A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
Rejuvenate® Modular Hip System 
Outcomes Study 
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center study of the outcomes of the 
Rejuvenate® Modular Hip System 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
Phone:  201-831-5000 
Clinical Study Manager: 
Christina Hawley 
325 Corporate Drive 
Mahwah, NJ 07430 
Phone:  858-344-9792 
Study Product: 
Rejuvenate® Modular Hip System 
Protocol Number: 
68 
IDE Number: 
N/A 
 
Version 1.0 
Date:  10/7/2009 
CONFIDENTIAL 
 
This document is confidential and the property of Stryker Orthopaedics.  No part 
of it may be transmitted, reproduced, published or used by other persons without 
prior written authorization from Stryker.

 
CONFIDENTIAL 
 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Orthopaedics 
 
 
 
 
 
 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
1.0 
10/7/2009 
New 
Diana F. Doumato 

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Table of Contents 
STUDY SYNOPSIS ...................................................................................................................... 1 
EVALUATION SCHEDULE .......................................................................................................... 6 
1 
INTRODUCTION ................................................................................................................... 7 
1.1 
BACKGROUND ................................................................................................................. 7 
1.2 
INVESTIGATIONAL DEVICE ................................................................................................ 9 
1.3 
PRECLINICAL DATA ....................................................................................................... 10 
1.4 
CLINICAL DATA TO DATE ............................................................................................... 10 
2 
STUDY OBJECTIVES ........................................................................................................ 10 
2.1 
EFFICACY ..................................................................................................................... 10 
2.1.1 Primary .................................................................................................................... 10 
2.1.2 Secondary ............................................................................................................... 11 
2.2 
SAFETY ........................................................................................................................ 15 
3 
CLINICAL STUDY PLAN ................................................................................................... 16 
3.1 
STUDY DESIGN ............................................................................................................. 16 
3.2 
NUMBER OF CENTERS ................................................................................................... 16 
3.3 
NUMBER OF SUBJECTS .................................................................................................. 16 
3.4 
ESTIMATED STUDY DURATION ....................................................................................... 16 
4 
ELIGIBILITY ....................................................................................................................... 17 
4.1 
INCLUSION CRITERIA ..................................................................................................... 17 
4.2 
EXCLUSION CRITERIA .................................................................................................... 18 
5 
SUBJECT ENROLLMENT ................................................................................................. 18 
5.1 
TREATMENT ASSIGNMENT ............................................................................................. 18 
5.2 
RANDOMIZATION ........................................................................................................... 18 
6 
DEVICE DESCRIPTION ..................................................................................................... 18 
6.1 
STUDY DEVICE .............................................................................................................. 18 
6.2 
DEVICE RETRIEVAL PROCESS ........................................................................................ 24 
7 
EVALUATIONS .................................................................................................................. 25 
7.1 
PREOPERATIVE VISIT .................................................................................................... 25 
7.2 
SURGERY ..................................................................................................................... 26 
7.3 
6-WEEK VISIT ................................................................................................................ 27 
7.4 
ANNUAL FOLLOW-UP VISITS .......................................................................................... 28 
8 
ADVERSE EVENTS ........................................................................................................... 29 
8.1 
REPORTING OF ADVERSE EVENTS ................................................................................. 29 
8.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................... 31 
8.3 
STUDY SPONSOR FAX NOTIFICATION BY INVESTIGATOR ................................................. 33 
8.3.1 Ethics Committee/Institutional Review Board Notification by Investigator .............. 33 
8.4 
RECORDING OF ADVERSE EVENTS ................................................................................. 34 
8.5 
MEDICAL MONITORING .................................................................................................. 34 
9 
STATISTICAL PLAN .......................................................................................................... 34 

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9.1 
EFFICACY ..................................................................................................................... 34 
9.1.1 Primary Efficacy Parameters ................................................................................... 34 
9.1.2 Secondary Efficacy Parameters .............................................................................. 34 
9.1.3 Primary Efficacy Hypothesis .................................................................................... 34 
9.1.4 Primary Efficacy Analysis ........................................................................................ 35 
9.1.5 Secondary Efficacy Analysis ................................................................................... 35 
9.2 
SAFETY PARAMETERS ................................................................................................... 35 
9.2.1 Safety Parameters ................................................................................................... 35 
9.2.2 Safety Analysis ........................................................................................................ 35 
9.3 
MISSING DATA .............................................................................................................. 36 
9.4 
STATISTICAL METHODOLOGY ......................................................................................... 36 
9.4.1 Data Summary ........................................................................................................ 36 
9.4.2 Sample Size Calculation ......................................................................................... 36 
9.4.3 Interim Analyses and early Stopping Considerations .............................................. 37 
9.4.4 Patient Populations ................................................................................................. 37 
10 STUDY PROCEDURES ...................................................................................................... 37 
10.1 
SUBJECT RECRUITMENT AND SCREENING ...................................................................... 37 
10.2 
PATIENT INFORMED CONSENT AND GUIDELINES ............................................................. 38 
10.3 
EARLY WITHDRAWAL OF SUBJECTS ............................................................................... 39 
11 DATA MANAGEMENT ....................................................................................................... 40 
11.1 
DATABASE .................................................................................................................... 40 
11.2 
CONFIDENTIALITY .......................................................................................................... 40 
11.3 
SOURCE DOCUMENTS ................................................................................................... 41 
11.4 
CASE REPORT FORMS .................................................................................................. 41 
11.5 
DATA CLARIFICATION REQUESTS ................................................................................... 42 
11.6 
PROTOCOL DEVIATIONS ................................................................................................ 42 
11.7 
RECORDS RETENTION ................................................................................................... 42 
12 RISK/BENEFIT ASSESSMENT ......................................................................................... 43 
12.1 
RISK CATEGORY ........................................................................................................... 43 
12.2 
POTENTIAL RISK ........................................................................................................... 43 
12.3 
EXPECTED COMPLICATIONS AND RATES OF OCCURRENCES ........................................... 44 
12.4 
PROTECTION AGAINST RISKS ........................................................................................ 46 
12.5 
POTENTIAL BENEFITS TO THE SUBJECT .......................................................................... 46 
13 STUDY MONITORING, AUDITING, AND INSPECTING ................................................... 47 
13.1 
STUDY MONITORING PLAN ............................................................................................ 47 
13.2 
AUDITING AND INSPECTING ............................................................................................ 47 
14 ETHICAL CONSIDERATIONS ........................................................................................... 48 
15 STUDY FINANCES ............................................................................................................. 48 
15.1 
FUNDING SOURCE ......................................................................................................... 48 
15.2 
CONFLICT OF INTEREST ................................................................................................. 48 
15.3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................ 49 
16 PUBLICATION PLAN ......................................................................................................... 49 
17 REFERENCES .................................................................................................................... 51 

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List of Appendices 
 
 
Appendix A 
 
Suggested Radiographic Technique 
Appendix B 
 
Biomechanical Measurements 
Appendix C 
 
Component List 
Appendix D 
 
Study Advertisements 
Appendix E 
 
Model Informed Patient Consent 
Appendix F 
 
Draft Case Report Forms 
Appendix G 
 
Patient Retention Program 

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List of Tables 
 
 
Table 1.  Rejuvenate® Modular Hip System Design Features ......................................... 8 
 
Table 2.  Rejuvenate® Modular Hip System Achieved Neck Length/Stem Compatibility
 ...................................................................................................................................... 23 
 
Table 3.  Rejuvenate® Modular Hip System Head/Neck Combinations ......................... 23 
 
Table 4.  Primary THA Expected Complication Rates ................................................... 45 
 

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List of Figures 
 
Figure 1.  Adverse Event Decision Tree……………………………………………………………...30

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List of Abbreviations 
 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Anteroposterior 
BMI 
Body Mass Index 
CRF 
Case Report Form 
CSA 
Clinical Study Associate 
CSM 
Clinical Study Manager 
DCF 
Data Clarification Form 
DCR 
Data Clarification Request 
EC 
Ethics Committee 
GCP 
Good Clinical Practice 
HHS 
Harris Hip Score 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LEAS 
Lower Extremity Activity Scale 
NIDJD 
Non-Inflammatory Degenerative Joint Disease 
PER 
Product Experience Report 
PI 
Primary Investigator 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-12 
Short Form-12 
THR 
Total Hip Replacement 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene 

Rejuvenate® Modular Outcomes Study                                                                                                         Page 1 
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Study Synopsis 
 
Title 
A prospective, post-market, multi-center study of the outcomes of the 
Rejuvenate® Modular Hip System  
Short Title 
Rejuvenate® Modular Outcomes Study 
Protocol Number 
68 
Phase 
Post-market 
Methodology 
This study will be a prospective, non-randomized evaluation of the 
Rejuvenate® Modular Hip System for primary total hip replacement 
(THR) with a cementless application in a consecutive series of 
patients who meet the eligibility criteria.   
 
Data from Secur-Fit™ HA monolithic femoral stem cases that are 
enrolled in the Trident® X3® Polyethylene Insert Study will be used as 
a historical control group. 
Study Duration 
• 
Minimum functional evaluation, assessment of health related 
quality of life (QOL) and radiographic follow-up of each 
primary THR case to 5 years 
• 
Enrollment period of 24 months 
• 
Completion of pain, satisfaction and survivorship patient 
questionnaire between 6 and 10 years 
• 
Approximate 12-year total duration 
Study Center(s) 
10 – 12 
Hypothesis 
The success rate, defined as freedom from femoral stem/neck 
construct revision/removal for any reason, for hips implanted with the  
Rejuvenate® Modular Hip System, is no worse than for hips 
implanted with the Secur-Fit™ HA monolithic femoral hip stem at 5 
years postoperative. 

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Objectives 
Primary: 
• 
To evaluate the success rate of cementless primary THR with 
the Rejuvenate® Modular Hip System as compared to the 
Secur-Fit™ HA monolithic femoral hip stem, through absence 
of revision at 5 years postoperative. 
Secondary: 
• 
To obtain natural preoperative biomechanical measurements 
and compare a preoperative plan to postoperative 
biomechanical measurements, within the Rejuvenate® 
Modular Hip System group. 
• 
To compare pain, function and health related QOL between 
the Rejuvenate® Modular Hip System group and the Secur-
Fit™ HA monolithic femoral stem group.  The following 
outcomes measures will be used for this comparison: 
o Harris Hip Score (HHS) 
o Short Form-12 (SF-12) 
o Lower Extremity Activity Scale (LEAS) 
• 
To review radiographic stability and complications between 
those implanted with the Rejuvenate® Modular Hip System 
and the Secur-Fit™ HA monolithic femoral stem group.  
Published complication rates with similar devices as well as 
complications related to modularity will be reviewed, as 
applicable. 
Number of Subjects 240 cases 

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Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Inclusions: 
A. Patient has signed an IRB approved, study specific Informed 
Patient Consent Form. 
B. Patient is a male or non-pregnant female age 18 years or 
older at time of study device implantation. 
C. Patient has primary diagnosis of Non-Inflammatory 
Degenerative Joint Disease (NIDJD). 
D. Patient is a candidate for a primary cementless total hip 
replacement. 
E. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations and 
rehabilitation. 
F. Patient’s operative femur templates to Rejuvenate® Modular 
Stem size 7-12. 
 
Exclusions: 
G. Patient has a Body Mass Index (BMI) ≥ 40. 
H. Patient has an active or suspected latent infection in or about 
the affected hip joint at time of study device implantation. 
I. 
Patient has a neuromuscular or neurosensory deficiency, 
which limits the ability to evaluate the safety and efficacy of 
the device. 
J. 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. 
K. Patient is immunologically suppressed or receiving steroids in 
excess of normal physiological requirements 
(e.g. > 30 days). 
L. Patient requires revision surgery of a previously implanted 
total hip replacement or hip fusion to the affected joint. 
M. Patient has a known sensitivity to device materials. 
N. Patient is a prisoner. 

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Study Device 
Rejuvenate® Modular Hip System 
 
Required Components: 
• 
Rejuvenate® Modular Stem 
• 
Rejuvenate® Modular Neck 
 
The femoral components must be used in a cementless application. 
Reference Therapy 
Secur-Fit™ HA  Monolithic Femoral Hip Stem 
Ancillary Devices 
Stryker acetabular components and femoral bearing heads must be 
used according to this study protocol.  The following ancillary devices 
are permissible: 
• 
Stryker Trident® or Tritanium™ Primary acetabular shells, with or 
without screw fixation, as well as Stryker Restoration® ADM 
acetabular shells 
• 
Stryker alumina ceramic inserts (for use with Trident® acetabular 
shells) or X3® inserts 
• 
Stryker LFIT™ CoCr heads; delta ceramic heads; or alumina 
ceramic heads with adaptor sleeve 

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Statistical 
Methodology 
Primary: 
The 90% confidence interval around the difference in success rate 
(Rejuvenate® Modular Hip System – Secur-Fit™ HA monolithic 
femoral stem) will be computed at 5 years postoperative.  For the 
non-inferiority comparison, the lower bound of this 90% confidence 
interval will be compared with -5%. 
 
Secondary: 
• 
A t-test or Wilcoxon test will be used to compare the 
postoperative biomechanical measurements to a preoperative 
plan. 
• 
Independent group t-tests will also compare HHS, SF-12 and 
LEAS at applicable time points between the Rejuvenate® Modular 
Hip System and Secur-Fit™ HA monolithic femoral stem groups.  
In addition, a paired t-test will compare the results preoperatively 
with each postoperative evaluation within the Rejuvenate® 
Modular Hip System group. 
• 
The adverse event (AE) rates and 95% confidence intervals will 
be presented within the Rejuvenate® Modular Hip System group.  
A Fisher’s exact test will be used to compare the AE rates 
between the Rejuvenate® Modular Hip System and the Secur-
Fit™ HA groups, if appropriate. 
• 
Radiographic data will be summarized in table format. 
 

Rejuvenate® Modular Outcomes Study                                                                                                         Page 6 
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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 
 
 
 
 
 
 
 
 
 
 
 
 
Preoperative 
Biomechanical 
Measurements 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
Postoperative 
Functional Evaluation 
 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
Postoperative 
Biomechanical 
Measurements 
 
 
X 
 
 
 
 
 
 
 
 
 
 
SF-12 
X 
 
X 
X
X
X
X
X 
Optional
Optional
LEAS 
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 inclue 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.  
Follow-up Questionnaire: The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain and whether or not 
there have been any revisions or removals of the study device since the last follow-up visit.

Rejuvenate® Modular Outcomes Study                                                                                                         Page 7 
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1 Introduction 
 
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 
Modular hip prostheses have been in clinical use since 1985.  In a study of 216 anatomic 
cementless THRs (208 patients) with ceramic bearings and modular necks, followed for a 
minimum of 3 years, the authors affirm that the advantages of this method include its 
adaptability to a variety of anatomical conditions.   From a clinical standpoint, all of the patients 
achieving long-term follow-up demonstrated improvement in pain, movement and walking.  
Radiographically, bone stability was observed in 98.8% of stems.  A total of 99.4% of stems 
were osseointegrated and only one case showed osteolysis requiring revision of stem and cup 
after 2 years.  This data supports the conclusion that neck modularity has not changed the 
survivorship of standard primary hip femoral components, while facilitating implantation in 
patients with varied anatomical conditions.1 
 
A review by Spitzer2 of a similar modular device’s 20-year clinical history shows that the 
prosthesis has performed well in both primary and revision cases.  The modular junction has 
survived with long-term clinical follow-up.  The author argues that despite concerns regarding 
fretting and failure at the modular junction, mid to long-term follow-up indicates that these issues 
do not pose a significant concern.  Furthermore, fixation by the proximal sleeve has proven 
reliable and durable, and loosening rates have been low, as evidenced by clinical data.3 
 
Stryker is introducing a modular hip prosthesis, the Rejuvenate® Modular Hip System.  The 
basic design of the Rejuvenate® Modular Hip System is similar to other total hip systems, both 
modular and monolithic, which are currently commercially distributed.  The Rejuvenate® Modular 
Hip System’s design features are based upon the previous success of Stryker’s hydroxylapatite 
(HA) coated monolithic femoral components.   
 
 

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Table 1.  Rejuvenate® Modular Hip System Design Features 
 
Product 
Identifying Features 
Based upon 
Clinical History 
of the Following 
Straight, 
Cementless 
Modular Stem 
TMZF® Alloy 
Plasma Spray 
PureFix™ HA 
Omnifit® HA 
Secur-Fit™ HA 
 
The Omnifit® HA femoral component has long-term survivorship in a relatively young patient 
group, with a low mechanical failure rate compared to other fixation methods at similar lengths 
of follow-up.  A total of 166 hips (146 patients) were followed for an interval of 15 to 18 years, 
with both femoral aseptic revision and mechanical failure rates at approximately 0.6%.4  
Omnifit® is considered Stryker’s gold standard for proximal HA-coated femoral stems.  The 
Rejuvenate® Modular Hip System is an updated version of the Omnifit®, modifying the C-taper 
trunnion and bulky neck geometry.  These features are considered weaknesses of the Omnifit® 
design. 
 
The Secur-Fit™ system, the historical control for this clinical study, was based on the geometry 
of the Omnifit® femoral stem.  The Secur-Fit™ HA stem retains the Omnifit® geometry, 
normalized design and PureFix™ HA coating to further enhance initial stem stability and 
augment proximal load transfer.  The Secur-Fit™ HA stem has a highly polished neck, 
decreasing the potential for polyethylene debris.  Each implant maintains the same geometry, 
regardless of stem size, allowing the stems to more closely match natural anatomy. 
 
In a clinical and radiographic review by Jaffe and Hawkins5 of 215 THRs in which a monolithic, 
normalized, proportionalized, cemented femoral component was implanted, the design was 
reported to allow for more efficient force transmission between prosthesis, cement and bone 
and to lessen failure rates at these interfaces.  Overall, the study showed an aseptic failure 
loosening rate of 3.9% at 15 years for the stem.  These results were favorable when compared 
with other first generation and second generation stems at similar follow-up.6  Although the 
Rejuvenate® Modular Hip System is intended for cementless application, the findings by Jaffe 
and Hawkins7 focus on a normalized femoral component.  As with the femoral stem studied, the 
Rejuvenate® Modular Stem includes a normalized pattern on the anterior and posterior aspects 
of the proximal end of the stem, facilitating load transmission in the proximal region of the femur. 

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The Secur-Fit™ system is the direct predecessor for the Rejuvenate® Modular Hip System.  The 
Rejuvenate® Modular Hip System introduces the concept of modularity, offering the surgeon 
additional intraoperative flexibility.  The mixing and matching of components, as described 
further in Section 6, Device Description, allows the surgeon to choose the best anatomical fit for 
the patient.  The Rejuvenate® Modular Hip System permits the matching of a proximal femoral 
neck in different lengths, angles and version, with different sizes of distal stems. 
 
This clinical study is necessary to compare the success of the Rejuvenate® Modular Hip System 
to the reported success of its monolithic predecessor.  The objective of the study is to show that 
neck modularity has not changed the survivorship of standard primary hip femoral components. 
1.2 
Investigational Device 
The Rejuvenate® Modular Hip System is fabricated from TMZF® alloy and features the 
PureFix™ HA fixation philosophy.  The stem is built upon the design features and clinical history 
of the existing Omnifit® and Secur-Fit™ Stryker femoral stems.  The device provides better 
patient matching by allowing for interchange of the femoral neck angle, femoral neck length, 
version and femoral head offset.  The Rejuvenate® Modular Hip System has a modular neck, 
allowing for 127°, 132° and 130° femoral neck angles.  The 130° modular neck is only available 
in the 16° version option.  Four femoral neck lengths are available, ranging from 30 mm to 42 
mm, in 4 mm increments.  Possible overall neck lengths range from 26 mm to 46 mm, utilizing 
V40 +/- 4 mm femoral heads. 
 
The Rejuvenate® Modular Hip System is intended for use in a cementless application.  It is 
designed to address the need for greater accuracy in reproducing offset, leg length and femoral 
neck version, as well as optimize range of motion (ROM) for primary hip patients.  Data in 
support of these marketing claims will be collected in the Rejuvenate® Modular Hip System 
Outcomes Study.   
 

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The Rejuvenate® Modular Hip System is cleared for use as follows: 
• FDA 510(k) K071082, original submission for sizes 7, 8, 9 and 10 
• FDA 510(k) K081044, line extension for compatability between the size 9 stem and the 
42 mm neck 
• FDA 510(k) K092561, for use with up to 46 mm of total neck length 
1.3 
Preclinical Data 
The following bench tests were conducted on the Rejuvenate® Modular Hip System: 
Description of the test 
               Report ID 
Mod. ISO-Neck Fatigue        
– RD-07-029 
ISO 7206-4 Distal Fixation Model 
– RD-07-028 
Fretting Size 7 
 
 
– RD-07-054 
Fretting Size 10 
 
 
– RD-07-100 
Flexion 
 
 
 
– RD-07-101 
Revision 
 
 
 
– RD-07-056 
Pull-off Strength/Disassembly 
– RD-07-055 
Copies of all test reports are available at Stryker Orthopaedics.   
1.4 
Clinical Data to Date 
A limited number of evaluation instrument sets and implants have been distributed in the United 
States to date.  Anecdotal feedback from the centers has been positive.  This study is the first 
prospective data collection on the Rejuvenate® Modular Hip System. 
 
2 Study Objectives 
 
2.1 
Efficacy 
2.1.1 Primary 
The primary objective of this study will be to evaluate the success rate of cementless 
primary THR with the Rejuvenate® Modular Hip System, as compared to the Secur-Fit™ 
HA monolithic femoral hip stem, a historical control.   Success will be defined as 
absence of femoral stem/neck construct revision/removal for any reason at 5 years 
postoperative.  It is expected that the survivorship of the Rejuvenate® Modular Hip 

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System group will be non-inferior to the survivorship reported for Secur-Fit™ HA 
monolithic femoral hip stem cases enrolled in the Trident® X3® Polyethylene Insert 
Study. 
2.1.2 Secondary 
The secondary objectives of this study will be to measure natural preoperative 
biomechanical measurements for creation of a preoperative plan, and compare to 
postoperative biomechanical measurements, within the Rejuvenate® Modular Hip 
System group.  It is expected that the postoperative measurements at the 6-week 
interval will be similar to the preoperative plan. 
 
Additionally, pain, function and health-related QOL between the Rejuvenate® Modular 
Hip System group and the Secur-Fit™ HA monolithic femoral hip stem group will be 
compared at postoperative time points.  It is expected that the HHS, SF-12 and LEAS 
outcomes in the study group will be non-inferior to the historical control. 
 
Lastly, radiographic stability and complications between those implanted with the 
Rejuvenate® Modular Hip System and the Secur-Fit™ HA monolithic femoral stem group 
will be reviewed.  Published complication rates with similar devices as well as 
complications related to modularity will be reviewed, as applicable. 
 
Clinical Outcomes: 
Clinical outcomes will be evaluated via the total HHS, including pain, motion and 
function, preoperatively, and at the 6-week, 1, 2, 3, 4 and 5-year visits.  Additional HHS 
data will be obtained at the 7-year and 10-year time points at investigational sites that 
choose to bring their subjects back in for these optional visits.  
 
Patient Outcomes: 
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.  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.  Additional patient 
outcomes data will be obtained at the 7-year and 10-year time points at investigational 
sites that choose to bring their subjects back in for these optional visits.  A questionnaire 

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for patient completion, intended to provide information on patient satisfaction, pain and 
whether or not there have been any revisions or removals of the study device since the 
last follow-up visit, is required at the 6, 7, 8, 9 and 10-year visits. 
 
Radiographic Outcomes: 
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 views allow for observations of any conditions involving the 
sacral wings, iliac bones, ischium, pubis as well as the femoral head and neck.  These 
views additionally display the critical relationship between the femoral neck’s longitudinal 
axis and the femoral shaft’s longitudinal axis for identification of displacement in the 
event of a femoral neck fracture.  The lateral view allows for evaluation of the entire hip 
joint as well as specifically the femoral head, neck and proximal shaft.8  Suggested 
radiographic technique for the views required is included in Appendix A. 
 
Radiographs will be evaluated by an independent reviewer throughout the course of the 
study.  Radiographic analysis of the 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; 
analysis of the acetabular component will employ three zones (Zone 1 – Zone 3) in the 
AP views.9,10  Numerous parameters will be reviewed by zone, including radiolucency, 
hypertrophy, and condensation.  Radiolucency in at least 50% of a zone and measuring 
at least 1 mm in width is defined as radiolucency present. 
 
Subsidence, migration and fixation will also be assessed.  Subsidence is defined as 
settling of the prosthetic component in bone, and is related to the distance between fixed 
bony landmarks and the prosthesis. 
 

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Biomechanical Measurements: 
Preoperatively, study radiographs will be taken by each investigator.  From these 
radiographs, each investigator will determine natural measurements and provide a 
detailed picture of each patient’s level of deformity, as follows. 
 
• 
Leg length discrepancy (centimeters) 
o Measurement of leg length discrepancy should be determined from the 
AP pelvis radiograph by drawing lines across both pelvic teardrops to 
meet both femurs.  These lines are to be used as the main reference lines 
for measuring the distance to the top of each lesser trochanter.11  The 
difference between these distances is the value of leg length discrepancy. 
• 
Natural femoral offset (millimeters) 
o Femoral offset should be determined by measuring the perpendicular 
distance from the center of the femoral head to the axis along the length 
of the femur.12 
• 
Natural femoral neck angle (degrees) 
o Femoral neck angle is the angle between the long axes of the femoral 
neck and femoral shaft.13 
• 
Qualitative assessment of natural femoral version (Retroverted, Neutral, 
Anteverted) 
o Proximal femoral version reflects the relationship of the axis of the 
femoral neck to the transcondylar axis of the distal femur.14  Qualitative 
determination of whether natural femoral version is retroverted, 
anteverted or in a state of neutral version should be made from the lateral 
radiograph. 
 
The investigator at each center will create a preoperative biomechanical measurement 
plan for each case from templating, reflecting desired postoperative measurements and 
the component sizes, angles and offsets that will be used to achieve these 
measurements.  All component sizes should be corrected for magnification (if any) prior 
to data collection on the study Case Report Form (CRF).  This may be accomplished by 
utilizing an external radiographic marker of known dimension prior to taking the 
preoperative radiograph.15 
 

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Preoperative Distance from Planned Center of Rotation 
• 
Vertical distance from the anatomic hip center to the planned center of rotation of 
the hip (millimeters) 
• 
Horizontal distance from the anatomic hip center to the planned center of rotation 
of the hip (millimeters) 
Components to be Used 
• 
Acetabular cup size 
• 
Femoral neck angle [127°, 132°, 130° (16° version option only)] 
• 
Femoral neck length (millimeters) 
• 
Femoral head size 
• 
Femoral head offset 
• 
Femoral stem size* 
• 
Femoral version (0°, ±8°, ±16°) 
*The Rejuvenate® Modular Stem will be available in sizes 7, 8, 9, 10, 11 and 12.  The 
Rejuvenate® Monolithic Stem will be available in sizes 4, 5 and 6; however, the 
Rejuvenate® Monolithic Stem may not be used according to this protocol.  Patients 
requiring a femoral stem in size 4, 5 or 6 should not be enrolled into the study.  
Investigators should template the femoral stem size to be used prior to completing the 
Inclusion/Exclusion CRF for enrollment into the study. 
Additional Planned Measurements 
• 
Amount of leg length to be restored (centimeters) 
o Measurement of leg length discrepancy should be determined from the 
AP pelvis radiograph by drawing lines across both pelvic teardrops to 
meet both femurs.  These lines are to be used as the main reference lines 
for then measuring the distance to the top of each lesser trochanters.16  
The difference between these distances is the value of leg length 
discrepancy.  From this value, the investigator will determine the amount 
of leg length he/she plans to restore. 
• 
Femoral offset to be achieved (millimeters) 
• 
Qualitative assessment of postoperative planned femoral version (Retroverted, 
Neutral, Anteverted) 
 
A postoperative check of biomechanical measurements will be performed by the 
investigator at each site from the 6-week radiographs to confirm the degree to which the 

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preoperative plan was achieved.  If an AE for instability exists, the postoperative check 
will be taken again at applicable postoperative intervals to confirm whether or not 
changes have occurred. 
 
Postoperative Distance from Planned Center of Rotation 
• 
Vertical distance from the postoperative hip center to the planned preoperative 
center of rotation of the hip (millimeters) 
• 
Horizontal distance from the postoperative hip center to the planned preoperative 
center of rotation of the hip (millimeters) 
Additional Postoperative Measurements 
• 
Leg length discrepancy (centimeters) 
• 
Final femoral offset (millimeters) 
• 
Final femoral neck angle used  [127°, 132°, 130° (16° version option only)] 
• 
Qualitative assessment of replaced femoral version (Retroverted, Neutral, Anteverted) 
These postoperative values will be compared to the preoperative plan to evaluate the 
degree of patient matching achieved with the Rejuvenate® Modular Hip System.   
 
Component sizes used intraoperatively will be automatically determined from catalog 
numbers provided on the Surgical Details CRF. 
 
Biomechanical measurements are outlined in Appendix B. 
2.2 
Safety 
All operative site events as well as all serious adverse events (SAEs), excluding elective 
procedures, will be collected and compared to the historical control group and to 
published data.  It is expected that the AE rates reported for the Rejuvenate® Modular 
Hip System will be comparable to those reported in the literature for similar modular 
stems and for the historical control group.  For incidence of femoral neck fracture, a 
complication related to modularity, it is expected that rates reported for the Rejuvenate® 
Modular Hip System will be comparable to those reported in the literature for similar 
modular stems.  Details regarding AE definitions, recording and reporting are in Section 
8 of this protocol, Adverse Events. 
 

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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 10 to 12 centers in the United States.  The enrollment goal ranges 
from 20 to 24 THA cases per center, utilizing the Rejuvenate® Modular Hip System.  The 
enrollment goal range is dependent upon the number of participating centers.   Although a 
range is presented, there is no maximum limit to the number of cases that a center may enroll.  
In the event that a center far exceeds the 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 IRB approval.  Non-compliance of a study 
center may result in termination of the center’s participation in the study. 
3.3 
Number of Subjects 
A total of 240 cases will be enrolled in this study.  All cases will receive the Rejuvenate® Modular 
Hip System.  Additionally, only the following ancillary devices may be used according to this 
study protocol: 
• 
Stryker Trident® or Tritanium™ Primary acetabular shells, with or without screw 
fixation, as well as Stryker Restoration® ADM acetabular shells 
• 
Stryker alumina ceramic inserts (for use with Trident® acetabular shells) or X3® 
inserts 
• 
Stryker LFIT™ CoCr heads; delta ceramic heads; or alumina ceramic heads with 
adapter sleeve 
 
The Rejuvenate® Modular Hip System is described in detail in Section 6 of this protocol, Device 
Description.   
3.4 
Estimated Study Duration  
The enrollment period is estimated to be a maximum of 24 months; cases will be evaluated as 
per the evaluation schedule until each case reaches 10 years.  Functional evaluation, 

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assessment of health related QOL and radiographic follow-up of each primary THR case to 5 
years is required.  Completion of the pain, satisfaction and survivorship patient questionnaire 
between 6 and 10 years is also required, with optional in-office visits at 7 and 10 years for 
collection of additional functional, QOL and radiographic data. 
 
To allow for a learning curve with the use of the system, enrollment of cases into the study will 
commence when three cases have been completed at the center using the Rejuvenate® 
Modular Hip System. 
 
4 Eligibility 
 
The following criteria will be used to distinguish patients eligible for enrollment into this study. 
4.1 
Inclusion Criteria 
A. Patient has signed an IRB approved, study specific Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female age 18 years or older at time of study device 
implantation. 
C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 
D. Patient is a candidate for a primary cementless total hip replacement. 
E. Patient is willing and able to comply with postoperative scheduled clinical and 
radiographic evaluations and rehabilitation. 
F. Patient’s operative femur templates to Rejuvenate® Modular Stem size 7-12. 

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4.2 
Exclusion Criteria 
G. Patient has a Body Mass Index (BMI) ≥ 40. 
H. Patient has an active infection within the affected hip joint. 
I. 
Patient requires revision surgery of a previously implanted total hip arthroplasty or hip 
fusion to the affected joint. 
J. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate 
the safety and efficacy of the device. 
K. Patient is diagnosed with systemic disease or current life threatening illness and is not 
able to carry on normal activities of daily life (e.g. Paget’s disease, renal osteodystrophy, 
rheumatoid arthritis). 
L. Patient is immunologically suppressed or receiving chronic steroids in excess of normal 
physiological requirements (e.g. > 30 days). 
M. Patient has a known sensitivity to device materials. 
N. Patient is a prisoner. 
 
5 Subject Enrollment 
 
5.1 
Treatment Assignment 
All subjects enrolled in this study will be assigned to receive the Rejuvenate® Modular Hip 
System. 
5.2 
Randomization 
This study will enroll under a non-randomized study design. 
 
6 Device Description 
6.1 
Study Device 
The Rejuvenate® Modular Hip System has been cleared for marketing in the United States, and, 
therefore, this study is considered a post-market assessment.  All cases in this study will receive 
the Rejuvenate® Modular Hip System, consisting of the Rejuvenate® Modular Stem and the 

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Rejuvenate® Modular Neck.  Additionally, only the following Stryker compatible ancillary 
devices may be used, according to this study protocol: 
• 
Stryker Trident® or Tritanium™ Primary acetabular shells, with or without screw 
fixation, as well as Stryker Restoration® ADM acetabular shells 
• 
Stryker alumina ceramic inserts (for use with Trident® acetabular shells) or X3® 
inserts 
• 
Stryker LFIT™ CoCr heads; delta ceramic heads; or alumina ceramic heads with 
adapter sleeve 
 
Device Description: 
The Rejuvenate® Modular Hip System consists of a modular stem and a modular neck.  It is 
similar to other modular and monolithic hip systems currently distributed.  It is intended for 
cementless, press-fit application and is designed for use with currently available Stryker femoral 
heads.  A description of the Rejuvenate® Modular Hip System components and compatible 
femoral heads follows.  Stryker acetabular components compatible with the chosen Stryker 
femoral heads must be used, according to this study protocol.  Appendix C gives an overview of 
all protocol-specified components. 
 
Modular Stem: 
The modular stem design is based on the Secur-Fit™ system.  The Rejuvenate® Modular Hip 
System includes a straight stem with a normalization pattern on the anterior and posterior 
aspects of the proximal end of the stem to facilitate press-fit stability and load transmission in 
the proximal region of the femur.  The stem has an internal opening which mates with the 
modular neck via an oblong Morse-type taper.  The drawing below depicts the stem design.  
 

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The Rejuvenate® Modular Stem will be available in sizes 7, 8, 9, 10, 11 and 12.  The 
Rejuvenate® Monolithic Stem will be available in sizes 4, 5 and 6; however, the Rejuvenate® 
Monolithic Stem may not be used according to this protocol.  Patients requiring a femoral 
stem in size 4, 5 or 6 should not be enrolled into the study.  Investigators should template the 
femoral stem size to be used prior to completing the Inclusion/Exclusion CRF for enrollment into 
the study. 
 
The hip stems will be fabricated from TMZF® (TiMoZrFe) alloy.  The Titanium plasma spray 
coating is Commercially Pure (CP) Titanium and the coating will be hydroxylapatite powder 
(Pure-Fix™ HA).  The HA coating thickness will be between 40 – 70 µm. 
The catalog numbers for the Rejuvenate® Modular Stem permissible according to this study 
protocol will be in the following format, where ‘XX’ varies by size: 
 
SPT-XX0000S 
Modular Neck: 
The modular necks are manufactured from CoCrMo alloy and are available in 16 options in 
various lengths ranging from 30 mm to 42 mm and angles of 0°, 8° and 16° version.  All modular 
necks, except for the 16° version, have varus and valgus options of 127° and 132° neck angles.  
The 16° version modular neck has a single neck-angle option of 130°.  The drawing below 
shows the various styles of necks.  
 
 
 
 
 
The catalog numbers for the Rejuvenate® Modular Necks permissible according to this study 
protocol are listed in Appendix C. 
 

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Each modular neck fits into a given stem to create two different constructs. 
 
 
 
The neck has two different tapers for mechanically locking the components:  stem to neck 
interconnection and neck to modular head interconnection.  Following is a drawing illustrating 
the interconnections between the three components. 
 

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Modular Heads: 
The modular neck is designed for use with Stryker V40 femoral heads with different offsets, or 
C-Taper Alumina heads when used with the adaptor sleeve.  Biolox® Delta Universal Taper 
Heads and sleeves may also be used.  The offset of the femoral head will be independent of the 
choice of femoral stem body size.  Total head/neck length equals head offset plus neck length. 
 
Tables 2 and 3 list the permissible stem/neck/head combinations. 
 
Femoral head
Modular Neck
V40 taper 
Modular Stem
Neck/Stem Interconnection

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Table 2.  Rejuvenate® Modular Hip System Achieved Neck Length/Stem Compatibility 
 
 
Table 3.  Rejuvenate® Modular Hip System Head/Neck Combinations 
 
 
Ancillary Devices: 
Only Stryker Trident® or Tritanium™ Primary acetabular shells, Stryker Restoration® ADM 
acetabular shells, Stryker alumina ceramic (for use with Trident® acetabular shells) or X3® 
inserts, and Stryker compatible femoral heads/sleeves, as described previously, may be used 
as ancillary devices according to this study protocol. 
 
X3® polyethylene is a highly cross-linked polyethylene manufactured through a proprietary 
process where the polyethylene receives 30 kiloGrays of gamma radiation, which generates 
free radicals and cross-linking in ultra high molecular weight polyethylene (UHMWPE) prior to 
machining.  The polyethylene is then annealed below melting point to promote cross-linking and 
maintains mechanical strengtha, crystallinityb, and densityc.  This also stabilizes the free 
radicalsd.  This process is repeated twice. 
                                                 
a X3® UHMWPE maintains mechanical properties for Tensile Yield Strength and Ultimate Tensile Strength 
of N2Vac® gamma sterilized UHMWPE as measured by ASTM D638.  Tensile Yield Strength was 23.2 ± 

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6.2 
Device Retrieval Process 
Stryker Orthopaedics will retrieve any Rejuvenate® Modular Hip System components and/or 
adjacent tissues for analysis to help characterize potential device-related complications.  In the 
event that any portion of the Rejuvenate® Modular Hip System is removed from a study subject, 
the outlined procedure should be followed. 
 
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. The SC or an identified field representative will retrieve the device and place it in the 
retrieval container. 
4. The SC or an identified Stryker representative will complete a Product Experience 
Report (PER). 
5. 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. 
 
                                                                                                                                                             
0.4 MPa and 23.5 ± 0.3 MPa for N2Vac® UHMWPE and X3® UHMWPE, respectively.  Ultimate Tensile 
Strength was 54.8 ± 2.5 MPa and 56.7 ± 2.1 MPa for N2Vac® UHMWPE and X3® UHMWPE, respectively. 
 
b X3® UHMWPE has similar crystalline and lamellar structure as N2Vac® gamma sterilized UHMWPE as 
measured by Small Angle X-ray Scattering (SAXS) and Differential Scanning Calorimetry (DSC) analysis.  
DSC determined crystallinity was 61.3 ± 0.8% and 61.7 ± 0.6% for N2Vac® UHMWPE and X3® UHMWPE, 
respectively.  Lamellar crystal thickness was 23.0 and 23.6 nanometers for N2Vac® UHMWPE and X3® 
UHMWPE, respectively. 
 
c X3® UHMWPE increases cross-link density over N2Vac® gamma sterilized UHMWPE by 87%, as 
measured by swell ratio, per ASTM F2214.  Cross-link density, as measured by swell ratio, was 0.08 ± 
0.00 mol/dl and 0.15 ± 0.01 mol/dl for N2Vac® UHMWPE and X3® UHMWPE, respectively. 
 
d 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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7 Evaluations 
7.1 
Preoperative Visit 
During the preoperative visit, patients that are possible candidates for this study will be 
screened to determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, 
the investigator will propose participation in the study to the patient, according to GCP 
guidelines.  Patients must sign an IRB approved study consent form prior to participating in any 
study related activities.  Consent must be obtained within four months of surgery. 
 
Once the subject has been consented, preoperative data will be collected including: 
demographics, medical history, HHS, AP hip, AP pelvis and lateral radiographs, SF-12, and 
LEAS. 
 
Additionally, the investigator will measure the following from preoperative radiographs, 
including: 
 
• 
Leg length discrepancy (millimeters) 
• 
Natural femoral offset (millimeters) 
• 
Natural femoral neck angle (degrees) 
• 
Qualitative assessment of natural femoral version (Retroverted, Neutral, Anteverted) 
 
The investigator will then proceed with a preoperative plan from templating, reflecting desired 
postoperative measurements and the component sizes, angles, and offsets that will be used to 
achieve the following measurements: 
 
Preoperative Distance from Planned Center of Rotation 
• 
Vertical distance from the anatomic hip center to the planned center of rotation of the hip 
(millimeters) 
• 
Horizontal distance from the anatomic hip center to the planned center of rotation of the 
hip (millimeters) 
 

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Components to be Used 
• 
Acetabular cup size 
• 
Femoral neck angle [127°, 132°, 130° (The 130° neck angle is only available in 16° of 
version.)] 
• 
Femoral neck length (millimeters) 
• 
Femoral head size 
• 
Femoral head offset 
• 
Femoral stem size* 
• 
Femoral version (0°, ±8°, ±16°) 
 
*The Rejuvenate® Modular Stem will be available in sizes 7, 8, 9, 10, 11 and 12.  The 
Rejuvenate® Monolithic Stem will be available in sizes 4, 5 and 6; however, the Rejuvenate® 
Monolithic Stem may not be used according to this protocol.  Patients requiring a femoral 
stem in size 4, 5 or 6 should not be enrolled into the study.  Investigators should template the 
femoral stem size to be used prior to completing the Inclusion/Exclusion CRF for enrollment into 
the study. 
 
Additional Planned Measurements 
• 
Amount of leg length to be restored (millimeters) 
• 
Femoral offset to be achieved (millimeters) 
• 
Qualitative assessment of planned postoperative femoral version (Retroverted, Neutral, 
Anteverted) 
 
All preoperative data must be collected within 4 months of the scheduled date of surgery, with 
the exception of radiographs, acceptable within 1 year of the scheduled date of surgery.  All 
information collected preoperatively will be used to quantify the sample population and compare 
postoperative progress. 
7.2 
Surgery 
 
Surgical details will be collected from the operative notes and at the time of surgery.  

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7.3 
6-week Visit 
Clinical data will be collected via office visit by the investigator at the 6-week postoperative 
interval.  Tools for postoperative evaluation will be the HHS, AP hip, AP pelvis and  lateral 
radiographs. 
 
Patient outcomes data will also be collected via patient questionnaires.  At the 6-week follow-up 
visit, the SF-12 and LEAS are required. 
 
All clinical data, radiographs, and patient outcomes data must be collected within ± 3 weeks of 
the 6-week postoperative milestone date. 
 
Additionally, each investigator will perform a postoperative check of biomechanical 
measurements from the 6-week radiographs: 
 
Postoperative Distance from Planned Center of Rotation 
• 
Vertical distance from the postoperative hip center to the planned preoperative center of 
rotation of the hip (millimeters) 
• 
Horizontal distance from the postoperative hip center to the planned preoperative center 
of rotation of the hip (millimeters) 
 
Additional  Postoperative Measurements 
• 
Leg length discrepancy (millimeters) 
• 
Final femoral offset (millimeters) 
• 
Final femoral neck angle used [127°, 132°, 130° (The 130° neck angle is only available 
in 16° of version.)] 
• 
Qualitative assessment of replaced femoral version (Retroverted, Neutral, Anteverted) 
 
These postoperative values will be compared to the preoperative plan to evaluate the degree of 
patient matching achieved with the Rejuvenate® Modular Hip System.   
 
Component sizes used intraoperatively will be automatically determined from catalog numbers 
provided on the Surgical Details CRF. 

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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 hip, AP pelvis and lateral radiographs. 
 
Patient outcomes data will also be collected via patient questionnaires.  At each of the 1-year, 
2-year, 3-year, 4-year and 5-year follow-up visits, the SF-12 and LEAS are required. 
 
All clinical data, radiographs, and patient outcomes data must be collected within ± 2 months of 
the 1-year and 2-year anniversary dates.  For remaining annual time points, the window 
expands to ± 3 months of the 3-year anniversary date and ± 4 months of the 4-year and 5-year 
anniversary dates. 
 
The initial phase of the study will conclude after the 5-year follow-up visit but, at investigational 
sites that choose to continue collecting clinical, patient outcome and radiographic data, subjects 
will be evaluated again at 7 and 10 years after surgery. 
 
In addition, 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 patient telephone interview or by the patient either at home or during a clinic visit.  The 
questionnaire will be used to obtain the following information, at a minimum: 
• 
Patient satisfaction with the hip replacement 
• 
Presence of any pain in the study hip 
• 
Any surgeries perfomed on the study hip 
 
The questionnaire will also provide information on any revisions and enable calculation of the 
Kaplan-Meier survival curve. 
 
For 7 through 10 years, the window is ± 4 months of the respective anniversary date.

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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 CRF 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 (as 
well as at optional 7 and 10-year 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. 
 
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
 

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Figure 1 
Adverse Event Decision Tree 
 

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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 CRF.  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 
CRF.  All clearly related signs, symptoms and abnormal diagnostic procedure results should be 
recorded in the source document and grouped under one diagnosis as appropriate.  The clinical 
course of each event should be followed until resolution or until it is determined at the end of the 
study that the AE will not resolve.   
8.2 
General Adverse Event Definitions 
Following is a list of general AE definitions.  For the purposes of this study, only SAEs, 
excluding elective procedures, as well as all AEs related to the operative site should be 
reported.   
Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation subject, which changes the 
medical baseline of the subject.  An AE can be an unfavorable and unintended sign, symptom 
or disease, whether or not related to the study device (AEs may also be referred to as 
complications).  See Section 8.1, Reporting of Adverse Events, for the AE reporting 
requirements for this study. 
 

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

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8.3 
Study Sponsor Fax Notification by Investigator 
Of reportable AEs, certain events must be faxed to Stryker within 24 hours for timely notification: 
• 
Events which meet the definition of serious 
o This does not include elective procedures, as these events are not reportable 
according to this study protocol.  
• 
Events which are deemed to be “related to” or “uncertain” in regard to relation to the 
device 
 An AE CRF must be completed by the investigator and faxed to Stryker within 24 hours.  The 
investigator will keep a copy of this AE CRF on file at the study center and submit the hard copy 
as per CRF data submission procedures.  Report SAEs to one of the following study personnel: 
 
Christina M. Hawley  
 
Michael Howard 
Phone:  858-344-9792 
 
Phone:  201-831-5807 
Fax:  201-831-6454 
 
 
Fax:  201-831-6454 
christina.hawley@stryker.com 
michael.howard@stryker.com 
 
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 
 
8.3.1 Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the Ethics 
Committee (EC) or Institutional Review Board (IRB) according to their specific 
requirements.  Copies of each report and documentation of EC/IRB notification and 
receipt will be kept with the investigator’s study files. 

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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 will be femoral stem/neck construct revision/removal for 
any reason. 
9.1.2 Secondary Efficacy Parameters 
The secondary efficacy parameters include: 
• 
Biomechanical measurement change from preoperative plan at 6-week visit 
• 
HHS at each visit 
• 
SF-12 scores at each visit 
• 
LEAS at each visit 
9.1.3 Primary Efficacy Hypothesis 
The primary hypothesis to be tested will be that the proportion of cases without femoral 
stem/neck construct revision/removal is no worse for patients with the Rejuvenate® 
Modular Hip System than for cases with the Secur-Fit™ HA monolithic femoral stem at 5 
years.  A non-inferiority comparison with a one-sided alpha set at 0.05, power of 80% 
and delta of 7% will be performed.  That is, the following hypothesis will be tested: 
H0: P1 < P2 – δ 
 
 
vs. 
 
Ha: P1 > P2 – δ 

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where P1 and P2 are the proportions of cases without femoral stem/neck construct 
revision/removal for any reason for the Rejuvenate® Modular Hip System group and the 
Secur-Fit™ HA monolithic femoral stem control group, respectively and δ=7%.  
9.1.4 Primary Efficacy Analysis 
A case success is defined as no incidence of femoral stem/neck construct 
revision/removal. The 90% confidence interval around the difference in success rate 
(Rejuvenate® Modular Hip System – Secur-Fit™ HA monolithic femoral stem) will be 
computed at 5 years postoperative.  For the non-inferiority comparison, the lower bound 
of this 90% confidence interval will be compared with -5%.  If it is greater than -5%, non-
inferiority is supported.  In addition, if it is greater than 0%, superiority is supported. The 
Kaplan-Meier survival curve will also be displayed using SAS/PROC LIFETEST. 
9.1.5 Secondary Efficacy Analysis 
A two-sided 0.05 alpha level will be used. 
 
For comparison of biomechanical measurements between a preoperative plan and 
postoperative measurements within the Rejuvenate® Modular Hip System group, a t-test 
or Wilcoxon test will be used. 
 
Independent group t-tests will compare HHS, SF-12 and LEAS at each time point 
between the Rejuvenate® Modular Hip System and Secur-Fit™ HA monolithic femoral 
stem groups.  In addition, a paired t-test will compare the results preoperatively with 
each postoperative evaluation within the Rejuvenate® Modular Hip System group. 
9.2 
Safety Parameters 
9.2.1 Safety Parameters 
Safety parameters will include all AEs reported for each group, radiographic stability at 
each postoperative visit and revision rates. 
9.2.2 Safety Analysis 
 
All AEs will be listed, tabulated and summarized by event, number and percent of 
cases/subjects.  AE rates and 95% confidence intervals will be presented.  In addition, a 

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Fisher’s exact test will be used to compare the AE rates between the Rejuvenate® 
Modular Hip System and the Secur-Fit™ HA groups or cohorts, if appropriate. 
 
For categorical variables, such as radiographic stability, the number and percent in each 
category will be presented.  
9.3 
Missing Data 
No missing data will be imputed for the primary analysis and secondary analyses.  
9.4 
Statistical Methodology 
9.4.1 Data Summary 
The following is a detailed proposal of statistical analyses planned for data collected 
during the study.   
 
Descriptive statistics will be computed for all preoperative conditions and demographic 
parameters.  That is, for continuous data (e.g. HHS) the N, mean, median, standard 
deviation, minimum and maximum will be computed.  For categorical data (e.g. gender) 
the frequency will be computed.  If appropriate, the data will be presented by the 
Rejuvenate® Modular Hip System and the Secur-Fit™ HA groups. 
 
Descriptive statistics and statistical comparisons for important demographic, efficacy and 
safety variables will be provided in tables.   
 
A survival analysis for revision/removal of the modular femoral stem/neck construct will 
be performed.  
9.4.2 Sample Size Calculation 
Given an estimated revision rate for both groups at 2.5% and a non-inferiority margin of 
5%, with a one-sided alpha of 0.05 and 80% power, a total of 147 cases per group are 
required to reject the null hypothesis that the revision rate for Rejuvenate® Modular Hip 
System cases is 5% greater than for Secur-Fit™ HA monolithic femoral stem cases.  In 
order to control for a 20% drop-out rate, 183 cases per group are required. 
 

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A total of 240 cases received the Secur-Fit™ HA femoral stem in   the Trident® X3® 
Polyethylene Insert Study, a historical control.  Therefore, although only 183 cases are 
needed for statistical power, 240 cases will be enrolled in the Rejuvenate® Modular Hip 
System Outcomes Study. 
9.4.3 Interim Analyses and early Stopping Considerations 
No interim analysis is planned.  
9.4.4 Patient Populations  
 
Modified Intent-to-Treat (ITT) Population:  The study population for analysis will 
include all subjects who receive the Rejuvenate® Modular Hip System or the Secur-Fit™ 
HA monolithic femoral stem.  This does not include cases censored from analysis for a 
reason that may have a significant impact on outcome.  
 
The primary and secondary efficacy analyses will be based on the per protocol 
population. 
 
Per Protocol Population:  The study population will include all subjects who receive the 
Rejuvenate® Modular Hip System or the Secur-Fit™ HA monolithic femoral stem.  This 
does not include cases that have major protocol violations including the violation of entry 
criteria.  In order for cases to be included in the per protocol population, the data 
required for analysis of a specific parameter must be present.  Any data of secondary 
variables will be included, where possible.  
 
The primary efficacy analyses and safety analysis will be based on the modified ITT 
population; the secondary efficacy analyses will be based on the per protocol population. 
 
10  Study Procedures 
10.1   Subject Recruitment and Screening 
 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  All patients recruited for this study will have the capacity to give informed consent.  
Advertising for the study at each center will be at the discretion of the investigator.  See 

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Appendix D for samples of study advertisements.  All handouts, brochures, advertisements, etc. 
must be approved by the IRB prior to the dissemination of any recruitment materials to potential 
subjects. 
10.2   Patient Informed Consent and Guidelines 
 
All patients for this study will be provided a consent form describing this study and providing 
sufficient information for them to make an informed decision about their participation.  The 
informed consent must contain all elements required by the FDA under 21 CFR Part 50, in 
addition to any other elements required by state, local and institutional policies.  See Appendix 
E for a copy of the Model Informed Patient Consent.  This consent form will be submitted with 
the protocol for review and approval by the IRB for the study.  All patients must provide written 
consent after having had adequate time to consider their participation in the study.  The formal 
consent of a patient, using the IRB approved consent form, must be obtained before that patient 
is submitted to any protocol related procedures that are not part of normal care.  Written 
documentation of consent must be provided on the consent’s signature page in addition to a 
note in the patient medical records indicating the date that consent was obtained.  The 
investigator-designated research professional obtaining the consent must also sign this consent 
form.  The patient or their legal representative should receive a signed copy of the consent 
according to GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
• 
Use a current IRB approved copy of the consent form. 
• 
Review the consent thoroughly with the patient before having them sign. 
• 
After the patient has consented to the procedures, ensure he/she signs and dates the 
consent form. 
• 
The person obtaining consent also signs and dates the signature page. 
• 
Provide a copy of the consent to the patient. 
• 
If required, provide the hospital with a copy of the signed consent. 
• 
Maintain the signed original in the patient’s study chart. 

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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 CRF 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 CRF 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: 
• 
Rejuvenate® Modular Stem 
• 
Rejuvenate® Modular Neck 
• 
Stryker Trident® or Tritanium™ Primary acetabular shells, with or without 
screw fixation, as well as Stryker Restoration® ADM acetabular shells 
• 
Stryker alumina ceramic inserts (for use with Trident® acetabular shells) 
or X3® inserts 
• 
Stryker LFIT™ CoCr heads; delta ceramic heads; or alumina ceramic 
heads with adapter sleeve 
 
Revision or removal of the Rejuvenate® Modular stem/neck construct constitutes a failure and 
study termination for the subject. 
 

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If acetabular insert or femoral head exchange is required during the study, the event is 
considered a reoperation and does not constitute a failure or study termination. 
 
If acetabular shell and insert 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 CRF 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 CRF 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 CRF will be completed. 
 
11  Data Management 
11.1  Database 
Data will be collected at each center and sent to Stryker for entry into a database which will 
reside at Stryker.  Subject data will be collected, processed and monitored according to the 
protocol schedule by Stryker or Stryker representatives.  Draft CRFs are provided in 
Appendix F.   
11.2 Confidentiality 
This study will comply with the 2002 privacy rule of the Health Insurance Portability and 
Accountability Act (HIPAA).  As such, Stryker will only collect that information which is 

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necessary to support the objectives of the clinical study.  Stryker will take precautions to ensure 
that data received is as de-identified as possible.  In the case that some identified information is 
received, Stryker will ensure that any identifying information will not be reported.  Study subjects 
will authorize Stryker to use their health information in support of the clinical study during the 
informed consent process.  Should a subject choose to withdraw authorization, Stryker may use 
data collected prior to the withdrawal of authorization in order to maintain data integrity.  
11.3 Source Documents 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical study necessary for the reconstruction and evaluation of the study.  Source 
data are contained in source documents.  Examples of these original documents and data 
records include:  hospital records, clinical and office charts, study worksheets, laboratory notes, 
memoranda, subject questionnaires, pharmacy dispensing records, recorded data from 
automated instruments, radiographs, subject files, and records kept at the pharmacy, at the 
laboratories and at medico-technical departments involved in the clinical study. 
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 CRFs 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 Case Report Forms 
The study CRFs are the primary data collection instrument for the study.  All data requested on 
the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is left 
blank because the procedure was not done or the question was not asked, write “N/D.”  If the 
item is not applicable to the individual case, write “N/A.”  All entries should be printed legibly in 
blue or black ink.  If any entry error has been made, to correct such an error, draw a single 
straight line through the incorrect entry and enter the correct data above it.  All such changes 
must be initialed and dated.  Do not erase or white out errors.  For clarification of illegible or 
uncertain entries, print the clarification above the item, initial and date it. 

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For specific instructions on CRF completion, please consult the Guide to Case Report Forms 
provided under separate cover.  CRFs should be completed, signed by the investigator and 
returned to Stryker within 2 weeks of the evaluation date. 
11.5 Data Clarification Requests 
If errors or omissions are noted by Stryker upon receipt of the forms, a data clarification form 
(DCF) or data clarification request (DCR) will be sent to the center for clarification.  Clarifications 
should be answered in a clear and comprehensible manner.  If the clarification requires a 
change to data captured on a CRF, the CRF should be modified accordingly.  The clarification 
should clearly document changes, independent of the CRF to which it refers.  DCFs and DCRs 
must be signed and dated by the investigator.  Completed clarifications should be returned to 
Stryker within 2 weeks of receipt.  Modified CRFs need not be included in conjunction to 
answered DCFs and 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 CRFs/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 

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termination.  These documents should be retained for a longer period if required by an 
agreement with Stryker. 
 
12  Risk/Benefit Assessment 
12.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of 
the primary THR procedure.  
12.2  Potential Risk 
The study involves the routine assessment of a primary THR procedure. The device under study 
has been cleared for marketing by the FDA and will be used according to its labeling.  
Assessment involves questionnaires, patient and physician assessments, and routine 
radiographs.  The information collected will be kept confidential and will comply with the HIPAA. 
 
While the expected life of THR components is difficult to estimate, it is finite.  These 
components are made of foreign materials, which are placed within the body for the potential 
restoration of mobility or reduction of pain.  However, due to the many biological, mechanical 
and physiochemical factors which affect these devices but cannot be evaluated in vivo, the 
components cannot be expected to indefinitely withstand the activity level and loads of normal 
healthy bone. 
 
Adverse effects associated with primary THR include the following: 
 
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 

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also be generated by third body wear.  Osteolysis can lead to future complications, including 
loosening, necessitating the removal and replacement of prosthetic components. 
 
Early and late loosening of total hip components can occur.  Early biomechanical loosening may 
result from inadequate initial fixation, latent infection, premature loading of the prosthesis or 
trauma.  Late loosening may result from trauma, infection, biological complications including 
osteolysis or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 
 
Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other 
biomechanical considerations. 
 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
 
Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur 
due to impaction of the component into the prepared femoral canal or acetabulum.  
Postoperative femoral or acetabular fracture can occur due to trauma, the presence of defects 
or poor bone stock. 
 
If bone screws are used, appropriate selection of bone screw length and location is essential to 
avoid damage to underlying soft tissue structures.  Perforation of the pelvic wall can result in 
internal bleeding and possible damage to vital organs. 
 
Metal sensitivity reactions have been reported following joint replacement. 
 
AEs may necessitate reoperation, revision, arthrodesis of the involved joint, girdlestone or 
amputation of the limb. 
12.3  Expected Complications and Rates of Occurrences 
The safety objective will compare the Rejuvenate® Modular Hip System complication rates to 
published rates.  Table 4 on the following page lists expected rates for primary THA, averaged 
from Stryker clinical studies as well as from published results. 
 

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Table 4.  Primary THA Expected Complication Rates 
 
Event 
SO Clinical Studies* 
Primary THA 
Related to Surgery 
 
 
Femoral crack/fracture 
3.78% 
1.37%17, 4.0%18 
Trochanteric crack/fracture 
0.54% 
3-17.6% range for all periprosthetic 
fractures19 
Acetabular crack/fracture 
0.30% 
(see above) 
Superficial wound infection 
0.94% 
1.0%20 
Deep joint infection 
0.54% 
2.05%21, 0.2%22 
Peroneal nerve palsy 
0.44% 
0-3.0%23 
Related to Implant 
 
 
Femoral stem fracture 
0.07% 
2.63%24 
Femoral head fracture 
0.0% 
1.27%25, 1.87%26 
Acetabular shell fracture 
0.0% 
Not available 
Acetabular insert fracture 
0.07% 
0.57%27, 0.63%28, 
1.12%29, 3.51%30 
Intraoperative acetabular insert chip 
0.47% 
1.8% at 3 to 5 years31 
Femoral component loosening 
0.30% 
0.6%32 at 15 years, 3.0%33
Acetabular component loosening 
2.53% 
10.0%34 
Acetabular migration 
0.10% 
Not available 
Femoral Subsidence 
0.24% 
1.23%35 
Dislocation 
3.30% 
6.1%36, 2.23% 
(range 0.7-7.0%)37 
Heterotopic bone formation 
2.90% 
46.0%38, 13.0% 
(range 3.0-50.0%)39 
Revision/femoral stem 
0.94% 
0.46% at 2 years, 
7.83% at 15 years40, 
11.3% at 5.75 years41 
Revision/femoral head 
0.98% 
Not available 
Revision/acetabular shell 
4.42% 
43% at 6 years42, 
0.46% at 2 years43 
Revision/acetabular insert 
4.38% 
Not available 
Revision/bone screws 
0.07% 
Not available 
Revision/other 
0.03% 
Not available 
Osteolysis/polyethylene wear 
0.13% 
17.0%44, 4.0% at 7-10 years45 
Other 
 
 
Postoperative femoral fracture 
1.01% 
0.68%46, 1.0% (range 0.1-2.1%) 
for all periprosthetic fractures47, 48 
Postoperative acetabular fracture 
0.0% 
(see above) 
Postoperative trochanteric fracture 
0.20% 
0.57%49 (also, see above) 
Genitourinary 
3.23% 
1.05%50, 0.8-35.0%51 
Gastrointestinal 
2.15% 
1.05%52, 1.2-4.6%53
Pulmonary Embolism 
0.44% 
1.05%54, 0.6%55 
Deep Vein Thrombosis 
0.82% 
1.3% (40.0-70.0% 
within the first 3 weeks)56 
Cardiovascular 
4.89% 
1.05%57, 0.5%58 
Death 
3.34% 
1.4%59, 0.18-0.95%60
 

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This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
*Data from the following Stryker sponsored clinical studies was used as a basis for this table:  
Omnifit® HA, ABC/Trident®, Meridian®, Citation®, Secur-Fit™, Accolade® TMZF and Trident® 
X3®.  There were 2,966 total cases (hips) in 2,697 subjects after combining results from these 
seven studies.  Percentages for operative and device related events were calculated by dividing 
the number of cases with one or more reported event by the number of cases (hips) enrolled.  
Systemic events were calculated by dividing the number of subjects with one or more reported 
events by the number of subjects enrolled.  The protocols for the Omnifit® HA and ABC/Trident® 
studies originally required that all AEs be reported; however, after these products became 
commercially available, the protocols were modified and required that only operative related 
events be reported.  For the ABC/Trident®, this change occurred in February 2003 and for the 
Omnifit® HA, in December 1990.  The protocol for the Trident® X3® and Accolade® TMZF studies 
required that operative site AEs and any event meeting the definition of a serious event be 
reported.  The protocols for Secur-Fit™, Citation® and Meridian® required that all AEs were 
reported.  Percentages for primary THR taken from published literature represent averages or 
ranges as noted. 
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.   
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. 
 
Subjects will have incentives to return for follow-up visits through an optional patient retention 
program.  Subjects will earn points for completing each follow-up visit within the windows 
outlined in the protocol and without protocol deviations.  They will then have the opportunity to 
redeem their points for a gift (See Appendix G, Patient Retention Program).  Use of this 
retention program by centers is optional.   
 

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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 representatives or agents of sponsors appointed 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 a 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 CRFs, 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 
• 
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 may be submitted to a regulatory 
agency 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 

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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 46 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 should provide a list 
of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided a consent form describing this study and 
providing sufficient information for patients to make an informed decision about their 
participation.  See Appendix E for a copy of the Model Informed Patient Consent.  This consent 
form must be modified to contain center specific information and submitted with the protocol for 
review and approval by the EC/IRB for the study.  The formal consent of a patient, using the IRB 
approved consent form, must be obtained before that patient is submitted to any study 
procedure.  This consent form must be signed by the patient or legally acceptable surrogate and 
the investigator-designated research professional obtaining the consent.  
 
15  Study Finances 
15.1 Funding Source 
This study is financed by Stryker Orthopaedics. 
15.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 

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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 
There is no compensation to subjects for participation in this study.  However, subject attrition 
can occur for a variety of reasons, including a subject’s loss of health insurance coverage or 
denied 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  
 
Under extreme circumstances, and with prior approval, Stryker may reimburse a subject for the 
cost of transportation to and from the investigator’s office for a protocol-required office visit. 
 
This policy is the same for all participating study subjects and does not bias against any 
particular subject or study cohort.   
 
16 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted 
to a peer-reviewed journal at the time the study cohort reaches 5 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. 

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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 
 
 
Assists with study questions requiring 
expert clinical opinion  
 
 
 
 
expert clinical opinion 
Assists with identification of investigators 
 
 
Assists with identification of investigators 
Reviews additional publication proposals submitted  
 
and maintains performance  
 
by investigators 
 
 
 
 
Updates investigators on progress 
Contributing author, if ICMJE guidelines met 
 
 
towards multi-center results 
 
 
 
 
 
 
 
 
Primary author, multi-center publication of  
 
 
 
 
 
 
 
 
 
primary endpoint data 
 
At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 5-year multi-center publication is 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 and that the data is accurately represented.  Any publications resulting from this study 
must be submitted to Stryker for review at least 60 days prior to submission of publication. 

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17 References 
 
                                                 
1 Antonietti, B., Paderni, S., Sama, D., Comitini V., & Sudanese, A. (2003).  Anatomic cementless total hip 
arthroplasty with ceramic bearings and modular necks: 3 to 5 years follow-up.  Chir. Organi. Mov., 88(3), 
259-265.   
 
2 Spitzer, A.I. (2005).  The SROM cementless femoral stem: History and literature review.  Orthopedics, 
28(9), 1117-1124.   
3 Ibid. 
 
4 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. 
 
5 Jaffe, W. (1999). Normalized and proportionalized cemented femoral stem survivorship at 15 years.  
Journal of Arthroplasty, 14(6), 708-713. 
6 Ibid. 
 
7 Ibid. 
8 Greenspan, A. (1992). Orthopedic radiology:  A practical approach (2nd ed.). New York:  Gower Medical 
Publishing. 
 
9 Steffen, J.B., Lukoschek, M., Kreutzer, J., Brocai, D., & Gruen, T.A. (2001). Dependency of cement 
mantle thickness on femoral stem design and centralizer. The Journal of Arthroplasty, 16(5), 648-657. 
 
10 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. 
11 Wedemeyer, C., Quitmann, H., Xu, J., Heep, H., von Knoch, M., & Saxler, G. (2007). Digital templating 
in total hip arthroplasty with the Mayo stem. Archives of Orthopaedic and Trauma Surgery. 
12 Charles, M.N., Bourne, R.B., Davey, J.R., Greenwald, A.S., Morrey, B.F., & Rorabeck, C.H., 1078-
1088. 
13 Charles, M.N., Bourne, R.B., Davey, J.R., Greenwald, A.S., Morrey, B.F., & Rorabeck, C.H. (2004). 
Soft-tissue balancing of the hip:  The role of femoral offset restoration. The Journal of Bone and Joint 
Surgery, 86, 1078-1088. 
14 Kudrna, J. (2005). Femoral version:  Definition, diagnosis, and intraoperative correction with modular 
femoral components. Retrieved September 23, 2008, from 
http://www.orthosupersite.com/view.asp?rID=3936 
15 Bono, J.V. (2004). Digital templating in total hip arthroplasty. The Journal of Bone and Joint Surgery, 
86, 118-122. 
16 Wedemeyer, C., Quitmann, H., Xu, J., Heep, H., von Knoch, M., & Saxler, G. (2007). Digital templating 
in total hip arthroplasty with the Mayo stem. Archives of Orthopaedic and Trauma Surgery. 
17 Chougle, A., Hemmady, M.V., & Hodgkinson, J.P. (2006). Long-term survival of the acetabular 
component after total hip arthroplasty with cement in patients with developmental dysplasia of the hip. 
The Journal of Bone and Joint Surgery,88(1), 71-79. 

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18 Greidanus, N.V., Mitchell, P.A., Masri, B.A., Garbuz, D.S., & Duncan, C.V. (2003). Principles of 
management and results of treating the fractured femur and after total hip arthroplasty. Instructional 
Course Lecture, 52, 309-322. 
19 Saleh, K.J., Kassim, R., Yoon, P., & Vorlicky, L.N. (2002). Complications of total hip arthroplasty. The 
American Journal of Orthopaedics, 31(8), 485-488. 
20 Salvati, E.A., Della Valle, A.G., Masri, B.A., & Duncan, C.P. (2003). The infected total hip arthroplasty. 
Instructional Course Lecture, 52, 223-245. 
21 Chougle, A., Hemmady, M.V., & Hodgkinson, J.P., 71-79. 
22 Nizar, N.M. et al. (2003). Rates and outcomes of primary and revision total hip replacement in the 
United States Medicare population. The Journal of Bone and Joint Surgery,85-A(1), 27-32. 
23 Kassis, R.A., Saleh, K.J., Almacari, G., Badra, M., Young, K., & Esterberg, J. Systemic complications 
following total hip arthroplasty. Journal of Southern Orthopaedic Association, 12(2), 112-116. 
24 Martínez de Aragón, J.S., Keisu, K.S. (2007). Twenty-one year results of the uncemented fully textured 
Lord hip prosthesis.  Clinical Orthopaedics and Related Research, 454,133-138. 
25 Park, Y.S., Hwang, S.K., Choy, W.S., Kim, Y.S., Moon, Y.W., & Lim, S.J. (2006). Ceramic failure after 
total hip arthroplasty with an alumina-on-alumina bearing.  The Journal of Bone and Joint Surgery, 88(4), 
780-787. 
26 Fayard, J.P., Chalencon, F., Passot, J.P., Dupre Latour, L., & Edorh, G. (2006). Ten-year results of 
ALIZE acetabular cup with hydroxyapatite coating and AURA hydroxyapatite-coated stem in total hip 
arthroplasty. The Journal of Arthroplasty, 21(7), 1021-1025. 
27 Murphy, S.B., Ecker, T.M., & Tannast, M. (2006). Two- to 9-year clinical results of alumina ceramic-on-
ceramic THA. Clinical Orthopaedics and Related Research, 453, 97-102. 
28 Ha, Y.C., Kim, S.Y., Kim, H.J., Yoo, J.J., & Koo, K.H. (2007). Ceramic liner fracture after cementless 
alumina-on-alumina total hip arthroplasty. Clinical Orthopaedics and Related Research, 458, 106-10. 
29 Park, Y.S., Hwang, S.K., Choy, W.S., Kim, Y.S., Moon, Y.W., & Lim, S.J., 780-787. 
30 Ito, H., Matsuno, T., Aok, Y., & Minami, A. (2004). Total hip arthroplasty using an Omniflex modular 
system: 5 to 12 years follow up. Clinical Orthopaedics and Related Research, 419, 98-106. 
31 D'Antonio, J., Capello, W., Manley, M., Naughton, M., & Sutton, K. (2005). A titanium-encased alumina 
ceramic bearing for total hip arthroplasty: 3- to 5-year results. Clinical Orthopaedics and Related 
Research, 441, 151-58.   
32 Capello, W.N., D’Antonio, J.A., Jaffe, W.L., Geesink, R.G., Manley, M.T., & Feinberg, J.R., 75-80. 
33 Thornhill, T. (1999). Revision total hip arthroplasty. New York: Springer-Verlag. 
34 Ibid. 
35 Incavo, S.J., Havener, T., Benson, E., McGrory, B.J., Coughlin, K.M., & Beynnon, B.D. (2004). Efforts 
to improve cementless femoral stems in THR:  2- to 5-year follow-up of a high-offset femoral stem with 
distal stem modification (Secur-Fit Plus). The Journal of Arthroplasty,19(1), 61-67. 
36 Theis, J.C., & Ball, C. (2003). Medium-term results of cementless hydroxyapatite-coated primary total 
hip arthroplasty: A clinical and radiological review. The Journal of Orthopaedic Surgery, 11(2), 159-165. 
37 Mahoney, C.R., & Pellicci, P.M. (2003). Complications in primary total hip arthroplasty: Avoidance and 
management of dislocations. Instructional Course Lecture, 52, 247-255. 
38 Sinha, R.K., Dungy, D.S., & Yeon, H.B. (2004). Primary total hip arthroplasty with a proximally porous-
coated femoral stem. The Journal of Bone and Joint Surgery, 86-A(6), 1254-1261. 

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This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
                                                                                                                                                             
39 Edmonson, A.S., & Crenshaw, A.H. (1980). Campbell’s Operative Orthopaedics. St. Louis: C.V. Mosby 
Co., 2188-2410. 
40 Capello, W.N., D'Antonio, J.A., Jaffe, W.L., Geesink, R.G., Manley, M.T., & Feinberg, J.R., 75-80. 
41 Duffy, P., Sher, J.L., & Partington, P.F. (2004). Premature wear and osteolysis in an HA-coated, 
uncemented total hip arthroplasty. The Journal of Bone and Joint Surgery, 86(1), 34-38. 
42 von Schewelov, T., Sanzén, L., Önsten, I., & Carlsson, A. (2004). Catastrophic failure of an 
uncemented acetabular component due to high wear and osteolysis: An analysis of 154 Omnifit 
prostheses with mean 6-year follow-up. Acta Orthopaedica Scandanavica, 75(3), 283-294. 
43 Antonietti, B., Paderni, S., Sama, D., Comitini V., & Sudanese, A., 259-65. 
44 Herrera, A., Canales, V., Anderson, J., Garcia-Araujo, C., Murcia-Mazon, A., & Tonino, A.J. (2004). 
Seven to 10 years follow up of an anatomic hip prosthesis: An international study. Clinical Orthopaedics 
and Related Research, 423, 129-137. 
45 Della Valle, C.J., Berger, R., Schott, S., Rosenberg, A., Jacobs, J., Quigley, L., & Galante, J. (2004). 
Primary total hip arthroplasty with a porous coated acetabular component. The Journal of Bone and Joint 
Surgery, 86, 1217-1222. 
46 Chougle, A., Hemmady, M.V., & Hodgkinson, J.P., 71-79. 
47 Greidanus, N.V., Mitchell, P.A., Masri, B.A., Garbuz, D.S., & Duncan, C.V., 309-322. 
48 Saleh, K.J., Kassim, R., Yoon, P., & Vorlicky, L.N., 485-488. 
49 Murphy, S.B., Ecker, T.M., & Tannast, M., 97-102. 
50 Meding, J.B., Keating, E.M., Ritter, M.A., Faris, P.M., & Berend, M.E. (2004). Minimum ten-year follow-
up of a straight-stemmed, plasma-sprayed, titanium-alloy, uncemented femoral component in primary 
total hip arthroplasty. The Journal of Bone and Joint Surgery, 86-A(1), 92-97. 
51 Kassis, R.A., Saleh, K.J., Almacari, G., Badra, M., Young, K., & Esterberg, J., 112-116. 
52 Meding, J.B., Keating, E.M., Ritter, M.A., Faris, P.M., & Berend, M.E., 92-97. 
53 Kassis, R.A., Saleh, K.J., Almacari, G., Badra, M., Young, K., & Esterberg, J., 112-116. 
54 Capello, W.N., D'Antonio, J.A., Jaffe, W.L., Geesink, R.G., Manley, M.T., & Feinberg, J.R., 75-80. 
55 Mantilla, C.B., Horlocker, T.T., Schroeder, D.R., Berry, D.J., & Brown, D.L. (2002). Frequency of 
myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or 
knee arthroplasty. Anesthesiology, 96(5), 1140-1146. 
56 Ibid. 
57 Capello, W.N., D'Antonio, J.A., Jaffe, W.L., Geesink, R.G., Manley, M.T., & Feinberg, J.R., 75-80. 
58 Mantilla, C.B., Horlocker, T.T., Schroeder, D.R., Berry, D.J., & Brown, D.L., 1140-1146. 
59 Salvati, E.A., Della Valle, A.G., Masri, B.A., & Duncan, C.P., 223-245. 
60 Kassis, R.A., Saleh, K.J., Almacari, G., Badra, M., Young, K., & Esterberg, J., 112-116. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix A 
 
 
Suggested Radiographic Technique 

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. 

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 
AP Femur  
A. Standard technique 
a. The subject should be supine with his/her sacrum flat against the table and legs in 
full extension, internally rotated 15°. 
b. The film cassette should be placed immediately below the table, parallel to the 
subject’s frontal plane. 
c. The x-ray beam should be directed perpendicular to the film cassette and should be 
centered toward the center of the involved femoral head. 
d. The distal tip of the femoral stem, femoral head and neck, greater and lesser 
trochanter and the acetabulum must be visible in this radiograph. 
 

Refer to Figure 2 for an acceptable AP femur radiograph. 
 
                            
                                                 Figure 2.  AP Femur View – Acceptable 
 
Refer to Figure 3 for AP subject positioning. 
 
 Figure 3.  AP 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 and the femur, including the distal tip of the stem, 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 
 
                                                 
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. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix B 
 
 
Biomechanical Measurement Protocol 
 
The CRFs in Appendix F should be referenced 
for all preoperative and postoperative data required.

The following lists biomechanical measurements required preoperatively and 
postoperatively according to this study protocol.  These measurements may not be 
standard as part of site data collection.  This appendix should be referenced in detail so 
that all source documentation is reflective of non-standard data points collected. 
A complete summary of all preoperative and postoperative data needed can be 
found in Appendix F. 
 
BIOMECHANICAL MEASUREMENTS 
An independent radiographic reviewer will be identified to assess radiographic stability 
during the study.  For collection of biomechanical measurements, however, the 
investigator at each site will obtain natural preoperative and replaced postoperative 
values, as well as create a preoperative plan from templating. 
 
Measurement Guidelines 
 
Measurement of leg length discrepancy should be determined from the AP pelvis 
radiograph by drawing lines across both pelvic teardrops to meet both femurs 
(Reference Line B in Figure 1, below).  These lines are to be used as the main reference 
lines for measuring the distance to the top of each lesser trochanter (Reference Line C 
in Figure 1, below).i  The difference between these distances is the value of leg length 
discrepancy.  From this value, the amount of leg length to be restored may be planned. 
 
Figure 1.ii  Reference Lines for Measuring Leg Length Discrepancy 
 

Femoral offset should be determined by measuring the perpendicular distance from the 
center of the femoral head to the axis along the length of the femur.iii 
 
Femoral neck angle is the angle between the long axes of the femoral neck and 
femoral shaft.iv 
 
Figure 2.v Femoral Offset “A” and Femoral Neck Angle “B” 
 
Qualitative determination of version:  Proximal femoral version reflects the 
relationship of the axis of the femoral neck to the transcondylar axis of the distal femur.vi  
Qualitative determination of whether natural femoral version is retroverted, anteverted or 
in a state of neutral version should be made from the lateral radiograph. 
 
 
Natural Preoperative Measurements 
 
Preoperatively, study radiographs will be taken by each investigator.  From these 
preoperative radiographs, the investigator at each site will provide a detailed picture of 
each patient’s level of deformity, as follows. 
 
• 
Leg length discrepancy (centimeters) 
• 
Natural femoral offset (millimeters) 
• 
Natural femoral neck angle (degrees) 
• 
Qualitative assessment of natural femoral version (Retroverted, Neutral, 
Anteverted) 

 
 
Preoperative Plan 
 
The investigator at each center will create a preoperative biomechanical measurement 
plan for each case from templating, reflecting desired postoperative measurements and 
the component sizes, angles and offsets that will be used to achieve these 
measurements.  All component sizes should be corrected for magnification (if any) prior 
to data collection on the study CRF.  This may be accomplished by utilizing an external 
radiographic marker of known dimension prior to taking the preoperative radiograph.vii 
 
Preoperative Distance from Planned Center of Rotation 
• 
Vertical distance from the anatomic hip center to the planned center of 
rotation of the hip (millimeters) 
• 
Horizontal distance from the anatomic hip center to the planned center of 
rotation of the hip (millimeters) 
  
 
Components to be Used 
• 
Acetabular cup size 
• 
Femoral neck angle [127°, 132°, 130° (The 130° neck angle is only available in 
16° of version.)] 
• 
Femoral neck length (millimeters) 
• 
Femoral head size  
• 
Femoral head offset 
• 
Femoral stem size* 
• 
Femoral version (0°, ±8°, ±16°) 

 
 
*The Rejuvenate® Modular Stem will be available in sizes 7, 8, 9, 10, 11 and 12.  The 
Rejuvenate® Monolithic Stem will be available in sizes 4, 5 and 6; however, the 
Rejuvenate® Monolithic Stem may not be used according to this protocol.  Patients 
requiring a femoral stem in size 4, 5 or 6 should not be enrolled into the study.  
Investigators should template the femoral stem size to be used prior to completing the 
Inclusion/Exclusion CRF for enrollment into the study. 
 
Additional Planned Measurements 
• 
Amount of leg length to restore (centimeters) 
• 
Femoral offset to achieve (millimeters) 
• 
Qualitative 
assessment 
of 
planned 
postoperative 
femoral 
version 
(Retroverted, Neutral, Anteverted) 
 
 
Postoperative Measurements 
 
A postoperative check of biomechanical measurements will be performed by the 
investigator at each site from the 6-week radiographs to confirm the degree to which the 
preoperative plan was achieved. 
 
If an AE for instability exists, Stryker will work with an independent radiographic reviewer 
to re-evaluate the case and confirm whether or not the postoperative biomechanical 
measurements have changed as a result of the AE. If changes have occurred, the 
reviewer will continue to assess radiographs at each applicable postoperative interval 
until the hip has stabilized. 
 
 
 

Postoperative Distance from Planned Center of Rotation 
• 
Vertical distance from the postoperative hip center to the planned 
preoperative center of rotation of the hip (millimeters) 
• 
Horizontal distance from the postoperative hip center to the planned 
preoperative center of rotation of the hip (millimeters) 
 
 
Additional Postoperative Measurements 
• 
Leg length discrepancy (centimeters) 
• 
Final femoral offset (millimeters) 
• 
Final femoral neck angle used [127°, 132°, 130° (The 130° neck angle is only 
available in 16° of version.)] 
• 
Qualitative assessment of replaced femoral version (Retroverted, Neutral, 
Anteverted) 
 
These postoperative values will be compared to the preoperative plan to evaluate the 
degree of patient matching achieved with the Rejuvenate® Modular Hip System.   
 
Component sizes used intraoperatively will be automatically determined from catalog 
numbers provided on the Surgical Details CRF. 
 

                                                 
i Wedemeyer, C., Quitmann, H., Xu, J., Heep, H., von Knoch, M., & Saxler, G. (2007). Digital 
templating in total hip arthroplasty with the Mayo stem. Archives of Orthopaedic and Trauma 
Surgery. 
ii Ibid. 
iii Charles, M.N., Bourne, R.B., Davey, J.R., Greenwald, A.S., Morrey, B.F., & Rorabeck, C.H. 
(2004). Soft-tissue balancing of the hip:  The role of femoral offset restoration. The Journal of 
Bone and Joint Surgery, 86, 1078-1088. 
iv Ibid. 
v Ibid. 
vi Kudrna, J. (2005). Femoral version:  Definition, diagnosis, and intraoperative correction with 
modular femoral components. Retrieved September 23, 2008, from 
http://www.orthosupersite.com/view.asp?rID=3936 
vii Bono, J.V. (2004). Digital templating in total hip arthroplasty. The Journal of Bone and Joint 
Surgery, 86, 118-122. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix C 
 
 
Component List 

 Rejuvenate® Modular Hip System 
Protocol-Specified Component List 
 
FEMORAL NECK COMPONENTS 
Neck Description 
Catalog 
Number 
Neck 
Length 
Retroversion/ 
Anteversion 
REJUVENATE® MOD NECK 0 V 
127/132 BLK 30 MM  
NLS-300000B 
30 mm 
0° 
REJUVENATE® MOD NECK 8 
AV/RV 127/132 YEL 30 MM  
NLV-300800Y 
30 mm 
8° 
REJUVENATE® MOD NECK 8 
RV/AV 127/132 GR 30 MM    
NLV-300800G 
30 mm 
8° 
REJUVENATE® MOD NECK 16 V 
130 PURPLE 30 MM   
NLS-301600P 
30 mm 
16° 
REJUVENATE® MOD NECK 0 V 
127/132 BLK 34 MM  
NLS-340000B 
34 mm 
0° 
REJUVENATE® MOD NECK 8 
AV/RV 127/132 YEL 34 MM  
NLV-340800Y 
34 mm 
8° 
REJUVENATE® MOD NECK 8 
RV/AV 127/132 GR 34 MM    
NLV-340800G 
34 mm 
8° 
REJUVENATE® MOD NECK 16 V 
130 PURPLE 34 MM   
NLS-341600P 
34 mm 
16° 
REJUVENATE® MOD NECK 0 V 
127/132 BLK 38 MM  
NLS-380000B 
38 mm 
0° 
REJUVENATE® MOD NECK 8 
AV/RV 127/132 YEL 38 MM  
NLV-380800Y 
38 mm 
8° 
REJUVENATE® MOD NECK 8 
RV/AV 127/132 GR 38 MM    
NLV-380800G 
38 mm 
8° 
REJUVENATE® MOD NECK 16 V 
130 PURPLE 38 MM   
NLS-381600P 
38 mm 
16° 
REJUVENATE® MOD NECK 0 V 
127/132 BLK 42 MM  
NLS-420000B 
42 mm 
0° 
REJUVENATE® MOD NECK 8 
AV/RV 127/132 YEL 42 MM  
NLV-420800Y 
42 mm 
8° 
REJUVENATE® MOD NECK 8 
RV/AV 127/132 GR 42 MM    
NLV-420800G 
42 mm 
8° 
REJUVENATE® MOD NECK 16 V 
130 PURPLE 42 MM   
NLS-421600P 
42 mm 
16° 
 

FEMORAL STEM COMPONENTS 
Stem 
Size 
Catalog # 
Stem Description 
7 
SPT-070000S 
REJUVENATE® STRGHT PRFIT TMZF® MOD STEM SIZE 7 
8 
SPT-080000S 
REJUVENATE® STRGHT PRFIT TMZF® MOD STEM SIZE 8 
9 
SPT-090000S 
REJUVENATE® STRGHT PRFIT TMZF® MOD STEM SIZE 9 
10 
SPT-100000S 
REJUVENATE® STRGHT PRFIT TMZF® MOD STEM SIZE 10 
11 
SPT-110000S 
REJUVENATE® STRGHT PRFIT TMZF® MOD STEM SIZE 11 
12 
SPT-120000S 
REJUVENATE® STRGHT PRFIT TMZF® MOD STEM SIZE 12 
 
  
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix D 
 
Study Advertisements 

Clinical Trial with Rejuvenate® Modular Hip System 
 
 
Dr. (name) of (practice) is participating in a clinical study evaluating a new 
primary hip replacement for cementless use in patients who are eligible for a 
primary total hip replacement.   
 
 
The Rejuvenate® Modular Hip System features a modular hip prosthesis with 
two components fitting together, allowing the device to be changed based on a 
patient’s anatomy.  This allows for more adaptability.  With a stem and neck 
used together, the Rejuvenate® Modular Hip System is intended for 
cementless, press-fit use.  It is compatible with other Stryker components as well.  
This system is currently being sold worldwide and is implanted in patients who 
need primary hip surgery. 
 
 
 
 
Dr. (name) is one of 10 to 12 surgeons nationwide selected to enroll qualifying 
patients into this clinical study. The data collected will be used to evaluate both 
short and long-term (10-year) performance of the components following surgery.  
 
The study includes males and non-pregnant females 18 years of age or older.  
These patients must be candidates for a primary hip replacement.  These 
patients must also be able to comply with requirements following surgery 
including weight bearing restrictions and self-evaluation questionnaires.  Enrolled 
patients will be required to come in for an evaluation and x-rays before surgery 
and follow-up evaluations and x-rays at 6 weeks, 1 year, 2 years, 3 years, 4 
years and 5 years.  A short follow-up questionnaire will be required annually at 
years 6 through 10 after surgery.  The doctor may choose to perform further 
follow-up evaluations at 7 years and 10 years.  
 
Meeting all of the above criteria does not guarantee participation in the study.  
Further consultation 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 or not you would like to participate.   
 
 If you are interested in participating in this study, please contact Dr. (name) or 
(study coordinator name) at the numbers listed below for further details.  
  
Your request for information about this study in no way commits you to 
participate.  In order to participate, you will have to meet specific criteria and 
sign a consent form that details all aspects of the study, the device and the risks 
associated with primary hip surgery.     
 
Dr. (name) 
 
 
 
 
 
Study Coordinator Name 
 
 
Practice Name 
 
 
 
 
Title 
Telephone Number   
 
 
 
Telephone Number 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix E 
 
Model Informed Patient Consent 

Patient’s Initials ______ 
 
   Page 1 of 5 
Model Informed Patient Consent 
 
 
I. 
Study Title:  Post-market Study of the Stryker Orthopaedics Rejuvenate® Modular Hip 
System 
II. 
Description of the Study  
You have been asked to take part in this research study because your physician has 
determined that you need surgery to replace your hip joint.  A total of approximately 240 
subjects from 10 - 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 Rejuvenate® Modular Hip System as compared to the Secur-Fit™ 
HA monolithic femoral hip stem, through absence of revision of femoral neck and stem 
(components implanted in your thigh bone) at 5 years postoperative.  We (Stryker 
Orthopaedics, implant manufacturer and sponsor of the study, and your physician) are 
doing this study to find out if Stryker Orthopaedics Rejuvenate® Modular Hip System is 
at least as good as hips implanted with the Secur-Fit™ HA monolithic femoral stem.   
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 two 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, 5, 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, 5, 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 
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 

Patient’s Initials ______ 
 
   Page 2 of 5 
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, 5, 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. 
You will have incentives to return for annual follow-up visits through a patient retention 
program.  Patients enrolled into the study are encouraged to complete all of their 
required follow-up visits.  You will earn points for completing each annual follow-up visit 
within the windows outlined in the protocol and without any protocol deviations.  You will 
then have the opportunity to redeem your points for a gift selected from a specific listing, 
or save them and work toward a higher-level gift.  As the follow-up visits increase in 
number, the point values associated with the visits will also increase.  The monetary 
value of the gifts is modest and should not influence your decision to participate in the 
study. 

Patient’s Initials ______ 
 
   Page 3 of 5 
 
 
 
 
 
 
 
 
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. 
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. 
VIII.  
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.   
 
IX. 
Device Retrieval Analysis Study 
 
The sponsor of this study is conducting an analysis of retrieved devices in the event that 
a study component that you have implanted by your physician is removed during the 
course of the investigation.  In the event the device ever requires removal, and with your 
permission, the sponsor has asked your physician to send your retrieved component to 
the sponsor for evaluation as part of your participation in the study.  Your retrieved study 
component and your individually identifiable information will not be released to outside 
parties.  The device will not be returned to you, nor will you receive directly the results of 
any tests, analysis, or evaluations on the returned device. 
Number of Visits 
Completed 
Award Level 
Points 
1 visit 
A 
100 points 
2 visits 
B 
200 points 
3 visits 
C 
300 points 
4 visits 
D 
400 points 
5 visits 
E 
500 points 
6 visits 
F 
600 points 
7 visits 
G 
700 points 

Patient’s Initials ______ 
 
   Page 4 of 5 
 
X. 
Clinical Trial Website Posting 
 
Information about this study will be posted on the following website: 
www.clinicaltrials.gov.  This website provides general information including, but not 
limited to, the number of patients enrolled in the study, the primary and secondary 
objectives/outcomes, and overall demographics (items such as average age, height and 
weight) of the study group.  In no way will specific patient information be posted on this 
website.        
XI. 
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. 
XII.   
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.   

Patient’s Initials ______ 
 
   Page 5 of 5 
 
XIII. 
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>. 
 
XIV.  
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 
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.   
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix F 
 
Case Report Forms 

Patient has an active or suspected latent infection in or about the affected hip joint at time of study device
implantation.
H.
L.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological
requirements (e.g. > 30 days).
B.
Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
G.
** All of the above must be answered “Yes” for the patient to be enrolled in the study.
F.
Patient’s operative femur templates to Rejuvenate™ Modular Stem size 7-12.
Patient has a Body Mass Index (BMI) > 40.
Rejuvenate    Modular Hip System
®
Patient has a known sensitivity to device materials.
M.
14Apr2010
Please fax to Stryker at (201) 831-6454 attn: Study Manager for a subject ID to be assigned.
I. INCLUSION CRITERIA
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
Page 1 of 1
OPERATIVE SIDE:
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
Right
Left
(use one form per side)
INCLUSION / EXCLUSION
SUBJECT ID:
Study #
Site #
Subject #
6 8
II. EXCLUSION CRITERIA
No
Yes
Yes
No
** All of the above must be answered “No” for the patient to be enrolled in the study.
III. COMMENTS
A.
Patient has signed an IRB approved, study specific
Informed Patient Consent Form.
DATE INFORMED CONSENT SIGNED
    D         D                 M         M         M                 Y          Y           Y          Y
Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
I.
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and
efficacy of the device.
J.
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
C.
E.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and
rehabilitation.
D.
Patient is a candidate for a primary cementless total hip replacement.
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.
K.
N.
Patient is a prisoner.

14Apr2010
I. DEMOGRAPHICS
Left
VISIT DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial
please use “-”)
DEMOGRAPHICS
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 2
III. DIAGNOSIS
II. CIGARETTE AND ALCOHOL USE
I.  CIGARETTE USE:  (Check One)
J.  ALCOHOL USE:  (Check One)
K.  INITIAL DIAGNOSIS:  (Check One)
Current cigarette smoker
Ex-cigarette smoker
# PACKS/DAY:
.
.
# YEARS:
# PACKS/DAY:
.
.
# YEARS:
Non-smoker
Date Stopped
    D         D                 M         M         M                 Y          Y           Y          Y
15+ drinks a week
8 - 14 drinks a week
3 - 7 drinks a week
< 3 drinks a week
Have not had alcohol in the last year
Have never had alcohol
Avascular Necrosis
Traumatic Arthritis
Osteoarthritis
H.  RACE:  (Check all that apply)
White
Native Hawaiian or other Pacific Islander
Black or African heritage
Asian
American Indian or Alaskan native
G.  ETHNICITY:  (Check One)
Not Hispanic or Latino origin
Hispanic or Latino origin
Female
F.  GENDER:  (Check One)
Male
Other (Specify)
E.  EMPLOYMENT STATUS:  (Check One)
D.  EDUCATION LEVEL:  (Check One)
B.  HEIGHT:
inches
C.  WEIGHT:
lbs.
A.  DATE OF BIRTH:
    D         D                 M         M         M                 Y          Y           Y          Y
< High School
High School Diploma
> High School
Working
Not Working
OPERATIVE SIDE:(Use one form per side)
Right
Rejuvenate    Modular Hip System
®

Page 2 of 2
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
DEMOGRAPHICS
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
SUBJECT ID: 6 8
Site #
Subject #
L.  CONCURRENT MEDICAL CONDITION: (Specify)
IV. PRESENT MEDICAL STATUS
None
Cancer
Cardiovascular
Dermatologic
Digestive
Endocrine / Metabolic
Immunologic / Lymphatic
Musculoskeletal
Neurologic
Psychologic
Respiratory
Substance Dependence
Urogenital
Other  (Specify)
V. COMMENTS
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
14Apr2010
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
Left
OPERATIVE SIDE:
(Use one form per side)
Right
Rejuvenate    Modular Hip System
®

F. SOCKS / SHOES (Check One)
14Apr2010
IV. COMMENTS
A. PAIN
None, or ignores it
Slight, occasional, no compromise in
activities
Mild, no effect on average activities, rarely moderate
pain with unusual activity, may take aspirin
Moderate pain, tolerable but makes concessions to pain. Some
limitations of ordinary activity or work. May require occasional pain
medication stronger than aspirin
Marked pain, serious limitation of activities
Totally disabled, crippled, pain in bed, bedridden
(Check One)
I. PAIN
D. DISTANCE WALKED (Check One)
Indoors only
Bed and chair only
Unlimited
Six blocks
Two or three blocks
B. LIMP (Check One)
C. SUPPORT (Check One)
II. FUNCTION / GAIT
None
Cane, long walks
Cane, most of the time
Two canes
Two crutches,
walker or
unable to walk
One crutch
I. ABSENCE OF DEFORMITY
III. FUNCTIONAL ACTIVITIES
Yes
No
(Operative side only)
None
Slight
Moderate
Severe or unable to walk
Fixed adduction < 10°
Leg length discrepancy < 3.2 cm
(Check One)
E. STAIRS
H. PUBLIC TRANSPORTATION
G. SITTING (Check One)
Unable to use stairs
In any manner
Normally using a railing
Normally without using a rail
Unable
With difficulty
With ease
High chair, 1/2 hour
Any chair, 1 hour
Unable to sit comfortably in any chair
Not able to use
Able to use
OPERATIVE SIDE:
Right
Left
(use one form per side)
VISIT DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial
please use “-”)
PRE-OP FUNCTIONAL EVALUATION
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 1
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
.
cm
 (Specify)
Fixed internal rotation in extension < 10°
Fixed flexion contracture < 30°
Yes
No
Present at current visit:
K. THIGH PAIN
(Operative side only)
Yes*
No
Is the Thigh Pain Distal?
Is the Thigh Pain Activity Limiting?
Is the Thigh Pain Constant?
Describe History or Causative Event:
*If Yes, complete the following:
Yes
No
Yes
No
Yes
No
Worst Pain
What is the subject’s perception of the Thigh Pain level on a One to Ten (1-10) scale?: (Check One)
Very slight pain
1
2
3
4
5
6
7
8
9
10
°
Adduction to
Permanent (Fixed) Flexion
°
External Rotation in Extension to
°
Flexion to
°
Internal Rotation in Extension to
°
Abduction to
°
J. RANGE OF MOTION
(Operative side only)
Rejuvenate    Modular Hip System
®

14Apr2010
A. LEG LENGTH DISCREPANCY:
    D         D                 M         M         M                 Y          Y           Y          Y
OPERATIVE SIDE:
Right
Left
(use one form per side)
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
PRE-OP BIOMECHANICAL MEASUREMENTS
Page 1 of 1
VISIT:
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial
please use “-”)
SUBJECT ID:
Study #
6 8
Site #
Subject #
B. NATURAL FEMORAL OFFSET:
C. NATURAL FEMORAL NECK ANGLE:
D. QUALITATIVE ASSESSMENT OF NATURAL FEMORAL VERSION:
Use the Lateral Radiograph: (Check one)
Retroverted
Anteverted
II. PREOPERATIVE PLAN
Neutral
E. DISTANCE FROM PLANNED CENTER OF ROTATION:
Vertical distance from the anatomic hip center to the PLANNED center of rotation of the hip:
mm
Horizontal distance from the anatomic hip center to the PLANNED center of rotation of the hip:
mm
F. LEG LENGTH TO RESTORE:
cm
G. FEMORAL OFFSET TO ACHIEVE:
mm
H. PLANNED POSTOPERATIVE FEMORAL VERSION: (Check one)
Retroverted
Anteverted
Neutral
Operative
Contralateral
* If Yes, indicate longer side:
Yes*
No
INVESTIGATORSIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
I. ACETABULAR CUP: (Check one)
Trident Hemispherical
Tritianium Primary Hemispherical
Trident PSL
Other (specify)
Restoration ADM
J. ACETABULAR CUP SIZE:
mm
O. FEMORAL STEM SIZE (mm): (Check one)
8
7
9
10
P. FEMORAL VERSION: (Check one)
-8°
-16°
0°
+16°
+8°
12
11
M. FEMORAL NECK ANGLE: (Check one)
130°
127°
132°
N. FEMORAL NECK LENGTH (mm): (Check one)
34
30
38
42
L. FEMORAL HEAD SIZE :
mm
K. FEMORAL HEAD OFFSET (mm): (Check one)
-5
-4
-2.7
-2.5
+0
+2.5
+3
+4
+5
+7.5
+8
+10
 IV. COMMENTS
 III. PLANNED COMPONENTS FOR USE
+12
Stamp Date Received:
°
mm
.
I. NATURAL PREOPERATIVE MEASUREMENTS
Rejuvenate    Modular Hip System
®

I. SURGICAL DETAILS
A.  APPROACH:   (Check one)
*If Yes, which muscle group(s)?
External Rotators
Gluteus Medius
Other
B.  MUSCLE REPAIR OR REATTACHMENT REQUIRED?
Yes*
Anterolateral
OPERATIVE SIDE:
Right
Left
(use one form per side)
SURGERY
DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial
please use “-”)
Posterolateral / Posterior
F.  NAVIGATION USED?
Yes*
No
*If Yes, complete the following:
System Used / Manufacturer:
Software Version:
Acetabulum:
Reamer Position:
Final Cup Position:
Femur: Broach Alignment
Inclination
Version
Femur: Stem Alignment
Anteverted
Retroverted
Anteverted
Retroverted
14Apr2010
Dual Incision
Other
Lateral
No
Broach Version:
Head Offset:
Neck Length:
Neck Angle:
mm
mm
.
Anteverted
Retroverted
Alignment:
Neck Version:
Head Offset:
Neck Length:
Varus
Valgus
Neck Angle:
mm
mm
.
N/A
Retroverted
Anteverted
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
SURGICAL DETAILS
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 2
Plane:
Anatomic
Functional
N/A
Planned Change in Leg Length:
mm
Planned Change in Offset:
mm
Inclination
Version
Final Change in Leg Length:
mm
Final Change in Offset:
mm
Combined Version:
(head, neck angle and acetabulum)
C. INCISION LENGTH:
D. DURATION OF SURGERY:
E. ESTIMATED BLOOD LOSS:
Specify:
Specify:
Specify:
Specify:
cc
N/A
N/A
N/A
or
cm
.
Skin
    to Skin
minutes
Rejuvenate    Modular Hip System
®

14Apr2010
Chronic Care Center
III. COMMENTS
INITIAL/DATE:
For Stryker Use Only
Monitored
Verification
Entry
Receipt
INVESTIGATOR SIGNATURE:
INVESTIGATOR NAME (PRINT):
Stamp Date Received:
DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
SURGICAL DETAILS
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 2 of 2
J.  FEMORAL NECK ANGLE USED: (Check one)
130°
127°
132°
Acetabular Shell
Modular Stem
Acetabular Insert
*If Yes, specify and attach a copy of the label(s):
H.  OTHER?
Yes*
No
Femoral Bearing Head
Modular Neck
K.  INTRAOPERATIVE COMPLICATION?
Yes*
No
*If Yes, complete AE form.
L.  DISCHARGED TO:  (Check One)
Skilled Nursing Facility
Other:  (Specify)
Rehabilitation Unit
Home
Anteverted
Neutral
Discharge Date:
    D         D                 M         M         M                 Y          Y           Y          Y
II. PROSTHESES
I.  MODULAR NECK VERSION:
G.  PROSTHESES - Attach a copy of the label(s)
Retroverted
•
•
•
•
•
Other: (Specify)
Reference #
Lot #
Other: (Specify)
Reference #
Lot #
Other: (Specify)
Reference #
Lot #
Rejuvenate    Modular Hip System
®

This survey asks for your views about your health. This information will help keep track of how you feel and how well you are able
to do your usual activities. Thank you for completing this survey!
For each of the following questions, please mark the circle that best describes your answer.
3)
VISIT:
3
Year
2
Year
1
Year
6
Week
5
Year
4
Year
10
Year
7
Year
Pre-Op
14Apr2010
SF-12v2™ Health Survey © 1994, 2002 by QualityMetric Incorporated and Medical Outcomes Trust. All Rights Reserved.
SF-12® is a registered trademark of Medical Outcomes Trust.
(SF-12v2 Standard, US Version 2.0)
I. SF-12v2TM Health Survey Standard Version
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?
In general, would you say your health is:  (Check one)
Excellent
Very Good
Good
Fair
Poor
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?
Moderate activities, such as moving a table, pushing a vacuum
cleaner, bowling, or playing golf    (Check one)
2)
Climbing several flights of stairs    (Check one)
b.
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 any emotional problems (such as feeling depressed or anxious)?
Accomplished less than you would like
(Check one)
a.
Did work or activities less carefully
than usual    (Check one)
b.
None of
the time
A little of
the time
Some of
the time
Most of
the time
All of
the time
Were limited in the kind of work or other
activities    (Check one)
b.
Accomplished less than you would like
(Check one)
a.
None of
the time
A little of
the time
Some of
the time
Most of
the time
All of
the time
OPERATIVE SIDE:
Right
Left
(use one form per side)
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial
please use “-”)
1)
a.
4)
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
SF-12v2™
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 2
Rejuvenate    Modular Hip System
®

Rejuvenate    Modular Hip System
®
VISIT:
3
Year
2
Year
1
Year
6
Week
5
Year
4
Year
10
Year
7
Year
Pre-Op
14Apr2010
SF-12v2™ Health Survey © 1994, 2002 by QualityMetric Incorporated and Medical Outcomes Trust. All Rights Reserved.
SF-12® is a registered trademark of Medical Outcomes Trust.
(SF-12v2 Standard, US Version 2.0)
I. SF-12 (continued)
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...
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.)? (Check one)
7)
Have you felt downhearted and
depressed? (Check one)
c.
Did you have a lot of energy? (Check one)
b.
Have you felt calm and peaceful?
(Check one)
a.
All of
the time
Most of
the time
Some of
the time
A little of
the time
None of
the time
All of
the time
Most of
the time
Some of
the time
A little of
the time
None of
the time
Not at all
A little bit
Moderately
Quite a bit
Extremely
During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home
and housework)? (Check one)
5)
DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
Page 2 of 2
Subject, please initial and date here:
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
6)
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
SF-12v2™
SUBJECT ID:
Study #
6 8
Site #
Subject #

14Apr2010
Please read through each description given below, pick the ONE that best describes your regular daily
activity, and put a check in that circle (Check only one circle).
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
(weather permitting).
I am up and about at will in my house and outside.  I also work outside the house in a:  (Please check the
best description of your work level).
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:  (Please check the best description of how often you participate in this activity).
I am up and about at will in my house and outside.  I also participate in vigorous physical activity such as
competitive level sports:  (Please check the best description of how often you participate in this activity).
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
moderately active job
extremely active job
occasionally
(2-3 times per month)
2-3 times per week
daily
minimally active job
occasionally
(2-3 times per month)
2-3 times per week
daily
I. LOWER EXTREMITY ACTIVITY SCALE
DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
Subject, please initial and date here:
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 1
LOWER EXTREMITY ACTIVITY SCALE (LEAS)
OPERATIVE SIDE:
Right
Left
(use one form per side)
SUBJECT INITIALS:
(If there is no middle initial
please use “-”)
VISIT:
3
Year
2
Year
1
Year
6
Week
5
Year
4
Year
10
Year
7
Year
Pre-Op
Rejuvenate    Modular Hip System
®

14Apr2010
A. PAIN
(Check One)
I. PAIN
B. LIMP (Check One)
II. FUNCTION / GAIT
None
Slight
Moderate
Severe or unable to walk
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
POST-OP FUNCTIONAL EVALUATION
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 2
OPERATIVE SIDE:
Right
Left
(use one form per side)
VISIT DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle
initial please use “-”)
°
Adduction to
Permanent (Fixed) Flexion
°
External Rotation in Extension to
°
Flexion to
°
Internal Rotation in Extension to
°
Abduction to
°
I. ABSENCE OF DEFORMITY
Yes
No
(Operative side only)
Fixed adduction < 10°
Fixed internal rotation in extension < 10°
Leg length discrepancy < 3.2 cm
Fixed flexion contracture < 30°
F. SOCKS / SHOES
III. FUNCTIONAL ACTIVITIES
(Check One)
E. STAIRS
H. PUBLIC TRANSPORTATION
G. SITTING (Check One)
Unable to use stairs
In any manner
Normally using a railing
Normally without using a rail
Unable
With difficulty
With ease
High chair, 1/2 hour
Any chair, 1 hour
Unable to sit comfortably
in any chair
Not able to use
Able to use
(Check One)
Mild, no effect on average activities, rarely
moderate  pain with unusual activity, may take
aspirin
Totally disabled, crippled, pain in bed,
bedridden
Slight, occasional, no compromise in
activities
Marked pain, serious limitation of
activities
None, or ignores it
Moderate pain, tolerable but makes concessions to pain.
Some limitations of ordinary activity or work. May require
occasional pain medication stronger than aspirin
None
Cane, long walks
Cane, most of the time
Two canes
Two
crutches,
walker or
unable to walk
One crutch
C. SUPPORT (Check One)
D. DISTANCE WALKED (Check One)
Indoors only
Bed and chair only
Unlimited
Six blocks
Two or three
blocks
VISIT:
3
Year
2
Year
1
Year
6
Week
5
Year
4
Year
10
Year
7
Year
K. RANGE OF MOTION
(Operative side only)
.
cm
 (Specify)
Yes
No
Present at current visit:
J. THIGH PAIN
(Operative side only)
Yes*
No
Is the Thigh Pain Distal?
Is the Thigh Pain Activity Limiting?
Is the Thigh Pain Constant?
Describe History or Causative Event:
*If Yes, complete the following:
Yes
No
Yes
No
Worst Pain
What is the subject’s perception of the Thigh Pain level on a One to Ten (1-10) scale?: (Check One)
Very slight pain
1
2
3
4
5
6
7
8
9
10
Yes
No
Rejuvenate    Modular Hip System
®

14Apr2010
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
Page 2 of 2
 V. COMMENTS
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
 IV. EVENTS
 USE THIS SECTION TO REPORT MEDICAL EVENTS OTHER THAN PROTOCOL DEFINED ADVERSE EVENTS.
SUBJECT ID:
Study #
Site #
Subject #
6 8
  L. Have there been any protocol defined Adverse Events since the last visit?
*If Yes, complete an AE form for each.
No
Yes*
    N. Has the subject been hospitalized for any elective surgery since the last visit?
No
Yes*
    M.  Has the subject seen a doctor for any medical event since the last visit?
No
Yes*
*If Yes, specify:
*If Yes, specify and check all that apply:
Contralateral Hip
Contralateral Knee
Ipsilateral Knee
O. Is anything currently affecting the subject’s function?
No
Yes*
POST-OP FUNCTIONAL EVALUATION
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
Contralateral Shoulder
Ipsilateral Shoulder
Other (Specify)
Cataract
*Provide details:
VISIT:
3
Year
2
Year
1
Year
6
Week
5
Year
4
Year
10
Year
7
Year
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
*If Yes, specify:
Rejuvenate    Modular Hip System
®

14Apr2010
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
Page 1 of 1
 II. COMMENTS
 I. ACTUAL POSTOPERATIVE MEASUREMENTS
SUBJECT ID:
Study #
Site #
Subject #
6 8
POST-OP BIOMECHANICAL MEASUREMENTS
OPERATIVE SIDE:
Right
Left
(use one form per side)
VISIT DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
VISIT:
6
Week
C. QUALITATIVE ASSESSMENT OF REPLACED FEMORAL VERSION:
Use the Lateral Radiograph:
Replaced femoral version: (Check one)
Retroverted
Anteverted
Neutral
D. POSTOPERATIVE DISTANCE FROM PLANNED CENTER OF ROTATION:
Vertical distance from the postoperative hip center to the planned preoperative center of rotation of the hip:
mm
Horizontal distance from the postoperative hip center to the planned preoperative center of rotation of the hip:
mm
B. FINAL FEMORAL OFFSET:
mm
INVESTIGATOR / REVIEWER
SIGNATURE:
DATE:
INVESTIGATOR / REVIEWER
NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
A. LEG LENGTH DISCREPANCY:
Operative
Contralateral
* If Yes, indicate longer side:
Yes*
No
Unscheduled-
Reviewer Collected
Rejuvenate    Modular Hip System
®

®
X-RAY REMINDER SHEET
X-RAY REMINDER SHEET
X-RAY REMINDER SHEET
X-RAY REMINDER SHEET
X-RAY REMINDER SHEET
Stryker
325 Corporate Drive, Mahwah, NJ 07430
Keep this reminder sheet in the subject’s study binder.
Not Obtained
(Complete and submit one Protocol Deviation Form
per interval)
Obtained
Instructions for Stryker Orthopaedics Clinical Study X-ray Labels
1.
Based on the protocol’s radiographic evaluation schedule, obtain copies of the subject’s X-rays.
a.
If the subject is bilateral and the view includes both sides, two copies of the films are needed.
b.
For viewing purposes, the film should always be the mirror image (not inverted).
i. If the subject’s operative side is (R), the joint should be on the (L) side of the film when being
viewed.
c.
Markers for (R) and (L) should be on the correct side.
i. If incorrect or missing, the film should be marked correctly.
2.
Complete a white X-ray label to ensure accurate identification of each film.
      (similar to CRF header information)
a.
Subject ID
b.
Subject Initials
c.
Date of X-ray
d.
Visit Interval
e.
Operative Side
f.
View
3.
For films, affix the label to the bottom of the film:
a.
Should not obscure the view
b.
Should not obscure the implant
c.
Should not cover the subject imprint details
d.
Should be positioned horizontally according to the view
4.
For digital X-rays, attach completed unpeeled labels to the CD case and write the Subject ID on the CD.
5.
Send the labeled X-rays to Data Entry for processing.  (Data Entry affixes a color-coded visit interval label over the
subject imprint to obscure the subject’s personal health information.)
6.
When the X-ray label supply is low, please contact the Clinical Study Manager to request more labels.
Date X-rays Sent:
Tracking Number:
COMMENTS
Keep this reminder sheet in the subject’s study binder.
Please do not send to Stryker.
Do not send to Stryker.
SUBJECT ID:
Study #
6 8
Site #
Subject #
14Apr2010
N/A
1.  A/P Pelvis
2. A/P Femur
3. Lateral
VISIT:
1
Year
6
Week
Pre-op
3
Year
2
Year
5
Year
4
Year
10
Year
7
Year
REjuvENATE   MoDulAR HIp SYSTEM
®

Are you satisfied with the results of your study total hip replacement?
NO*
YES
Have you had any surgery on your study hip during the time since your last study required visit/contact?
NO
YES*
3.
2.
AE Onset Date:
Subject, please initial and date here:
QUESTIONNAIRE
COMPLETED BY:
Mail
Phone
Visit
II. FOR COORDINATOR’S USE ONLY
*Coordinator, if Yes in Question 1 above, specify, complete Adverse Event form and provide date:
*Coordinator, if No in Question 2 above, specify:
*Coordinator, if Yes in Question 3 above, specify, complete Adverse Event form and provide date:
    D         D                 M         M         M                 Y          Y           Y          Y
Subject comment:
Subject comment:
Subject comment:
AE Onset Date:
    D         D                 M         M         M                 Y          Y           Y          Y
A.
B.
C.
Please specify below for responses marked with an asterisk.
Rejuvenate    Modular Hip System
®
14Apr2010
Do you have any pain in your hip that has the study hip replacement?
1.
NO
YES*
I. HIP QUESTIONS
VISIT :
OPERATIVE SIDE:
Right
Left
(Use one form per side)
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
FOLLOW-UP QUESTIONNAIRE
SUBJECT ID:
Study #
6 8
Site #
Subject #
Page 1 of 1
6
Year
7
Year
8
Year
9
Year
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
10
Year
DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
 D         D                 M         M         M                 Y          Y           Y          Y

14Apr2010
Stryker
®
Page 1 of 2
B. SYSTEMIC EVENTS
Respiratory (Specify)
Cancer (Specify)
Cardiovascular (Specify)
Dermatologic (Specify)
Digestive (Specify)
Urogenital (Specify)
Neurologic (Specify)
Pulmonary Embolism
Thrombophlebitis
Other (Specify)
Trauma (Specify)
Musculoskeletal (Specify)
DVT
 Specify:
325 Corporate Drive, Mahwah, NJ 07430
ADVERSE EVENT
SUBJECT ID:
Study #
6 8
Site #
Subject #
GENERAL INFORMATION
I. DESCRIPTION
SUBJECT INITIALS:
(If there is no middle initial
please use “ - ”)
OPERATIVE SIDE:(Use one form per side)
ONSET
DATE:
Right
Left
    D         D                 M         M         M                 Y          Y           Y          Y
(Check one event in Section A or Section B)
A. OPERATIVE SITE EVENTS
Acetabular Component Loosening
Acetabular Insert Crack / Fracture
Acetabular Migration (If > 3mm)
Acetabular Shell Crack / Fracture
Bursitis
Deep Joint Infection
Device Allergic Reaction
Dislocation
Osteolysis
Reflex Sympathetic Dystrophy (RSD)
Soft Tissue Trauma
Subluxation
Wound Related (Specify)
Other (Specify)
Femoral Component Loosening
Femoral Component Subsidence
Sciatic Nerve Palsy
Wound Hematoma
Femoral Crack / Fracture
Femoral Neck Crack / Fracture
Femoral Stem Crack / Fracture
Intra-Prosthetic Dislocation
Modular Junction Dissociation
Acetabular Crack / Fracture
Hip Pain
Femoral Bearing Head Crack / Fracture
Superficial Wound Infection
Heterotopic Bone Formation (Type III / IV)
Tendonitis
Trochanteric Crack / Fracture
Trochanteric Non-Union
* If Yes or Uncertain, please explain and fax all pages to Stryker within 24 hours.
E. DEVICE RELATED? (Check one)
Uncertain*
C. WHEN DID THE EVENT OCCUR? (Check one)
Pre-Op
Post-Op
Intra-Op
D. DESCRIBE CIRCUMSTANCES, INCLUDING HISTORY OR CAUSATIVE EVENT.  SPECIFY SIGNS, SYMPTOMS AND DISEASES.
II. COMPLICATION / CONCURRENT MEDICAL EVENT
Yes*
No
If Serious -- FAX all pages to Stryker within 24 hours.
Fax number: (201) 831-6454. Please include copies of applicable source documentation.
Resulted in inpatient hospitalization
Resulted in prolonged existing hospitalization
Resulted in persistent or significant disability/incapacity
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
Resulted in permanent impairment of a body function or permanent
damage to a body structure
    D         D                 M         M         M                 Y          Y           Y          Y
F. SERIOUSNESS Does this event meet the definition of serious?
Yes*
No
* If Yes, check all that apply.
* Specify when Adverse Event became SERIOUS:
Rejuvenate    Modular Hip System
®

14Apr2010
Stryker
®
Page 2 of 2
      D         D                M         M         M               Y          Y           Y          Y
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
IV. COMMENTS
RESOLUTION OF EVENT:
Unresolved as of
Resolved as of
* Submit copy of this form when event resolved.
       D        D                M         M         M                Y          Y          Y          Y
*
Date of Treatment
PER#
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle initial please use “-”)
ADVERSE EVENT
SUBJECT ID:
ONSET DATE:
    D         D                 M         M         M                 Y          Y           Y          Y
III. TREATMENT
Study #
6 8
Site #
Subject #
REVISIONS / REMOVALS:    (Check all that apply)
Yes*
No
  * If Yes, specify below
Femoral Bearing Head
Modular Neck / Modular Stem     (Complete Study Termination form)
Other
      D         D                M         M         M               Y          Y           Y          Y
For Stryker Implants, submit PER form and implant(s) to Stryker.
Acetabular Insert
Acetabular Shell
RE-OPERATIONS:    (Specify)
      D         D                M         M         M               Y          Y           Y          Y
OTHER TREATMENTS:    (Specify)
ANESTHESIA USED?
Yes
No
Rejuvenate    Modular Hip System
®

For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
Modular Neck / Modular Stem*
10
Year
9
Year
8
Year
7
Year
6
Year
*(Complete Study Termination form)
Rejuvenate    Modular Hip System
®
14Apr2010
A.  TYPE OF DEVIATION  (Check one)
B.  Briefly describe the deviation and why this occurred.
NOTICE OF PROTOCOL DEVIATION
Page 1 of 1
DATE OF
DEVIATION:
Stryker
®
325 Corporate Drive, Mahwah, NJ 07430
OPERATIVE SIDE:
GENERAL INFORMATION
SUBJECT INITIALS:
(If there is no middle
initial please use “ - ”)
Right
Left
(use one form per side)
    D         D                 M         M         M                 Y          Y           Y          Y
I. DEVIATION INFORMATION
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
    D         D                 M         M         M                 Y          Y           Y          Y
Informed Consent:
Study procedures performed prior to informed consent
Incorrect informed consent version used
Other (Specify)
  (Check one)
Inclusion / Exclusion:  Subject enrolled does not meet the inclusion / exclusion criteria
SUBJECT ID:
Study #
6 8
Site #
Subject #
Protocol specified study component(s) not implanted  (Check all that apply)
Treatment:
Acetabular Shell
Femoral Bearing Head
Acetabular Insert
Other: (Specify)
5
Year
(Specify one selection)
Missed entire visit
Deviation in visit (Check all that apply and specify)
Required form(s)/X-ray(s) not done
X-ray Unevaluable (i.e. unreadable/poor quality)
Evaluation(s) occurred outside of protocol specified time window
Evaluation(s):  (Specify one visit below)
VISIT :
4
Year
3
Year
2
Year
1
Year
6
Week
Pre-Op
Other (Specify)
(Report One Deviation per form)
(If Deviation in visit, specify
each form/X-ray)
X-ray - A/P Femur
X-ray - A/P Pelvis
LEAS
SF-12
Follow-up Questionnaire
X-ray - Lateral
Biomechanical Measurement
Functional Evaluation

STUDY TERMINATION
Page 1 of 1
Stryker
325 Corporate Drive, Mahwah, NJ 07430
GENERAL INFORMATION
SUBJECT ID:
Study #
Site #
Subject #
6 8
OPERATIVE SIDE:
SUBJECT INITIALS:
(If there is no middle
initial please use “-”)
Right
Left
(use one form per side)
A. DID SUBJECT COMPLETE STUDY ACCORDING TO PROTOCOL?
* If No, answer questions B and C
Yes
    D         D                 M         M         M                 Y          Y           Y          Y
TERMINATION
DATE:
No*
I. STUDY TERMINATION
C. WAS STUDY DEVICE IN PLACE AT DATE OF LAST CONTACT?
No
Yes
Subject Withdrawal
Revision/Removal of Study Device (Complete AE form)
Other (Specify)
Surgery Not Performed (Specify)
D        D                   M         M         M               Y          Y           Y          Y
INVESTIGATOR SIGNATURE:
DATE:
INVESTIGATOR NAME (PRINT):
II. COMMENTS
    D         D                 M         M         M                 Y          Y           Y          Y
For Stryker Use Only
Monitored  __________________
INITIAL/DATE:
Receipt  __________________
Entry  __________________
Verification  __________________
Stamp Date Received:
Death  (Complete AE form)
Investigative Site Terminated
Lost To Follow-Up
1st phone call:
2nd phone call:
3rd phone call:
List efforts to
contact subject:
Certified letter sent:
Additional efforts:
B. CHECK ONE PRIMARY REASON BELOW:
®
Study Device Not Implanted (Specify, complete Protocol Deviation form)
Rejuvenate    Modular Hip System
®
14Apr2010

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix G 
 
Patient Retention Program 

 
 
 
 
  An Open-label Evaluation of the 
Rejuvenate® Modular Hip System  
 
Patient Retention Program  
 
 
 
AWARDS
 
Orthopaedics 

 
A Prospective Open-label Evaluation of the Rejuvenate® Modular Hip System 
 
• 
Who is eligible to participate? 
 
Enrolled subjects for the Rejuvenate® Modular Hip System post-market study who have undergone primary cementless total hip 
replacement according to the protocol and are returning for the 1-year visit after completion of the 6-week follow-up visit, without 
deviation  
 
• 
How long the program will run? 
 
Start of enrollment until 6 months after the last study subject has returned for the 10-year follow-up visit 
 
• 
Individual Rewards  
 
 
Subjects advance one prize level for each annual follow-up visit completed within the windows outlined in the protocol (visit 
schedule noted below) and without any postoperative protocol deviations.  Upon exit from the study, subjects have the 
opportunity to receive a gift selected from a specific listing that corresponds to the prize level earned.  Values may be divided to 
receive multiple awards.  As the annual follow-up visits increase in number, the award level will also increase.  For example, a 
subject that attends all annual follow-up visits would receive a G level award, a subject that has missed one annual follow-up visit or 
deviated in any one postoperative visit would receive a F level award and so on.  
  
 
 

 
• 
If a subject would then like to redeem his/her points prior to study withdrawal, they may at any time.  The subject would continue in the 
study, but the amount of points redeemed would be deducted from their total points moving forward.  For example: 
o A subject decides to redeem their points after completing the 1-year, 2-year and 3-year visits according to protocol.  The subject 
plans to continue in the study for the 7-year and 10-year time points. 
o The subject may redeem 300 points (or any lesser amount of points in 100-point increments) for completing three postoperative 
visits according to protocol.  If a subject chooses to redeem 300 points, he/she could either receive the Level C award booklet 
or Level A and Level B booklets at once. 
o As the subject continues in the study, the number of points already redeemed is deducted from the number of points that would 
have been available for redemption at each later visit.  For instance, after 10 years if 300 points were already redeemed, the 
subject would only be eligible for 400 points upon study closure. 
o The maximum number of points that can be redeemed over the course of the study is 700. 
 
• 
Bilateral subjects do not accumulate double points.  Points are accrued per subject, not per hip enrolled. 
 
• 
When subjects have completed the study by reaching the 10-year follow-up visit, they request an award booklet and order form from 
their SC.  The award booklet will only contain the awards that the patient is eligible to receive according to the total gift level they have 
earned at that time.  The subject selects the award and completes and mails in the order form.  Awards may also be redeemed online 
at www.ecgy.net. 
 
• 
All awards will be shipped directly to the subject’s address (no P.O. boxes) with postage and/or shipping charges prepaid by Stryker.  In 
the event a parcel arrives in a damaged or unsatisfactory condition, the SC is notified so that Stryker may be informed.  Rewards 
should not be returned without specific instructions.   
 
• 
Please allow 3 to 6 weeks for delivery.  If, in the rare instance, the selection cannot be delivered immediately, the subject will be notified 
by postcard.  If the selection becomes unavailable, it may be substituted with another selection from the same award level.  Samples of 
prizes at each award level follow.