Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
Phase: NA
Conditions: Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-Perthes Disease
Sponsor: Zimmer Biomet

 
 
 
 
 
 
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Taperloc Complete Microplasty vs Taperloc Complete 
Standard: Randomized  
Controlled Study on Bone Mineral Density 
 
 
 
PROTOCOL NUMBER (Study ID): INT.CR.GH3.13 
 
PROTOCOL VERSION:  3.0 (Amendment 1) 
 
PROTOCOL DATE: 12 January 2017 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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Table of Contents 
 
1. INTRODUCTION 
1.1. BACKGROUND 
1.2. DEVICE DESIGN AND DESCRIPTION 
1.3. RATIONALE FOR CURRENT STUDY 
1.4. STUDY PURPOSES 
2. STUDY DESIGN 
2.1. OVERALL DESIGN 
2.2. STUDY GROUPS/TREAMENTS 
2.3. NUMBER OF SITES AND SUBJECTS/PROCEDURES 
2.4. EFFICACY AND/OR SAFETY HYPOTHESES  
2.5. PRIMARY AND SECONDARY ENDPOINTS 
2.6. ASSESSMENT PROCEDURE  
2.6.1. ASSESSMENT PARAMETERS AND METHODS 
2.6.2. ASSESSMENT TIMELINES/SCHEDULE  
2.6.3. ALLOWED WINDOW OF EACH SCHEDULE  
2.7. STUDY DURATION 
3. SELECTION AND WITHDRAWAL OF SUBJECTS 
3.1. INCLUSION CRITERIA 
             3.2. EXCLUSION CRITERIA 
3.3. SUBJECT WITHDRAWAL 
4. PROTOCOL DEVIATION MANAGEMENT AND REPORTING 

 
 
 
 
 
 
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5. ADVERSE EVENT MANAGEMENT AND REPORTING 
6. DATA ANALYSES 
6.1. SAMPLE SIZE JUSTIFICATION 
6.2. DESCRIPTION OF STATISTICAL ANALYSES 
7. DATA COLLECTION, HANDLING AND RETENTION 
7.1. SOURCE DOCUMENT REQUIREMENTS 
7.2. CASE REPORT FORMS 
7.3. ELECTRONIC DATA ENTRY 
7.4. STUDY DOCUMENT RETENTION 
8. DATA REPORTING  
9. MONITORING PLAN  
9.1. FREQUENCY 
9.2. SAMPLING PLAN 
9.3. MONITORING TASKS 
9.4. STUDY CLOSE-OUT  
10. LABELING  
11. ETHICAL AND REGULATORY REQUIREMENTS 
11.1. CODE OF CONDUCT 
11.2. INSTITUTIONAL REVIEW BOARDS 
11.3. INFORMED CONSENT 
11.4. SUBJECT CONFIDENTIALITY 
12. INSURANCE AND INDEMNIFICATION  
13. APPENDICS 
 
 

 
 
 
 
 
 
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STUDY SUMMARY 
 
TITLE Taperloc Microplasty vs. Taperloc Standard: Randomized Controlled Study 
on Bone Mineral Density 
DESIGN Multi-Center Comparative Two Armed Randomized Controlled Study 
(Centralized Randomization run by Sponsor) 
PURPOSE The primary purpose of this study is to measure the postoperative changes in 
bone mineral density, comparing the Taperloc Complete Reduced Distal 
Microplasty stem and the standard length Taperloc Complete Reduced Distal 
stem. 
OUTCOME MEASURES The primary outcome measures are the change in bone mineral density in 
the Gruen zones surrounding the stem measured by DEXA and incidence of 
thigh pain. 
The secondary outcome measures are the assessment of leg length and 
femoral offset, to determine the suitability of the implant size range and neck 
geometry, standard clinical scores (i.e. modified Harris Hip Score), 
complications, and survivorship analysis.  
POPULATION 100 Patients: 
50 with Taperloc Complete Reduced Distal stem. 
50 with Taperloc Complete Reduced Distal Microplasty stem 
Up to four sites will be used to enroll patients into this study 
ELIGIBILITY To be included in the study, a patient must be prescribed a primary total hip 
arthroplasty with the Taperloc system. The Taperloc system is to be used in 
accordance to the indications for use and contraindications detailed in the 
approved labeling of the device.  
DURATION 1 year recruitment, and 5 years follow up 
STUDY SPONSOR Zimmer Biomet 
 
 
 
 

 
 
 
 
 
 
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1. INTRODUCTION 
1.1. BACKGROUND 
The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, 
thereby preserving bone density, and preventing long term instability and loosening secondary to 
proximal bone resorption.   The primary aim of this study is therefore to compare the 
postoperative changes in bone density with the Taperloc Microplasty stem, using the standard 
length Taperloc stem as a control. 
In addition, the Taperloc stem has historically had a neck angle of 138°.   There have been 
criticisms that this neck angle is too high for the typical Korean population.    The newer Taperloc 
Complete system (both Microplasty and standard length) has a neck angle of 133°.    A 
secondary aim is occurrence ratio of thigh pain difference between Microplasty and standard 
stem in Korean population 
1.2. DEVICE DESIGN AND DESCRIPTION 
The Taperloc stem is designed after the philosophy of a flat tapered wedge.  It has evolved to 
incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, 
and facilitate multiple surgical techniques. 
The Flat Tapered Wedge Geometry enhances proximal loading, preserves bone, and provides 
rotational stability.  Standard and lateralized options reproduce various patient anatomies without 
lengthening the leg 
The stem is manufactured from Titanium Alloy Ti-6AL-4V, which allows for stress transfer to 
preserve cortical density.  Titanium alloy porous plasma spray coating allows for initial scratch-fit 
stability and bone fixation.   The Reduced Distal Stem Option allows the stem to be used in 
femoral canals with proximal/distal mismatch 
The Microplasty Stem has a stem length reduced by 35 mm.  This accommodates a minimally 
invasive approach, preserves soft tissues and bony structures, and ensures proximal stress 
transfer. 
 
 
 
 

 
 
 
 
 
 
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Product codes for the stems to be used in this study are listed below: 
Full Length, Reduced Distal 
 
Microplasty 
Size 
Standard 
Offset 
High  
Offset 
 
Size 
Standard 
Offset 
High 
Offset 
5x130 
51-100050 
51-101050 
 
5x95 
51-108050 
51-109050 
6x132 
51-100060 
51-101060 
 
6x97.5 
51-108060 
51-109060 
7x134 
51-100070 
51-101070 
 
7x99 
51-108070 
51-109070 
8x136 
51-100080 
51-101080 
 
8x101 
51-108080 
51-109080 
9x137 
51-103090 
51-104090 
 
9x102.5 
51-106090 
51-107090 
10x140 
51-103100 
51-104100 
 
10x105 
51-106100 
51-107100 
11x142 
51-103110 
51-104110 
 
11x107.5 
51-106110 
51-107110 
12x144 
51-103120 
51-104120 
 
12x109 
51-106120 
51-107120 
13x146 
51-103130 
51-104130 
 
13x111 
51-106130 
51-107130 
14x148 
51-103140 
51-104140 
 
14x113 
51-106140 
51-107140 
15x150 
51-103150 
51-104150 
 
15x115 
51-106150 
51-107150 
16x152 
51-103160 
51-104160 
 
16x117 
51-106160 
51-107160 
17x154 
51-103170 
51-104170 
 
17x119 
51-106170 
51-107170 
18x156 
51-103180 
51-104180 
 
18x121 
51-106180 
51-107180 
20x160 
51-103200 
51-104200 
 
20x125 
51-106200 
51-107200 
22x164 
51-103220 
51-104220 
 
22x129 
51-106220 
51-107220 
24x167 
51-103240 
51-104240 
 
24x132 
51-106240 
51-107240 
 
 
 
 
1.3. RATIONALE FOR CURRENT STUDY 
Stress shielding in cementless hip replacement leads to bone resorption.  Not only does that 
increase the likelihood of long term aseptic loosening, but the reduction in bone stock could 
compromise the outcome of revision surgery.  This is particularly important considering that 
cementless components are frequently used preferentially in young patients.  Not only is the 
revision risk for a given implantation time higher with young patients, but life expectancy is higher 
as well.  This means that young patients are much more likely to need revision surgery in their 
lifetime.  Preservation of bone stock in order to keep revision options open is therefore a very 
important consideration.  
One way to preserve the bone stock and to reduce stress-shielding bone resorption of the 
proximal femur is by removing the distal stem of the femoral component and providing 
metaphyseal fixation.  Alternatively, reducing the size of the distal stem could also encourage 
metaphyseal fixation.  The questions arise which is most effective at encouraging proximal load 

 
 
 
 
 
 
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transfer, and whether it is possible to obtain strong and long-lasting fixation of the femoral 
component without diaphyseal anchoring.  
The rationale for this study is therefore to determine whether radiographic results and stress 
shielding are similar between the short and conventional length cementless femoral components 
with identical metaphyseal design.  
1.4. STUDY PURPOSES 
The main objectives of the study are to: 
 
Compare the postoperative changes in bone density with the Taperloc Microplasty stem, 
using the standard length Taperloc stem as a control. 
 
Compare and confirm the stability and fixation of short and standard Taperloc hip 
implants. 
 
Compare clinical scores in patients receiving the short and standard Taperloc stems. 
 
Collect survivorship data 
 
Determine whether the geometry and options available with the Taperloc Complete hip 
system can accurately reconstruct leg length and offset in this patient population. 
2. STUDY DESIGN 
2.1. OVERALL DESIGN 
This study is a multi centre, prospective two-way randomized comparative study, involving 100 
patients, recruited among up to 2 centers (approximately 50 patients from each site). Patients will 
be randomized at the time of surgery into two groups, as detailed below. 
2.2. STUDY GROUPS/TREATMENTS 
The first group will receive a Taperloc Complete Reduced Distal standard length stem, and the 
second group will receive a Taperloc Complete Reduced Distal Microplasty stem. 
2.3. NUMBER OF SITES AND SUBJECTS/PROCEDURES 
The total sample size is 100 hips in 100 patients recruited from up to two sites.   
2.4. EFFICACY AND/OR SAFETY HYPOTHESES  

 
 
 
 
 
 
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There will be no difference of BMD change between both groups. 
2.5. PRIMARY AND SECONDARY ENDPOINTS 
Primary Endpoints: 
 Change in bone mineral density around the implant 
 Incidence of thigh pain 
Secondary Endpoints: 
 Postoperative restoration of femoral offset and leg length 
 Radiographic measurements of stability and fixation 
 Overall Survivorship 
 Harris Hip Score 
 Complications 
2.6. ASSESSMENT PROCEDURE  
2.6.1. ASSESSMENT TIMELINES/SCHEDULE  
 
Pre-op 
Intraop 
Immediate 
Post-op 
6 weeks 
6 months 
1 year 
2 years 
5 years 
Operative Form 
 
X 
 
 
 
 
 
 
Standard 
Radiographs 
X 
 
 
X 
 
X 
X 
X 
DEXA 
 
 
X 
 
 
X 
X 
X 
Modified Harris 
Hip Score 
X 
 
 
 
X 
X 
X 
X 
Thigh pain 
X 
 
 
X 
X 
X 
X 
X 
Complications 
 
Any Time 
 
 
 
 
 
 
 

 
 
 
 
 
 
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2.6.2. ALLOWED WINDOW OF EACH SCHEDULE  
Follow-up Time 
Point 
Allowed Window 
Immediate Post-Op 
+ 1 Week 
 6 weeks 
1-2 Months 
6 months 
+/- 1 Month 
1 Year 
+/- 2 Months 
2 Year 
+/- 3 Months 
5 Year 
+/- 6 Months 
2.7. STUDY DURATION 
The estimated study duration is 6 years with 1 year allotted for site and patient enrollment and 5 
years of active follow-up.  
3. SELECTION AND WITHDRAWAL OF SUBJECTS 
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the 
package insert of Taperloc hip Implants. 
3.1. INCLUSION CRITERIA 
Patients suitable for primary Total Hip Replacement 
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the 
composite diagnoses of: 
a. Osteoarthritis 
b. Avascular necrosis 
c. Legg Perthes 
d. Rheumatoid arthritis 
e. Diastrophic variant 
f. 
Fused hip 
g. Sequelae of slipped capital epiphysis 
h. Traumatic arthritis 
i. 
Patients aged over 20 

 
 
 
 
 
 
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j. 
Patients must be able to understand instructions and be willing to return for follow-up 
             3.2. EXCLUSION CRITERIA 
Absolute contraindications include: infection, sepsis, and osteomyelitis.  
Relative contraindications include:  
a. Uncooperative patient or patient with neurologic disorders who are incapable of following 
directions 
b. Small femoral canal  
c. Severe osteoporosis (patients over 65 years old)  
d. Metabolic disorders which may impair bone formation 
e. Osteomalacia 
f. 
Distant foci of infections which may spread to the implant site 
g. Rapid joint destruction, marked bone loss or bone resorption apparent on 
roentgenogram 
h. Vascular insufficiency, muscular atrophy, or neuromuscular disease 
i. 
Pregnancy  
j. 
Fracture of the pelvis 
k. Subcapital fractures 
3.3. SUBJECT WITHDRAWAL 
It is recognized that the subject’s participation in this study is entirely voluntary, and that she/he 
may refuse to participate and may withdraw from participation at any time without jeopardy to any 
future medical care.  It is also recognized that the investigator, at his/her discretion, may withdraw 
a subject from this study based upon his/her professional judgment.  In event of subject 
withdrawal, applicable local procedures should be followed. 
If a patient is withdrawn or rescinds their consent, a “Lost to Follow-up” case report form (CRF) 
should be completed detailing the reason for the patient withdrawal.  If the patient has not yet 
reached the primary endpoint, the study Sponsor should be contacted to discuss whether or not 
the patient should be replaced.  The site should also notify their Institutional Review Board (IRB) 
if applicable.  If a patient is withdrawn from the study by the investigator, the patient should be 
notified of their removal by a letter from the site.   

 
 
 
 
 
 
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It is required that patients return within the defined follow-up period to complete all study 
assessment forms and radiographs.  Patients that miss or will not return for follow-up are not 
considered “protocol deviations” or “lost to follow-up.”   
4. PROTOCOL DEVIATION MANAGEMENT AND REPORTING 
Any deviation from the protocol should be documented on the “Protocol Deviation” CEF.  Protocol 
Deviations should be reported to the study Sponsor within ten days of knowledge of the reported 
event. 
5. ADVERSE EVENT MANAGEMENT AND REPORTING 
Any adverse event, according to definitions section 18, should be documented on the “Complication” 
CRF.  A record of all adverse events, including details of the nature, onset, duration, severity, 
relationship to the device, relationship to the operative procedure and outcome, will be made on the 
relevant section(s) of the subject’s CRF.  
Complications should be reported to the study Sponsor within ten days of knowledge of the reported 
event.  If the event is considered an unanticipated adverse event, it should be reported to the study 
Sponsor within 5 days of knowledge of the reported event. 
6. DATA ANALYSES 
6.1. SAMPLE SIZE JUSTIFICATION  
We performed a sample size calculation based on detecting a difference in the incidence of 
postoperative thigh pain between the 2 study groups, assuming an overall α error (2 sided) of 5% 
with a statistical power of 80% (β error = .20). We assumed that the incidence of thigh pain in the 
conventional femoral implant group would be 15% compared to 5% in the short anatomical 
femoral implant group at 2-year follow-up. With these assumptions, approximately 40 patients per 
study group were needed. 
6.2. DESCRIPTION OF STATISTICAL ANALYSES 
Significance Levels 
The Type I error rate for the primary study analysis will be 0.05.  
Comparisons for secondary, exploratory, and safety analyses will use α = 0.05, with no 
adjustment for multiple comparisons. 

 
 
 
 
 
 
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Models for Continuous Measures 
Comparisons of study groups with regard to continuous baseline and secondary outcomes will be 
performed using standard statistical tests and will be chosen as appropriate for the scale and 
distribution of the measures being analyzed.  For example, a t-test, Wilcoxon test, or one-way 
ANOVA (as appropriate) can be performed to assess differences.   
Categorical Data Analyses 
Comparisons of study groups with regard to categorical baseline, secondary and safety outcomes 
will be performed using standard statistical tests and will be chosen as appropriate for the scale 
and distribution of the measures being analyzed.   
Exploratory Analyses 
Exploratory Analyses described below will be carried out if possible, depending on the data.  If 
empty cells exist or models do not converge, these analyses will not be performed. 
Repeated measures ANOVA models will be developed for each of the Gruen Zones to determine 
the effect of visit (time), treatment and baseline value of BMD on the BMD results.  Baseline 
factors may also be included.  To determine whether a factor has an effect on the BMD results, a 
Type 3 analysis of effects based on the F test will be conducted. Hypothesis testing will use α = 
0.05. 
7. DATA COLLECTION, HANDLING AND RETENTION 
7.1. SOURCE DOCUMENT REQUIREMENTS 
Source documentation for this study will be maintained to document the treatment and study 
course of a subject and to substantiate the integrity of the study data. Source documentation may 
include, but not be limited to, worksheets, hospital and/or clinic or office records documenting 
subject visits including study and other treatments or procedures, medical history and physical 
examination information, laboratory and special assessments results, pharmacy records, device 
accountability records, and medical consultations (as applicable). 
Before the study starts, a record of the source document for each endpoint will be recorded and 
kept at the site and with the Sponsor.  If for any reason this source document changes, the record 
will need updated, and communicated to the Sponsor. 
 

 
 
 
 
 
 
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7.2. CASE REPORT FORMS 
Data for this study will be collected and documented on the subject Case Report Forms (CRFs) 
provided which may be in paper form or in an electronic form.  Authorized study site personnel 
will complete CRFs only. CRFs must be reviewed for completeness and accuracy, and signed by 
the investigator or his/her designees.  
Since there is a potential for errors, inaccuracies, and misinterpretation in transcribing data onto 
the CRFs, the following documents must be available at all times for inspection and comparison 
to the CRFs by the study monitor when appropriate: 
 
data query forms 
 
originals and photocopies/certified copies of all relevant records and reports 
 
copies of test results 
Sample CRFs to be used with this study are provided in Appendix 2. 
7.3. ELECTRONIC DATA ENTRY 
When using electronic data handling and/or remote electronic data systems, the Sponsor should: 
 
Ensure and document that the electronic data processing system(s) conforms to the 
Sponsor’s established requirements for completeness, accuracy, reliability, and 
consistent intended performance (i.e. validation). 
 
Maintain SOPs for using these systems. 
 
Ensure that the systems are designed to permit data changes in such a way that the data 
changes are documented and that there is no deletion of entered data (i.e. maintain an 
audit trail, data trail, edit trail). 
 
Maintain a security system that prevents unauthorized access to the data. 
 
Maintain a list of the individuals who are authorized to make data changes. 
 
Maintain adequate backup of the data. 
 
Safeguard the blinding, if any (e.g. maintain the blinding during data entry and 
processing). 
7.4. STUDY DOCUMENT RETENTION 
Study documents should be retained for a season after the study is complete as required by local, 
state, national, or international health authorities. 

 
 
 
 
 
 
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8. DATA REPORTING  
The site will provide study progress and data summary reports to the Sponsor per frequency agreed 
by both parties. 
9. MONITORING PLAN  
The Sponsor of this study may monitor the data collection to ensure that the study is being conducted 
consistent with the protocol. The following describes the monitoring activities, which may take place 
during the course of the study. 
9.1. FREQUENCY 
Pre-Study Visit/Conference: 
Prior to initiation of the study, the study manager will provide the investigator with all the 
necessary information to enable him/her to carry out his/her responsibilities.  This prepares 
the site with an in-depth training on the protocol, CRFs, and data collection process for the 
length of the study.  The study manager will also train the site on using the Sponsor’s Joint 
Assist database.  
Monitoring of the Data 
Monitoring of the data will occur at least annually, and as often as monthly.  Times when this may 
be appropriate include: 
 
Monthly Invoicing 
 
Quarterly Review 
 
Annual Reports 
 
While performing data analysis for marketing material or publication. 
9.2. SAMPLING PLAN 
 
All data will be monitored for completeness and accuracy on at least an annual basis. 
9.3. MONITORING TASKS 
The Sponsor will continually monitor the progress of the study.  These activities include: 
 
Tracking of patient enrollment 
 
Review of all electronic patient data forms received for completeness 

 
 
 
 
 
 
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 
Tracking of patients to ensure follow-ups are being completed at appropriate 
intervals 
 
Review of all adverse reactions 
 
Maintaining open communication with all investigational sites in order to 
ensure the quality of the study. 
 
In-house audits as needed 
Upon completion of any type of monitoring, the site is responsible for resolving all 
discrepancies found in a timely manner.   All discrepancies found within the Joint Assist 
database will be queried and sent directly to the site.  Delays in resolving queries are to 
be avoided at all costs; this provides the study with the most accurate data, prevents 
delay in reporting procedures & publication, and safeguards in the event of an audit by 
the relative regulatory authority in the region. 
9.4. STUDY CLOSE-OUT  
When a site has completed their data collection, a visit may be necessary by a Sponsor’s 
monitor to ensure all data has been obtained.  Data will be reviewed for completeness, and 
monitored to ensure that all discrepancies have been resolved. 
10. LABELING  
The devices and products will be used in accordance with their instructions for use and/or approved 
labeling.  The package insert for the device(s) in this study is included in the Investigator Binder. 
11. ETHICAL AND REGULATORY REQUIREMENTS* 
12.1. CODE OF CONDUCT 
The investigator will ensure that the clinical study is conducted in accordance with  
1. Protocol 
2. Regulatory and IRB requirements  
3. ISO 14155, GCP 
This study is for academic purposes and safety of the products will also be assessed.  
12.2. INSTITUTIONAL REVIEW BOARDS 

 
 
 
 
 
 
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The investigator must obtain appropriate Institutional Review Board (IRB) approval before the 
study can be initiated.  A copy of the written approval from the IRB and a copy of the approved 
informed consent form should be sent to the Sponsor.  A list of the IRB members (including their 
institution affiliations, gender makeup, and occupations); or a statement from the IRB specifying 
that the membership comply with applicable regulations is to be provided to the Sponsor.  This 
must be done on an annual basis and copies sent to the Sponsor as long as the study is open at 
the site. 
Any changes to the protocol must be discussed and approved by the Sponsor in writing unless 
the change is made to assure the safety of the subject.  In the non-emergent setting, after 
agreement on the changes has been reached, an amendment to the protocol will be provided by 
the Sponsor for submission to the IRB for review and approval prior to initiation of the change. 
Any change made emergently must be documented in the subject's medical record and reported 
to the Sponsor within the time period required by IRB and applicable regulations. 
The investigator must immediately forward to the IRB any written safety reports or updates from 
the Sponsor. 
The investigator must keep the IRB informed of the progress of the study as required by the IRB 
but at least annually. 
12.3. INFORMED CONSENT 
Subjects (or the subject's legally authorized representative) will be provided with an informed 
consent and patient information sheet in order to give ample opportunity to review the consent 
and ask questions. The signed informed consent will be obtained before any study procedures 
begin. If the subject agrees to participate in the study, the subject/representative must sign the 
informed consent form.  The witness and the investigator must also sign the informed consent 
form.  A copy of the informed consent form should be given to the subject/representative. All 
subjects who meet all of the entry criteria will be considered for inclusion in this study. Any 
subject meeting any of the exclusion criteria will be excluded from the study. 
The informed consent form must be approved by the institution’s IRB.   
Subjects will be informed of new information learned during the study, which may affect the 
subject’s decision to continue participation in the study. 

 
 
 
 
 
 
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An Informed Consent Log will be completed to document the existence of the signed informed 
consent form.  The log will contain: Subject ID, date informed consent form signed, and the 
version signed.  The monitor will initial and date the log once the executed informed consent form 
has been reviewed.  Signed informed consent forms (or copies) are to be maintained in the study 
file and must be available for verification by monitors or inspectors. 
12.4. SUBJECT CONFIDENTIALITY 
The CRFs do not include any patient identifying information.  Therefore, once the data is entered 
in the online database a patient can no longer be identified. 
Once the site enters a patient into Joint Assist, the database will assign the patients an ID 
number.  It is the responsibility of the investigator to maintain a list of patient identification and 
Joint Assist ID numbers throughout the course of the study.  By assigning patients a unique ID 
number, their identity is protected in Joint Assist, the online database.  The database is restricted, 
allowing an investigator to only view and enter data from his/her patients.  User authentication is 
required to view research data.  The data is transmitted to a centralized database through a 
secured (SSL) channel on the Internet.  Data in transit is in 128-bit encryption.  The access to the 
centralized database is limited to those who are responsible for maintaining the database. 
12. INSURANCE AND INDEMNIFICATION  
This arrangement will be negotiated by site in their investigator agreement. 
13. APPENDICS 
Appendix 1 Informed Consent Draft for Use in Submission to IRB 
Appendix 2 Case Report Forms 
Appendix 3 Regulatory Approval Info / Package Insert 
Appendix 4 Surgical Technique & Product Brochures 
GLOSSARY OF ABBREVIATIONS 
DEXA:  Dual Energy X-ray Absorptiometry