Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Conditions: Avascular Necrosis, Osteoarthritis, Hip, Inflammatory Arthritis, Post-Traumatic Osteoarthritis of Hip
Sponsor: Zimmer Biomet

CLINICAL INVESTIGATION PLAN 
CIP ID: CME2010-25H 
NCT03672929 
 
Allofit® IT with HXPE in Total Hip Arthroplasty 
 
A multi-center, prospective, non-controlled post market 
surveillance study 
 
Revision 01 
02. February 2011 
 
 
STUDY SPONSOR 
 
Zimmer GmbH 
Sulzerallee 8 
P.O. Box 
CH-8404 Winterthur 
Switzerland 
Tel. +41 52 262 79 71 
 

 
François Geiger, 02.02.2011, Rev. 01 
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Table of Content 
1 
CONTACT INFORMATION/ LIST OF INVESTIGATORS ........................................................ 4 
2 
STUDY SYNOPSIS ................................................................................................................... 5 
3 
STUDY PROCEDURE FLOWCHART ...................................................................................... 7 
4 
DATA COLLECTION OVERVIEW ............................................................................................ 8 
5 
INTRODUCTION ....................................................................................................................... 9 
6 
STUDY OBJECTIVES ............................................................................................................. 11 
7 
STUDY DESIGN ...................................................................................................................... 12 
7.1 
GENERAL .......................................................................................................................... 12 
7.2 
STUDY DURATION .............................................................................................................. 13 
8 
STUDY POPULATION ............................................................................................................ 13 
9 
STUDY OUTCOME MEASURES/ ENDPOINTS ..................................................................... 14 
9.1 
OUTCOME MEASURES/ ENDPOINTS .................................................................................... 14 
10 
DATA COLLECTION & MANAGEMENT................................................................................ 15 
10.1 
CASE REPORT FORMS ....................................................................................................... 15 
10.2 
GENERAL INSTRUCTIONS FOR COMPLETION OF CASE REPORT FORMS ................................. 16 
10.3 
PATIENT PRIVACY AND IDENTIFICATION ............................................................................... 16 
10.4 
SUBMISSION OF CASE REPORT FORMS / X-RAYS ................................................................ 17 
10.5 
MONITORING VISITS ........................................................................................................... 17 
10.6 
DATA ENTRY ..................................................................................................................... 17 
11 
STUDY PROCEDURE ............................................................................................................. 18 
11.1 
OFFER STUDY PARTICIPATION ............................................................................................ 18 
11.2 
PATIENT ENROLLMENT LOG................................................................................................ 18 
11.3 
DETERMINATION OF ELIGIBILITY .......................................................................................... 18 
11.4 
INFORMED CONSENT.......................................................................................................... 18 
11.5 
BASELINE/PRE-OPERATIVE ASSESSMENT ............................................................................ 19 
11.6 
SURGICAL TECHNIQUE ....................................................................................................... 19 
11.7 
SURGERY UNTIL DISCHARGE ASSESSMENT ......................................................................... 19 
11.8 
FOLLOW-UP PROCEDURES (DATA COLLECTION) .................................................................. 20 
11.9 
MINIMIZATION OF SUBJECTS LOST TO FOLLOW-UP............................................................... 20 
11.10 RADIOGRAPHIC DEFINITIONS AND METHODS ....................................................................... 21 
11.11 REPORTING OF ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ..................................... 22 
12 
IMPLANT INFORMATION ...................................................................................................... 22 
12.1 
DESCRIPTION OF THE DEVICE ............................................................................................. 22 
12.2 
RISKS ............................................................................................................................... 23 
13 
STATISTICAL CONSIDERATIONS/ EVALUATION .............................................................. 23 
13.1 
ANALYSIS OBJECTIVES ....................................................................................................... 23 
13.2 
VARIABLES FOR ANALYSIS .................................................................................................. 24 
13.3 
SAMPLE SIZE JUSTIFICATION .............................................................................................. 25 
14 
MANAGEMENT OF INCURRENT EVENTS ........................................................................... 25 
14.1 
DEFINITIONS ...................................................................................................................... 25 
14.2 
REPORTING AND DOCUMENTATION OF ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ... 26 
14.3 
REPORTING AND DOCUMENTATION OF SERIOUS ADVERSE EVENTS AND SERIOUS ADVERSE 
DEVICE EFFECTS ............................................................................................................... 26 

 
François Geiger, 02.02.2011, Rev. 01 
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14.4 
RECOMMENDED REVISION PROCEDURE .............................................................................. 27 
14.5 
DOCUMENTATION AND REPORTING FLOW CHART ................................................................ 29 
14.6 
PATIENT WITHDRAWAL ....................................................................................................... 30 
14.7 
LOST TO FOLLOW-UP ......................................................................................................... 30 
14.8 
PROTOCOL DEVIATION ....................................................................................................... 30 
14.9 
TERMINATION OF THE TRIAL ............................................................................................... 30 
15 
QUALITY CONTROL AND QUALITY ASSURANCE ............................................................. 30 
16 
ETHICS AND REGULATORY ................................................................................................. 31 
16.1 
STANDARDS ...................................................................................................................... 31 
16.2 
ETHICS COMMITTEE APPROVAL .......................................................................................... 31 
16.3 
PATIENT INFORMATION AND CONSENT ................................................................................ 31 
16.4 
INDEMNITY......................................................................................................................... 32 
17 
AMENDMENT TO CLINICAL INVESTIGATION PLAN .......................................................... 32 
18 
PUBLICATION POLICY .......................................................................................................... 32 
19 
SIGNATURES ......................................................................................................................... 32 
20 
REFERENCES ........................................................................................................................ 33 
APPENDIX A 
LIST OF INVESTIGATORS ............................................................................... 37 
APPENDIX B 
CASE REPORT FORMS (CRF) ........................................................................ 39 
APPENDIX C 
PATIENT INFORMATION AND PATIENT CONSENT ..................................... 58 
APPENDIX D 
INVESTIGATOR’S CONSENT TO THE CLINICAL INVESTIGATION PLAN .. 63 
 

 
François Geiger, 02.02.2011, Rev. 01 
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1 
Contact Information/ List of Investigators 
 
Sponsor: 
Zimmer GmbH 
 
Clinical Investigators: 
See Appendix A 
 
Clinical Study Manager: 
François Geiger, CRA 
On-site Monitoring: 
François Geiger, CRA 
Data-Management: 
Zimmer Warsaw 
Statistical Analysis: 
Zimmer Warsaw and Winterthur 
Quality Assurance: 
Dr. Hassan Achakri, Director Intl Clinical Affairs 
 

 
François Geiger, 02.02.2011, Rev. 01 
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2 
Study Synopsis 
 
Title: Allofit® IT with HXPE in Total Hip Arthroplasty 
A multi-center, prospective, non-controlled post market surveillance 
study 
Sponsor: Zimmer GmbH 
Objectives/ 
Endpoints: 
The objectives of this study are to obtain survival and outcome data 
on the Allofit IT Shell in combination with the Longevity® Liner when 
used in primary total hip arthroplasty. This will be done by analysis of 
standard scoring systems, radiographs and adverse event records. 
Data will be used to monitor pain, mobility and survivorship, and to 
confirm the safety and performance of the Allofit IT HXPE Bearing 
System.  
Safety will be evaluated by monitoring the frequency and incidence 
of adverse events. 
Performance will be determined by comparing the overall pain and 
functional performances, survivorship, subject quality-of-life and ra-
diographic parameters of study subjects who received the Allofit IT 
HXPE Bearing System. 
Pain and functional performance will be measured using the Harris 
Hip Score, survivorship will be based on removal or intended remov-
al of the device, subject quality-of-life will be determined by evalua-
tion of the Oxford Hip Score, and radiographic parameters by analy-
sis of x-rays. 
Indication/ 
Target Popula-
tion: 
Patients, suffering from severe hip pain and disability requiring total 
hip arthroplasty, who meet the inclusion/ exclusion criteria (see Sec-
tion 8). 
Study Design: Multi-center, prospective, non-controlled  
Clinical Phase: Post-market 
Number of Sub-
jects: 
A total of 200 patients will be enrolled in this study 
Length of Study: 12 years (2 year enrollment plus 10 years follow-up): follow-up visits 
at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively. 
Study Device: Allofit IT Shell in combination with: 

 
François Geiger, 02.02.2011, Rev. 01 
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HXPE Articulation:  
 
 
Longevity Liner with either Metal 
 
 
 
 
 
or Ceramic compatible Femoral 
 
 
 
 
 
Heads  
Femoral Component:  
 
Alloclassic® Zweymüller Hip  
 
 
 
 
 
Stem or CLS® Spotorno®,  
 
 
 
 
 
Avenir® Müller Stem, or  
 
 
 
 
 
Fitmore® Stem 
Scores: Harris Hip Score (HHS); Oxford Hip Score; EuroQol (EQ-5D) 
Safety Assess-
ments: 
Safety will be assessed by appropriate recording and reporting of 
adverse events throughout the study. All system components are CE 
marked and commercially available. 
Statistical Analy-
sis 
Data collected will be summarized and reported to each participating 
Investigator. Statistical analysis is conducted by Zimmer or its de-
signee. 
Documentation: Paper / electronic 
 
This Clinical Investigation Plan is written in accordance with the ISO 14155 Standard for 
the Clinical Investigation of Medical Devices (part 1 and 2) [1;2]. 

 
François Geiger, 02.02.2011, Rev. 01 
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3 
Study Procedure Flowchart 
 
6-12 WE -10 YEARS  POST-OP 
Investigator to complete 
Inclusion/ Exclusion (1), 
Demographic Evaluation (2), 
Physical Exam (5), Harris Hip 
Score (9), Concomitant 
Medication Record (10) and 
Radiographic Eval Form (11) 
Provide Patient 
Information & 
collect Informed 
Consent 
Did Patient agree 
& sign 
Informed Consent? 
Is the patient a 
candidate for total 
hip arthroplasty? 
Preoperative Examination 
YES 
Do not consider 
patient for study 
NO 
YES 
NO 
Investigator to complete 
Operative Form (3) and 
Radiographic Eval Form (11) 
Investigator to complete 
Immediate Postoperative 
Evaluation (4) 
At 6 months, 1, 2, 3, 5, 7, and 
10 years, Investigator to 
complete Physical Exam (5), 
Harris Hip Score (9), 
Concomitant Medication 
Record (10), and 
Radiographic Eval Form (11) 
At 6 months, 1, 2, 3, 5, 7 and 
10 years, Patient to complete 
Oxford Hip Score (17), 
Patient Activity Questionnaire 
(7), and EQ-5D (8) 
Subject Terminated 
If a patient is lost to follow-
up or withdraws from the 
study for another reason, 
a Study Completion Form 
(14) must be completed 
 
Adverse Events 
If a complication/adverse 
event occurs, an Adverse 
Events Report (12) must 
be completed 
 
Explanted Devices 
If one or more of the 
components are revised, 
an Explanted Device Form 
(15) must be completed 
 
Protocol Deviations 
If a deviation from the 
protocol occurs, a Protocol 
Deviation Form (13) must 
be completed 
END  
PRE-OPERATIVE 
INTRA-OP 
IMMED. POST-OP 
Do not consider 
patient for study 
Patient to complete Oxford 
Hip Score (17), Patient Activity 
Questionnaire (7), and EQ-5D 
(8) 
Does Patient meet 
all of the inclusion 
and none of the 
exclusion criteria?
Patient is not 
eligible for study 
NO 
YES 

 
François Geiger, 02.02.2011, Rev. 01 
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4 
Data Collection Overview 
The following table indicates the forms to be completed at a certain time point: 
 
Form Name 
Pre-op 
Surgery 
Immediate 
Post-op 
6 month (± 
1 month) 
1, 2, 3, 5, 7, 10 
years post-op  
(± 2 months) 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion 
Criteria (pages 1 & 2) 
X 
 
 
 
 
Demographic 
Evaluation 
X 
 
 
 
 
Operative 
Information (pages 1 
& 2) 
 
X 
 
 
 
Immediate Post-op 
Evaluation 
 
 
X 
 
 
Physical Exam 
X 
 
 
X 
X 
Oxford Hip Score 
● 
 
 
● 
● 
Patient Activity 
Questionnaire 
● 
 
 
● 
● 
EQ-5D 
● 
 
 
● 
● 
Harris Hip Form 
X 
 
 
X 
X 
Concomitant 
Medication Record 
X 
 
 
X 
X 
Radiographic 
Evaluation (pages 1 
& 2)  
X 
X 
 
X 
X 
Adverse Event 
^ 
^ 
^ 
^ 
^ 
Protocol Deviation 
^ 
^ 
^ 
^ 
^ 
Study Completion 
^ 
^ 
^ 
^ 
^ 
Explanted Device 
 
^ 
^ 
^ 
^ 
 
X 
Form completed by Investigator or designee 
● 
Form is completed by patient 
^ 
Form is completed when indicated 

 
François Geiger, 02.02.2011, Rev. 01 
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5 
Introduction 
Total hip arthroplasty (THA) is a medical procedure where an arthritic, degenerative or 
fractured total hip joint is replaced with a prosthetic device. Since the inception of modern 
THA in 1961 [3], THA has become a widely accepted orthopedic procedure. In 2006, 
533,000 total hip replacements were performed in Germany, France, Great Britain, and 
Italy [4] alone after non-operative treatment of a dysfunctional hip had failed to provide 
relief from painful and debilitating symptoms. Traditionally, THA was performed on 
patients between 60 and 75 years old [5]. Due greatly to continuous improvement in 
implant design, the range of THA patients has broadened to include both young and very 
old patients [5;6].  
Major indications of THA include osteoarthritis, rheumatoid arthritis, avascular necrosis 
and hip fractures [6]. The THA surgical procedure involves replacing the head of the femur 
and acetabulum or socket with an artificial prosthesis. This system is composed of a 
femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral 
stem, and an acetabular component or shell that replaces the acetabulum.  
Ultimately, returning patients to a normal routine that affords them the freedom of mobility 
without pain and stiffness is the optimal goal of a THA procedure. Improving the overall 
quality of patients’ lives, THA has an 84-90% patient satisfaction rate [3;7-9] and implant 
survival of up to 90% [10-16], as reported in published literature.  
The Allofit IT Acetabular System incorporates a proven exterior shell structure possessing 
15 years of history, with advanced bearing surfaces. Over 300,000 Allofit Acetabular 
Shells have been implanted since its initial clinical launch in 1994 [17].  
Polyethylene was first used in articular joints in 1962 when Sir John Charnley implanted a 
hip prosthesis that included a high-density, high-molecular weight polyethylene 
component. After failed attempts with other materials, this high-density polyethylene 
proved adequate for low-demand patients. But as joint-replacement surgery became more 
common on younger and more active patients, demands increased and articulating 
surfaces required a more durable material.  
Today, Ultra-High Molecular Weight Polyethylene (UHMWPE) is the material used in a 
majority of orthopaedic bearing components. The success of this higher molecular weight 
polyethylene is due to many favorable properties, including abrasion resistance, impact 
strength, low coefficient of friction, chemical inertness, and resistance to stress cracking.  
 

 
François Geiger, 02.02.2011, Rev. 01 
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As researchers gain a better understanding about the important role played by this 
bearing material in determining the longevity of prosthetic joints, and as the physical 
demands of bearing surfaces continue to increase, implant manufacturers are searching 
for ways to further improve the performance of polyethylene. The primary concern 
regarding polyethylene performance is wear damage and the impact of polyethylene wear 
debris on the arthroplasty, as well as on the surrounding tissue.  
Although total hip replacements are known to survive more than 15 years [18-22] there is 
growing evidence showing that debris from polyethylene may be a limiting factor in the 
service life of some implants. [23-26] These concerns center around osteolysis and 
subsequent aseptic loosening, which have been reported to be associated with wear 
debris from polyethylene and other sources. [27;28] In total hip components, the wear 
particles typically generated are smaller than 1μm (micron) and are therefore referred to 
as submicron particles. These are generated by both abrasive wear and adhesive wear of 
polyethylene, as are larger particles. 
Preliminary research shows that submicron particles are more likely to result in a host 
response than are larger particles. Furthermore, the greater the number of sub-micron 
particles the greater the host response. [28] A study found that 85 percent of the 
polyethylene particles from hips were less than 1μm in diameter [29]. Four percent of the 
particles in hips were larger than 2μm.  
In addition to the raw material used, processing, design of the implants, and the 
sterilization and packaging of the implants are further factors that determine the ultimate 
performance characteristics of a given orthopaedic implant manufactured from 
polyethylene. Longevity HXLPE is manufactured by subjecting conventional UHMWPE to 
high-dose electron beam radiation, followed by melt-annealing. This process fully 
crosslinks broken molecular chains in the polymer, leaving virtually no free radicals to 
promote oxidation. This process creates a 3-dimensional structure that is more resistant to 
abrasion and a ten-fold wear rate reduction compared to conventional polyethylene 
control samples ([30]) 
Since 1995, numerous in vitro studies have been published suggesting improved wear 
resistance (increased surface hardness) and increased resistance to creep (decreased 
ductility) of crosslinked polyethylene compared to non-crosslinked conventional 
polyethylene ([31-33]). Clinical reports in the literature have confirmed decreases in 
abrasive wear, creep, and generation of particle wear debris, as demonstrated by the data 
reported in the selected literature ([34-38]) on Longevity HXLPE liners used in Trilogy 
shells. 

 
François Geiger, 02.02.2011, Rev. 01 
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The subject of this clinical investigation is the Allofit IT Shell in combination with the 
Longevity Liners in primary total hip arthroplasty. This system consists of a cementless 
modular Acetabular Shell, a modular liner, and a modular femoral head. The 
characteristics of this THA system may allow for reduction in wear and osteolysis as 
compared to other approved and marketed THA systems and thus increase the expected 
implant life. 
 
6 
Study Objectives 
The objective of this study is to obtain survival and outcome data on the Allofit IT Shell in 
combination with Longevity Liners in primary total hip arthroplasty. This will be done by 
analysis of standard scoring systems, radiographs and adverse event records. Data will 
be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy 
of the Allofit IT with HXPE in primary total hip arthroplasty.  
a) Safety: 
Will be evaluated by monitoring the frequency and incidence of adverse events 
(AE), serious adverse events (SAE), adverse device effects (ADE) and serious 
adverse device effects (SADE) 
b) Efficacy: 
Will be determined by comparing the overall pain and functional performances 
(based on the Harris Hip Scoring system), survivorship, subject quality-of-life and 
radiographic parameters (radiolucencies, osteolysis, subsidence, cup migration, 
change in cup angle and change in femoral shaft angle) of study subjects who 
received the Allofit IT Acetabular System 
a. Pain and Functional Performance:  
 
Measurements will be based on the Harris Hip Scoring (HHS) System [39] 
b. Subject Quality-of-Life: 
 
Will be determined by the Oxford Hip Score [42] and the EQ-5D [41] 
c. Radiographic parameters: 
X-rays will be evaluated for radiolucencies, cup migration, osteolysis, 
subsidence, and change in cup angle 
d. Survivorship: 

 
François Geiger, 02.02.2011, Rev. 01 
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Based on removal or intended removal of the device and will be determined 
using the Kaplan-Meier method 
The data will meet Zimmer’s obligation to collect device vigilance and post market 
surveillance information for European regulatory bodies. 
 
7 
Study Design 
7.1 
General 
The study design is a multi-center, prospective, non-controlled, consecutive cohort post-
market clinical follow-up study involving orthopedic surgeons skilled in total hip 
arthroplasty and experienced with the implants subject of this study. In total, 5 centers will 
be involved. This number of clinical sites will permit assessment of the consistency among 
a multitude of Investigators. A total number of 200 subjects will be included in the study. It 
is anticipated that each clinical site will enroll 40-60 eligible study subjects, who have 
provided written informed consent.  
Ethics Committee (EC) approval for each site has to be obtained prior to conducting this 
research. Sequentially, all eligible patients will be offered study enrollment at each center 
to avoid potential selection bias. All potential subjects will be required to participate in an 
informed consent process and sign an EC approved written informed consent prior to 
study enrollment. It is anticipated the enrollment period may be 12 months or longer to 
assure an adequate number of cases at each site.  
Each case enrolled will receive an Allofit IT HXPE Bearing System. The study is designed 
to be prospective to ensure that the study population is representative of the type of 
population that the device is intended to treat. The subjects included will be candidates for 
an Allofit IT HXPE Bearing System. All system components are CE-marked and 
commercially available. Patients will be selected according to the subject selection criteria 
described in section 8. 
All subjects will undergo preoperative clinical, functional and radiographic evaluations, 
total hip arthroplasty, immediate post-operative evaluations and post-operative clinical, 
functional and radiographic evaluations at 6 months (± 1 month), 1 year (± 2 months), 2 
year (± 2 months), 3 year (± 2 months), 5 year (± 2 months), 7 year (± 2 months), and 10 
year (± 2 months).  

 
François Geiger, 02.02.2011, Rev. 01 
page 13 of 64 
7.2 
Study Duration 
After the initial visit followed by the surgery, the patient is expected to participate in the 
study for a time period of 10 years. Cases will be recruited during a period of 24 months, 
and the study will last until complete collection of the 10 years follow-up data. 
 
8 
Study Population 
The study population will be comprised of 200 males and females who require primary 
total hip arthroplasty. Subjects will be enrolled at 5 investigative centers. Subjects must be 
geographically accessible throughout the study and be willing and able to attend required 
follow-up appointments. Candidates who express interest in study participation will be 
offered informed consent, and eligibility will be determined based upon the 
inclusion/exclusion criteria.  
 
A. Inclusion Criteria 
• Patient is 18 to 75 years of age, inclusive. 
• Patient is skeletally mature. 
• Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based 
on physical exam and medical history including the following: 
o Avascular necrosis (AVN) 
o Osteoarthritis (OA) 
o Inflammatory arthritis (i.e. Rheumatoid arthritis) 
o Post-traumatic arthritis 
• Patient has no history of previous prosthetic replacement device (any type, including 
surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s). 
• Patient has a Harris Hip Score <70 in the affected hip 
• Patient is willing and able to provide written informed consent. 
• Patient is willing and able to cooperate in the required post-operative therapy. 
• Patient is willing and able to complete scheduled follow-up evaluations as described 
in the Informed Consent. 
• Patient has participated in the Informed Consent process and has signed the Ethics 
Committee approved informed consent. 
 
B. Exclusion Criteria 
• The patient is:  

 
François Geiger, 02.02.2011, Rev. 01 
page 14 of 64 
o A prisoner 
o Mentally incompetent or unable to understand what participation in the 
study entails 
o A known alcohol or drug abuser 
o Anticipated to be non-compliant. 
• The patient has a neuromuscular disorder, vascular disorder or other conditions that 
could contribute to prosthesis instability, prosthesis fixation failure, or complications 
in postoperative care. 
• The patient has a vascular (large and small vessel disease) insufficiency.  
• The patient has a neurologic condition in the ipsalateral or contralateral limb which 
affects lower limb function. 
• The patient has a diagnosed systemic disease that could affect his/her safety or the 
study outcome. 
• The patient is known to be pregnant. 
• The patient is unwilling or unable to give informed consent, or to comply with the 
follow-up program. 
• The patient has received an investigational drug or device within the previous 6 
months. 
• The patient has an active or latent infection in or about the affected hip joint or an 
infection distant from the hip joint that may spread to the hip hematogenously. 
• The patient has insufficient bone stock to fix the component. Insufficient bone stock 
exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and 
radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess 
the presence of adequate bone stock.  
• The patient has osteoradionecrosis in the operative hip joint 
• The patient has a known sensitivity or allergic reaction to one or more of the 
implanted materials. 
• The patient has known local bone tumors in the operative hip. 
• The patient is Grade III obese with a Body Mass Index (BMI) > 40. 
 
9 
Study Outcome Measures/ Endpoints 
The aim of the Allofit IT with HXPE is to restore function and gait, and alleviate pain in the 
long-term.  
9.1 
Outcome Measures/ Endpoints 
• Pain and Functional Performance (HHS) [39] 

 
François Geiger, 02.02.2011, Rev. 01 
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• Safety (adverse events)  
• Survivorship (Kaplan Meier) 
• Subject Quality-of-Life (Oxford Hip Score) [42] and EQ-5D [41] 
• Radiographic parameters (Radiolucencies, cup migration, osteolysis, subsidence, 
and change in cup angle 
 
10 Data Collection & Management 
10.1 Case Report Forms 
The data will be collected on study specific Case Report Forms (CRF) provided by the 
Sponsor (see Appendix B).  
It is a requirement that two sets of CRFs are completed for patients having bilateral hip 
replacement. 
The following information and data will be collected on all hips entered into the study: 
The Inclusion/Exclusion Criteria Form (form 1) determines if the patient meets all 
inclusion criteria and none of the exclusion criteria.  
The Demographic Evaluation Form (form 2) collects demographic data, diagnosis, and 
relevant medical and surgical history. 
The Operative Information (form 3A and B) collects details on the surgical approach, 
anesthesia, OR time, blood loss and the implant components.  
The Immediate Postoperative Evaluation Form (form 4) is completed at the first post-
operative appointment. This form gathers data on length of hospital stay, discharge 
disposition, and deep vein thrombosis (DVT) prophylaxis. 
The Physical Exam Forms (form 5) collects the patient weight, leg length discrepancy, 
Trendelenburg and Charnley Classification.  
The Oxford Hip Score (form 17) consists of 12 questions specific to the hip and is a 
patient completed form [42].  
The Patient Activity Questionnaire (form 7) collects data on patient activity level and 
patient satisfaction of the outcome. This form is completed by the patient.  
The EQ-5D (EuroQol) Questionnaire (form 8) is completed by the patient and assesses 
his/her general health status. The EQ-5D is used to derive a quality of life index used for 
health economics considerations [41]. 

 
François Geiger, 02.02.2011, Rev. 01 
page 16 of 64 
The Harris Hip Form (form 9) ascertains the patient’s level of pain, activity level and post 
surgical satisfaction. This form should be completed by the Investigator [42].  
The Concomitant Medication(s) Form (form 10) collects details on the medication given 
to the patient.  
The Radiographic Evaluation 1 and 2 Form (form 11A and B) is completed by the 
Investigator or its designee upon review of the protocol required x-rays.  
The Adverse Events Report (form 12) is completed as needed for each patient 
complication noted. A separate form is completed for each complication. Multiple 
complications per visit are to be recorded on one form. 
The Protocol Deviation Form (form 13) collects information on the reason for the 
protocol deviation. 
The Study Completion Form (form 14) is completed when the patient completes the 
study. If there is a change to the active participation of a patient in the study, it is 
necessary to complete this form. Examples include lost-to-follow-up, death, refusal to 
return for an assessment, or withdrawal from a study.  
The Explanted Device Form (form 15) is completed by the Investigator or his/her 
designee and details reason and results on explanted devices.  
 
10.2 General Instructions for Completion of Case Report Forms 
The data will be collected on study specific Case Report Forms (CRF) provided by the 
Sponsor (see Appendix B).  
• The Investigator will be responsible for the accuracy and completeness of the CRFs. 
• All data must be completed in the pre-defined CRFs.  
• No items should be left blank unless directed. 
• CRFs are to be completed with black or blue ink. 
• CRFs have to be legible.  
• Corrections have to be identified by initials and date. 
• The Investigator or designee has to sign and date the CRFs where indicated. 
 
10.3 Patient Privacy and Identification 
When a subject is considered eligible for entry into this study, each hip enrolled will 
receive a unique case ID (maximum of 6 digits) allocated by the Sponsor. The case ID 
must be recorded on all study documentation related to the enrolled device. Subjects with 

 
François Geiger, 02.02.2011, Rev. 01 
page 17 of 64 
bilateral hip replacements will require two sets of Case Report Forms and thus will have 
two different case IDs. 
All patient related data documented on the Case Report Forms as well as on any 
additional self assessment form, will be kept anonymously. On these forms the patients 
will only be tracked by their initials, the date of birth and a patient number. This code can 
only be decoded by the study centre itself. 
10.4 Submission of Case Report Forms / X-Rays 
Each completed CRF has to be photocopied or scanned and submitted to the Sponsor. 
The original CRFs must be kept in the Investigator’s CRF folder. Copies of the original X-
Ray film taken at the site during the indicated evaluations should be made available to the 
Sponsor upon request. The CRFs can be submitted by 
 
• 
E-MAIL: 
francois.geiger@zimmer.com 
• 
POST MAIL: 
Zimmer GmbH 
International Clinical Affairs 
Sulzerallee 8 
P.O. Box 
CH-8404 Winterthur 
Switzerland 
 
10.5 Monitoring Visits 
Prior to initiating any clinical use of the devices under study, Zimmer will conduct a site 
initiation visit to ensure the Investigators understand the use and application of the 
devices under study, the Investigators and staff have adequate time and resources to 
implement and follow the Clinical Investigation Plan, and ensure the Investigators have 
access to the target patient population under study. Prior to initiation of the study, the 
Investigator must have a fully executed Clinical Trial Agreement and EC approval of the 
Clinical Investigation Plan and Informed Consent. Further monitoring visits (including the 
closing visit) will take place as needed.  
The Study Monitor occasionally requires access to the patient records, Patient Consent 
Forms, original Case Report Forms, radiographs and relevant office notes during visits for 
monitoring purposes. 
10.6 Data Entry 
The Sponsor will enter and verify all data in a central database.  
The management of all data will be the responsibility of Zimmer or its designee. The use 
or disclosure of all protected health information will comply with the data protection act. All 

 
François Geiger, 02.02.2011, Rev. 01 
page 18 of 64 
information will be treated with strict adherence to professional standards of 
confidentiality. Data analysis will be conducted at the Corporate Offices in Warsaw, 
Indiana, USA or Winterthur, Switzerland. All data will be encrypted and all personnel in the 
data management team will comply with the data protection act.  
Each participating Investigator will receive study reports on their own data and the collated 
data for the whole study group. Study metrics, e.g. summary tables, graphical output and 
descriptive statistics will be produced and may be available as hard copy. Strict 
confidentiality of individual hospital data will be maintained. 
 
11 Study Procedure 
11.1 Offer Study Participation 
For each consecutive patient presenting as a candidate for total hip arthroplasty, study 
participation shall be offered. Based on the patient response, the patient may be invited to 
enroll in the clinical study. Prior to patient enrollment, the patient must participate in the 
Informed Consent process, participate in the inclusion/exclusion process, and sign the 
Ethics Committee (EC) approved Informed Consent. 
11.2 Patient Enrollment Log 
A Patient Enrollment Log shall be maintained throughout the study and is included in the 
Investigator Binder. All patients who are screened and offered study participation and/or 
are participating in the inclusion/exclusion process and/or are consented for the study 
shall be entered in the log regardless of study eligibility. Finally subjects enrolled in the 
study must be sequentially entered in the log as well.  
11.3 Determination of Eligibility 
Patient eligibility for enrollment will be determined for consenting candidates based upon 
the inclusion/ exclusion criteria. Patients must meet all of the inclusion criteria and none of 
the exclusion criteria in order to be offered enrollment into the study. Determination of 
eligibility may include an interview to assess significant patient medical/ surgical history, 
history of present illness/ injury, evaluation of present pain and functional capacity, and a 
radiographic assessment. Eligible patients will be offered enrollment into the study. For 
the purposes of this clinical study, patients will be considered subjects after enrollment 
has been completed.  
11.4 Informed Consent 
All patients must sign a written Informed Consent (Appendix C) approved by the Ethics 
Committee (EC), prior to participate in the inclusion/ exclusion criteria screening process 

 
François Geiger, 02.02.2011, Rev. 01 
page 19 of 64 
and thus prior to be enrolled in the clinical study. This signed document is required for 
patients to be enrolled in the study and to receive the devices as defined by this protocol 
and will further serve as documentation of an offer to participate in the study for those 
patients who elect not to do so. No patient will be enrolled without having signed the 
Informed Consent.  
11.5 Baseline/Pre-operative Assessment 
Data required for completion of the pain, functional and quality-of-life evaluations as well 
as the radiographic evaluations will be collected preoperatively. All subject data will be 
used in the analysis of overall pain and functional performance, survivorship, and 
radiographic parameters and will include the following Case Report Forms (CRF): 
1. Inclusion / Exclusion Criteria Form 
2. Demographic Evaluation Form 
3. Physical Exam Form 
4. Oxford Hip Score Form 
5. Patient Activity Questionnaire Form 
6. Harris Hip Form 
7. Concomitant Medication Record 
8. Radiographs Evaluation Form (standing anteroposterior (AP) and standard lateral 
views of the operative hip)  
9. EQ-5D Form 
11.6 Surgical Technique 
The surgical technique for the Allofit IT Acetabular System (Doc. No. 06.01651.012) is 
provided in the Investigator Binder. 
11.7 Surgery until Discharge Assessment 
Post-operative management for study subjects will follow the standard-of-care for patients 
undergoing total hip arthroplasty. Required surgical and discharge data will include, but is 
not limited to the following: 
1. Operative Information Form  
2. Immediate Post-op Evaluation Form 
3. Radiographs Evaluation Form (supine anteroposterior (AP) view of the operative 
hip) 
4. Adverse Events 
5. Protocol Deviations 

 
François Geiger, 02.02.2011, Rev. 01 
page 20 of 64 
11.8 Follow-up Procedures (Data Collection) 
Data required for completion of the pain, functional and quality-of-life evaluations as well 
as the radiographic evaluations will be collected postoperatively at 6 months (± 1 month), 
1 year (± 2 months), 2 year (± 2 months), 3 year (± 2 months), 5 year (± 2 months), 7 year 
(± 2 months), and 10 year (± 2 months). Post-discharge data collection will include, but is 
not limited to the following: 
1. Physical Exam Form 
2. Oxford Hip Score Form 
3. Patient Activity Questionnaire Form 
4. Harris Hip Form 
5. Concomitant Medication Record 
6. Radiographs Evaluation Form (standing anteroposterior (AP) and standard lateral 
views of the operative hip)  
7. EQ-5D Form 
8. Adverse Event Form (if any) 
9. Protocol Deviation Form (if any) 
10. Explanted Device Form (if any) 
11. Study Completion Form (if the case) 
Patient follow-up is expected to continue through 10 years of follow-up for each case 
although it is expected that a few subjects may succumb to other medical problems or 
otherwise lost to follow-up prior to completion of the 10 years of follow-up. All subject data 
will be used in the analysis of overall pain and functional performance, survivorship, and 
radiographic parameters. Data will continue to be collected until the subject completes the 
study, is lost to follow-up, one or several devices are removed due to revision, or the study 
is otherwise closed.  
11.9 Minimization of Subjects Lost to Follow-up 
Subject follow-up is extremely important for the conduct of a clinical study. The 
expectation is to maintain the highest rate of follow-up compliance possible throughout 
this study. In an effort to minimize lost to follow-up study subjects, the following 
recommendations and/or study requirements are essential to ensure proper patient 
selection and compliance:  
1. Patient Eligibility: Subjects will be selected according to patient eligibility criteria 
detailed in Section 8 and are expected to return for all follow-up visits.  

 
François Geiger, 02.02.2011, Rev. 01 
page 21 of 64 
2. Patients Counseled: Patients will be counseled during the informed consent 
process on the importance of returning for follow-up visits.  
3. Patient Exclusion: Patients who are not willing to return for study required follow-
up visits and/or are not willing to comply with the follow-up schedule will not be 
considered for enrollment in the study.  
4. Subject Due Listings: In addition to proper patient selection, Zimmer will provide 
subject due notices to the sites on a regular basis in order to track each study 
participant and monitor adherence to the required follow-up visit timeframes. The 
subject due listings will facilitate scheduling the subjects for their return office 
visits.  
5. Financial Hardship: If during the course of the study it is determined that a subject 
is experiencing a financial hardship that prevents the subject from returning for 
follow-up visits, Zimmer should be notified to discuss possible financial assistance 
which may be available to the subject.  
6. Contact Tracking: Attempts to contact subjects will be documented. It is 
recommended that the first three attempts be made by telephone.  
 
Recommended Contact Attempts 
If 
then 
A response is not received from 
the three phone calls 
The Investigator should send a letter to the 
subject explaining the follow-up agreement 
per the informed consent. 
A response is not received from 
the Investigator’s letter 
The Investigator should send a certified 
letter to the subject. 
A response is not received from 
the Investigator’s certified letter 
The Investigator should use any additional 
contacts provided by the subject to contact 
the subject. 
If all attempts to contact the 
subject are unsuccessful or the 
subject is contacted and chooses 
to withdraw from the study 
The 
Study 
Completion 
CRF 
will 
be 
completed and will specify the reason the 
subject is no longer participating in this 
study. 
 
11.10 Radiographic Definitions and Methods 
All radiographic evaluations performed according to the protocol will be reviewed by the 
Investigator at the time of the evaluation for assessment of post-operative adverse events 
as well as for standard patient management purposes. If a radiographic adverse event is 
identified by the Investigator during the course of the investigation, the Investigator must 
document the event and report the radiographic findings on Adverse Event Report CRF 
for Sponsor review. In addition, assessments of radiographic films for evidence of 

 
François Geiger, 02.02.2011, Rev. 01 
page 22 of 64 
radiolucencies, osteolysis, subsidence, acetabular cup migration, and change in 
acetabular cup angle, will be performed. 
11.10.1 
Required Radiographic Views 
Standing anteroposterior (AP) and standard lateral radiographs of the operative hip are 
required to be captured before surgery and at 6 months, 1, 2, 3, 5, 7, and 10 years post-
operatively. At the immediate post-operative interval, only a supine AP view of the 
operative hip is required.  
Every effort should be made to obtain all radiographic views for every interval at the same 
institution to maintain consistency. However, if radiographs are completed at a different 
institution within the required interval and copies or originals are available, they may be 
used for study submission provided they meet the required specifications.  
11.11 Reporting of Adverse Events and Adverse Device Effects 
Adverse Events and Adverse Device Effects have to be documented during the whole 
course of the study (for details see Section 14). 
 
12 Implant Information 
12.1 Description of the Device  
A. Investigational Devices 
1. Allofit® IT Acetabular Shell 
2. Longevity® Liner 
B. Investigational Device Description 
1. Allofit IT Acetabular Shell 
The shells are mainly made from Titanium (Protasul®-Ti Alloy). The shells 
are available with or without screw holes. The Allofit IT Shells have no 
screw holes, the Allofit-S IT Shells allow for the use of screws to provide 
additional fixation and security, particularly in those cases where acetabular 
bone stock is deficient. Only 6.5 mm diameter Allofit Screws (Catalog 
numbers 4301-07-xxx) and 6.5 mm diameter Trilogy® screws (Catalog 
numbers 00-6250-065-xx) should be used with the Allofit-S IT Acetabular 
Shell. Screw holes that are not utilized for fixation and the dome hole may 
be closed with optional plugs.  
The Allofit IT Acetabular Shell is packaged without a liner. The selection of 
an appropriate liner is required to complete the acetabular component.  
 

 
François Geiger, 02.02.2011, Rev. 01 
page 23 of 64 
2. Longevity Liner 
The Longevity Liners are made from long Polyethylene chains (CH2)n 
which are cross-linked by E-beam irradiation. The Longevity Liners are 
secured in the shell by a snap feature. Anti-rotation tabs provide rotational 
stability. The inner diameter of the liner must match outer diameter of the 
selected femoral head. 
C. Intended use / Surgical Technique 
Total Hip arthroplasty is intended to reduce pain and increase hip mobility. 
A system consisting of a stem, a femoral head and a cup (= shell + liner) is 
used for the treatment of degenerative diseases or trauma of the hip. The 
articulation is comprised of a femoral head and a corresponding liner. All 
components are intended for single use only.  
The surgical technique for the Allofit IT Acetabular System (Doc. No. 
06.01651.012) can be found in the Investigator Binder. 
12.2 Risks  
The risks associated with the use of the Allofit IT Acetabular System are similar to those 
with the use of other standard acetabular hip systems when used for the same clinical 
indication. These risks are categorized as those anticipated to be related to general 
surgical risks, total hip arthroplasty risks, or those potential risks associated with the 
investigational system. Unanticipated adverse events may occur as well. 
 
13 Statistical Considerations/ Evaluation 
13.1 Analysis Objectives 
The assessment of efficacy for subjects receiving the total hip replacement system will be 
determined using the overall pain score and functional performance. Clinical success will 
be defined as a modified Harris Hip score of > 80 that included a rating of ‘mild’, or ‘no 
pain’; a failure will be defined as a modified Harris Hip score < 80. Any study hip that 
required a subsequent surgical intervention where a stem head, cup, or liner was 
removed, or where a removal was planned, was considered a failure regardless of the 
Harris Hip score. Success rates will be expressed as percentages and primary summary 
results will be presented in tables which will contain the number and percentage of 
patients classified as a clinical success for the treatment group. 

 
François Geiger, 02.02.2011, Rev. 01 
page 24 of 64 
The assessment of safety will be evaluated by monitoring the frequency and incidence of 
adverse device effects in investigational subjects. As part of the safety profile, a survival 
analysis will be done. 
The endpoints that contributed to the composite success will be summarized separately, 
that is, the Harris Hip Scores, both function and pain. Additionally, there are measures of 
interest which will be used to assess the investigational device such as radiographic 
success, all components included in the assessment of radiologic success, the Oxford Hip 
Score patient satisfaction scores, patient activity scores, concomitant medication usage, 
and incidence of adverse events. 
13.2 Variables for Analysis 
Key demographic, baseline and peri-operative characteristics will be summarized for the 
Allofit IT Acetabular Shell with a Longevity Liner, both overall, and for each investigative 
site. Demographic, baseline, and peri-operative data will include: 
• 
Demographics 
• 
Age 
• 
Gender 
• 
Body Mass Index 
• 
Alcohol use 
• 
Tobacco use 
• 
Baseline Characteristics 
• 
Preoperative Harris Hip Pain Score 
• 
Preoperative Harris Hip Functional Score 
• 
Preoperative Activity Level 
• 
Concomitant Medication 
• 
Preoperative Radiographic assessment 
• 
Diagnosis 
• 
Oxford Patient Satisfaction 
• 
Peri-Operative 
• 
Surgery time 
• 
Blood loss 
• 
Hospital stay  - defined as the date of discharge minus the date of surgery 
Summaries will be done and compared preoperatively and at 6-12 weeks, 12 months, and 
24 months initially. Long-term follow-up will be further compared at 3, 5, 7, and 10 years 
postoperatively. 

 
François Geiger, 02.02.2011, Rev. 01 
page 25 of 64 
For dichotomous variables and for variables with more than two responses, the number 
and percentage of patients in each category will be presented for the treatment. For 
continuous variables, descriptive statistics including counts, means, medians, standard 
deviations, minima, and maxima will be presented for the treatment group.  
13.3 Sample Size Justification 
Sample size for the Allofit IT HXPE Study was estimated using the McHugh and Le 
method [43] with an alpha (Type I) error level of 0.05, a non-inferiority margin of 5.2% (δ), 
and an assumed survival rate of 90% at 10 years from ODEP. 
The confidence limit approach, as discussed by McHugh and Le [43], can be used to 
calculate this sample size estimate. Specifically, we infer that the non-inferiority margin 
provides the absolute precision (5% δ) for the difference between the fixed rate in the 
historical control group and the rate estimated for the experimental group over the course 
of the study. Sample size estimation utilizes the following formula: 
HC
HC
HC
w
p
p
w
p
p
Z
n
)
1(
)
1(
exp
exp
exp
1
−
+
−
=
−α
δ
      
where δ represents the non-inferiority margin, n represents the group size, pexp represents 
the rate in the experimental group, pHC represents the rate in the historical control group, 
wexp represents a weight (i.e., allocation weight) to accommodate unequal group size for 
the experimental group, wHC represents the allocation weight  to accommodate unequal 
group size for the historical control group, and Z1-α represents the value of a standard 
normally distributed random variable corresponding to a cumulative probability of one 
minus alpha (0.05).  
When adjusting for a ceiling in the calculation, and added attrition rate of 20% there is a 
sample size requirement of 195 for the experimental group. A sample size of 200 is 
therefore planned for enrolment in this study. 
Sample size was estimated using SAS v. 9.1.3 for Windows. 
 
14 Management of Incurrent Events 
14.1 Definitions 
As defined by EN ISO 14155-1 [1] and ISO 14155-2 [2]: 
Adverse Event 

 
François Geiger, 02.02.2011, Rev. 01 
page 26 of 64 
An Adverse Event is defined as any untoward medical occurrence in a subject. This 
definition does not imply that there is a relationship between the adverse event and the 
device under investigation. 
Adverse Event is synonymous with complication or medical event. 
Serious Adverse Event 
A Serious Adverse Event is defined as an Adverse Event that: 
• 
leads to death, 
• 
leads to a serious deterioration in the health of the subject that 
1) resulted in a life –threatening illness or injury, 
2) resulted in an impairment of a body structure or a body function,  
3) required in-patient hospitalization or prolongation of existing hospitalization, 
4) resulted in medical or surgical intervention to prevent permanent impair-
ment to body structure or a body function, 
• 
leads to fetal distress, fetal death or a congenital abnormality or birth defect. 
Adverse Device Effect 
An Adverse Device Effect is defined as ‘any untoward and unintended response to a 
medical device’. This definition includes any event resulting from insufficiencies or 
inadequacies in the instructions for use or the deployment of the device. This definition 
includes any event that is a result of a user error. 
Serious Adverse Device Effect 
A Serious Adverse Device Effect is defined as ‘an Adverse Device Effect that has resulted 
in any of the consequences characteristic of a Serious Adverse Event or that might have 
led to any of these consequences if suitable action had not been taken or intervention had 
not been made or if circumstances had been less opportune’. 
14.2 Reporting and Documentation of Adverse Events and Adverse Device Effects 
Adverse Events and Adverse Device Effects have to be documented on the Adverse 
Events Report Form over the whole time of the investigation. Further the outcome of such 
complications has to be documented and any changes in outcome to be updated during 
the course of the study. 
14.3 Reporting and Documentation of Serious Adverse Events and Serious 
Adverse Device Effects 
Serious Adverse Events and Serious Adverse Device Effects have to be documented on 
the Adverse Events Report Form over the whole time of the investigation. The outcome of 

 
François Geiger, 02.02.2011, Rev. 01 
page 27 of 64 
such complications has to be documented and any changes in outcome to be updated 
during the course of the study. 
14.4 Recommended Revision Procedure 
14.4.1 
Revision Methods 
Standard total hip replacement and revision methods will be utilized in the event 
of a device failure resulting in revision of one or more of the System 
Components (i.e. acetabular shell, liner, head, or femoral stem). 
14.4.2 
Prior to Revision Surgery 
Prior to revision surgery, the Investigator must evaluate the acetabular and 
femoral components for any evidence of migration, change in cup angle, 
radiolucencies or osteolysis by comparing the immediate post-operative and 
most recent post-operative radiographs of the operative hip.  
14.4.3 
During the Revision Surgery 
During the revision surgery, the Investigator must carefully inspect the surgical 
site for any evidence of acetabular or femoral instability, excessive surface wear 
or the presence of any other acetabular or femoral component damage. If it is 
believed the acetabular or femoral components are unstable for any reason or 
damaged in any way, it is recommended the unstable/damaged acetabular or 
femoral component(s) be removed and revised.  
14.4.4 
Explanted Investigational Device Analysis  
In the event of an investigational device revision, all components revised should 
be returned to Zimmer for analysis. The Investigator must notify the study 
manager prior to the return of any device. 
For used, contaminated devices, immerse the implant in 10 percent neutral 
buffered formalin, label the implant container to identify the catalog number, 
Investigator name, Case ID, date of removal, and include a statement indicating 
the implant is from an IDE study.  
Properly prepared specimens are to be sent to: 
 
Zimmer GmbH 
 
International Clinical Affairs 
 
François Geiger 
 
Cost Center 113505 
 
Sulzerallee 8 
 
CH-8404 Winterthur 
 
Switzerland 

 
François Geiger, 02.02.2011, Rev. 01 
page 28 of 64 
 
Once the analysis is complete, a copy of the report will be maintained in the 
study subject record by Zimmer International Clinical Affairs and a copy will be 
sent to the Investigator for his/her study records. A summary of all detailed 
explant reports will be provided in the Annual Reports. 
 
All SAEs and SADEs have to be reported to the Clinical Study Manager as soon as 
possible by sending a copy of the Adverse Events Report Form either by fax to or e-mail 
to: 
Zimmer GmbH 
International Clinical Affairs 
Sulzerallee 8 
P.O. Box 
CH-8404 Winterthur 
Switzerland 
Tel. +41 52 262 79 71 
Fax +41 52 244 34 90 
francois.geiger@zimmer.com 
 

 
François Geiger, 02.02.2011, Rev. 01 
page 29 of 64 
14.5 Documentation and Reporting Flow Chart 
 
START
Adverse Event or Adverse 
Device Effect?
Serious Adverse Event or 
Serious Adverse Device 
Effect?
Investigator to document on corresponding form 
and report to sponsor.
Sponsor to review event with Investigator and 
inform other investigators, Regulatory Authorities 
and Ethic Committee(s) according to local and 
national regulations. 
END
END
Investigator to document 
on corresponding form 
and review with Sponsor.
YES
NO
NO
YES
 

 
François Geiger, 02.02.2011, Rev. 01 
page 30 of 64 
14.6 Patient Withdrawal  
Subjects may withdraw from the study at any time. If possible, a final evaluation will be 
completed for all subjects who no longer wish to participate in this investigational study. 
The reason for the subject withdrawal must be documented on the Study Completion case 
report form.  
14.7 Lost to Follow-up 
Patients will be considered lost to follow-up after they have missed a visit and a 
reasonable number of attempts to locate and evaluate them have failed. This has to be 
documented on Study Completion Form. In particular the reason must be documented. 
14.8 Protocol Deviation 
The Investigator should not deviate from the agreed Clinical Investigation Plan unless it is 
to eliminate hazard to the patient. However, any deviation from the Clinical Investigation 
Plan has to be documented on the Protocol Deviation Form and reported to the Sponsor. 
14.9 Termination of the Trial 
The study terminates for each patient 10 years after surgery with the final visit. Reasons 
for an earlier termination can be found in sections 14.6 and 14.7. 
In the case of early termination of the study the Investigators have to be informed by the 
Sponsor. The regulatory authority(ies) and ethic committee(s) shall also be informed 
according to local and national regulations including the reason for termination.  
 
15 Quality Control and Quality Assurance 
The study is conducted in accordance with the Declaration of Helsinki [44] and the ISO 
14155 Standard for the Clinical Investigation of Medical Devices part 1 and 2 [1;2]. 
The Investigator will be required to permit representative(s) of the Sponsor’s monitoring 
team to inspect all Case Report Forms and corresponding sections of the study patients 
office records and/or hospital original medical records. These audits will be done for 
quality assurance purposes i.e. verifying adherence to the Clinical Investigation Plan and 
the completeness and accuracy of the data being entered on the Case Report Forms. 
Moreover, local national authorities could audit the sites as well. In this particular case, all 
documents requested by the auditor(s) have to be available and handed out.  
The Clinical Investigation Plan will be provided to all participating study centers. The 
Investigators will be fully trained in the proper reporting and submission of trial data prior 

 
François Geiger, 02.02.2011, Rev. 01 
page 31 of 64 
to patient enrolment. Completed Case Report Forms will be reviewed before entering the 
data into a central database by the Sponsor. 
The Clinical Study Manager is responsible for generating data queries for missing or 
unclear data if needed. It is the responsibility of the Clinical Study Manager to ensure data 
quality. 
There are regular meetings between the Investigators and Zimmer International Clinical 
Affairs staff. Written correspondence to all sites is used to inform the Investigators of 
routine study details and to update them on study status. 
 
16 Ethics and Regulatory 
16.1 Standards 
The study is conducted in accordance with the Declaration of Helsinki [44] and the ISO 
14155 Standard for the Clinical Investigation of Medical Devices part 1 and 2 [1;2]. 
16.2 Ethics Committee Approval 
Each Investigator will be responsible for obtaining national and/or local ethics committee 
approval (if appropriate) prior to conducting the research. Copies of Research Ethic 
Committee approval must be provided to Zimmer International Clinical Affairs to be 
retained on file. In circumstances where no ethics approval is required a signed letter to 
this effect should be provided to Zimmer International Clinical Affairs.  
The Ethics Committee that approved the clinical investigation plan must be notified by the 
Investigator of any device related/possibly device related serious adverse events that 
occur during the course of the study and also of any clinical investigation plan 
amendments. The Ethics Committee must also be provided with a copy of the final clinical 
report, if applicable. 
16.3 Patient Information and Consent 
Prior to the treatment of the patients the Investigator will provide explanation about the 
study in detail, handout the Patient Information Form and the Patient Consent Form (see 
Appendix C). He will also be available for any question the patient has about the study. 
Further he will explain alternative treatment methods and that the patient’s data will be 
protected. 
Finally a written consent of the patient will be obtained prior to surgery by signing the 
Patient Consent Form. The permission for the use of patient data for medical and 
scientific purposes is given as part of the Patient Consent Form. 

 
François Geiger, 02.02.2011, Rev. 01 
page 32 of 64 
16.4 Indemnity 
If an injury is caused to a patient as a result of procedures undertaken in accordance with 
the Study, the Sponsor is liable for damages resulting from the Study. 
 
17 Amendment to Clinical Investigation Plan 
All amendments shall be agreed with the Sponsor and the Investigator(s) and be recorded 
with a justification for the amendment. Approval of the Ethics Committee that reviewed the 
original Clinical Investigation Plan must be obtained if required according to the 
corresponding regulations. 
 
18 Publication Policy 
Both the Clinical Investigator and the Sponsor have the right to publish or allow the results 
of the clinical trial to be published. The Clinical Investigator recognizes that the Sponsor 
has a special interest in the results of the clinical study and will submit manuscripts to the 
Sponsor prior to publication. If the Sponsor desires changes to be made, these are 
communicated to the Clinical Investigator within an appropriate time period. 
Pooled data may be used for training and meetings. 
 
19 Signatures 
Herewith, the undersigned certify that they have read and examined the present protocol 
carefully and declare that they are in agreement with the demands and conditions noted. 
They hereby consent that they will perform the study according to the requirements of the 
Declaration of Helsinki [44] and the ISO 14155 standard [1;2]. 
Clinical Study Manager (Name/ Date/ Signature) 
François Geiger, CRA 
 
 
Quality Assurance (Name/ Date/ Signature) 
Hassan Achakri, Director Int. 
Clinical Affairs 
 
 
 
The Declaration of Consent of each participating Investigator can be found in Appendix D. 

 
François Geiger, 02.02.2011, Rev. 01 
page 33 of 64 
20 References 
Reference List 
 
 [1]  ISO 14155-01. Clinical investigation of medical devices for human subjects - Part 1: 
General requirements. 1. 2003.  
Ref Type: Art Work 
 [2]  ISO 14155-02. Clinical investigation of medical devices for human subjects - Part 2: 
Clinical investigation plans. 1. 2003.  
Ref Type: Art Work 
 [3]  Pramanik S, Agarwal AK, Rai KN: Chronology of total hip joint replacement and 
materials development. Trends Biomater Artif Organs 19:15-26, 2005 
 [4]  Millennium Research Group. European Market for Large-Joint Reconstruction 
Implants 2007.  2006. Toronto, Canada. 12-4-2007.  
Ref Type: Report 
 [5]  National Institutes of Health (U.S.).Office of the Director. Total Hip Replacment. NIH 
consensus statement on total hip replacement.U.S.Department of Health and 
Human Services National Institutes of Health (Office of the Director): NIH 
Consensus and State-of-the-Science Statements Sept 12-14 12[5], 1-31. 1994. 29-
3-2007.  
Ref Type: Report 
 [6]  Duke University Center for Demographic Studies. Effects of Advanced Medical 
Technologies - Musculoskeletal Diseases. Phase I Final Report (Part C), 1-101. 31-
1-2006.  
Ref Type: Report 
 [7]  Espehaug B, Havelin LI, Engesaeter LB, Langeland N, Vollset SE: Patient 
satisfaction and function after primary and revision total hip replacement. Clin Orthop 
Relat Res135-148, 1998 
 [8]  Jones CA, Voaklander DC, Johnston DW, Suarez-Almazor ME: Health related 
quality of life outcomes after total hip and knee arthroplasties in a community based 
population. J Rheumatol 27:1745-1752, 2000 
 [9]  Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME: Patients' 
expectations and satisfaction with total hip arthroplasty. J Arthroplasty 12:387-396, 
1997 
[10]  Aamodt A, Nordsletten L, Havelin LI, Indrekvam K, Utvag SE, Hviding K: 
Documentation of hip prostheses used in Norway: a critical review of the literature 
from 1996--2000. Acta Orthop Scand 75:663-676, 2004 
[11]  Archibeck MJ, Berger RA, Jacobs JJ, Quigley LR, Gitelis S, Rosenberg AG, Galante 
JO: Second-generation cementless total hip arthroplasty. Eight to eleven-year 
results. J Bone Joint Surg [Am] 83-A:1666-1673, 2001 

 
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[12]  Callaghan JJ, Albright JC, Goetz DD, Olejniczak JP, Johnston RC: Charnley total hip 
arthroplasty with cement. Minimum twenty-five-year follow-up. J Bone Joint Surg 
[Am] 82:487-497, 2000 
[13]  Callaghan JJ, Templeton JE, Liu SS, Pedersen DR, Goetz DD, Sullivan PM, 
Johnston RC: Results of Charnley total hip arthroplasty at a minimum of thirty years. 
A concise follow-up of a previous report. J Bone Joint Surg [Am] 86:690-695, 2004 
[14]  Garellick G, Malchau H, Herberts P: Survival of hip replacements. A comparison of a 
randomized trial and a registry. Clin Orthop Relat Res157-167, 2000 
[15]  Malchau H, Herberts P, Eisler T, Garellick G, Soderman P: The Swedish Total Hip 
Replacement Register. J Bone Joint Surg Am 84 Suppl 2:2-20, 2002 
[16]  Poon PC, Rennie J, Gray DH: Review of total hip replacement. The Middlemore 
Hospital experience, 1980-1991. N Z Med J 114:254-256, 2001 
[17]  Data on File at Zimmer.  2010.  
Ref Type: Report 
[18]  Charnley J, Halley DK: Rate of wear in total hip replacement. Clin Orthop Relat 
Res170-179, 1975 
[19]  Fowler JL, Gie GA, Lee AJ, Ling RS: Experience with the Exeter total hip 
replacement since 1970. Orthop Clin North Am 19:477-489, 1988 
[20]  Harris WH: The first 32 years of total hip arthroplasty. One surgeon's perspective. 
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[21]  Kavanagh BF, Dewitz MA, Ilstrup DM, Stauffer RN, Coventry MB: Charnley total hip 
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[22]  Wroblewski BM, Siney PD: Charnley low-friction arthroplasty of the hip. Long-term 
results. Clinical Orthopaedics191-201, 1993 
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[24]  Howie DW: Tissue response in relation to type of wear particles around failed hip 
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Sarmiento A: The origin of submicron polyethylene wear debris in total hip 
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[29]  Schmalzried TP, Campbell P, Brown IC, Schmitt AA, Amstutz HC. Polyethylene 
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[43]  McHugh RB, Le CT: Confidence Estimation and the Size of a Clinical Trial.   Controlled 
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Human Subjects.  2008.  
Ref Type: Art Work 
 
 
 
 

 
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Appendix A List of Investigators 

 
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Name 
Professional 
Position 
Name and Address 
of Institution 
Principal 
Investigator 
Dr. Ambrosius Müller 
Leitender Arzt 
Klinik für Orthopädie 
Kliniken Dr. Erler 
gGmbH, Nürnberg, 
Deutschland 
 
 
 
 
Further 
Investigators 
Prof. Reinhard Windhager 
Leitung der 
Universitätsklinik 
für Orthopädie 
Medizinische Universität 
Wien, Österreich 
 
Dr. Chaled El Masry 
Facharzt für 
Orthopädie und 
Unfallchirurgie 
Klinik Vincentinum, 
Augsburg, Deutschland 
 
Prof. François Gouin 
Chief of the 
Department of 
orthopaedic and 
trauma surgery 
Centre Hospitalier 
Universitaire, Nantes, 
France 
 
Dr. Jose Senaris 
Head of the 
Department of 
Traumatology 
and Orthopaedic 
Surgery 
Hospital Clinico 
Universitario de 
Santiago de 
Compostela, Spain 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix B Case Report Forms (CRF) 

 
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Appendix C Patient Information and Patient Consent 

 
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Allofit® IT with HXPE in Total Hip Arthroplasty 
A multi-center, prospective, non-controlled post market surveillance study 
 
PATIENT INFORMATION 
 
 
 
 
Dear patient, 
 
You are currently being treated for a degenerative disease or trauma of your hip. The 
conservative treatments have failed and therefore your surgeon has recommended the 
implantation of a Zimmer total hip replacement system. In this regard you are being invited 
to take part in a study (sometimes called a Clinical Investigation). Before you decide to 
participate, it is important for you to understand why the study is being conducted and 
what it will involve. Please take time to read the following information carefully and discuss 
it with friends, relatives and your general practitioner/health care professional if you wish. 
Ask your surgeon if there is anything that is not clear or if you would like to receive more 
information. Take time to decide whether you wish to take part. 
What is the purpose of the study? 
This study will investigate how well the patients are doing after their treatment with the 
Zimmer total hip replacement system that you will receive, the Allofit IT HXPE Bearing 
System. This will be performed by taking radiographs, and by asking you to complete 
some questionnaires concerning your health/well-being and pain before your surgery and 
at the follow-up - examinations. The anonymized patient data from different study centres 
is then being collected and evaluated in up to 200 patients. This information is very 
important for the surgeons as well as the manufacturer of the implant, as it provides the 
scientific basis for a continuous improvement in the treatment of patients with 
degenerative diseases or trauma of the hip. This information may be used for future 
product market approvals as well. 
What is a total hip replacement system? 
Hip joints can become damaged by disease, such as arthritis and this causes the hip to be 
very painful and difficult to move. If other treatments (such as steroids or pain-relieving 
drugs) do not help, the patient can undergo hip replacement surgery. This involves an 
operation. An orthopaedic surgeon replaces the hip joint by removing the diseased parts 
of the joint and inserting an artificial hip joint (prosthesis) made of metal. The total hip 
replacement system you will receive is sometimes used in active or younger patients. It 
was developed according to the latest scientific knowledge by leading surgeons together 
with the company Zimmer. 
Description of the device 
The Allofit IT Acetabular System is composed of three components: a femoral (thighbone) 
component with femoral head, an acetabular shell (hip socket) component, and an 
acetabular liner component which fits inside the acetabular shell component. All system 
components are CE marked and commercially available. 

 
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Allofit IT Acetabular Shell 
The acetabular shell is made from Titanium (Protasul®-Ti Alloy). This component replaces 
the damaged surface of the hip socket. Screws may be used to secure the shell in your 
hip socket if necessary. 
Longevity® Liner 
The Longevity Liner is made from highly cross-linked Polyethylene and is secured in the 
acetabular shell by a snap feature.  
 
 
 
What other types of treatment are available?  
A hip operation is normally carried out when no other treatments are available. For 
example, a surgeon may suggest that a patient undergo hip surgery when the patient no 
longer benefits from steroid injections and/or pain-relieving drugs. There are a few 
surgical procedures, other than the hip replacement, that may offer benefit to some 
patients, although this is very dependent on how damaged the hip is. If you require more 
information, please discuss the alternatives with your surgeon. 
What happens in this clinical study? 
The participation in this study does not change anything in the care or after-care you 
would normally receive when having the surgery. Before your surgery, your surgeon will 
examine you. This will involve measuring how much you can move your legs and asking 
you how much pain you feel during certain activities. Standard radiological images will be 
taken. You will then undergo surgery, which involves a general anesthesia. During 
surgery, your hip will be opened up, the diseased parts of your joint removed and then the 
artificial hip implanted. After the operation, you may receive physiotherapy to help the 
healing process. You will be asked to visit the surgeon at 6 months, 1, 2, 3, 5, 7, and 10 
years after your surgery. Each time, you will be asked to complete a set of questionnaires. 
Questions will include how much pain you feel, how much movement you have in your 
hips, your current quality of life, and radiological images of your hip joint will also be taken. 
This data will be used to provide an indication of how successful your surgery has been. 
Who can you contact if you have questions regarding the study? 
If you have questions regarding the study, please feel free to contact the following 
surgeon any time: (Surgeon Name, Phone +xxxx). 

 
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Potential Benefits and Risks 
Many people have received a hip replacement surgery. After surgery, they have found 
they suffer from much less pain and can move their hip more easily. We hope your 
treatment will also be very successful, although this cannot be guaranteed. The 
information we get from documenting the outcome of your surgery will help us to measure 
the performance of this prosthesis and show that it can offer long-term benefit to many 
patients. 
Any surgery involves a small risk – from the anesthesia and from the surgical procedure. 
The foreseeable risks and possible side effects associated with the surgical procedure will 
be explained to you by the surgeon. Furthermore, there is a possibility that the surgery 
may not give all the benefits we hope. The risks, however, are not greater than if you were 
undergoing the surgery without participating in this study. If you need any more 
information or to report a study related injury, please contact your surgeon. If an injury is 
caused to you as a result of procedures undertaken in accordance with the Study, Zimmer 
is liable for damages resulting from the Study. 
How do you take part in the study? 
You are free to decide whether you want to take part in this study. Refusal to participate 
will not result in any penalty or loss of benefits for which you are otherwise entitled. If you 
decide to participate, please sign the consent form that confirms you have read this leaflet 
and you agree to be part of the study. Clinical appointments will then be made to start the 
treatment. 
If you consent to take part in this study, your medical records will remain confidential at all 
times, although relevant sections may be inspected by a qualified member of the 
International Clinical Affairs Department of Zimmer, the sponsoring company. This is 
necessary to verify that the study is being carried out correctly and the data collected is 
true and accurate. The data generated from this study will be stored by the Zimmer 
International Clinical Affairs Department on paper and electronically for up to 15 years 
after study termination. Access to this data will be limited to those directly involved in the 
running of the study and to the regulatory authorities. You will only be identified by your 
study identification number, date of birth, initials, sex and date of surgery. Your name will 
not be disclosed outside the hospital at any time. You have the right to see the information 
that Zimmer holds about you, please contact your surgeon if you wish to do so. The data 
generated from this study may be published in a scientific journal, but you will not be 
identified as an individual in any publication. 
 
You can leave this study at any moment and for whatever reason. Furthermore, this 
will not have any detrimental effect on your subsequent treatment. The treatment 
will carry on as if you had never been part of the study. If any new significant 
findings become available during the study which could affect your willingness to 
continue participation, you will be notified. 

 
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PATIENT INFORMED CONSENT FORM 
 
Study Title: Allofit® IT with HXPE in Total Hip Arthroplasty 
A multi-center, prospective, non-controlled post market surveillance study 
 
 
To be completed by the patient: 
Have you read the information sheet about this study?  
 
 
YES/NO 
Have you been able to ask questions about this study?  
 
 
YES/NO 
Have you received answers to all your questions?  
 
 
 
YES/NO 
Have you received enough information about this study? 
 
 
YES/NO 
Which surgeon have you spoken to about this study? 
 
 
 
Dr. / Mr. / Prof.…………………………………………... 
Do you understand that you are free to withdraw from this study? 
 
YES/NO 
At any time? 
 
 
 
 
 
 
YES/NO 
Without giving a reason for withdrawing? 
 
 
 
 
YES/NO 
Without affecting your future medical care? 
 
 
 
 
YES/NO 
Do you agree to take part in this study? 
 
 
 
 
YES/NO 
Are you involved in any other trials/studies? 
 
 
 
 
YES/NO 
How many? 
 
Do you give authorization for your data to be stored by Zimmer? 
 
YES/NO 
 
 
Signed:………………………………………………………….. 
Date:…………… 
 
 
Name (Block Letters):…………………………………………. 
 
 
Surgeon:……………………………………………………….. 
Date:…………… 
 
 
Name (Block Letters):…………………………………………. 

 
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Appendix D Investigator’s Consent to the Clinical Investigation Plan 

 
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Investigators Agreement 
Allofit® IT with HXPE in Total Hip Arthroplasty 
A multi-centre, prospective, non-controlled post market surveillance study 
Clinical Investigation Plan ID CME2010-25H 
I, as an Investigator, have read the Clinical Investigation Plan for this study and agree that 
it contains all the necessary details for me to carry out this study. I will conduct the study 
as outlined therein. This includes that I will follow the inclusion / exclusion criteria for 
appropriate patient selection for study participation. 
 
I will, if necessary, provide Zimmer with a copy of the written approval from the Ethics 
Review Body. I will also make sure that all other applicable requirements for study 
conduction in my study centre are met. 
 
I will aim to finalize patient recruitment at my study centre within 12 months after study 
start. I will also aim to record the data of all study subjects until the 10-years follow-up 
visit. 
 
I will fill in the Case Report Forms provided by Zimmer for this clinical study and will 
provide them on a regular basis to Zimmer International Clinical Affairs for verification. 
Furthermore, I will answer all data related questions upon request. 
I am aware that I am allowed to publish my results and that Zimmer shall have the right to 
review all manuscripts before submission. I am also aware that my data must not be 
published without having given my permission. However, Zimmer has the right to make 
use of the results obtained from this study for internal training and marketing purposes. 
Herewith, the undersigned certifies that he/ she has read and examined the present 
protocol carefully and declares that he/ she is in agreement with the demands and 
conditions noted. He/ she hereby consent that he/ she will perform the study according to 
the requirements of the Declaration of Helsinki [44] and the ISO 14155 standard [1;2]. 
Investigator (Name/ Date/ Signature)