIA
Yes
No
A.
Patient has signed an IRB/EC approved study specific Informed Patient Consent Form.
B.
Patient is a male or non-pregnant female, skeletally mature and age 18 - 75 years at time of 
study device implantation. 
C.
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
D.
Patient is a candidate for a primary cementless acetabular replacement.
G.
Patient has an active or suspected latent infection in or about the affected hip joint at time of study 
device implantation. 
 
H.
Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety 
and efficacy of the device.
I.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. 
Paget’s disease) leading to progressive bone deterioration.
J.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological 
requirements (e.g. > 30 days).
K.
** All of the above must be answered "No" for the patient to be enrolled in the study.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic 
evaluations and rehabilitation.
** All of the above must be answered "Yes" for the patient to be enrolled in the study.
Yes
No
F.
Patient has a Body Mass Index (BMI) ≥ 40.
E.
Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the 
affected joint. 
 
L.
Patient has a known sensitivity to device materials.
M.
Patient is a prisoner.
  II. EXCLUSION CRITERIA
  III. COMMENTS
17_January_2011  Ver, 1.0 EDC
Page 1 of 1

(DD-MMM-YYYY)
DEMOGRAPHICS
SUBJECT ID:
SUBJECT INITIALS:
VISIT DATE:
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. DEMOGRAPHICS
A.  DATE OF BIRTH:
(DD-MMM-YYYY)
D. EDUCATION LEVEL:  
 
E.  EMPLOYMENT STATUS: 
cm
inches
kg
US / English
Metric
Auto Calculate 
Read Only
lbs
B.  HEIGHT:
C.  WEIGHT:
BMI
Select appropriate Unit of Measure for Height and Weight.
Less Than High School
High School Diploma
Greater Than High School
Working
Not Working
F.  GENDER:
Male
Female
G.  ETHNICITY: 
H.  RACE:
American Indian or Alaskan native
Asian
Black or African
Native Hawaiian or other Pacific Islander
White
Hispanic or Latino origin
Not Hispanic or Latino origin
  II. CIGARETTE AND ALCOHOL USE
I.   CIGARETTE USE:
Non-smoker
Current cigarette smoker
Ex-cigarette smoker
(Specify # Packs/Day and # Years below)
(Specify # Packs/Day, # Years, and Date Stopped)
Date Stopped
(DD-MMM-YYYY)
J.  ALCOHOL USE: 
Have never had alcohol
Have not had alcohol in the last year
Less than 3 drinks a week
3 -7 drinks a week
8 - 14 drinks a week
15+ drinks a week
# PACKS/DAY:
# YEARS:
  III. DIAGNOSIS
If the subject is a current or past cigar and/or pipe 
smoker, please select "Non-smoker" and enter a 
comment on Page 2 of this CRF.
K.  INITIAL DIAGNOSIS: 
Osteoarthritis
Traumatic Arthritis
Avascular Necrosis
Other (Specify)
Page 1 of 2
08_April_2011  Ver, 1.0 EDC

DEMOGRAPHICS
Restoration ADM X3  Acetabular System
®
  IV. PRESENT MEDICAL STATUS
L. CONCURRENT MEDICAL CONDITION: 
None
Cancer
Cardiovascular
Dermatologic
Digestive
Endocrine / Metabolic
Immunologic / Lymphatic
Musculoskeletal
Neurologic
Psychologic
Respiratory
Substance Dependence
Urogenital
Other (Specify)
  V. COMMENTS
Reason for Save
Verification / Confirmation Method
Page 2 of 2
08_April_2011  Ver, 1.0 EDC
®

Page 1 of 1
LOWER EXTREMITY ACTIVITY SCALE  
(LEAS)
SUBJECT INITIALS:
SUBJECT ID:
VISIT:
  GENERAL INFORMATION
  I. LOWER EXTREMITY ACTIVITY SCALE
I am confined to bed all day.
I am confined to bed most of the day except for minimal transfer activities (going to the bathroom, etc.).
I am either in bed or sitting in a chair most of the day.
I sit most of the day, except for minimal transfer activities, no walking or standing.
I sit most of the day, but I stand occasionally and walk a minimal amount in my house. (I may rarely leave
the house for an appointment and may require the use of a wheelchair or scooter for transportation.)
I walk around my house to a moderate degree but I don't leave the house on a regular basis. I may leave
the house occasionally for an appointment.
I walk around my house and go outside at will, walking one or two blocks at a time.
I walk around my house, go outside at will and walk several blocks at a time without any assistance
(weather permitting).
I am up and about at will in my house and can go out and walk as much as I would like with no restrictions
I am up and about at will in my house and outside.  I also work outside the house in a:
(weather permitting).
I am up and about at will in my house and outside.  I also participate in relaxed physical activity such as
jogging, dancing, cycling, swimming:
I am up and about at will in my house and outside.  I also participate in vigorous physical activity such as
competitive level sports:
occasionally (2-3 times per month)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
moderately active job
extremely active job
minimally active job
2-3 times per week
daily
Enter data as completed by the subject per paper questionnaire.
daily
occasionally (2-3 times per month)
  II. COMMENTS
Yes
No
Subject Initials are present on paper CRF?
SUBJECT INITIALS DATE:
2-3 times per week
(Please check the best description of your work level.)
(Please check the best description of how often you participate in this activity.)
(Please check the best description of how often you participate in this activity.)
Record the date the subject 
completed the questionnaire.
17_January_2011  Ver, 1.0 EDC
(DD-MMM-YYYY)
Reason for Save
Verification / Confirmation Method
Restoration ADM X3  Acetabular System
®
®

SUBJECT ID:
SUBJECT INITIALS:
SF - 12 v2 
VISIT:
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. SF-12™ HEALTH SURVEY STANDARD VERSION
1) In general, would you say your health is:
Excellent
Very Good 
Good
Fair
Poor
a. Moderate activities, such as moving a table, pushing 
a vacuum cleaner, bowling, or playing golf  
 
The following questions are about activities you might do during a typical day.  Does your health now limit you in 
these activities?  If so, how much?
b. Climbing several flights of stairs  
 
Yes, 
 limited 
a lot
Yes, 
 limited 
a little
No, 
not limited 
at all
During the past 4 weeks, how much of the time have you had any of the following problems with your work 
or other regular daily activities as a result of your physical health? 
 Accomplished less than you would like 
 
All of  
the time
Most of  
the time
Some of 
the time
A little of 
the time
None of 
the time
 
 
 
Were limited in the kind of work or other 
activities 
 
All of  
the time
Most of  
the time
Some of 
the time
A little of 
the time
None of 
the time
During the past 4 weeks, how much of the time have you had any of the following problems with your work or 
other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Accomplished less than you would like 
  
None of 
the time
A little of 
the time
Some of 
the time
Most of  
the time
All of  
the time
Did work or other activities less carefully than usual 
 
None of 
the time
A little of 
the time
Some of 
the time
Most of  
the time
All of  
the time
b.
a.
a.
b.
(SF-12v2 Standard, US Version 2.0)
SF-12® is a registered trademark of Medical Outcomes Trust.
SF-12v2™ Health Survey © 1994, 2002 by QualityMetric Incorporated and Medical Outcomes Trust. All Rights Reserved.
17_January_2011  Ver, 1.0 EDC
Enter data as completed by the subject per paper questionnaire.
Page 1 of 2
2)
3)
4)

Reason for Save
Verification / Confirmation Method
During the past 4 weeks, how much did pain interfere with your normal work (including both work outside 
the home and housework)? 
  
 
Not at all
A little bit
Moderately
Quite a bit
Extremely
These questions are about how you feel and how things have been with you during the past 4 weeks.  For each 
question, please give the one answer that comes closest to the way you have been feeling.  How much of the time 
during the past 4 weeks... 
 Have you felt calm and peaceful? 
 
All of  
the time
Most of  
the time
Some of 
the time
A little of 
the time
None of 
the time
A little of 
the time
None of 
the time
All of  
the time
Most of  
the time
Some of 
the time
Did you have a lot of energy? 
 
A little of 
the time
None of 
the time
Some of 
the time
Most of  
the time
All of  
the time
Have you felt downhearted and depressed? 
 
A little of 
the time
None of 
the time
Some of 
the time
Most of  
the time
All of  
the time
During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting friends, relatives, etc.)? 
 
a.
5)
c.
b.
7)
Subject Initials are present on paper CRF?
SF-12® is a registered trademark of Medical Outcomes Trust.
17_January_2011  Ver, 1.0 EDC
SF-12v2™ Health Survey © 1994, 2002 by QualityMetric Incorporated and Medical Outcomes Trust. All Rights Reserved.
(SF-12v2 Standard, US Version 2.0)
Page 2 of 2
SF - 12 v2 
6)
Restoration ADM X3  Acetabular System
®
®
  II. SF-12 (CONTINUED)
  COMMENTS  
No
Yes
(DD-MMM-YYYY)
SUBJECT INITIALS DATE:
Record the date the subject 
completed the questionnaire.

PRE-OP FUNCTIONAL EVALUATION
SUBJECT ID:
VISIT DATE:
(DD-MMM-YYYY)
SUBJECT INITIALS:
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. PAIN
Reason for Save
Verification / Confirmation Method
27_January_2011 Ver. 1.0 EDC
None, or ignores it
Slight, occasional, no compromise in activities
Marked pain, serious limitation of activities
Totally disabled, crippled, pain in bed, bedridden
A. PAIN
B. LIMP 
C. SUPPORT 
D. DISTANCE WALKED 
E. STAIRS
F. SOCKS / SHOES 
G. SITTING 
H. PUBLIC  TRANSPORTATION
I. ABSENCE OF DEFORMITY
(Operative side only) Yes   No
Fixed flexion contracture < 30°
Fixed adduction < 10°
Fixed internal rotation in extension < 10°
Leg length discrepancy < 3.2 cm
J. RANGE OF MOTION    (Operative side only)
Permanent (Fixed) Flexion
°
Flexion to 
°
Abduction to
°
Adduction to
°
External Rotation in Extension to
°
Internal Rotation in Extension to
°
None
Slight
Moderate
Severe or unable to walk
None
Cane, long walks
Cane, most of the time
One crutch
Two canes
Two crutches, walker or unable to walk
Unlimited
Six blocks
Two or three blocks
Indoors only
Bed and chair only
Normally without using a rail
Normally using a railing
In any manner
Unable to use stairs
With ease
With difficulty
Unable
Any chair, 1 hour
High chair, 1/2 hour
Unable to sit comfortably in any chair
Able to use
Not able to use
Moderate pain, tolerable but makes concessions to pain.  Some limitations of ordinary activity or work.   
May require occasional pain medication stronger than aspirin
Mild, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin
  II. FUNCTION / GAIT
  III. FUNCTIONAL ACTIVITIES
HHS
Select "Yes" to indicate there is no deformity.  Select "No" to indicate there is a deformity.
Auto Calculate 
Read Only
cm
If no leg length discrepancy exists 
record 0 cm and check Yes.
Page 1 of 1
  IV. COMMENTS

(DD-MMM-YYYY)
SURGICAL DETAILS
SUBJECT ID:
SURGERY DATE:
Page 1 of 1
27_January_2011 Ver.1.0 EDC
Reason for Save
Verification / Confirmation Method
cc
G. PROSTHESES - 
Acetabular Shell
Acetabular Insert
Femoral Bearing Head
A.  APPROACH
C. NAVIGATION USED?
J. DISCHARGED TO: 
Discharge Date:
DD-MMM-YYYY
Skilled Nursing Facility
Rehabilitation Unit
Home
Other: (Specify)
Chronic Care Center
 (Check One)
Modular / Femoral Stem
Modular Neck
SUBJECT INITIALS:
Anterior/ Anterolateral
Posterior/ Posterolateral
Dual Incision
Lateral
Yes*
No
External Rotators
Gluteus Medius
Other
Yes
No
*If Yes, which muscle group?
B. MUSCLE REPAIR OR REATTACHMENT REQUIRED?
D. INCISION LENGTH
cm
minutes
Skin to Skin
E. DURATION OF SURGERY
F. ESTIMATED BLOOD LOSS
H. OTHER?
*If Yes, specify and attach a copy of the label(s):
No
Yes*
Yes*
No
Reference #
Lot #
Other (Specify)
Please go to Subject Information screen and enter data 
in Products tab.
Upload a PDF copy of the component label(s) implanted.
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. SURGICAL DETAILS
  II. PROSTHESIS
I. INTRAOPERATIVE COMPLICATION?
*If Yes, complete AE form.
  III. COMMENTS
Submit Surgical Details CRF only if surgery is performed and subject receives study device.
Submit
Add Row
Reset
x

POST-OP FUNCTIONAL EVALUATION
SUBJECT IDENTIFIER:
VISIT DATE:
(DD-MMM-YYYY)
SUBJECT INITIALS:
VISIT: 
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. PAIN
27_January_2011 Ver. 1.0 EDC
None, or ignores it
Slight, occasional, no compromise in activities
Marked pain, serious limitation of activities
Totally disabled, crippled, pain in bed, bedridden
A. PAIN
B. LIMP 
C. SUPPORT 
D. DISTANCE WALKED 
E. STAIRS
F. SOCKS / SHOES 
G. SITTING 
H. PUBLIC  TRANSPORTATION
I. ABSENCE OF DEFORMITY
(Operative side only) Yes   No
Fixed flexion contracture < 30°
Fixed adduction < 10°
Fixed internal rotation in extension < 10°
Leg length discrepancy < 3.2 cm
J. RANGE OF MOTION    (Operative side only)
Permanent (Fixed) Flexion
°
Flexion to 
°
Abduction to
°
Adduction to
°
External Rotation in Extension to
°
Internal Rotation in Extension to
°
None
Slight
Moderate
Severe or unable to walk
None
Cane, long walks
Cane, most of the time
One crutch
Two canes
Two crutches, walker or unable to walk
Unlimited
Six blocks
Two or three blocks
Indoors only
Bed and chair only
Normally without using a rail
Normally using a railing
In any manner
Unable to use stairs
With ease
With difficulty
Unable
Any chair, 1 hour
High chair, 1/2 hour
Unable to sit comfortably in any chair
Able to use
Not able to use
Moderate pain, tolerable but makes concessions to pain.  Some limitations of ordinary activity or work.   
May require occasional pain medication stronger than aspirin
Mild, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin
  II. FUNCTION / GAIT
  III. FUNCTIONAL ACTIVITIES
HHS 
Select "Yes" to indicate there is no deformity.  Select "No" to indicate there is a deformity.
Auto Calculate 
Read Only
If no leg length discrepancy exists 
record 0 cm and check Yes.
cm
Page 1 of 2

Reason for Save
Verification / Confirmation Method
Page 2 of 2
27_January_2011 Ver. 1.0 EDC
K.  Have there been any protocol defined Adverse Events since the last visit?
POST-OP FUNCTIONAL EVALUATION
*If Yes, complete an AE form for each.
USE THIS SECTION TO REPORT MEDICAL EVENTS OTHER THAN PROTOCOL DEFINED ADVERSE EVENTS.
L.  Has the subject seen a doctor for any medical event since the last visit?
*If Yes, specify:
M.  Has the subject been hospitalized for any elective surgery since the last visit?
N.  Is anything currently affecting the subject's function?
*If Yes, specify:
*Provide Details
*If Yes, specify (check all that apply)
Yes*
No
Yes*
No
Yes*
No
 Contralateral Hip
 Contralateral Knee
 Ipsilateral Knee
 Contralateral Shoulder
 Ipsilateral Shoulder
 Cataract
 Other (Specify)
Yes*
No
  IV. EVENTS
Restoration ADM X3  Acetabular System
®
®
  V. COMMENTS

FOLLOW-UP QUESTIONNAIRE
SUBJECT INITIALS:
VISIT:
1.  Do you have any pain in your hip that has the study hip replacement?
Reason for Save
Verification / Confirmation Method
Page 1 of 1
27_January_2011 Ver. 1.0 EDC
QUESTIONNAIRE COMPLETED BY:
2.  Are you satisfied with the results of your study hip replacement?
Subject comment:
Subject comment:
Coordinator comment:
SUBJECT ID:
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
4.  Has your study hip dislocated since your last study required visit/contact?
3.  Have you had any surgery on your study hip since your last study required visit/contact?
Visit
Mail
Phone
YES
NO
YES
NO
YES
NO
Coordinator comment:
Subject comment:
Coordinator comment:
Coordinator:  Review all responses to determine if an AE has occurred and complete an AE 
form.
  I.  HIP QUESTIONS 
Coordinator comment:
YES
NO
Subject comment:
  COMMENTS
If the subject completed this questionnaire over the phone please check Yes.
Subject initials are present on paper CRF?
DATE:
YES
NO
(DD-MMM-YYYY)
Submit

Page 1 of 1
By placing a checkmark in one box in each group below, please indicate which  
statements best describe your own health state today.
Mobility
Usual Activities (e.g. work, study, housework, family or leisure activities)
Pain / Discomfort
Anxiety / Depression
(DD-MMM-YYYY)
SUBJECT ID:
EQ-5D
Restoration  ADM X3  Acetabular System
VISIT:
DATE OF ASSESSMENT:
® 
SUBJECT INITIALS:
® 
  GENERAL INFORMATION
I have no problems in walking about
I have some problems in walking about
I am confined to bed
I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed
Self-Care
Enter value marked by subject from paper CRF (0-100).
  COMMENTS
Reason for Save
EQ VAS SCORE
Verification / Confirmation Method
Subject Initials are present on paper CRF?
Yes
No
20120501 Ver.1.0

Page 1 of 1
Restoration ADM X3  Acetabular System
27_January_2011 Ver. 1.0 EDC
DATE OF DEVIATION:
(DD-MMM-YYYY)
SUBJECT ID:
SUBJECT INITIALS:
NOTICE OF PROTOCOL DEVIATION
Reason for Save
Verification / Confirmation Method
Femoral Bearing Head
Modular / 
Femoral Stem
9 
Year
6 
Week
7  
Year
10  
Year
4 
Year
2  
Year
1  
Year
3 
Year
5 
Year
6 
Year
8 
Year
(If Deviation in visit, specify each form/X-ray)
SF-12
Other:
* Complete Study Termination form
  I. DEVIATION INFORMATION
  COMMENTS
Modular Neck
Serious Adverse Event reported to Sponsor after 24 hours of knowledge of event 
(Select if entire visit did not occur; no CRF and X-ray completed)
Informed Consent: 
Study procedures performed prior to informed consent
Incorrect informed consent version used
Other 
Inclusion / Exclusion: Subject enrolled does not meet the Inclusion / Exclusion criteria
Treatment: Protocol specified study component(s) not implanted (Check all that apply)
Acetabular Shell*
Acetabular Insert*
Missed entire visit
Deviation in visit (Check all that apply and specify)
Required form(s)/X-ray(s) not done
Unevaluable X-ray (i.e. unreadable/poor quality)
Evaluation(s) occurred outside of 
protocol specified time window
Evaluation(s): (Specify one visit below)
VISIT :
Pre-Op
X-ray - A/P Pelvis
LEAS
Follow-up Questionnaire
Functional Evaluation
X-ray - Lateral
A. TYPE OF DEVIATION 
B. Briefly describe the deviation and why this occurred.
®
®
  GENERAL INFORMATION

17_January_2011  Ver, 1.0 EDC
ONSET DATE:
(DD-MMM-YYYY)
SUBJECT ID:
SUBJECT INITIALS:
ADVERSE EVENT
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. DESCRIPTION
E. DEVICE RELATED?
* If Yes or Uncertain, please explain and upload applicable de-identified 
source documentation to the Subject Binder.
Yes*
No
Uncertain*
D. DESCRIBE CIRCUMSTANCES, INCLUDING HISTORY OR CAUSATIVE EVENT.  SPECIFY SIGNS, SYMPTOMS AND DISEASES.
* If Yes, check all that apply.
Resulted in inpatient hospitalization
Resulted in prolonged existing hospitalization
Resulted in persistent or significant disability/incapacity
Resulted in permanent impairment of a body function or permanent damage to a 
body structure
Necessitated medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body structure
Was a life threatening situation
Resulted in patient death
If Serious, please upload applicable de-identified source documentation to the Subject Binder.
F. SERIOUSNESS Does this event meet the definition of serious?  
* Specify when Adverse Event became SERIOUS: 
If Serious date is the same as Onset date, enter Onset date.  
(DD-MMM-YYYY)
Yes*
No
Page 1 of 2
(Check one event in Section A or Section B)
A. OPERATIVE SITE EVENTS
B. SYSTEMIC EVENTS
Adverse Event Code
Adverse Event Description
C. WHEN DID THE EVENT OCCUR?
Femoral Neck Crack / Fracture
Acetabular Insert Crack / Fracture
Acetabular Migration (If > 3mm)
Acetabular Shell Crack / Fracture
Deep Joint Infection
Femoral Bearing Head Crack / Fracture
Femoral Component Loosening
Femoral Component Subsidence
Femoral Stem Crack / Fracture
Heterotopic Bone Formation (Type III / IV)
Osteolysis
Reflex Sympathetic Dystrophy (RSD)
Soft Tissue Trauma
Superficial Wound Infection
Tendonitis
Trochanteric Crack / Fracture
Wound Hematoma
Other (Specify) 
Cancer (Specify)
Cardiovascular (Specify)
Dermatologic (Specify)
Digestive (Specify)
DVT
Musculoskeletal (Specify)
Neurologic (Specify)
Pulmonary Embolism
Respiratory (Specify)
Thrombophlebitis
Trauma (Specify)
Urogenital (Specify)
Other (Specify)
Acetabular Component Loosening
Hip Pain
Trochanteric Non-Union
Device Allergic Reaction
Intra-Prosthetic Dislocation
Iliopsoas Tendon Impingement
Nerve Palsy
Thigh Pain
Trochanteric Bursitis
Femoral Head Dislocation
Pre-Op
Intra-Op
Post-Op
  II. COMPLICATION / CONCURRENT MEDICAL EVENT

Page 2 of 2
Reason for Save
Verification / Confirmation Method
  III. TREATMENT
REVISIONS / REMOVALS:
(Check all that apply)
Date of Treatment
(DD-MMM-YYYY)
(DD-MMM-YYYY)
RE-OPERATIONS: (Specify) 
                Re-operations are for study hip only and do not include revisions or removals. 
OTHER TREATMENTS: (Specify)
For Stryker Implants, submit PER form and implant(s) to Stryker.
* If Yes, specify below
ANESTHESIA USED?
Yes*
No
Acetabular Insert    (Complete Study Termination Form)
Acetabular Shell    (Complete Study Termination Form)
Femoral Bearing Head
Modular Neck
Modular / Femoral Stem
Other 
No
Yes
(DD-MMM-YYYY)
Diagnostic tests are not considered Treatments.  Do not include X-rays and MRIs.
  IV. COMMENTS
  FOR STRYKER USE ONLY
RESOLUTION OF EVENT:
* Update this information if the Event has been resolved.
(DD-MMM-YYYY)
Unresolved as of
Resolved as of
PER #
ADVERSE EVENT
Restoration ADM X3  Acetabular System
®
®
17_January_2011  Ver, 1.0 EDC
Add Row
Reset
x

SUBJECT INITIALS:
TERMINATION DATE:
SUBJECT ID:
(DD-MMM-YYYY)
Page 1 of 1
STUDY TERMINATION
Restoration ADM X3  Acetabular System
®
®
  GENERAL INFORMATION
  I. STUDY TERMINATION
C.
WAS STUDY DEVICE IN PLACE AT DATE OF LAST CONTACT?
A. DID SUBJECT COMPLETE STUDY ACCORDING TO PROTOCOL?
*If No, answer questions B and C.
No*
Yes
No
Yes
B.
CHECK ONE PRIMARY REASON BELOW:
Death
(Complete AE form)
Investigative site terminated (Inform the IRB and provide Stryker with a copy of IRB acknowledgement.)
Additional efforts:
Lost to follow-up
1st phone call:
2nd phone call:
3rd phone call:
Certified letter sent
List efforts to
contact subject:
Subject Withdrawal
Revision/Removal of Study Device (Complete AE and PER forms)
Other (Specify below)
Study Device Not implanted (Specify below) 
 
(DD-MMM-YYYY)
(DD-MMM-YYYY)
(DD-MMM-YYYY)
(DD-MMM-YYYY)
Surgery Not Performed (Specify below)
  II. COMMENTS
If Yes, enter Termination Date as the date of the subject's last evaluation.
Enter date of death as the Termination Date.
Enter date of study close-out visit as the Termination Date.
Enter date of Stryker termination approval given as the Termination Date.
Enter date of revision / removal procedure as the Termination Date.
Enter date of surgery as the Termination Date.
Select if subject voluntarily withdrew from the study.
Enter date subject notified site of withdrawal as the Termination Date.
Enter date of surgeon termination or surgery cancellation as the Termination Date.
17_January_2011  Ver, 1.0 EDC
Reason for Save
Verification / Confirmation Method