A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Stryker Orthopaedics

 
 
 
 
 
 
 
 
 
Secur-Fit Advanced Outcomes Study 
 
Clinical Study Protocol 
A prospective, post-market, multi-center evaluation of the clinical outcomes of the 
Secur-Fit Advanced Hip Stem 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Secur-Fit Advanced Hip Stem 
Protocol Number: 
75 
510(k) Clearance  Number: 
K122853 – February 1, 2013 
 
Version 3.0 
Date:  17 August 2022  
 
 
 
 
 
 
 
 
 
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.

Secur-Fit Advanced Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 3.0 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Page i 
 
 
Protocol Change History 
 
Version 
Description 
Changed By 
A 
New 
Kristin L. Given 
1.0 
Final 
Kristin L. Robinson 
2.0 
Amended Version 1.0 – Section 15.3 Subject Stipends or 
Payments has been edited to incorporate language regarding 
inclusion of subject stipends for protocol-related visits. 
Candice Kelly 

Secur-Fit Advanced Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 3.0 
 
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Page ii 
3.0 
Change: Number Cases 
Previous language: Cases will be enrolled until 326 cases 
have received the Secur-Fit Advanced Hip Stem. 
New language: Cases will be enrolled until 314 cases have 
received the Secur-Fit Advanced Hip Stem. 
Rationale for Change: Reduction of cases to 314 poses no 
risk to the statistical analysis and demonstration of long-
term safety and effectiveness of the Secur-Fit Advanced 
Hip Stem. 
 
Change: Primary Objective 
Previous language: To evaluate and determine the success 
rate, defined as absence of stem revision for aseptic 
loosening or femoral fracture, at 5 years postoperative with 
the Secur-Fit Advanced Hip Stem.  
New language: To evaluate and determine the success rate, 
defined as absence of stem revision for aseptic loosening or 
device-related femoral fracture, at 5 years postoperative 
with the Secur-Fit Advanced Hip Stem.  
Rationale for Change: Clarification that femoral fractures 
which are unrelated to the study device will not be included 
in primary analysis. 
 
Change: Secondary Objective 
Previous language: To evaluate rate of femoral fracture 
among patients implanted with the Secur-Fit Advanced Hip 
Stem within 30 days postoperative, and compare with rates 
reported for other primary hip stems in the literature. 
New language: To evaluate rate of device-related femoral 
fracture among patients implanted with the Secur-Fit 
Advanced Hip Stem within 30 days postoperative, and 
compare with rates reported for other primary hip stems in 
the literature 
Candice Kelly 

Secur-Fit Advanced Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 3.0 
 
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Page iii 
Version 
Description 
Changed By 
Rationale for Change: Clarification that femoral fractures 
which are unrelated to the study device will not be included 
in the secondary endpoint evaluation. 
 
Change: Secondary Objective 
Previous language: To demonstrate that surgeons can use 
the Secur-Fit Advanced Hip Stem to consistently match a 
preoperative plan for femoral head center, offset and leg 
length postoperatively. 
New language: [Removal of endpoint] 
Rationale for Change: This secondary objective is no longer 
required to support Stryker’s business needs, and removal 
does not affect safety or performance. 

Secur-Fit Advanced Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 3.0 
 
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Page iv 
Table of Contents 
STUDY SYNOPSIS ..................................................................................................................................................... 2 
EVALUATION SCHEDULE ..................................................................................................................................... 8 
1 
INTRODUCTION .............................................................................................................................................. 9 
1.1 
BACKGROUND ................................................................................................................................ 9 
1.2 
STUDY DEVICE ............................................................................................................................. 10 
1.3 
PRECLINICAL DATA ...................................................................................................................... 10 
1.4 
CLINICAL DATA TO DATE............................................................................................................... 11 
2 
STUDY OBJECTIVES .................................................................................................................................... 12 
2.1 
EFFICACY .................................................................................................................................... 12 
2.1.1 
Primary .................................................................................................................................. 12 
2.1.2 
Secondary ............................................................................................................................. 12 
2.1.3 
Additional Data Collection ..................................................................................................... 12 
2.2 
SAFETY ....................................................................................................................................... 14 
3 
CLINICAL STUDY PLAN ............................................................................................................................. 14 
3.1 
STUDY DESIGN ............................................................................................................................ 14 
3.2 
NUMBER OF CENTERS .................................................................................................................. 14 
3.2.1 
Centers for Standard Data Collection ................................................................................... 14 
3.3 
NUMBER OF SUBJECTS ................................................................................................................. 15 
3.4 
ESTIMATED STUDY DURATION ...................................................................................................... 15 
4 
ELIGIBILITY .................................................................................................................................................. 15 
4.1 
INCLUSION CRITERIA .................................................................................................................... 15 
4.2 
EXCLUSION CRITERIA ................................................................................................................... 16 
5 
SUBJECT ENROLLMENT ............................................................................................................................ 16 
5.1 
TREATMENT ASSIGNMENT ............................................................................................................ 16 
5.2 
RANDOMIZATION .......................................................................................................................... 16 
6 
DEVICE DESCRIPTION ............................................................................................................................... 17 
6.1 
STUDY DEVICE ............................................................................................................................. 17 
6.2 
DEVICE RETRIEVAL PROCESS ....................................................................................................... 21 
7 
EVALUATIONS .............................................................................................................................................. 22 
7.1 
PREOPERATIVE VISIT ................................................................................................................... 22 
7.2 
SURGERY .................................................................................................................................... 23 
7.3 
6-WEEK VISIT ............................................................................................................................... 23 
7.4 
ANNUAL FOLLOW-UP VISITS .......................................................................................................... 23 
8 
ADVERSE EVENTS ........................................................................................................................................ 24 
8.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 24 
8.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 26 
8.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 28 
8.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 28 
8.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 29 
8.5 
MEDICAL MONITORING ................................................................................................................. 29 
9 
STATISTICAL PLAN ..................................................................................................................................... 29 
9.1 
EFFICACY .................................................................................................................................... 29 
9.1.1 
Primary Efficacy Parameters ................................................................................................. 29 
9.1.2 
Secondary Efficacy Parameters ............................................................................................ 29 

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Page v 
9.1.3 
Primary Efficacy Analysis ...................................................................................................... 30 
9.1.4 
Secondary Efficacy Analysis ................................................................................................. 30 
9.2 
SAFETY ....................................................................................................................................... 31 
9.2.1 
Safety Parameters ................................................................................................................. 31 
9.2.2 
Safety Analyses ..................................................................................................................... 31 
9.3 
MISSING DATA ............................................................................................................................. 31 
9.4 
STATISTICAL METHODOLOGY ........................................................................................................ 31 
9.4.1 
Data Summary....................................................................................................................... 31 
9.4.2 
Sample Size Justification ...................................................................................................... 32 
9.4.3 
Interim Analyses .................................................................................................................... 32 
9.4.4 
Analysis Population ............................................................................................................... 33 
10 
STUDY PROCEDURES .................................................................................................................................. 33 
10.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 33 
10.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 33 
10.3 
EARLY WITHDRAWAL OF SUBJECTS............................................................................................... 34 
11 
DATA MANAGEMENT ................................................................................................................................. 36 
11.1 
DATABASE ................................................................................................................................... 36 
11.2 
CONFIDENTIALITY ......................................................................................................................... 36 
11.3 
SOURCE DOCUMENTS .................................................................................................................. 36 
11.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 37 
11.5 
DATA CLARIFICATION REQUESTS .................................................................................................. 37 
11.6 
PROTOCOL DEVIATIONS ............................................................................................................... 37 
11.7 
RECORDS RETENTION .................................................................................................................. 38 
12 
RISK/BENEFIT ASSESSMENT .................................................................................................................... 38 
12.1 
RISK CATEGORY .......................................................................................................................... 38 
12.2 
POTENTIAL RISK .......................................................................................................................... 38 
12.3 
EXPECTED COMPLICATIONS AND RATES OF OCCURRENCES ........................................................... 39 
12.4 
PROTECTION AGAINST RISKS........................................................................................................ 40 
12.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 40 
13 
STUDY MONITORING, AUDITING, AND INSPECTING ....................................................................... 40 
13.1 
STUDY MONITORING PLAN ............................................................................................................ 40 
13.2 
AUDITING AND INSPECTING ........................................................................................................... 41 
14 
ETHICAL CONSIDERATIONS .................................................................................................................... 41 
15 
STUDY FINANCES ......................................................................................................................................... 42 
15.1 
FUNDING SOURCE ........................................................................................................................ 42 
15.2 
CONFLICT OF INTEREST ................................................................................................................ 42 
15.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 42 
16 
PUBLICATION PLAN .................................................................................................................................... 43 
17 
REFERENCES ................................................................................................................................................. 45 
 
 
 

Secur-Fit Advanced Outcomes Study 
 
 
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Page vi 
List of Appendices 
 
Appendix A 
 
FDA 510(k) Clearance Letter  
Appendix B 
 
Suggested Radiographic Technique 
Appendix C 
 
Component Listing 
Appendix D 
 
Retrieved Implant Analysis Protocol 
Appendix E 
 
Study Advertisements 
Appendix F 
 
Model Informed Patient Consent 
Appendix G 
 
Draft Specifications for Electronic Case Report Forms 
Appendix H 
 
Product Labeling 
 
 
 

Secur-Fit Advanced Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page vii 
List of Figures and Tables 
Figure 1: Secur-Fit Advanced  A/P View ...................................................................................18 
 
Table 1: Secur-Fit Advanced Stem Offsets ...............................................................................19 
Table 2: Femoral Head Compatibility ........................................................................................20 
Table 3: Secur-Fit Advanced Compatible Acetabular Components ...........................................21 
 
 
 
 
 

Secur-Fit Advanced Outcomes Study 
    
Stryker Orthopaedics Clinical Study Protocol  
 
 
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Page viii 
List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Anteroposterior 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CP 
Commercially Pure 
CSM 
Clinical Study Manager 
DCR 
Data Clarification Request 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
International Conference of Harmonisation Good Clinical Practice 
HA 
Hydroxylapatite 
HHS 
Harris Hip Score 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LEAS 
Lower Extremity Activity Scale 
PER 
Product Experience Report 
PI 
Principal Investigator 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-12 
Short Form-12 
THA 
Total Hip Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene
 
 

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Title 
A prospective, post-market, multi-center evaluation of the clinical 
outcomes of the Secur-Fit Advanced Hip Stem 
Short Title 
Secur-Fit Advanced Outcomes Study 
Protocol Number 
75 
Type 
Post-market 
Methodology 
This study is a prospective, open-label, post-market, non-randomized, 
multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for 
primary total hip arthroplasty (THA) with a cementless application in a 
consecutive series of patients who meet the eligibility criteria.  The total 
enrollment goal for the study is 314 cases, all of which will receive the 
Secur-Fit Advanced Hip Stem.   
Study Duration 
1. Follow-up of each primary THA case to 10 years 
2. Enrollment period of 24 months 
3.   Approximate 12-year total duration 
Study Center(s) 
5 to 8 investigational centers 
Hypothesis 
The success rate of the Secur-Fit Advanced femoral stem, defined as 
absence of stem revision for aseptic loosening or device-related 
femoral fracture, is no worse than 99% at 5 years postoperative with a 
non-inferiority margin of 2.5%. 
Study Synopsis 

Secur-Fit Advanced Outcomes Study 
 
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Objectives 
Primary: 
• 
To evaluate and determine the success rate, defined as absence 
of stem revision for aseptic loosening or device-related femoral 
fracture, at 5 years postoperative with the Secur-Fit Advanced Hip 
Stem.  
Secondary: 
• 
To evaluate all-cause revision and removal rates with the Secur-
Fit Advanced Hip Stem and compare with those reported for other 
primary hip stems in the literature. 
• 
To evaluate rate of device-related femoral fracture among patients 
implanted with the Secur-Fit Advanced Hip Stem within 30 days 
postoperative, and compare with rates reported for other primary 
hip stems in the literature. 
• 
To demonstrate the close relationship between the seating height 
of the Secur-Fit Advanced Hip Stem and its associated femoral 
broach. 
 

Secur-Fit Advanced Outcomes Study 
 
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Additional Data 
Collection 
• 
Function and health related quality of life (QOL) will be compared 
between the Secur-Fit Advanced Hip Stem and published results 
for other primary hip systems, the following outcomes measures 
will be collected: 
o Harris Hip Score (HHS) 
o Short Form-12 (SF-12) 
o Lower Extremity Activity Scale (LEAS) 
o EQ-5D 
1-year, 2-year and 5-year SF-12,LEAS and HHS will be presented 
with respect to improvement from preoperative scores.  EQ-5D 
data will be summarized and presented. 
• 
An additional Follow-up Questionnaire will be administered 
annually in postoperative years 3, 4 and 6-10 to assess patient  
satisfaction and pain, and to capture adverse events.  
• 
Radiographic stability and complications will be compared 
between those implanted with the Secur-Fit Advanced Hip Stem 
and published results for other primary hip systems. 
Number of Cases 
Cases will be enrolled until 314 cases have received the Secur-Fit 
Advanced Hip Stem. 

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Inclusion/Exclusion 
Criteria 
Inclusions: 
A. Patient has signed an IRB/EC approved, study specific 
Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female, skeletally mature and 
age 21-75 years at time of study device implantation. 
C. Patient has a diagnosis of Non-Inflammatory Degenerative 
Joint Disease. 
D. Patient is a candidate for primary total hip arthroplasty. 
E. Patient is willing and able to comply with postoperative 
scheduled 
clinical 
and 
radiographic 
evaluations 
and 
rehabilitation. 
Exclusions: 
F. Patient has previously undergone open surgical intervention on 
the operative hip. 
G. Patient has a prior femoral fracture, with or without deformity, 
on the operative side. 
H. Patient has an existing total hip replacement on the 
contralateral side. 
I. Patient requires simultaneous bilateral total hip replacement. 
J. Patient has a Body Mass Index (BMI) > 45. 
K. Patient has an active or suspected latent infection in or about 
the affected hip joint at time of study device implantation. 
L. Patient has a neuromuscular or neurosensory deficiency that 
would create an unacceptable risk of instability, prosthesis 
fixation failure or complications in postoperative care, or which 
limits the ability to evaluate the safety and efficacy of the 
device. 

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Inclusion/Exclusion 
Criteria 
Exclusions (continued): 
M. Patient has bone stock that is inadequate for support or fixation 
of the prosthesis, or is diagnosed with a systemic disease (e.g. 
Lupus Erythematosus) or a metabolic disorder (e.g. Paget’s 
disease) leading to progressive bone deterioration. 
N. Patient is immunologically suppressed or receiving steroids in 
excess of normal physiological requirements (e.g. > 30 days). 
O. Patient has a known sensitivity to device materials. 
P. Patient is a prisoner. 
Study Device 
Secur-Fit Advanced Hip Stem 
Required Components : 
1. Secur-Fit Advanced Femoral Stem 
The femoral component must be used in a cementless application. 
 
Stryker acetabular components and femoral bearing heads must be 
used according to this study protocol.  The following ancillary devices 
are permissible: 
• 
Compatible Stryker femoral bearing heads 
• 
Compatible Stryker acetabular shells, liners and inserts 
The compatible Stryker head and acetabular components are listed in 
the surgical protocol. 

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Statistical 
Methodology 
Primary Objective: 
o 5-year success rate of the Secur-Fit Advanced Hip Stem with an 
endpoint of revision for aseptic loosening or device-related femoral 
fracture will be compared with a 99% success rate, with a 2.5% 
noninferiority margin. 
Secondary Objectives: 
o The Kaplan-Meier survival curve of revision/removal for the Secur-
Fit Advanced Hip Stem will be displayed. 
o The rate of device-related femoral fracture within 30 days of index 
THA will be reported. 
o The mean amount of unintended exposure or countersink of the 
femoral component upon final seating will be presented. 

Secur-Fit Advanced Outcomes Study                               
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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 Digital 
Template 
S 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Postoperative 
Functional 
Evaluation 
 
 
X 
X 
X 
 
 
X 
 
Optional 
 
 
Optional 
SF-12 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
LEAS 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
EQ-5D 
X 
 
X 
X 
X 
X 
X 
X 
 
Optional 
 
 
Optional 
Lauenstein 
lateral 
and anteroposterior 
(AP) 
pelvis 
radiographs 
X 
 
X 
X 
X 
 
 
X 
 
Optional 
 
 
Optional 
Follow-up 
Questionnaire 
 
 
As 
needed 
As 
needed 
As 
needed 
X 
X 
As 
needed 
X 
X 
X 
X 
X 
X: Evaluation is required for all cases. 
S: Templating and preoperative plan will be collected for a subset of patients at select sites. 
Functional Evaluation: The Functional Evaluations include the HHS, a subjective outcomes tool completed by the investigator that measures function, pain and motion. 
SF-12:  The SF-12 is a 12 item patient questionnaire that evaluates general health and well-being. 
LEAS: The LEAS is a self-administered patient evaluation designed to reflect patient activity.  
EQ-5D: The EQ-5D is a standardized instrument for use as a measure of health outcome. 
Follow-up Questionnaire: The Follow-up Questionnaire is a short patient questionnaire intended to provide information on dislocation, patient satisfaction, pain and whether 
or not there have been any revisions or removals of the study device since the last follow-up visit.
Evaluation Schedule 

Secur-Fit Advanced Outcomes Study                                                                                                                Page 9 
Stryker Orthopaedics Clinical Study Protocol  
 
 
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This document is a protocol for a human research study.  This study will be conducted in 
compliance with the protocol, Good Clinical Practice (GCP) Standards, associated Federal 
regulations and all applicable research requirements.  
1.1 Background 
THA is one of the most clinically successful and cost-effective interventions in health care.  
Numerous surgeons have reported excellent long-term results in terms of reducing pain, 
improving function and QOL in patients with debilitating hip disease.1 
 
Cemented as well as cementless hip stems have shown good results in THA, even in younger 
patients.2  Implant design may contribute to the success of an implant.  In a multi-center study of 
251 cases receiving proximally hydroxyapatite-coated straight, collarless femoral stems 
manufactured from titanium alloy (OmniFit HA), radiographic evaluations performed by D’Antonio 
et al.3 indicated a high rate of early and continuing fixation and consistent adaptive bone 
remodeling around the stem through 6 years postoperative.  Fifteen-year results from the same 
study demonstrated excellent long-term survivorship with a revision rate of 0.6% for both aseptic 
loosening and mechanical failure of the femoral stem.4  Additionally, in a series of 31 bilateral 
patients implanted with OmniFit HA, Schwarzkopf et al.5 observed femoral component 
survivorship of 100% through the 23-year follow-up period for the 27 patients available. 
 
Following the design philosophy of the successful OmniFit HA stem, the next generation of 
double-wedge, metaphyseal filling stems introduced by Stryker was the Secur-Fit family.  The 
main design change from OmniFit to Secur-Fit was the addition of a proximal roughened titanium 
surface to which the hydroxyapatite (HA) is applied.  The neck angle of the Secur-Fit stem is 132°; 
this angle is decreased to 127° in the Secur-Fit Plus design to produce increased femoral offset.  
In a retrospective review of 105 cases implanted with either Secur-Fit or Secur-Fit Plus at 5 to 10 
years postoperative, Incavo et al.6 reported that all stems achieved and maintained stable fixation.  
Equal leg lengths were achieved in 82% of Secur-Fit cases and 92% of Secur-Fit Plus cases, 
leading the authors to note that availability of both a standard- and high-offset option may facilitate 
soft-tissue balancing intraoperatively without adversely affecting postoperative leg length.  
 
1 
Introduction 

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The stem body design of the Secur-Fit Advanced Hip Stem is based on the Secur-Fit HA Hip 
Stem (K982032, K041170).  Like the predicate for body design, the Secur-Fit Advanced  Hip Stem 
is a straight stem with a normalization pattern on the anterior and posterior aspects of the proximal 
end to facilitate press-fit stability and load transmission to the proximal region of the femur.  Based 
on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral 
shear stresses to compressive forces, which may facilitate proximal loading.(RD-13-001).  The 
distal portion of the stem has a polished tip, and the neck region has been polished and shot 
peened.  The stem neck is designed with a Howmedica Osteonics V40 taper on the proximal end 
and is available in both 127° and 132° neck-stem angles. The Secur-Fit Advanced Hip Stem is 
manufactured from Titanium (Ti-6Al-4V) alloy with a commercially pure Titanium (CP Ti) and HA 
coating to establish good initial fixation.   
1.2 Study Device 
The Secur-Fit Advanced Hip Stem was cleared for use under FDA 510(k) K122853 on 
February 1, 2013.  See Appendix A for the FDA clearance letter.  
 
The Secur-Fit Advanced Hip Stem is intended for cementless, press-fit application, and will be 
available in nine sizes ranging from size 4 through 12.  Sizes 4 and 5 are available with a 132° 
offset angle only; all other sizes are available in both 127° and 132° offset angles.  Details of the 
device design are presented in Section 6, Device Description.    
1.3  Preclinical Data 
The following bench tests (with test report numbers) were conducted with the Secur-Fit Advanced 
Hip Stem: 
  
Coating Thickness (MT01016) 
The mean coating thickness for the titanium plasma sprayed coating and Pure-Fix HA coating 
was 0.446 mm and 0.058 mm respectively. 
 
Tensile Bond Strength (MT01016) 
The average tensile strength of the titanium plasma sprayed and Pure-Fix HA coated specimens 
were 39.11 MPa. 
 
 
 

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Shear Bond Strength (MT01016) 
The average shear bond strength of the PureFix HA on the titanium plasma sprayed coating was 
23.85 MPa. 
   
Fatigue Strength (MT01016) 
Fatigue strength of the Titanium Plasma sprayed and PureFix HA coating on the shot peened 
Ti6Al-4V ELI substrate was 552 MPa at ten (10) million cycles. 
 
Abrasion Resistance (MT01016) 
The average weight loss as a result of abrasion testing of the PureFix HA and Titanium plasma 
sprayed coupons was 1.57 mg. 
 
Neck Fatigue Testing (RD-12-092) 
All eight 127° Size 8 Secur-Fit Advanced Hip Stems successfully withstood 5340N (1200lbf) for 
ten million (10 x 106) cycles without failure and with no loss of mechanical integrity as specified 
by ISO 7206-6.  Based on loading characteristics, the maximum head offset for the Size 4 stem 
is +5 mm. 
 
Distal Fatigue Testing (RD-12-093) 
Eight 127° Size 6 representative stems, which were plasma spray HA coated over plasma spray 
CP Ti proximal coating, were used for testing.  The stems were oriented at 10° valgus/9° flexion 
at a potting level of 80 mm from the worst case (+12 mm) head center consistent with ISO 7206-
4.  All eight 127° Size 6 Secur-Fit Advanced Hip Stems successfully withstood 2300 N (517 lbf) 
for five million (5.0 x 106) cycles without failure and with no loss of mechanical integrity as specified 
by ISO 7206-4:2010. 
 
The results of the bench top testing conducted for the new Secur-Fit Advanced Hip Stem identified 
acceptance criteria were met. 
Copies of all test reports are available at Stryker Orthopaedics.   
 
1.4  Clinical Data to Date 
This study is the first Stryker sponsored multi-center prospective data collection on the Secur-Fit 
Advanced Hip Stem. 

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2.1 Efficacy 
2.1.1 Primary 
The primary objective of this study is to evaluate the success rate of cementless 
primary total hip replacement with the Secur-Fit Advanced Hip Stem.  Success will 
be defined as absence of femoral stem revision for aseptic loosening or device-
related femoral fracture at 5 years postoperative.  It is expected that the success rate 
of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected 
reference rate of 99% at 5 years postoperative. 
2.1.2 Secondary 
The secondary objectives of this study will include evaluation of all-cause revision 
and removal rates with the Secur-Fit Advanced Hip Stem and comparison with those 
reported for other primary hip systems in the literature. 
 
Additionally, the rate of device-related femoral fracture among patients implanted with 
the Secur-Fit Advanced Hip Stem within 30 days postoperative will be evaluated and 
compared with rates reported for other primary hip stems in the literature. 
 
The close relationship between the seating height of the Secur-Fit Advanced Hip 
Stem and its associated femoral broach will also be demonstrated by intraoperatively 
measuring the component exposure or countersink upon final seating. 
2.1.3 Additional Data Collection 
 
Clinical Outcomes: 
Clinical outcomes will be evaluated with the total HHS, including pain, motion and 
function, preoperatively and at the 6-week, 1, 2 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 in for these optional visits.  
 
 
 
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Patient Outcomes: 
Pain, function and health related QOL will be compared between the Secur-Fit 
Advanced Hip Stem and reports in the literature for other primary femoral stems on 
the market.  The SF-12 is a 12 item patient self-assessment evaluating health and 
general well-being.  The LEAS is a tool that has been developed and validated to 
evaluate the level of patient activity.  The EQ-5D is a standardized instrument for use 
as a measure of health outcome.  These tools will be used to assess patient health-
related QOL and will be collected preoperatively and at the 6-week, 1, 2, 3, 4, and 5-
year time points.   
 
A Follow-up Questionnaire will be administered annually in postoperative years 3, 4 
and 6-10 to assess patient satisfaction and pain, and to capture AEs.  This 
questionnaire, which will also be completed during each interval through 5 years 
postoperative at which the subject is not seen by the investigator, will provide the 
information necessary to create an accurate Kaplan-Meier Survival Curve.  Patient 
outcomes data will also be obtained at the 7-year and 10-year time points at 
investigational sites that choose to bring their subjects back in for these optional visits, 
in addition to the required Follow-up Questionnaire described. 
 
Radiographic Outcomes: 
To assess radiographic stability as compared with other primary femoral stems, 
radiographs will be taken and collected in the low AP pelvis and Lauenstein lateral 
views for the preoperative, 6-week, 1, 2 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 low AP pelvis view allows for measurement of the position of the hip center, 
femoral offset and neck angle, and any leg length discrepancy.  The Lauenstein 
lateral view allows for evaluation of the entire hip joint as well as the femoral head, 
neck and proximal shaft.7 Suggested radiographic technique for the views required is 
included in Appendix C. 
 
Radiographs will be evaluated by an independent reviewer throughout the course of 
the study.  Radiographic analysis of the acetabular component will employ three 

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zones (Zone 1 – Zone 3) in the AP view.8,9  Radiographic analysis of the femoral 
component will employ seven zones (Zone 1 - Zone 7) in the AP views and seven 
zones (Zone 8 – Zone 14) in the  lateral view.  Numerous parameters will be reviewed 
by zone, including radiolucency, hypertrophy, condensation and migration.  
Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is 
defined as radiolucency present.  Cases that present with subsidence of greater than  
5 mm, migration of greater than 5° in any direction or at least 2 mm radiolucency in 
all zones within a single view will be considered radiographic failures.  
2.2 Safety 
All operative site events occurring at any time as well as all serious adverse events (SAEs) 
occurring in the perioperative period (intraoperative to hospital discharge) will be collected and 
compared to published data.  It is expected that the AE rates reported for the Secur-Fit Advanced 
Hip Stem will be comparable to those reported in the literature for other primary femoral stems on 
the market.  Details regarding AE definitions, recording and reporting are in Section 8 of this 
protocol, Adverse Events. 
 
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 
 
3.2.1 Centers for Standard Data Collection 
 
Cases will be enrolled at five to eight centers.  The enrollment goal is approximately 41 
cases per center utilizing the Secur-Fit Advanced Hip Stem but will vary dependent upon 
the number of participating centers.   Although a goal is presented, there is no maximum 
limit to the number of cases that a center may enroll.  In the event that a center far exceeds 
the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the 
data.  All participating centers will comply with the federal regulations regarding patient 
informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) 
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approval.  Non-compliance of a study center may result in termination of the center’s 
participation in the study. 
 
3.3  Number of Subjects 
Cases will be enrolled until a total of 314 cases receive the Secur-Fit Advanced Hip Stem.   
3.4 Estimated Study Duration  
The enrollment period is estimated to be a maximum of 24 months; cases will be evaluated as 
per the evaluation schedule until each case reaches 10 years. 
 
To allow for a learning curve with the use of the device, enrollment of cases into the study will 
commence when three cases have been completed at the center using the Secur-Fit Advanced 
Hip Stem. 
 
 
The following criteria will be used to distinguish patients eligible for enrollment into this study.  
Proper implant selection must consider design, fixation, and environmental variables including: 
patient weight, age, bone quality and size, activity level and pre-operative level of health, as well 
as the surgeon’s experience and familiarity with the device.   
4.1 Inclusion Criteria 
A. Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form. 
B. Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time 
of study device implantation. 
C. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease. 
D. Patient is a candidate for primary cementless total hip arthroplasty. 
E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic 
evaluations and rehabilitation. 
 
 
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4.2 Exclusion Criteria 
F. Patient has previously undergone open surgical intervention on the operative hip. 
G. Patient has a prior femoral fracture, with or without deformity, on the operative side. 
H. Patient has an existing total hip replacement on the contralateral side. 
I. Patient requires simultaneous bilateral total hip replacement. 
J. Patient has a Body Mass Index (BMI) > 45. 
K. Patient has an active or suspected latent infection in or about the affected hip joint at time 
of study device implantation. 
L. Patient has a neuromuscular or neurosensory deficiency that would create an 
unacceptable risk of instability, prosthesis fixation failure or complications in postoperative 
care, or which limits the ability to evaluate the safety and efficacy of the device 
M. Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is 
diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder 
(e.g. Paget’s disease) leading to progressive bone deterioration. 
N. Patient is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements (e.g. > 30 days). 
O. Patient has a known sensitivity to device materials. 
P. Patient is a prisoner. 
 
 
5.1 Treatment Assignment 
All subjects will receive the Secur-Fit Advanced Hip Stem. 
5.2 Randomization 
The study will enroll under a non-randomized study design. 
 
 
 
 
 
5 Subject Enrollment 

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6.1 Study Device 
The Secur-Fit Advanced Hip Stem has been cleared for use in the United States; therefore, this 
study is considered a post-market assessment.  All cases in this study will receive the Secur-Fit 
Advanced Hip Stem. 
 
The Secur-Fit Advanced Hip Stem is a straight stem intended for cementless, press-fit application. 
It is a non-porous coated femoral stem with a fit and fill design to provide rotational stability. The 
stem body design is based on the Secur-Fit HA Hip Stem.  Like the predicate for body design, the 
Secur-Fit Advanced Hip Stem is a straight stem with a normalization pattern on the anterior and 
posterior aspects of the proximal end (depicted in Figure 1) to facilitate press-fit stability and load 
transmission to the proximal region of the femur.  Based on 3-Dimensional simulations, these 
normalizations are designed to convert medial and lateral shear stresses to compressive forces, 
which may facilitate proximal loading.(RD-13-001).  Medial curvature of the stem is proportional 
and size-specific. 
 
The Secur-Fit Advanced Hip Stem will be fabricated from Titanium (Ti-6Al-4V) Alloy, with a CPTi 
plasma spray coating covered with a HA powder (Pure-Fix HA).  The distal portion of the stem 
has a polished tip, and the neck region has been polished and shot peened. 
 
The Secur-Fit Advanced Hip Stem will be available in 9 sizes ranging from size 4 through 12; the 
catalog numbers are listed in Table 1.  Stem length will range from 110 mm to 
160 mm, increasing in length as the stem size increases.  Stem length is measured from the 
medial calcar point to the distal tip of the stem. The stem’s neck is designed with a Howmedica 
Osteonics V40 taper on the proximal end similar in design to the Accolade II.  
 
 
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Figure 1: Secur-Fit Advanced  A/P View 
 
 
 
 
The only difference in the V40 taper of the Secur-Fit Advanced  Hip Stem to the Accolade II is the 
taper length.  The neck lengths of the Secur-Fit Advanced Hip Stem range from 26 mm to 40 mm 
and grow with stem size.  Additionally, the necks are available in two angles (127° and 132°) that 
provide dual head offsets.  Sizes 4 and 5 are available with a 132° offset angle only; all other 

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sizes are available in both 127° and 132° offset angles.  Overall femoral offsets achievable with 
a +0 mm head range from 31.5 mm to 53.7 mm. 
 
Table 1: Secur-Fit Advanced Stem Offsets 
 
 
The following femoral component catalog numbers are permissible according to this study 
protocol and are in the following format, where ‘XX’ varies by size: 
1601-XX127 
1601-XX132 
The full listing of permissible femoral component catalog numbers may be found in Appendix D. 
 
Additionally, only the following Stryker compatible ancillary devices may be used, according to 
this study protocol: 
o Compatible Stryker femoral bearing heads 
o Compatible Stryker acetabular shells, liners and inserts 
 
 
 
 
 
 
The compatible Stryker head and acetabular components are listed in the surgical protocol. 
 

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For reference, compatible femoral heads and acetabular components are listed in Table 2 and Table 
3 below.  In the case of any uncertainty regarding device compatibility, the current version of the Secur-
Fit Advanced surgical protocol should be reviewed. 
 
Table 2: Femoral Head Compatibility 
 
*Maximum head offset for Size 4 stem is +5 
 
 
 
 
 
 
 

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Table 3: Secur-Fit Advanced Compatible Acetabular Components 
 
 
6.2 Device Retrieval Process 
Stryker Orthopaedics will retrieve the Secur-Fit Advanced Hip Stem and/or adjacent tissues for 
analysis to help characterize potential device-related complications.  In the event that the Secur-
Fit Advanced Hip Stem is removed from a study subject, the procedure outlined in the Retrieved 
Implant Analysis Protocol (Appendix E) should be followed.  In addition: 
 

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1. When revision of a study subject is scheduled, the study coordinator (SC) should contact 
the Clinical Study Manager (CSM) or other Stryker Clinical Research personnel assigned 
to the project, as soon as possible. 
2. Stryker Clinical Research will send a retrieval container to the SC. 
3. After the device is explanted, the SC or an identified Stryker field representative will 
retrieve the device and place it in the retrieval container, following the instructions in 
Appendix E. 
4. The SC, an identified field representative or Stryker Clinical Research will complete a 
Product Experience Report (PER). 
5. If not completed by Stryker Clinical Research, the PER should be faxed or emailed to 
Stryker Product Surveillance at 201-831-6775 or soprodexreports@stryker.com, as well 
as to Stryker Clinical Research at 201-831-6454 or to the Clinical Research email 
addresses listed on the Sponsor Contact Sheet. 
6. The PER should be attached to the retrieval container and sent to Product Surveillance.  
A de-identified operative report should be included, when available. 
7. Stryker Clinical Research will follow up with Product Surveillance to obtain a PER number. 
8. A summary of results will be provided to the investigator upon his/her request. 
 
7.1 Preoperative Visit 
During the preoperative visit, patients that are possible candidates for this study will be screened 
to determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, the 
investigator will propose participation in the study to the patient, according to GCP guidelines.  
Patients must sign an IRB/EC approved Informed Patient Consent Form prior to participating in 
any study related activities.  Consent must be obtained within 4 months prior to surgery. 
 
Once the patient has been consented, preoperative data will be collected including: 
demographics, medical history, HHS, SF-12, LEAS, EQ-5D, AP pelvis and Lauenstein lateral 
radiographs.  At sites participating in the preoperative planning subset, investigators will submit 
digital images of each subject’s preoperative template as well as additional information regarding 
planned biomechanical parameters and devices to be implanted. 
 
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All preoperative data must be collected within 4 months prior to the scheduled date of surgery, 
with the exception of radiographs, acceptable within 1 year prior to the scheduled date of surgery.  
All information collected preoperatively will be used to quantify the sample population and 
compare postoperative progress. 
7.2 Surgery 
Surgical details will be collected from the operative notes and at the time of surgery.  
7.3 6-week Visit 
During the 6-week visit (± 3 weeks), the following evaluations will be collected:  HHS, SF-12, 
LEAS, EQ-5D, AP pelvis and Lauenstein lateral radiographs. 
 
In the event that an in-person visit cannot be conducted and radiographs cannot be obtained, a 
Follow-up Questionnaire will be completed via mail, online completion (if available), or telephone 
interview with the subject by investigative site personnel.  
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 and 5-year.  Tools for postoperative evaluation at each of 
these intervals will be the HHS, AP pelvis and Lauenstein lateral radiographs.  In the event that 
an in-person visit cannot be conducted and radiographs cannot be obtained, a Follow-up 
Questionnaire will be completed via mail, online completion (if available), or telephone interview 
with the subject by investigative site personnel.  
 
Patient outcomes data will also be collected with the Follow-up Questionnaire, SF-12, LEAS, and 
EQ-5D patient questionnaires at each office visit and at the 3-year and 4-year intervals via mail 
or online completion, if available.  
 
All clinical data, radiographs, and patient outcomes data must be collected within ± 2 months of 
the 1-year and 2-year anniversary dates.  For remaining annual time points, the window expands 
to ± 3 months of the 3-year anniversary date and ± 4 months of the 4-year through  
10-year anniversary dates. 
 

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The initial phase of the study will continue for 5 years after surgery and include collection of the 
previously described radiographs, HHS, SF-12, LEAS and EQ-5D patient questionnaires.  In the 
second phase of the study, all subjects will complete a brief Follow-up Questionnaire annually at 
the 6-year, 7-year, 8-year, 9-year and 10-year follow-up intervals.  This form may be completed 
by the SC during a subject telephone interview, or by the subject either at home or during a clinic 
visit.  The questionnaire will be used to obtain the following information, at a minimum: 
 
• 
Subject satisfaction with the hip replacement 
• 
Presence of any pain in the study hip 
• 
Any surgeries performed on the study hip 
 
The questionnaire will also provide information on any revisions and enable calculation of the 
Kaplan-Meier Survival Curve. 
 
Additionally, at investigational sites that choose to continue collecting clinical and radiographic 
data during the second phase of the study, subjects will be evaluated again at 7 and 10 years 
after surgery. 
 
8.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
• 
All AEs that meet the definition of serious and occur within the perioperative period 
(intraoperative to hospital discharge)  
 
• 
All AEs related to the operative site, regardless of seriousness or time of occurrence 
 
 
On postoperative functional evaluations, investigators and SCs will be prompted to question 
subjects as to whether they have seen a doctor for any reason, been hospitalized for any reason 
or have a current impediment to their function. 
 
Additionally, SCs will be responsible for following up with the subjects regarding any questionable 
responses received on the Follow-up Questionnaire administered in postoperative years 6 
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through 10.  If it is determined upon this further investigation that a protocol-defined AE has 
occurred, the SC will be responsible for completing an AE eCRF, submitting the event to Stryker 
and reporting to the IRB/EC, as required. 
   
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
Figure 4.  Adverse Event Decision Tree 
 
 
 
Start 
Site becomes 
aware of 
Adverse Event 
Is the event 
related to the 
operative 
site? 
Does the AE 
meet the 
criteria for 
Seriousness? 
Do NOT report 
to Stryker 
Did the event 
occur within 
the 
perioperative 
period? 
Report AE to 
Stryker via AE 
eCRF 
End 
Yes 
Yes 
Yes 
No 
No 
No 

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

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

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8.3 Study Sponsor Notification by Investigator 
Of reportable AEs, certain events must be submitted to Stryker within 24 hours for timely 
notification: 
 
Adverse events that require time sensitive reporting: 
An adverse event should be reported to Stryker Clinical Research either by telephone/fax/email 
within 24 hours of the site becoming aware of the event if any of the following apply: 
• 
The AE is considered by the investigator to be device related or if the investigator 
is uncertain regarding the device related assessment; 
• 
The AE required a reoperation of the study hip or a revision of any study hip 
components. 
 
An AE eCRF must be completed within 24 hours.  If a SAE occurs, the de-identified source 
documentation must be uploaded to the appropriate location within Stryker’s Electronic Data 
Capture (EDC) system within 24 hours of the investigative center’s SAE awareness.  See Section 
11, Data Management, for additional details of Stryker’s EDC system. These reports will be 
evaluated by Stryker to determine if a PER is required. 
 
It is recommended that all other reportable AEs are submitted through eCRF entry within 2 weeks. 
 
At the time of the initial report, the following information should be provided: 
 
• 
Subject number 
• 
A description of the event 
• 
Date of onset 
• 
Current status 
• 
Whether 
study 
treatment 
was 
discontinued 
• 
Investigator assessment of the 
association between the event and 
the study treatment 
 
8.3.1 Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the EC or IRB 
according to their specific requirements.  Copies of each report and documentation of 
EC/IRB notification and receipt will be kept with the investigator’s study files. 

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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.  
 
 
9.1 Efficacy 
9.1.1 Primary Efficacy Parameters 
 
The primary efficacy parameter is the success rate at 5 years postoperative with the 
Secur-Fit Advanced Hip Stem, where success is defined as absence of femoral stem 
revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years 
postoperative. 
 
9.1.2 Secondary Efficacy Parameters 
 
The secondary efficacy parameters include: 
• 
The all-cause revision and/or removal rates of  the Secur-Fit Advanced Hip Stem;  
• 
The rate of device-related femoral fracture among patients implanted with the 
Secur-Fit Advanced Hip Stem within 30 days postoperative; and 
• 
The component exposure or countersink upon final seating intraoperative.  
 
Additional data will be collected as noted in Section 2.1.3; related details are in Section 
9.4.1 Data Summary.  
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9.1.3 Primary Efficacy Analysis 
 
The primary hypothesis to be tested will be that the success rate at 5 years 
postoperative with the Secur-Fit Advanced Hip Stem is not worse than 99% with a non-
inferiority margin of 2.5%.   
 
That is, the following hypothesis will be tested: 
H0:  Pt <= 99% - 2.5%  HA:  Pt > 99%- 2.5% 
 
Here, Pt is the success rate at 5 years postoperative with the Secur-Fit Advanced Hip 
Stem  
 
A 90% two-sided confidence interval will be computed for the success rate at 5 years. If 
the lower bound of the confidence interval is greater than 96.5%, then the non-inferiority 
hypothesis will be supported.  
 
9.1.4 Secondary Efficacy Analysis 
 
The all-cause revision and/or removal rates of  the Secur-Fit Advanced Hip Stem will be 
reported.   
 
The rate of device-related femoral fracture among patients implanted with the Secur-Fit 
Advanced Hip Stem within 30 days postoperative will be evaluated.  
 
The mean amount of unintended exposure or countersink of the femoral component upon 
final seating will be presented; standard deviation, median, minimum, and maximum will 
be displayed.  
 
 
The analysis for the additional data collection is in 9.4.1 Data Summary.  
 

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9.2 Safety 
9.2.1 Safety Parameters 
 
Safety parameters include all protocol-defined adverse events as well as revision and/or 
removal rates.  For details regarding protocol-defined adverse events, see Section 8.1. 
 
9.2.2 Safety Analyses 
 
The frequency and percentage of all protocol-defined adverse events will be tabulated.  
For details regarding protocol-defined adverse events, see Section 8.1. 
 
9.3 Missing Data 
 
No missing data will be imputed. 
 
 
9.4 Statistical Methodology 
 
9.4.1 Data Summary 
 
Descriptive statistics will be computed for all baseline conditions and demographic 
parameters.  That is, for continuous data, the N, mean, median, standard deviation, 
minimum and maximum will be computed.  For categorical data, the frequency will be 
computed. The data will be presented by appropriate subgroups (e.g., center, gender).  
 
A  Kaplan-Meier survivorship curve will be displayed for  revision  and/or  removal of the 
Secur-Fit Advanced Hip Stem for aseptic loosening or device-related femoral fracture. 
 
A  Kaplan-Meier survivorship curve will be displayed for all-cause revision and/or removal 
of the Secur-Fit Advanced Hip Stem.  
 
For the additional data collected according to Section 2.1.3, data will be summarized 
according to visit.  For parameters represented by continuous variables (e.g., ROM), the 

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summaries will consist of the N, mean, median, standard deviation, minimum, and 
maximum values.  For categorical variables (e.g., Mobility from EQ-5D), the frequency and 
percentage in each category will be presented.  A paired t-test will be performed to 
evaluate the change in clinical and patient outcomes, preoperative to 5 years within the 
Secur-Fit Advanced Hip Stem. The 1-year, 2-year and 5-year SF-12, LEAS and HHS will 
be presented with respect to improvement from preoperative scores. 
 
For the Follow-up Questionnaire, frequency  and percentage will be computed for each 
category according to visits.  Applicable lists based on Follow-up Questionnaire will be 
generated to capture AEs. 
  
For radiographic data, data will be presented according to visits for available parameters.  
Frequency and percentage will be computed for radiolucency according to visit.  Lists will 
be generated for migration over time.  Radiographic failure will be evaluated, where 
radiographic failure is defined as subsidence of greater than 5 mm, migration of greater 
than 5° in any direction or at least 2 mm radiolucency in all zones within a single view.  
 
Documentation of statistical analyses utilizing SAS® software version 9.1.3 or higher. 
 
9.4.2 Sample Size Justification 
 
With a reference value of 99% of success rate at 5 years, under the regular assumptions 
of 5% significance level (or 95% one-sided confidence interval), 80% power, 2.5% non-
inferiority margin, the sample size is 277.  After factoring a 15% lost to follow-up rate, the 
final sample size is 326.  A significant decrease in screening/enrollment occurred after 
2018, resulting in a final sample size of 314 cases.  
 
9.4.3 Interim Analyses 
No interim analysis is planned. 
 
 
 
 
 

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9.4.4 Analysis Population 
 
Per Protocol Population: The study population for analysis will include all non-censored 
subjects who receive the Secur-Fit Advanced Hip Stem and are available for efficacy 
evaluation. 
 
The primary and secondary efficacy analyses will be based on the per protocol population.   
 
 
Safety Population: The safety population will include all non-censored subjects who 
received the Secur-Fit Advanced Hip Stem. 
 
The safety analysis will be based on the safety population. 
 
10.1  Subject Recruitment and Screening 
Patients will be recruited at the study centers during preoperative visits through normal referral 
patterns.  All patients recruited for this study will have the capacity to give informed consent.  
Advertising for the study at each center will be at the discretion of the investigator.  All handouts, 
brochures, advertisements, etc. must be approved by the IRB/EC prior to the dissemination of 
any recruitment materials to potential subjects.  Study advertisement content may be found in 
Appendix F. 
10.2   Patient Informed Consent and Guidelines 
All patients for this study will be provided an Informed Patient Consent Form describing this study 
and providing sufficient information for them to make an informed decision about their 
participation.  The Informed Patient Consent Form must contain all elements required by the FDA 
under 21 CFR Part 50, in addition to any other elements required by state, local and institutional 
policies.  For international sites, the applicable country regulations are required.  See Appendix 
G for a copy of the Model Informed Patient Consent.  This will be submitted with the protocol for 
review and approval by the IRB/EC for the study.  All patients must provide written consent after 
having had adequate time to consider their participation in the study.  The formal consent of a 
patient, using the IRB/EC approved Informed Patient Consent Form, must be obtained before that 
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patient is submitted to any protocol related procedures that are not part of normal care.  Written 
documentation of consent must be provided on the Informed Patient Consent Form’s signature 
page in addition to a note in the patient medical records indicating the date that consent was 
obtained.  The investigator-designated research professional obtaining the consent must also 
sign this Informed Patient Consent Form.  The patient or his/her legal representative should 
receive a signed copy of the Informed Patient Consent Form, according to GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
• 
Use a current IRB/EC approved copy of the Informed Patient Consent Form. 
• 
Review thoroughly with the patient before having them sign. 
• 
After the patient has consented to the procedures, ensure he/she signs and dates the 
Informed Patient Consent Form. 
• 
The person obtaining consent also signs and dates the signature page. 
• 
Provide a copy of the Informed Patient Consent Form to the patient. 
• 
If required, provide the hospital with a copy of the signed Informed Patient Consent Form. 
• 
Maintain the signed original in the patient’s study chart. 
10.3  Early Withdrawal of Subjects 
 
When and How to Withdraw Subjects 
In the event that the subject is discontinued by the investigative center prior to the final study 
evaluation, the subject will be notified by the center that he/she is no longer in the study and a 
Study Termination eCRF will be completed.   
 
The following is a list of reasons for which subjects may be withdrawn and the date of termination 
that should be used on the Study Termination eCRF in each situation.  This list is not all inclusive: 
Termination Reason 
 
 
 
Date of Termination 
Death 
 
 
 
 
 
Date of death 
Investigative center termination  
 
Date of study close-out visit 
Lost to follow-up  
 
 
 
Date Stryker termination approval given 
Voluntary withdrawal 
 
 
 
Date subject notified center of withdrawal 
Revision/removal of study device  
 
Date of revision/removal procedure 
Study device not implanted 
 
 
Date of surgery 
Surgery not performed 
 
 
 
Date Stryker termination approval given 
 

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At the time of study surgery it is required that the following components are implanted for each 
treatment group: 
 
Secur-Fit Advanced Hip Stem with any compatible Stryker acetabular components:  
o Secur-Fit Advanced Hip Stem 
o Compatible Stryker femoral head 
o Compatible Stryker acetabular insert 
o Compatible Stryker acetabular liner (if used) 
o Compatible Stryker acetabular shell 
 
Revision or removal of the Secur-Fit Advanced Hip Stem for device-related femoral fracture or 
aseptic loosening constitutes a failure.  Revision or removal of the Secur-Fit Advanced Hip Stem 
for any reason requires study termination for the subject. 
 
If revision of the femoral head or any acetabular component is required during the study, the event 
does not constitute a failure or study termination. 
 
If the subject fails to return for his/her follow-up appointments, every effort should be made to 
contact the subject to assess his/her health status.  If, after attempting to contact the subject 
through three documented phone calls and a certified letter, the subject still does not respond, 
he/she will be considered lost to follow-up.  A Study Termination eCRF will be completed only 
after notifying Stryker of the subject’s status and being given approval to terminate.   
 
In the event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  If the surgery is rescheduled more than 4 months from the date of 
preoperative data collection, the subject will need to be re-consented, all preoperative data will 
need to be re-collected and all original preoperative data will need to be removed from the 
database.  If the surgery is not to be rescheduled or if the subject is no longer considered an 
appropriate study candidate, a Study Termination eCRF may be completed only after notifying 
Stryker of the subject’s status and being given approval to terminate. 
 
When a subject completes the study according to protocol, including the final study evaluation, a 
Study Termination eCRF will be completed. 
 

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11.1  Database 
Data will be collected at each center and entered into Stryker’s Electronic Data Capture (EDC) 
system.  The system can be accessed remotely by each investigative center and the data entered 
will be managed by Stryker.  Subject data will be processed and monitored according to the 
protocol schedule by Stryker or Stryker representatives.  Draft specifications to support eCRFs 
are provided in Appendix H. 
11.2  Confidentiality 
This study will comply with the 2002 HIPAA privacy rule.  As such, Stryker will only collect that 
information which is necessary to support the objectives of the clinical study.  Stryker will take 
precautions to ensure that data received is as de-identified as possible.  In the case that some 
identified information is received, Stryker will ensure that any identifying information is not 
reported.  Study subjects will authorize Stryker to use their health information in support of the 
clinical study during the informed consent process.  Should a subject choose to withdraw 
authorization, Stryker may use data collected prior to the withdrawal of authorization in order to 
maintain data integrity.  
11.3  Source Documents 
Source data include all information, original records of clinical findings, observations or other 
activities in a clinical study necessary for the reconstruction and evaluation of the study.  Source 
data are contained in source documents.  Examples of these original documents and data records 
include:  hospital records, clinical and office charts, study worksheets, laboratory notes, 
memoranda, subject questionnaires, pharmacy dispensing records, recorded data from 
automated instruments, radiographs, subject files, and records kept at the pharmacy, at the 
laboratories and at medico-technical departments involved in the clinical study. 
All data points collected during preoperative and follow-up visits must be documented in the 
subject’s chart.  This includes range of motion values, pain and function as well as AEs and 
additional comments.  The informed consent process should also be documented in the patient 
chart.  Monitors, defined further in Section 13, will be comparing the eCRFs against source 
documents for adequacy.  The monitors will seek to draw a reference between each data point 
on the eCRF and the subject’s chart.  Thus, one cannot derive pain, ROM or function based on a 
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chart note that reads “Patient doing well.”  Every effort should be made to ensure complete source 
documentation.  
Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
11.4  Electronic Case Report Forms 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be documented.  All missing data must be explained.  It is recommended that 
eCRFs be completed and electronically signed by the investigator within 2 weeks of the evaluation 
date. 
11.5  Data Clarification Requests 
If errors or omissions are noted by Stryker upon review of the data entered into the eCRFS, a 
data clarification request (DCR) will be sent to the center within the EDC system.  Queries should 
be answered in a clear and comprehensible manner.  If the clarification requires a change to study 
data, the EDC system will update the eCRF automatically with the data captured in the DCR 
response.  The investigative center will be required to reapply their electronic signature to the 
modified eCRF.  Modified eCRFs need not be printed and included in conjunction to answered 
DCRs. 
11.6  Protocol Deviations 
Any deviation from this protocol will be recorded in Stryker’s Clinical Trial Management System 
and must be reported to the EC/IRB by the investigational site according to their reporting 
procedures.  Protocol Deviations for this study may include the following; this list may not be all-
inclusive:  
 
• 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
• 
Patient enrolled does not meet the inclusion/exclusion criteria 
• 
Protocol specified study component(s) not implanted 
• 
Visit deviations, including: 
o Unavailable primary endpoint 
 

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If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
11.7  Records Retention 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or in the case of non-compliance, 2 years after the date of investigative center 
termination.  These documents should be retained for a longer period if required by an agreement 
with Stryker. 
 
12.1  Risk Category 
There are no additional risks associated with participating in this study over and above that of the 
primary THA procedure.  
12.2  Potential Risk 
The study involves the routine assessment of a primary THA procedure.  The Secur-Fit Advanced 
Hip Stem has been cleared for use by the FDA and will be used according to its labeling, included 
in Appendix I.  Assessment involves questionnaires, patient and physician assessments as well 
as routine radiographs.  The information collected will be kept confidential and will comply with 
the HIPAA privacy rule. 
 
While the expected life of THA components is difficult to estimate, it is finite.  These components 
are made of foreign materials, which are placed within the body for the potential restoration of 
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 THA include the following: 
Serious complications may be associated with any total joint replacement surgery.  These 
complications include, but are not limited to:  infection; genitourinary disorders; gastrointestinal 
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disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; 
myocardial infarction or death. 
 
With all implanted devices, asymptomatic, localized progressive bone resorption (osteolysis) may 
occur around the prosthetic components as a consequence of foreign-body reaction to the 
particulate matter of metal, UHMWPE and/or ceramic.  Particulate is generated by interaction 
between components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can 
be generated by third body wear.  Osteolysis can lead to future complications, including loosening, 
necessitating the removal and replacement of prosthetic components. 
 
Early and late loosening of total hip components can occur.  Early biomechanical loosening may 
result from inadequate initial fixation, latent infection, premature loading of the prosthesis or 
trauma.  Late loosening may result from trauma, infection, biological complications including 
osteolysis or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 
 
Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other 
biomechanical considerations. 
 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
 
Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur 
due to impaction of the component into the prepared femoral canal or acetabulum.  Postoperative 
femoral or acetabular fracture can occur due to trauma, the presence of defects or poor bone 
stock. 
 
Metal sensitivity reactions have been reported following joint replacement. 
 
AEs may necessitate reoperation, revision, arthrodesis of the involved joint, girdlestone or 
amputation of the limb. 
12.3  Expected Complications and Rates of Occurrences 
Complications associated with THA procedures, such as those performed with the Secur-Fit 
Advanced Hip Stem, have been reported. These include the potential for: injury to the hip’s 
neurovascular structures, loosening of the components, malseating of the acetabular liner, 

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heterotopic bone formation, infection, deep vein thrombosis, pulmonary embolism, metal 
sensitivity reactions, intraoperative or postoperative fracture of the femur or acetabulum, and the 
need for re-operation, revision, arthrodesis of the involved joint, girdlestone or amputation of the 
limb.  The safety objective will compare the complication rates of the Secur-Fit Advanced Hip 
Stem to published rates.   
12.4  Protection Against Risks 
Subjects will be treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or well 
being of the subject, this deviation will be promptly reported to both the EC/IRB and Stryker.   
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 
device by comparing it to published results for other similar devices.  Information gathered in this 
study may benefit others undergoing this procedure in the future. 
 
13.1  Study Monitoring Plan 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects 
involved in a clinical investigation and the quality and integrity of data submitted as a result of the 
investigation. 
 
This study will be monitored at least once per year, with additional monitoring as necessary. The 
investigator will allocate adequate time for such monitoring activities.  The investigator will also 
ensure that the monitor or other compliance or quality assurance reviewer is given access to all 
study-related documents and study-related facilities, as applicable, and has adequate space to 
conduct the monitoring visit, when applicable.  The monitor will review all source documents and 
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compare them to the data contained in the eCRFs, in addition to performing a periodic review of 
regulatory documents such as EC/IRB approvals.  The monitors will need the following: 
• 
An area where they can review study data, when monitoring is conducted on site 
• 
Access to eCRF data for all cases 
• 
Access to source documentation 
• 
Regulatory documents 
• 
Time to discuss findings with the SC and the investigator  
13.2  Auditing and Inspecting 
A quality assurance audit is a form of review that provides additional confidence to the sponsor 
concerning the validity and accuracy of clinical study data that must be submitted to the FDA or 
for publication.  The purpose of investigator audits is to ensure that the investigator has 
maintained all study information according to the sponsor’s protocol and standard operating 
procedures and in compliance with FDA regulations. 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, 
Stryker and/or government regulatory bodies of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data).  The investigator will 
ensure the capability for inspections of applicable study-related facilities. 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56 as well as 45 CFR Parts 160 and 164. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
EC/IRB for formal approval of the study conduct.  The decision of the EC/IRB concerning the 
conduct of the study will be made in writing to the investigator and a copy of this decision will be 
provided to Stryker before commencement of this study.  The investigator may be asked to 
provide a list of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study will be provided an Informed Patient Consent Form 
describing this study and providing sufficient information for patients to make an informed decision 
about their participation.  This Informed Patient Consent Form must be modified to contain center 
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specific information and submitted with the protocol for review and approval by the EC/IRB for the 
study.  The formal consent of a patient, using the EC/IRB approved Informed Patient Consent 
Form, must be obtained before that patient is submitted to any study procedure.  This Informed 
Patient Consent Form must be signed by the patient or legally acceptable surrogate and the 
investigator-designated research professional obtaining the consent.  
 
15.1  Funding Source 
This study is financed by Stryker Orthopaedics. 
15.2  Conflict of Interest 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 
Committee-sanctioned conflict management plan that has been reviewed and approved by 
Stryker prior to participation in this study.   
15.3  Subject Stipends or Payments 
Subject attrition can occur for a variety of reasons, including a subject’s loss of health insurance 
coverage.  In a case where a patient has lost health insurance coverage and no other coverage 
is available, Stryker may, on a case-by-case basis, reimburse investigators for office visits and 
radiographic charges for subjects involved in this study in order to facilitate data retrieval.  The 
physician or the office staff should contact the CSM prior to scheduling the subject to discuss this 
possibility and receive pre-approval.  After receipt of the completed data forms, the physician 
must submit either evidence of coverage denial (e.g. explanation of benefits) or a letter explaining 
that the subject does not have insurance.  Other visits, procedures and assessments done other 
than those specified in the protocol will not be reimbursed.  Reimbursement may be provided 
under the following conditions: 
• 
Study subjects lose insurance coverage after enrollment into the study 
• 
An insurance carrier refuses to pay for a follow-up visit and/or radiographs     
• 
An insurance carrier refuses to provide a subject referral to see the investigator for follow-
up  
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Additionally, at pre-determined study visit intervals, Stryker may reimburse subjects with a modest 
stipend for protocol-required data collection. This stipend system must be approved by the 
Institution’s IRB prior to implementation and will be based upon individual IRB approval from each 
site. 
 
This policy is the same for all participating study subjects and does not bias against any particular 
subject or study cohort.  
It is anticipated that publication of the multi-center study results will be compiled and submitted to 
a peer-reviewed journal at the time the study cohort reaches 2, 5 and 10 years of follow-up.  Early 
results with regard to surgical information and postoperative biomechanics may be published prior 
to the 2-year time point.  Additional publication proposals may also be made by investigators at 
any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 
 
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. 
 
 
 
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The following summarizes the possible roles of these parallel positions: 
Chair 
PI 
Contributes to study design 
Contributes to study design 
Assists with study questions requiring expert 
clinical opinion 
Assists with study questions requiring expert 
clinical opinion 
Assists with identification of investigators 
Assists with identification of investigators and 
maintains performance 
Reviews additional publication proposals 
submitted by investigators 
Updates investigators on progress towards 
multi-center results 
Contributing author, if ICMJE guidelines met 
Primary author, multi-center publication of 
primary endpoint data 
 
At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 2, 5 and 10-year multi-center publications are submitted.  Although Stryker 
will not be involved in coordinating these independent manuscripts, all publications of the data 
shall be submitted to Stryker for review prior to submission for publication.  Stryker shall not edit 
or otherwise influence the publications other than to ensure that confidential information is not 
disclosed, that no off-label use of Stryker devices is promoted and that the data is accurately 
represented.  Any publications resulting from this study must be submitted to Stryker for review 
at least 60 days prior to submission of publication. 
 
 

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1. 
 
 
1 Huo, M.H., Parvizi, J., Bal, B.S. & Mont, M.A. (2009).  What’s New in Total Hip Arthroplasty.  The 
Journal of Bone and Joint Surgery, 91(10), 2522-2534.  
2 Langdon IJ, Bannister GC (1999). Cemented hip replacement in patients younger than 50 years: 16-24 
year results. Hip International, 9: 151-153. 
3 D’Antonio, J.A., Capello, W.N., & Manley, M. (1996). Remodeling of bone around hydroxyapatite-coated 
femoral stems. Journal of Bone and Joint Surgery, 78-A, 1226-34. 
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 follow-up. Clinical Orthopaedics and 
Related Research, 453, 75-80. 
5 Schwarzkopf, R., Olivieri, P., & Jaffe, W.L. (2012). Simultaneous bilateral total hip arthroplasty with 
hydroxyapatite-coated implants : A 20-year follow-up. Journal of Arthroplasty, 27(7), 1364-9. 
6 Incavo, S.J., Beynnon, B.D., & Coughlin, K.M. (2008). Total hip arthroplasty with the Secur-Fit® and 
Secur-Fit® Plus femoral stem design:  A brief follow-up report at 5 to 10 years. Journal of Arthroplasty, 
23(5), 670-676. 
7 Greenspan, A. (1992).  Orthopedic radiology: A practical approach (2nd ed.) New York: Gower Medical 
Publishing. 
8 Breusch, S.J., Lukoschek, M., Kreutzer, J., Brocai, D., & Gruen, T.A. (2001). Dependency of cement 
mantle thickness on femoral stem design and centralizer. Journal of Arthroplasty, 16(5), 648-657. 
9 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. 
17 
References