THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Stryker Orthopaedics

                                                                                                                           
 
                                                                                                      
 
 
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THE ATX REGISTRY 
 
ACCOLADE STEM & TRIDENT/TRITANIUM CUP 
WITH X3 INSERT 
 
INTERNATIONAL MULTICENTRE 
SURVEILLANCE REGISTER 
Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 20130830 
 
 
 
 
 
 
 
 
Reference: ATX20130830 
 
 
 
 
 
 
 
 
Version: 3.0 

                                                                                                                           
 
                                                                                                      
 
 
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Protocol Change History 
 
 
Version 
Description 
Changed by 
Version 2.0  
- 12JUL2012  
Added Accolade II stem as a femoral option; 
Added Accolade II product description and 
References 22-24 
Added Appendix IX  
Changed contact person for adverse events 
and surveillance monitoring to Chadi Aziz as 
actual study manager 
Chadi Aziz 
Clinical Study Manager 
Version 3.0 
- 30AUG2013 
Changed upper age limit in inclusion criteria 
1 from 70 to 75 years of age 
Removed PTD visit from table in section 5, 
as PTD is not a separate visit 
Changed description of FU intervals in 
section 7 
Changed email address and person to 
contact for SAE notifications as well as 
surveillance monitoring  to Sietske Witvoet as 
actual study manager 
Sietske Witvoet 
Clinic al Study Manager 
 
 
 
 
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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TABLE OF CONTENTS 
1 
INTRODUCTION ....................................................................................................................................... 7 
2 
SURVEILLANCE DESIGN ....................................................................................................................... 8 
3 
OBJECTIVES & METHODS .................................................................................................................... 8 
4 
SELECTION OF PATIENTS .................................................................................................................... 8 
4.1 
NUMBER OF PATIENTS........................................................................................................................... 8 
4.2 
PATIENT SELECTION CRITERIA .............................................................................................................. 9 
5 
LENGTH OF SURVEILLANCE AND VISIT SCHEDULE ................................................................. 10 
6 
DESCRIPTION OF THE DEVICES ....................................................................................................... 11 
6.1 
FEMORAL COMPONENTS ..................................................................................................................... 11 
6.2 
ACETABULAR COMPONENT ................................................................................................................ 12 
7 
PATIENT EVALUATIONS ..................................................................................................................... 13 
7.1 
EVALUATIONS AT EACH ASSESSMENT ................................................................................................. 13 
8 
ADVERSE EVENTS ................................................................................................................................. 14 
8.1 
DEFINITIONS ....................................................................................................................................... 14 
8.2 
DOCUMENTATION AND REPORTING OF ADVERSE EVENT BY THE INVESTIGATOR ................................. 15 
9 
PATIENT WITHDRAWALS ................................................................................................................... 16 
10 
ELECTRONIC DATA CAPTURE: ECRF ............................................................................................. 16 
11 
SURVEILLANCE MONITORING ......................................................................................................... 17 
12 
ANALYSIS OF RESULTS ....................................................................................................................... 17 
12.1 
STATISTICAL ANALYSIS ...................................................................................................................... 17 
13 
PUBLICATION OF RESULTS ............................................................................................................... 18 
14 
RISK BENEFIT ANALYSIS .................................................................................................................... 18 
14.1 
RISK .................................................................................................................................................... 18 
14.2 
MINIMIZATION OF RISKS..................................................................................................................... 18 
14.3 
BENEFIT .............................................................................................................................................. 18 
15 
ETHICAL CONSIDERATIONS ............................................................................................................. 19 
15.1 
DECLARATION OF HELSINKI ............................................................................................................... 19 
15.2 
INFORMED CONSENT........................................................................................................................... 19 
15.3 
PATIENT INSURANCE (PRODUCT LIABILITY) ........................................................................................ 19 
15.4 
PERSONAL DATA PROTECTION ............................................................................................................ 19 
16 
REFERENCES .......................................................................................................................................... 20 
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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APPENDICES 
I 
Declaration of Helsinki 
II 
Patient Information Sheet and Informed Consent 
III       Investigator agreement 
IV 
Accolade Component Sizes 
V 
Trident Component Sizes 
VI 
Tritanium Component Sizes 
VII 
X3 Component Sizes 
VIII 
Head Component Sizes 
IX 
Accolade II Component Sizes 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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THE ATX REGISTRY 
 
ACCOLADE/ACCOLADE II STEM & TRIDENT/TRITANIUM 
CUP WITH X3 INSERT 
INTERNATIONAL MULTICENTRE SURVEILLANCE 
REGISTER 
 
PROTOCOL SUMMARY 
 
 Surveillance design:  
International multicentre, prospective follow-up of a consecutive series of patients. 
 Objectives:  
To verify the Accolade/Accolade II stem and Trident/Tritanium cup safety during follow-
up and survivorship as described by Kaplan-Meier survival curves. 
To document the patient clinical outcome of the patients who are eligible for a hip 
arthroplasty surgery involving an Accolade/Accolade II stem and Trident/Tritanium cup.  
 Regulatory status of the device:  
Name of the hip system: 
TMZF  hip stem. Accolade II stem. Trident and 
Tritanium cup and X3-liner. All components are CE-marked and approved for sale in 
Europe. 
 Participating institutions: 
Each clinic need to recruit at least 20 patients and maximum 100 patients. Institutions 
willing to participate to the register and fulfilling the local and international applicable 
regulatory requirements can participate. Sufficient human and technical resources in the 
centre are expected to ensure optimal data collection. 
 Patients to be enrolled:  
All patients eligible for a hip arthroplasty surgery involving the Accolade or Accolade II 
stem and Trident or Tritanium cup who have been informed about this surveillance 
register and who freely consent to participate will be enrolled in the register.  
Patients will be enrolled prospectively.    
 Clinical evaluations:  
Adverse events/adverse events: All intra-operative and post-operative adverse events. 
Standard clinical parameters, Harris Hip Score, Oxford Hip Score and EQ5D will be 
registered preoperatively and at each follow-up visit. 

                                                                                                                           
 
                                                                                                      
 
 
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ATX-REGISTRY 
INTERNATIONAL MULTICENTRE SURVEILLANCE 
REGISTER 
 
1 INTRODUCTION 
Total hip replacement is one of the most common and successful techniques used in 
orthopaedic surgery. Alongside with cemented hip arthroplasties, cementless hip replacement 
has proven its value [1-6]. Still, the survival of hip implants is not indefinite. One of the 
causes for implant failure is loosening and osteolysis as a consequence of particulate wear or 
stress-shielding. 
Many studies have investigated the factors that influence implant fixation and stability [7, 8]. 
Over the years knowledge on stability, fixation and preservation of bone stock has increased 
considerably. Also better understanding of joint kinematics allows designing implants with 
reduced joint reaction forces which again may lead to improved survival of implants. Stem 
designs have been changed accordingly. Important features in stem design are fit and fill, 
stem geometry, strain distribution, type and extent of coating [7-11] 
Tapered stems, designed to provide mediolateral stability within the femoral canal, have had 
greater success. A clinical register in which 71 cases were implanted with a wedge fit, cobalt-
chrome, cementless stem, resulted in a revision rate of 0% for aseptic loosening, and 
incidence of thigh pain of 1.4% at a minimum ten year follow-up.12 This is lower than 
incidence of thigh pain at earlier visits, where it is reported to be 5% at two years follow-up.  
Decrease in thigh pain is seen with continuing follow-up. In a register conducted by Pellegrini 
et. al.13 a 3.5% rate of thigh pain was reported at a mean follow-up 6.5 years (range five to 
eight years). Likewise, lower rates of thigh pain have been reported with similar tapered 
wedge fit designs: 4% by Hozack et al 14 and 6% by McLaughlin and Lee. 15  Conversely, 
higher rates of thigh pain have been reported with some uncemented femoral stems with 
different designs. Rates of thigh pain for different stem designs have been reported to be 9.4% 
by Engh and Massin 10, 15% by Heekin et al 17 and 20% by Maloney et al 18. The superior 
results seen with the wedge fit stem can be partially attributed to excellent initial stability with 
subsequent bone in-growth.12 It is likely that the tapered design allows for gradual transfer of 
stresses from the stem to the bone. Engineering analysis of the tapered design has been 
published which supports the stress transfer effect. 12, 13, 19 
The Stryker 
constructed from a beta titanium alloy (TMZF®).  The alloy can, which can offer 25% greater 
flexibility than standard Ti-6Al-4V, yielding a modulus that more closely approximates that 
of bone. In addition, this proprietary alloy maintains a 20% higher tensile strength than Ti-
6Al-4V.  Other features include a circumferential plasma spray over the proximal body that 
assists with mechanical engagement in bone and provides an optimum interface for fixation. 
Fixation is aided by a HA coating. (2 Pure Fix
long term clinical results (10 years) in a multi-centre register. 
Accolade II is the first Morphometric Wedge design, an evolution of the tapered 
wedge stem. The stem is uniquely designed with a size specific medial curvature to fit a broad 
 (Optimized length and fit 
based on a sample size of 556 CT scans).22,23 Mechanical testing has shown this design 
facilitates initial press-fit stability24 and load transmission in the proximal region of the femur. 

                                                                                                                           
 
                                                                                                      
 
 
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The tapered wedge design of the Accolade TMZF and Accolade II Femoral 
Component provides firm mediolateral stability within the femoral canal. An offering of 
standard (132°) and extended (127°) offset options enhances soft tissue tensioning without 
significantly affecting leg length when adjusting joint stability.  Furthermore, the TMZF alloy 
provides the opportunity to reduce the neck geometry thus optimizing the available range of 
motion while maintaining strength. 
femoral head with the associated range of offsets and neck lengths.  Both forged Vitallium® 
alloy and zirconia ceramic heads can be used. 
The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium 
cup survivorship over years. 
2 SURVEILLANCE DESIGN 
This is a prospective international multicentre surveillance register. The surveillance register 
will be conducted in accordance to the applicable regulatory requirements including local 
health data protection laws. Where applicable, Ethics Committees will be informed about the 
register and if required, Ethics Committee authorisation/favourable opinion will be asked 
prior to the register start.  
All institutions willing to participate to the register, able to recruit at least 20 patients (up to 
100 patients) and fulfilling the local and international applicable regulatory requirements can 
participate. Sufficient human and technical resources are expected in the institution to ensure 
optimal data collection. All patients eligible for a hip arthroplasty surgery involving the 
Accolade or Accolade II stem and Trident/Tritanium cup who have been informed about this 
surveillance register and who freely consent to participate will be enrolled in the register 
(written informed consent described in appendix 3 will be obtained from the patients). 
3 OBJECTIVES & METHODS 
 Safety & survivorship: All adverse events / failures or revision of the Accolade stem, 
Accolade II stem and Trident/Tritanium cup will be documented in order to draw 
Kaplan Meier survival curves of the Accolade stem and Trident/Tritanium cup over 
follow-up. 
 Clinical outcome: Standard clinical parameters (Harris hip score, Oxford Hip Score 
and EQ5D) will be obtained to allow the surgeon to assess the clinical outcome of the 
patient. 
The register will follow the standard clinical procedures used by the institutions for 
patient selection for hip arthroplasty surgery, patient surgery and patient follow-up. 
Therefore there will be, with regard to this register, no additional assessment, 
examination, procedure or follow-up visits compared to those usually performed in the 
institution (routine standard normal procedures).  
4 SELECTION OF PATIENTS 
4.1 Number of patients 
Up to 1000 patients who received the Accolade or Accolade II stem and Trident/Tritanium 
cup with X3 liner can be enrolled into the ATX Surveillance Register. 

                                                                                                                           
 
                                                                                                      
 
 
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4.2 Patient selection criteria 
All patients in a participating centre matching all of the inclusion criteria and none of the 
exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium 
cup with X3 liner will be recorded in the Register. 
4.2.1 Inclusion criteria 
Patients suitable for inclusion in the trial will be those fulfilling all the following selection 
criteria: 
1. Male and non-pregnant female patients between 18-75 years of age. 
2. Patients requiring uncemented primary THA, suitable for the use of the Accolade stem 
and Trident/Tritanium cup. 
3. Patients with a diagnosis of osteoarthritis (OA). 
4. Patients who understand the conditions of the study and are willing and able to comply 
with the post-operative scheduled clinical and radiographic evaluations and the 
prescribed rehabilitation. 
5. Patients who signed the Ethics Committee approved Informed Consent Form prior to 
surgery. 
4.2.2 Exclusion criteria 
Patients with any of the following will be excluded from the trial: 
1. Patients who require revision of a previously implanted hip prosthesis. 
2. Patients who had a THA on contralateral side within the last 6 months. 
3. Patients who had a THA on contralateral side more than 6 months ago and the 
rehabilitation period outcome was considered unsatisfactory or not good (Harris Hip 
Score < 85). 
4. Patients who will need lower limb joint replacement for another joint within one year. 
5. Patients requiring bilateral hip replacement. 
6. Patients who have had a prior procedure of acetabular osteotomy. 
7. Patients with acute femoral fractures 
8. Obese patien
activities of daily living (body mass index, kg/m2: BMI  35). 
9. Patients with active or suspected infection. 
10. Patients with malignancy  active malignancy. 
11. Patients with severe osteopor
osteodystrophy. 
12. Patients immunologically suppressed, or receiving steroids in excess of physiologic 
dose requirements. 
13. The patient has a neuromuscular or neurosensory deficit which would limit the ability 
to assess the performance of the device or the patient has a neurological deficit which 

                                                                                                                           
 
                                                                                                      
 
 
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on the implant during the healing period. 
14. Female patients planning a pregnancy during the course of the study. 
15. Patients with systemic or metabolic disorders leading to progressive bone 
deterioration. 
16. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be 
compliant with the prescribed post-operative routine and follow-up evaluation 
schedule. 
17. Patients with other severe concurrent joint involvements, which can affect their 
outcome. 
18. Patients with other concurrent illnesses, which are likely to affect their outcome such 
as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring 
dialysis. 
19. Patient with a known sensitivity to device materials. 
20. Patients under the protection of law (e.g. guardianship). 
 The patient will be informed by the Investigator (or his designated representative) of the 
purpose of the data collection. The patient will be informed that his/her medical records are 
subjected to review as necessary. The confidentiality of the patient will be maintained at all 
times and the collected data will be anonymous. The patient will be told that he/she is free to 
refuse the collection of his/her clinical data and to withdraw from the Surveillance at any time 
without compromising future medical care. A signed Patient Informed Consent will be 
obtained prior to patient participation (appendix 3). 
5 LENGTH OF SURVEILLANCE AND VISIT SCHEDULE 
The length of surveillance and patient visit schedule is based on the routine procedures of the 
institution. The surveillance system is set-up to record data at 1 year, 3 years, 5 years, 7 years 
and 10 years follow-up. 
Visit schedule 
VISIT 
TIME WINDOW 
Pre-op. 
Date of or any time post the date of written 
informed consent up to 4 months prior to the 
date of surgery. 
Operation 
N/A 
1 year post-op. 
± 3 months 
3 years post-op. 
± 6 months 
5 years post-op. 
± 6 months 
7 year post-op 
± 6 months 
10 years post-op. 
± 6 months 
                 

                                                                                                                          
                                                                                                      
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6
DESCRIPTION OF THE DEVICES
All components of the THA systems used in this Surveillance obtained the CE mark and are
approved for sale and use throughout Europe.
6.1
Femoral Components
The Stryker 
TMZF
and Accolade II femoral stems are designed for the 
cementless total hip arthroplasty. 
The Accolade
TMZF
is a single use stem intended for cementless fixation, to replace the 
proximal portion of the femur in primary total hip arthroplasty. The Accolade
TMZF
is a 
tapered wedge design, comprised of a proprietary beta titanium alloy.  The proximal body is 
plasma sprayed providing an optimum interface for application of Pure Fix
HA coating.  
The bone sparing design accommodates either a small or standard size incision or a variety of 
approaches.  There are two neck angles available, the standard 132 and the extended 127 . 
There are 13 stem sizes available, 9 full sizes (0-8) and 4 half sizes (2.5, 3.5, 4.5, 5.5), for 
each neck angle. The additional half sizes were developed to accommodate differences in 
patient anatomy. (See Appendix IV for the device description details).
The Accolade II stem is a morphometric taper wedge design with a size specific medial 
curvature (see illustration below).
The following table shows the comparison between the Accolade and Accolade II designs and 
main features:

                                                                                                                           
 
                                                                                                      
 
 
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There are 12 stem sizes for Accolade II (size 0 to 11) for each neck angle. (Please refer to 
Appendix IX for more Accolade II detailed information) 
6.2 Acetabular Component 
As Acetabular component either Trident or Trident Tritanium can be used. 
Trident  
family of products provides a range of acetabular shells to help surgeons 
choose the right shell and bearing option for the patient in question. These include PSL or 
 or non HA coated cups and no hole, cluster hole or multi 
hole options. 
-
shells are available in sizes 40mm-68mm. They can be used with: 
 
 inserts 0°, 10°, excentric, elevated rim, or constrained, in sizes 
22mm-44mm (depending on type of insert), for use with either a CoCr, 
Alumina                   
 Ceramic, BIOLOX delta 
 and Alumina inserts 0° in sizes 
28mm-36mm, for use with either a Alumina Ceramic or BIOLOX delta Ceramic head. 
Please note, in this surveillance registry ONLY X3 liner is approved! 
TridentTritanium
 
h a highly porous ingrowth 
surface. 
Commercially Pure 
and 
locking 
mechanism 
from the 
TridentAcetabular 
syste
Hemispherical comes as solid back shells (no holes), cluster shells and multi-hole shells. 
The hemispherical shells are available in sizes 44mm-72mm 
polyethylene inserts 0° (in sizes 22mm-44mm), 10° (in sizes 22mm-36mm) or with elevated 
rim (in sizes 28mm-36mm). The inserts are provided for either a CoCr, 
 
Alumina Ceramic, BIOLOX delta Ceramic, or 
 Please note that in this 
surveillance registry ONLY X3 liners are approved! 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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7 PATIENT EVALUATIONS 
Patients will be assessed pre-operatively, per-operatively and post-operatively. The follow-up 
intervals will be as specified in section 5.  
7.1 Evaluations at each assessment 
7.1.1 Pre-operative Evaluation 
 
- Clinical History 
 Patient ID (Study,Site,Subject) 
 Date of birth, weight height, Gender  
 Visit Date  
 Cigarette and Alcohol use  
 Charnley patient category  
 Privious surgery to hip planned for operation  
 Primary Diagnosis  
 
 
- Clinical Evaluation 
 Patient ID (Study,Site,Subject) 
 Operative site  
 Date of informed consent signed  
 Inclusion/ Exclusion  
 Harris Hip Score Evaluation  
 Oxford Hip Score  
 EQ5D 
 
7.1.2 Intra-operative Evaluation 
 
- Surgical details 
 Surgery Date  
 Operative Side  
 Surgical approach 
 Minimally invasive surgery and size of incision 
 Anaesthesia class and type 
 Duration of surgery 
 Intra-operative adverse events 
 Components used and sizes 
 Solid back / Cluster shells and Multi-hole shells 
 Systemic antibiotic prophylaxis 
 NSAIDs 
 
7.1.3 Post-operative Evaluation 
Patients will be assessed post operatively as per the visit schedule in section 5. 

                                                                                                                           
 
                                                                                                      
 
 
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 - Clinical Evaluation 
 Date of assessment 
 Adverse events 
 Harris Hip Score Evaluation 
 Oxford Hip Score 
 EQ5D 
7.1.4 Adverse events and device removal events 
 Onset date  
 When Did the event occur (Intra-op, Post-op) 
 Operative site events  
 Systemic events  
 Device related  
 Seriousness  
 Treatment  
o Revision/Removal  
o Reoperations  
o Other treatment  
 Resolution of event  
 
7.1.5 Termination 
 Date of termination of Surveillance 
 Date of last visit assessment 
 Reason for termination 
 
 
8 ADVERSE EVENTS 
The investigator is required to document all operative site and general medical adverse events, 
including date of occurrence, date diagnosed, type of complication and treatment. 
 
8.1 Definitions 
8.1.1 Adverse event 
An adverse event 
or worsens during the period of observation in the Register. This definition does not imply 
that there is a relationship between the adverse event and the device under investigation. [21] 
Surgical procedures themselves are not adverse events; they are therapeutic measures for 
conditions that require surgery. The condition for which the surgery is required is an adverse 
event, if it occurs or is detected during the Register follow-up period. 
 

                                                                                                                           
 
                                                                                                      
 
 
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A serious adverse event is an adverse event which 
a) led to a death 
b) led to a serious deterioration in the health of a subject that 
1. resulted in a life-threatening illness or injury 
2. resulted in a permanent impairment of a body structure or a body function 
3. required in-patient hospitalization or prolongation of existing hospitalisation 
4. resulted in medical or surgical intervention to prevent permanent impairment to body 
structure or a body function 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
 
8.1.2  Adverse device effect 
An adverse device effect 
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 
 [21]  
A serious adverse device effect 
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 
 
8.2 Documentation and reporting of adverse event by the investigator 
All subjects who have adverse events, whether considered associated with the use of the 
implant or not, must be monitored to determine the outcome. 
The assessment of the causal relationship between the adverse event and the device will be 
reported by the surgeon as: 
- 
definitively 
- 
probably 
- 
possibly 
- 
probably not 
- 
definitively not 
 
All serious adverse events, serious adverse device effect, adverse device effects and 
unexpected adverse events, in accordance with the above definitions, must be reported to the 
sponsor within 24 hours from their occurrence, using the adverse event report form. Written 
and detailed subsequent follow-up reports will be provided to the sponsor. 
 
A Serious Adverse Event report form should be completed by the investigator and sent by 
email (AE.Clinical@stryker.com) to the sponsor, within 24 hours. If at the time of sending 
the report, all details are not available by the investigator; this one must send it with the 
available data and then seek to obtain complementary information. The complementary 
information will be sent by the investigator to the sponsor as soon as it will be available. 

                                                                                                                           
 
                                                                                                      
 
 
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Please contact your local Stryker Clinical contact, or the study manager for any adverse 
events. 
 
In addition, all adverse events, serious or not, occurring between two planned visits will be 
reported in the CRF.  
Death will be both reported in the serious adverse event report form and in the termination 
form part of the CRF. 
 
Moreover the investigator should send to the Sponsor a copy of the imaging exam when 
performed at the time of the adverse event.  
The investigator will evaluate the adverse event and determine the most appropriate actions.  
The sponsor will report to Competent Authorities and Ethic Committees adverse events 
occurred during the study in accordance with applicable regulations. 
 
9 PATIENT WITHDRAWALS 
Patients are free to withdraw from the Surveillance at any time and are under no obligation to 
provide a reason for doing so. Patients who withdraw from the Surveillance should have the 
if at all possible. All 
attempts should be made to ascertain whether any patient apparently lost to follow up has 
actually chosen not to return or is deceased. 
 
10 ELECTRONIC DATA CAPTURE: eCRF 
All the above-mentioned pre-operative patient assessments, intra-operative details and post-
operative follow-up assessments will be recorded on a CRF (Case Report Forms) which will 
be provided to any centre being part of the ATX Register. 
The CRF will be provided electronically (secured electronic data capture:EDC). A patient 
blank paper case report form can be printed by surgeons wishing data collection on paper 
before data entry in the EDC. After EDC data entry, a hard copy can be printed as well for 
each patient by the surgeon(s). This EDC system (NetRegulus RM) complies with the FDA 
and international requirements for electronic database(s) security and performances. 
The system will be secured to prevent unauthorized access to the data or to the system by 
using the combination of user ID and password which will be provided by Stryker SA to the 
authorised users of each centre. The investigator will maintain a list of individuals who are 
authorized to enter or correct data in the system.  
The surgeon and his/her other defined users will receive system documentation, training and 
support for the use of the EDC. All required information collected during the following period 
must be entered by the investigator or designated representative in the EDC. All data entry, 
modification or deletion will be recorded automatically in an electronic audit trail (tracking of 
the data entered or modified). The combination of both user ID and password will correspond 
to the surgeon electronic signature which will be required for patient data validation. 
The secured database will be physically hosted by Stryker Orthopaedics Mahwah, New Jersey 
(US).  

                                                                                                                           
 
                                                                                                      
 
 
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Strict confidentiality and anonymity will be applied: only the subject number will be recorded 
in the database.  
The investigator will maintain a personal subject identification list (subject numbers with the 
corresponding subject names) to enable records to be identified. 
 
11 SURVEILLANCE MONITORING 
During the course of the ATX Registry and thereafter until the centre has been closed, the 
monitor(s) possibly visit the Centre(s) recruiting patients into the Registry by prior 
arrangement. The clinical Study manager or monitor can also be contacted concerning any 
problems or queries regarding the clinical ATX Registry. 
 
Clinical Study Manager Europe: 
Sietske Witvoet 
 
 
 
 
 
Telephone:  
 
 
 
+31(0) 6 52540394 
Fax: 
 
 
 
 
+31(0) 418569777 
E-Mail: 
 
             
sietske.witvoet@stryker.com 
 
The monitor shall be given unhindered access to monitor relevant source documents 
(including medical records) to enable complete data verification, but with respect to the 
7.4. 
12 ANALYSIS OF RESULTS 
Results obtained from the ATX Registry will be tabulated and statistically analysed by 
interim analysis of the data will be made once appropriate patients are included in the 
Registry.  
12.1 Statistical Analysis 
ty and survivorship of the 
Accolade stem and Trident/Tritanium cup during the follow-up. The main failure item to be 
considered for Kaplan-Meier survival curves is surgical revision of the Accolade stem or 
Trident/Tritanium cup but all other adverse events types can be separately considered as 
failures for Kaplan-Meier survival curve assessment.  
In addition to the Kaplan Meier survival curves, the surgeons involved in the register will 
have the possibility to analyse the following statistical descriptions/comparisons: 
 Demographic and pre-operative assessments 
 Intra-operative assessments 
 Post-operative pain and function assessments: Harris Hip Score.  
 Oxford Hip Score 
 Quality of Life assessments: EQ5D 
 Adverse events and device-related adverse events 
 Revisions/removals 

                                                                                                                           
 
                                                                                                      
 
 
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Frequency and percent distributions will be presented in tabular form for categorical 
variables. The mean, standard deviation, minimum and maximum values will be presented for 
quantitative variables. 
13 PUBLICATION OF RESULTS 
By signing the protocol, the investigator agrees to the results of the study being used for 
publication and for informing medical and pharmaceutical professionals. If necessary, names, 
addresses, qualifications and the role of the investigator in the study shall be notified to the 
authorities. 
The sponsor shall compile a final study report. 
The co-ordinating investigator and the principal investigators at each centre must confirm, by 
their signature, that they have read the report. They must confirm that to their knowledge, the 
report describes the study results, and the way in which it has been conducted, accurately. 
The method and timetable for compiling the publications shall be defined by mutual 
agreement between the Sponsor and the Investigators. 
 
14 RISK BENEFIT ANALYSIS 
14.1 Risk 
As in any surgical procedure, certain risks are associated with total joint arthroplasty. These 
risks include but are not limited to: anaesthetic and post-anaesthetic reactions (such as 
hyperaemia), allergic reactions to prophylactic antibiotics or blood transfusions, damage to 
blood vessels or nerves, trochanteric or femoral fractures during implantation, perforation of 
the cortical wall, or death. Post-operatively, a patient may experience thrombophlebitis, 
pulmonary embolus, dislocation, pain, limp, component loosening, osteolysis due to wear 
debris or the need for additional surgery. Fracture of the prosthesis is a potential complication. 
 
14.2 Minimization of Risks 
Pre-clinical, clinical, and mechanical testing of the Stryker Accolade
 TMZF  Hip Stem, the 
Accolade II stem and Trident/Tritanium cup indicate that the above mentioned risks should 
not occur at a rate greater than that for any other type of total hip arthroplasty reported in the 
literature. 
 
14.3 Benefit 
Patient benefits should include relief of pain and increase in functional capabilities, in 
addition to better assessment of the effect of prosthesis design and materials on functional and 
radiographic performance and bone remodelling around cementless femoral prostheses. This 
will increase the current scientific body of knowledge concerning total hip arthroplasty. 

                                                                                                                           
 
                                                                                                      
 
 
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15 ETHICAL CONSIDERATIONS 
15.1 Declaration of Helsinki 
The Surveillance 
(Declaration of Helsinki, October 2008) (see Appendix II). 
In accordance with the Declaration of Helsinki, where applicable, all centres will gain written 
Ethics Committee approval prior to enrolling patients in the Surveillance. Ethics Committee 
approval for the data collection must be gained either from the local responsible Ethics 
Committee at the investigator site or from an adequately constituted (according to ISO14155-
1: 2003) independent Ethics Committee. 
15.2 Informed Consent 
All recruited patients will sign and date the informed consent form before any investigational 
procedure or visit is performed. Only the latest ethics committee approved version is a valid 
document. The patient is provided with a copy of the information letter and consent form. 
The investigator is acquainted with the contents of the information sheet and answers patient 
questions regarding participation in the study.   
15.3 Patient Insurance (product liability) 
Participating patients in this Surveillance are covered by Stryker SA product liability 
insurance. 
15.4 Personal data protection 
Stryker SA affirms and upholds the principle of the patient rights to protection against 
invasion of privacy. All data recorded in the CRFs or used for further evaluation are coded by 
patient number and age. Identification is restricted to authorized persons. In all data analyses 
the identity of patients will remain anonymous. Anonymous patient data may be stored and 
electronically processed by Stryker Europe for the purpose of scientific evaluation and may be 
forwarded to a company and/or an authority located in- and outside Europe for registration 
and/or marketing purposes. Only authorized representatives of Stryker Europe and health 
authorities will have allowed access to personal medical records for the sole purpose of 
checking the accuracy of data collected in the trial. 
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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16 REFERENCES 
1. Geesink RGT: Osteoconductive Coatings for Total Joint Arthroplasty. Clin Orthop  395: 53, 2002 
2. Geesink R, Hoefnagels N: Eight years results of HA-coated primary total hip replacement. Acta 
Orthop Belg  63: 72, 1997 
3. Oosterbos CJ, Rahmy AI, Tonino AJ: Hydroxyapatite coated hip prosthesis followed up for 5 years. 
Int Orthop  25: 17, 2001 
4. McNally SA, Shepperd JA, Mann CV et al: The results at nine to twelve years of the use of a 
hydroxyapatite- coated femoral stem. J Bone Joint Surg Br  82: 378, 2000 
5. Manley MT, Capello WN, D'Antonio JA et al: Fixation of acetabular cups without cement in total 
hip arthroplasty. A comparison of three different implant surfaces at a minimum duration of follow-up 
of five years. J Bone Joint Surg Am  80: 1175, 1998 
6. D'Antonio JA, Capello WN, Manley MT et al: Hydroxyapatite femoral stems for total hip 
arthroplasty: 10- to 13-year followup. Clin Orthop  393: 101, 2001 
7. Poss R, Walker P,  Spector M et al: Strategies for improving fixation of femoral components in total 
hip arthroplasty. Clin Orthop 235: 181, 1988 
8. Bobyn JD, Mortimer ES, Glassman AH et al: Producing and avoiding stress shielding. Laboratory 
and clinical observations of noncemented total hip arthroplasty. Clin Orthop  274: 79, 1992 
9. Rosenthall L, Bobyn JD, Tanzer M: Bone densitometry: influence of prosthetic design and 
hydroxyapatite coating on regional adaptive bone remodelling. Int Orthop  23: 325, 1999 
10. Al Hertani W, Waddell JP, Anderson GI: The effect of partial vs. full hydroxyapatite coating on 
periprosthetic bone quality around the canine madreporic femoral stem. J Biomed Mater Res  53:518, 
2000 
11. McAuley JP, Sychterz CJ, Engh CA, Sr.: Influence of porous coating level on proximal femoral 
remodeling. A postmortem analysis. Clin Orthop  371: 146, 2000 
12. Sakalkale D, Eng K, Hozack W: Minimum 10-year results of a tapered cementless hip 
replacement.  Clin Orthop Relat Res 363:138-44, 1999. 
13. Pellegrini VD, Hughes SS, Evarts CM:  A collarless cobalt-chrome femoral component  in 
uncemented total hip arthroplasty:  Five to eight year follow-up.  J Bone Joint Surg 74B:814-821, 
1992. 
14. Hozack WJ, Rothman RH, Eng K, Mesa J: Primary cementless hip arthroplasty with a titanium 
plasma sprayed prosthesis. Clin Orthop Relat Res 333:217-225, 1996. 
15. McLaughlin JR, Lee KR:  Total hip arthroplasty with an uncemented femoral component: 
Excellent results at ten year follow-up.  J Bone Joint Surg 79B:900-907, 1997. 
16. Engh CA, Massin P:  Cementless total hip arthroplasty using the anatomic medullary locking 
stem.  Clin Orthop Relat Res 249:141-158,1989. 
17. Heekin RD, Callaghan JJ, Hopkinson WJ, Savory CG, Xenos JS: The porous coated anatomic 
total hip prosthesis, inserted without cement.  Results after five to seven years in a prospective 
register. J Bone Joint Surg 75A:77-91, 1993 
18. Maloney WJ, Jasty M, Harris WH, et al: Endosteal erosion in association with stable uncemented 
femoral components. J Bone Joint Surg 72A:1025-1034, 1990 
19. Vresilovic EJ, Hozack WJ, Rothman RH: Incidence of thigh pain after uncemented total hip 
arthoplasty as a function of femoral stem size. J Arthroplasty 11:304-311, 1996. 
20. Hoefnagels NHM, Dhert WJA, Gosens T, Van Langelaan EJ, Geesink RGT, Bulstra SK, De Vet R, 
Okhuysen S. De oxford heup score: Een nederlandstalige patiëntenvragenlijst ter evaluatie van de 

                                                                                                                           
 
                                                                                                      
 
 
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-item questionnaire on the preceptions of 
patients about THR (accepted by ned tijdschrift voor orthopedie) 
21. International Standard ISO14155 part 1 and 2, first edition 2003-02-15. ISO 14155-1 and 2: 2003 
(E). 
22. Wuestemann T, Bastian A, Schmidt W, Cedermark C, Parvizi J, Rothman R. A novel technique for 
studying proximal femoral bone morphology for hip implant design. 2010 ORS Poster# 2217 
23. Wuestemann T, Bastian A, Parvizi J, Nessler J, Kolisek F. A novel tapered hip stem design 
optimized for femoral fit in a wide array of bone types. 2011 EFORT 
24.  Race A, Wuestemann, T, Collopy D. Comparison of the immediate post-operative stability of a 
novel tapered hip stem to a predicate design. 2012 ORS 

                                                                                                                           
 
                                                                                                      
 
 
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                                      APPENDIX I 
 
DECLARATION OF HELSINKI WORLD MEDICAL ASSOCIATION 
DECLARATION OF HELSINKI 
Ethical Principles for Medical Research Involving Human Subjects 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
41st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
52nd WMA General Assembly, Edinburgh, Scotland, October 2000 
53th WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added) 
55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added) 
59th WMA General Assembly, Seoul, October 2008 
 
A. INTRODUCTION 
 
1. The World Medical Association (WMA) has developed the Declaration of Helsinki 
as a statement of ethical principles for medical research involving human subjects, 
including research on identifiable human material and data. 
The Declaration is intended to be read as a whole and each of its constituent 
paragraphs should not be applied without consideration of all other relevant 
paragraphs. 
 
2. Although the Declaration is addressed primarily to physicians, the WMA 
encourages other participants in medical research involving human subjects to adopt 
these principles. 
 
3. It is the duty of the physician to promote and safeguard the health of patients, 
including those who are involved in medical research. The physician's knowledge 
and conscience are dedicated to the fulfilment of this duty. 
 
 
 
best interest when 
 
 
5. Medical progress is based on research that ultimately must include studies 
involving human subjects. Populations that are underrepresented in medical research 
should be provided appropriate access to participation in research. 
 
6. In medical research involving human subjects, the well-being of the individual 
research subject must take precedence over all other interests. 
 
7. The primary purpose of medical research involving human subjects is to 
understand the causes, development and effects of diseases and improve 
preventive, diagnostic and therapeutic interventions (methods, procedures and 
treatments). Even the best current interventions must be evaluated continually 
through research for their safety, effectiveness, efficiency, accessibility and quality. 
 

                                                                                                                           
 
                                                                                                      
 
 
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8. In medical practice and in medical research, most interventions involve risks and 
burdens. DoH 2/Oct2008 
 
9. Medical research is subject to ethical standards that promote respect for all human 
subjects and protect their health and rights. Some research populations are 
particularly vulnerable and need special protection. These include those who cannot 
give or refuse consent for themselves and those who may be vulnerable to coercion 
or undue influence. 
 
10. Physicians should consider the ethical, legal and regulatory norms and standards 
for research involving human subjects in their own countries as well as applicable 
international norms and standards. No national or international ethical, legal or 
regulatory requirement should reduce or eliminate any of the protections for research 
subjects set forth in this Declaration. 
 
B. PRINCIPLES FOR ALL MEDICAL RESEARCH 
 
11. It is the duty of physicians who participate in medical research to protect the life, 
health, dignity, integrity, right to self-determination, privacy, and confidentiality of 
personal information of research subjects. 
 
12. Medical research involving human subjects must conform to generally accepted 
scientific principles, be based on a thorough knowledge of the scientific literature, 
other relevant sources of information, and adequate laboratory and, as appropriate, 
animal experimentation. The welfare of animals used for research must be 
respected. 
 
13. Appropriate caution must be exercised in the conduct of medical research that 
may harm the environment.  
 
14. The design and performance of each research register involving human subjects 
must be clearly described in a research protocol. The protocol should contain a 
statement of the ethical considerations involved and should indicate how the 
principles in this Declaration have been addressed. The protocol should include 
information regarding funding, sponsors, institutional affiliations, other potential 
conflicts of interest, incentives for subjects and provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in the 
research register. The protocol should describe arrangements for post-register 
access by register subjects to interventions identified as beneficial in the register or 
access to other appropriate care or benefits. 
 
15. The research protocol must be submitted for consideration, comment, guidance 
and approval to a research ethics committee before the register begins. This 
committee must be independent of the researcher, the sponsor and any other undue 
influence. It must take into consideration the laws and regulations of the country or 
countries in which the research is to be performed as well as applicable international 
norms and standards but these must not be allowed to reduce or eliminate any of the 
protections for research subjects set forth in this Declaration. The committee must 
have the right to monitor ongoing studies. The researcher must provide monitoring 
information to the committee, especially information about any serious adverse 

                                                                                                                           
 
                                                                                                      
 
 
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events. No change to the protocol may be made without consideration and approval 
by the committee. 
 
16. Medical research involving human subjects must be conducted only by 
individuals with the appropriate scientific training and qualifications. Research on 
patients or healthy DoH3/Oct2008 volunteers requires the supervision of a competent 
and appropriately qualified physician or other health care professional. The 
responsibility for the protection of research subjects must always rest with the 
physician or other health care professional and never the research subjects, even 
though they have given consent. 
 
17. Medical research involving a disadvantaged or vulnerable population or 
community is only justified if the research is responsive to the health needs and 
priorities of this population or community and if there is a reasonable likelihood that 
this population or community stands to benefit from the results of the research. 
 
18. Every medical research register involving human subjects must be preceded by 
careful assessment of predictable risks and burdens to the individuals and 
communities involved in the research in comparison with foreseeable benefits to 
them and to other individuals or communities affected by the condition under 
investigation. 
 
19. Every clinical trial must be registered in a publicly accessible database before 
recruitment of the first subject. 
 
20. Physicians may not participate in a research register involving human subjects 
unless they are confident that the risks involved have been adequately assessed and 
can be satisfactorily managed. Physicians must immediately stop a register when the 
risks are found to outweigh the potential benefits or when there is conclusive proof of 
positive and beneficial results. 
 
21. Medical research involving human subjects may only be conducted if the 
importance of the objective outweighs the inherent risks and burdens to the research 
subjects. 
 
22. Participation by competent individuals as subjects in medical research must be 
voluntary. Although it may be appropriate to consult family members or community 
leaders, no competent individual may be enrolled in a research register unless he or 
she freely agrees. 
 
23. Every precaution must be taken to protect the privacy of research subjects and 
the confidentiality of their personal information and to minimize the impact of the 
register on their physical, mental and social integrity. 
 
24. In medical research involving competent human subjects, each potential subject 
must be adequately informed of the aims, methods, sources of funding, any possible 
conflicts of interest, institutional affiliations of the researcher, the anticipated benefits 
and potential risks of the register and the discomfort it may entail, and any other 
relevant aspects of the register. The potential subject must be informed of the right to 
refuse to participate in the register or to withdraw consent to participate at any time 

                                                                                                                           
 
                                                                                                      
 
 
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without reprisal. Special attention should be given to the specific information needs of 
individual potential subjects as well as to the methods used to deliver the information. 
After ensuring that the potential subject has understood the information, the 
physician or another appropriately qualified individual must then seek the potential 
-given informed consent, preferably in writing. If the consent cannot be 
expressed in writing, the non-written consent must be formally documented and 
witnessed. DoH/Oct2008 
 
25. For medical research using identifiable human material or data, physicians must 
normally seek consent for the collection, analysis, storage and/or reuse. There may 
be situations where consent would be impossible or impractical to obtain for such 
research or would pose a threat to the validity of the research. In such situations the 
research may be done only after consideration and approval of a research ethics 
committee. 
 
26. When seeking informed consent for participation in a research register the 
physician should be particularly cautious if the potential subject is in a dependent 
relationship with the physician or may consent under duress. In such situations the 
informed consent should be sought by an appropriately qualified individual who is 
completely independent of this relationship. 
 
27. For a potential research subject who is incompetent, the physician must seek 
informed consent from the legally authorized representative. These individuals must 
not be included in a research register that has no likelihood of benefit for them unless 
it is intended to promote the health of the population represented by the potential 
subject, the research cannot instead be performed with competent persons, and the 
research entails only minimal risk and minimal burden. 
 
28. When a potential research subject who is deemed incompetent is able to give 
assent to decisions about participation in research, the physician must seek that 
assent in addition to the consent of the legally authorized representative. The 
 should be respected. 
 
29. Research involving subjects who are physically or mentally incapable of giving 
consent, for example, unconscious patients, may be done only if the physical or 
mental condition that prevents giving informed consent is a necessary characteristic 
of the research population. In such circumstances the physician should seek 
informed consent from the legally authorized representative. If no such 
representative is available and if the research cannot be delayed, the register may 
proceed without informed consent provided that the specific reasons for involving 
subjects with a condition that renders them unable to give informed consent have 
been stated in the research protocol and the register has been approved by a 
research ethics committee. Consent to remain in the research should be obtained as 
soon as possible from the subject or a legally authorized representative. 
 
30. Authors, editors and publishers all have ethical obligations with regard to the 
publication of the results of research. Authors have a duty to make publicly available 
the results of their research on human subjects and are accountable for the 
completeness and accuracy of their reports. They should adhere to accepted 
guidelines for ethical reporting. Negative and inconclusive as well as positive results 

                                                                                                                           
 
                                                                                                      
 
 
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should be published or otherwise made publicly available. Sources of funding, 
institutional affiliations and conflicts of interest should be declared in the publication. 
Reports of research not in accordance with the principles of this Declaration should 
not be accepted for publication. DoH/Oct2008 
 
C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH 
MEDICAL CARE 
 
31. The physician may combine medical research with medical care only to the 
extent that the research is justified by its potential preventive, diagnostic or 
therapeutic value and if the physician has good reason to believe that participation in 
the research register will not adversely affect the health of the patients who serve as 
research subjects. 
 
32. The benefits, risks, burdens and effectiveness of a new intervention must be 
tested against those of the best current proven intervention, except in the following 
circumstances: 
 
proven intervention exists; or 
 
placebo is necessary to determine the efficacy or safety of an intervention and the 
patients who receive placebo or no treatment will not be subject to any risk of serious 
or irreversible harm. Extreme care must be taken to avoid abuse of this option. 
 
33. At the conclusion of the register, patients entered into the register are entitled to 
be informed about the outcome of the register and to share any benefits that result 
from it, for example, access to interventions identified as beneficial in the register or 
to other appropriate care or benefits. 
 
34. The physician must fully inform the patient which aspects of the care are related 
to the research. The refusal of a patient to participate in a register 
decision to withdraw from the register must never interfere with the patient-physician 
relationship.  
 
35. In the treatment of a patient, where proven interventions do not exist or have 
been ineffective, the physician, after seeking expert advice, with informed consent 
from the patient or a legally authorized representative, may use an unproven 
intervention if in the physician's judgement it offers hope of saving life, re-establishing 
health or alleviating suffering. Where possible, this intervention should be made the 
object of research, designed to evaluate its safety and efficacy. In all cases, new 
information should be recorded and, where appropriate, made publicly available.                               

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX II 
ATX REGISTER 
PATIENT INFORMATION SHEET AND INFORMED CONSENT 
 
My surgeon informed me that he is participating in collaboration with Stryker 
SA, the manufacturer of my hip prosthesis, to a surveillance register of the 
Accolade hip prosthesis in combination with Trident and Tritanium uncemented 
cup in order to document the long term safety and survivorship of these 
implants. I
 understood that many patients from different European 
hospitals/clinics will freely take part in this register. I also understood that there 
will be no additional assessment/questionnaires or clinical visits for this register 
compared to the usual clinical practice required for the follow-up of my hip in 
the hospital/clinic where I have been operated. 
I agree that Stryker SA, the manufacturer of my new hip, receives my 
anonymous coded clinical information which is related to my new hip. I 
understand that this hip underwent some developments and that my clinical data 
is used to confirm the safety and efficacy of the implant. I understand that my 
clinical data collected during the surveillance register is recorded electronically 
in a secured database and also possibly on paper, and that access is limited to 
only a few authorized persons. I agree that my clinical information is possibly 
used for publications and that I will never be recognized in such a publication.  
I understand that my participation is voluntary and that at any time I can refuse 
that new information will be recorded without affecting the received quality of 
care.  
 
 
 
 
 
 
Su
 
 
   
 
 
OPTIONAL 
 
 
 
  
 
      Relative/ Representative/Other  

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX III 
INVESTIGATOR AGREEMENT 
ATX REGISTER 
SURGEON AGREEMENT 
 
I have read and understood the ATX Register procedures stated in this document and I agree 
to conduct the Register according to its contents. 
 
 
NAME OF SURGEON  
 : 
 
NAME OF REGISTER CENTRE: 
 
ADDRESS OF REGISTER CENTRE: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SIGNATURE: 
 
 
DATE: 

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX IV 
ACCOLADE COMPONENT SIZES 
 
Accolade TMZF Cementless Femoral Stem (127° Neck Angle) 
 
 
 
 Catalog 
Number   
 Stem 
Size   
 Stem Length (from Medial Calcar) 
Neck Length  
 Offset 
(+0mm)   
 
 6021-0030*   
 0   
86mm 
30mm 
 37mm   
 
 6021-0130   
 1   
110mm 
30mm 
 38mm   
 
 6021-0230   
 2   
115mm 
30mm 
 39mm   
 
 6021-2530   
 2.5   
118mm 
30mm 
 40mm   
 
 6021-0335   
 3   
120mm 
35mm 
 43mm   
 
 6021-3535   
 3.5   
124mm 
35mm 
 43mm   
 
 6021-0435   
 4   
125mm 
35mm 
 44mm   
 
 6021-4535   
 4.5   
129mm 
35mm 
 45mm   
 
 6021-0537   
 5   
130mm 
37mm 
 48mm   
 
 6021-5537   
 5.5   
133mm 
37mm 
 49mm   
 
 6021-0637   
 6   
135mm 
37mm 
 49mm   
 
 6021-0740   
 7   
140mm 
40mm 
 53mm   
 
 6021-0840   
 8   
145mm 
40mm 
 54mm   
 
 
 
 
 
 
 
Accolade TMZF Cementless Femoral Stem (132° Neck Angle ) 
 Catalog 
Number   
 Stem 
Size   
 Stem Length (from Medial Calcar) 
Neck Length 
 Offset 
(+0mm)   
 
 6020-0030*   
 0   
86mm 
30mm 
 33mm   
 
 6020-0130   
 1   
110mm 
30mm 
 34mm   
 
 6020-0230   
 2   
115mm 
30mm 
 35mm   
 
 6020-2530   
 2.5   
118mm 
30mm 
 36mm   
 
 6020-0335   
 3   
120mm 
35mm 
 39mm   
 
 6020-3535   
 3.5   
124mm 
35mm 
 39mm   
 
 6020-0435   
 4   
125mm 
35mm 
 40mm   
 
 6020-4535   
 4.5   
129mm 
35mm 
 41mm   
 
 6020-0537   
 5   
130mm 
37mm 
 44mm   
 
 6020-5537   
 5.5   
133mm 
37mm 
 45mm   
 
 6020-0637   
 6   
135mm 
37mm 
 45mm   
 
 6020-0740   
 7   
140mm 
40mm 
 48mm   
 
 6020-0840   
 8   
145mm 
40mm 
 49mm   
 
 *Available by request.   
 
 
  
  
 

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX V 
TRIDENT COMPONENT SIZES 
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX VI 
TRITANIUM COMPONENT SIZES 
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX VII 
X3 COMPONENT SIZES 
 

                                                                                                                           
 
                                                                                                      
 
 
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APPENDIX VIII 
HEAD COMPONENT SIZES 
 
V40 Delta Ceramic 
Head 
mm 
Offset 
 
 
 
 6570-0-028   
 28   
 -4   
 
 
 
 6570-0-328   
 28   
 -2.7   
 
 
 
 6570-0-128   
 28   
 0   
 
 
 
 6570-0-228   
 28   
+4 
 
 
 
 6570-0-032   
32 
 -4   
 
 
 
 6570-0-132   
32 
0 
 
 
 
 6570-0-232   
 32   
 +4   
 
 
 
 6570-0-036   
36 
 -5   
 
 
 
 6570-0-436   
 36   
 -2.5   
 
 
 
 6570-0-136 
 36   
 0   
 
 
 
 6570-0-536   
 36   
 +2.5   
 
 
 
 6570-0-236   
 36   
 +5   
 
 
 
 6570-0-736   
 36   
 +7.5   
 
 
 
 
 
 
 
 
 
Universal Taper 
Biolox Delta Ceramic 
Head 
mm 
Offset 
 
Universal Adapter 
sleeves 
offset 
6519-1-028 
28 
+0 
 
6519-T-025 
-2.5 
6519-1-032 
32 
+0 
 
6519-T-100 
+0 
6519-1-036 
36 
+0 
 
6519-T-204 
+4 
6519-1-040 
40 
+0 
 
 
 
6519-1-044 
44 
+0 
 
 
 
 
 
 
 
 
 
V40 LFIT CoCr Head 
mm 
off set 
 
 
 
 6260-9-122   
 22   
 +0   
 
 
 
 6260-9-222   
 22   
 +3   
 
 
 
 6260-9-322   
 22   
 +8   
 
 
 
 6260-9-026   
 26   
 -3   
 
 
 
 6260-9-126   
 26   
 +0   
 
 
 
 6260-9-226   
 26   
 +4   
 
 
 
 6260-9-326   
 26   
 +8   
 
 
 
 6260-9-426   
 26   
 +12   
 
 
 
 6260-9-028   
 28   
 -4   
 
 
 
 6260-9-128   
 28   
 +0   
 
 
 
 6260-9-228   
 28   
 +4   
 
 
 
6260-9-628 
28 
 +6 
 
 
 
 6260-9-328   
 28   
 +8   
 
 
 
 6260-9-428   
 28   
 +12   
 
 
 
 6260-9-032   
 32   
 -4   
 
 
 
 6260-9-132   
 32   
 +0   
 
 
 
 6260-9-232   
 32   
 +4   
 
 
 
 6260-9-332   
 32   
 +8   
 
 
 
 6260-9-432   
 32   
 +12   
 
 
 
 6260-9-036   
 36   
 -5   
 
 
 
6260-8-036 
36 
 -4   
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
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 6260-9-136   
 36   
 +0   
 
 
 
6260-8-236 
36 
 +4   
 
 
 
 6260-9-236   
 36   
 +5   
 
 
 
6260-8-336 
36 
 +8   
 
 
 
6260-9-336 
 36   
 +10   
 
 
 
 6260-9-040   
 40   
 -4   
 
 
 
 6260-9-140   
 40   
 +0   
 
 
 
 6260-9-240   
 40   
 +4   
 
 
 
 6260-9-340   
 40   
 +8   
 
 
 
 6260-9-440   
 40   
 +12   
 
 
 
 6260-9-044   
 44   
 -4   
 
 
 
 6260-9-144   
 44   
 +0   
 
 
 
 6260-9-244   
 44   
 +4   
 
 
 
6260-9-344 
44 
 +8   
 
 
 
6260-9-444 
44 
+12 
 
 
 
 
 
 
 
 
 
V40 Vitallium CoCr  
Head 
mm 
Offset 
 
 
 
6260-4-122 
22 
+0 
 
 
 
6260-4-222 
22 
+3 
 
 
 
6260-4-322 
22 
+8 
 
 
 
6260-5-026 
26 
-3 
 
 
 
6260-5-126 
26 
+0 
 
 
 
6260-5-226 
26 
+4 
 
 
 
6260-5-326 
26 
+8 
 
 
 
6260-5-426 
26 
+12 
 
 
 
6260-5-028 
28 
-4 
 
 
 
6260-5-128 
28 
+0 
 
 
 
6260-5-228 
28 
+4 
 
 
 
6260-5-628 
28 
+6 
 
 
 
6260-5-328 
28 
+8 
 
 
 
6260-5-428 
28 
+12 
 
 
 
6260-5-032 
32 
-4 
 
 
 
6260-5-132 
32 
+0 
 
 
 
6260-5-232 
32 
+4 
 
 
 
6260-5-332 
32 
+8 
 
 
 
6260-5-432 
32 
+12 
 
 
 
 
 
 
 
 
 
V40 Alumina head 
mm 
Offset 
 
 
 
6565-0-028 
28 
-2.7 
 
 
 
6565-0-128 
28 
+0 
 
 
 
6565-0-228 
28 
+4 
 
 
 
6565-0-032 
32 
-4 
 
 
 
6565-0-132 
32 
+0 
 
 
 
6565-0-232 
32 
+4 
 
 
 
6565-0-036 
36 
-5 
 
 
 
6565-0-136 
36 
+0 
 
 
 
6565-0-236 
36 
+5 
 
 
 
 

                                                                                                                           
 
                                                                                                      
 
 
ATX International Surveillance Register-20130830      Version 3.0 
37/37 
APPENDIX IX 
ACCOLADE II COMPONENT SIZES