Stryker NTX Registry Scorpio NRG Triathlon Total Knee, Triathlon PKR With X3 Insert International Multicentre Outcomes Register
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics

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Stryker NTX Registry 
 
Scorpio NRG, Triathlon Total Knee, Triathlon PKR 
with X3 Insert 
 
International Multicentre Outcomes Register 
 
 
 
 
 
Date: February 2011 
Reference: K-S-044 
NCT Number: NCT02525562 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Stryker NTX Registry 
 
Scorpio NRG, Triathlon Total Knee, Triathlon PKR 
with X3 Insert 
 
International Multicentre Outcomes Register 
 
 
Protocol 
 
 
Prepared by: Rebekah Stainforth 
Clinical Study Manager Knee 
 
Reviewed by: Eric Garling 
Clinical Research Manager, Europe 
 
Approved by: Hanna Schlyter 
Clinical Research Director, Europe 
 
 
 
Date: February 2011 
Reference: K-S-044 
 
 
 
This Stryker NTX Registry Protocol contains confidential and proprietary information about 
Stryker devices, for the exclusive use of the Investigator. This information may not be disclosed 
to any other person without the prior written approval of Stryker Clinical Europe. 

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TABLE OF CONTENTS 
PROTOCOL SUMMARY ................................................................................................................................................................................ 3 
EVALUATION SCHEDULE.............................................................................................................................................................................. 8 
1 
INTRODUCTION .................................................................................................................................... 9 
2 
SURVEILLANCE DESIGN ....................................................................................................................... 10 
3 
OBJECTIVES & METHODS .................................................................................................................... 11 
4 
DESCRIPTION OF THE DEVICES .................................................................................................................... 11 
4.1 
SCORPIO NRG TOTAL KNEE................................................................................................................................................... 12 
4.2 
TRIATHLON TOTAL KNEE ........................................................................................................................................................ 13 
4.3 
TRIATHLON PKR PARTIAL KNEE RESURFACING SYSTEM ...................................................................................................... 15 
5 
SELECTION OF PATIENTS ..................................................................................................................... 16 
5.1 
PARTICIPATING INSTITUTIONS................................................................................................................................................ 16 
5.2 
NUMBER OF PATIENTS ............................................................................................................................................................ 16 
5.3 
PATIENT SELECTION CRITERIA ................................................................................................................................................. 16 
5.4 
PATIENT ID ............................................................................................................................................ 17 
6 
STUDY DURATION .............................................................................................................................. 17 
VISIT SCHEDULE ........................................................................................................................................... 17 
6.1 
PATIENT EVALUATIONS .......................................................................................................................................................... 18 
7 
ADVERSE EVENTS ................................................................................................................................ 19 
7.1 
DEFINITIONS ........................................................................................................................................................................... 20 
7.2 
DOCUMENTATION AND REPORTING OF ADVERSE EVENT BY THE INVESTIGATOR ................................................................. 21 
8 
PATIENT WITHDRAWALS .................................................................................................................... 22 
9 
ELECTRONIC DATA CAPTURE: ECRF ...................................................................................................... 22 
10 
SURVEILLANCE MONITORING ............................................................................................................. 23 
11 
ANALYSIS OF RESULTS AND REPORTS .................................................................................................. 23 
11.1 
STATISTICAL METHODOLOGY ................................................................................................................................................. 24 
12 
PUBLICATION OF RESULTS .................................................................................................................. 25 
13 
RISK BENEFIT ANALYSIS ...................................................................................................................... 25 
13.1 
RISK ......................................................................................................................................................................................... 25 
13.2 
MINIMIZATION OF RISKS ........................................................................................................................................................ 25 
13.3 
BENEFIT ................................................................................................................................................................................... 26 
14 
ETHICAL CONSIDERATIONS.......................................................................................................................... 26 
14.1 
DECLARATION OF HELSINKI .................................................................................................................................................... 26 
14.2 
INFORMED CONSENT .............................................................................................................................................................. 26 
14.3 
PATIENT INSURANCE (PRODUCT LIABILITY) .................................................................................................... 26 
14.4 
PERSONAL DATA PROTECTION ............................................................................................................................................... 27 
15 
GLOSSARY .......................................................................................................................................... 27 
16 
REFERENCES ....................................................................................................................................... 30 
APPENDIX I - DECLARATION OF HELSINKI .......................................................................................................... 32 
APPENDIX II - PATIENT INFORMATION SHEET AND INFORMED CONSENT ........................................................ 37 
APPENDIX III - PRODUCT COMPONENT SIZES .................................................................................................... 39 

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Stryker NTX Registry 
Scorpio NRG, Triathlon Total Knee, Triathlon PKR with X3 Insert 
International Multicentre Outcomes Register 
Protocol Summary 
 
 
Title 
Stryker NTX Registry – International Multicentre Outcomes Register 
(NRG, Triathlon and X3 registry) 
Short Title 
NTX Registry 
Protocol Number 
K-S-044 
Phase 
Post-market 
Surveillance design 
International multicentre, prospective follow-up of a consecutive 
series of patients 
 
 
 
Objectives 
Provide outcomes information with regard to surgical and implant 
performance and patient clinical outcomes of the patients who are 
eligible for a either a Total Knee Arthroplasty (TKA) replacement 
surgery involving either: 
• Scorpio NRG Total Knee System with X3 insert 
• Triathlon Total Knee System with X3 insert 
or Partial Knee Resurfacing (unicompartmental knee arthroplasty, 
UKA) involving: 
• Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 

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Study Duration 
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, 3, 5, 7 and 10 years follow-up. 
The implant will be followed for 10 years or until it has to be revised, 
the patient dies or emigrates (unless the patient withdraws 
participation). 
Definition of revision: at least one part of the implant has to be revised. 
 
Participating 
institutions 
Up to sixteen institutions willing to participate in the Stryker Clinical 
Registry need to recruit at least 20 patients and maximum 100 
patients. Institutions must fulfil the local and international applicable 
regulatory requirements. Sufficient human and technical resources in 
the centre are expected to ensure optimal data collection. 
 
 
 
 
 
 
Number of Patients 
Up to 1600 patients will be included (20-100 per centre). 
All patients eligible for either 
a Total Knee Arthroplasty (TKA) replacement surgery involving either: 
• Scorpio NRG Total Knee System with X3 insert 
• Triathlon Total Knee System with X3 insert 
or Partial Knee Resurfacing (unicompartmental knee arthroplasty, 
UKA) involving: 
• Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 
who have been informed about this outcomes register and who freely 
consent to participate (with the signed and dated inform consent) will 
be enrolled in the register. Patients will be enrolled prospectively. 

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Inclusion Criteria 
1. Patients requiring primary TKA, suitable for the use of the Scorpio 
NRG with X3 insert or Triathlon Total Knee System with X3 insert, 
or, patients requiring partial knee resurfacing (unicompartmental 
knee) suitable for the use of the Triathlon PKR (Partial Knee 
Resurfacing) System with X3 insert 
2. Patients who understand the conditions of the outcomes registry 
and are willing and able to comply with the standard post- operative 
evaluations and the prescribed rehabilitation. 
3. Patients who signed the Informed Consent Form (approved by 
Ethics Committee if required) prior to surgery. 
Exclusion Criteria 
None 
 
Patient ID 
Each patient participating in the registry will be allocated a unique 
number for the duration of the surveillance. The investigator will 
maintain a personal subject identification list (subject numbers with 
the corresponding subject names) to enable records to be identified. 

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All components of the Scorpio NRG Total Knee System (with CR and PS 
insert), Triathlon Total Knee System (with CR and PS insert and CS 
insert) as well as the Triathlon Partial Knee Resurfacing System 
(Triathlon PKR) with X3 used in this clinical registry have been CE 
marked (CE0086) according to the Medical Device Directive 93/42/EEC 
and therefore are approved for sale on the European market. 
Scorpio NRG™ Total Knee: The following implants from the product 
Portfolio can be included: 
 
Femur 
• 
CR Femoral Component – cemented / cementless 
• 
PS Femoral Component - cemented / cementless 
Tibia (fixed bearing 
only) 
• 
Scorpio Tibial Baseplate – cemented / cementless 
Insert 
• 
NRG CR (Cruciate Retaining) – X3 
• 
NRG PS (Posterior Stabilising) – X3 
Patella resurfacing 
(optional) 
• 
Medialized / Concentric / Universal Dome - X3 
 
 
Study Devices 
Triathlon™ Total Knee: The following implants from the product 
Portfolio can be included: 
 
Femur 
• 
CR Femoral Component – cemented / cementless 
• 
PS Femoral Component - cemented / cementless 
Tibia (fixed bearing 
only) 
• 
Primary Tibial Baseplate – cemented / cementless 
• 
Universal Baseplate - cemented 
Insert 
• 
Triathlon™ CR (Cruciate Retaining) – X3 
• 
Triathlon™ CS (Cruciate Substituting) – X3 
• 
Triathlon™ PS (Posterior Stabilising) – X3 
Patella resurfacing 
(optional) 
• 
Cemented - Symmetric / Asymmetric - X3 
 
Triathlon™ PKR Partial Knee Resurfacing System: The following 
implants from the product Portfolio can be included: 
 
Femur 
• 
Triathlon™ PKR femur (left medial-LM/right lateral-RL) – 
cemented 
Tibia 
(fixed 
bearing only) 
• 
Triathlon™ PKR Baseplate (LM/RL) – cemented 
Insert 
• 
Triathlon™ PKR tibia insert (LM/RL) – X3 

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Analysis of results 
and reports 
Results will be analysed by Stryker Clinical. There will be 2 types of 
annual reports on register data. i) Stryker Clinical will prepare a report 
on the overall dataset ii) each Investigator will receive a confidential 
report from data from their own institute including benchmarks 
relative to the average without disclosure of the results of other 
departments. 
Possible analyses of the data include: 
• 
Safety during follow-up and Survivorship as described by 
Kaplan-Meier survival curves: 
o 
Adverse events: All intra-operative and post-operative 
adverse events will be recorded. 
o 
Survivorship with regard to the revision of the entire 
system or system components (e.g. insert only, tibia base 
plate only) 
o 
Survivorship with regard to re-operation without 
component exchange 
• 
Patient clinical outcome 
o 
Standard clinical parameters and KSS (Knee Society Score) 
as well as patient questionnaires (EQ5D (EuroQol Group) 
and KOOS (Knee Injury and Osteoarthritis Outcome 
Score)) preoperatively and each follow-up visit. 
 
 
Statistical 
Methodology 
• Survival will be described by Kaplan-Meier survival curves 
• 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 

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Evaluation Schedule 
 
The evaluation schedule is based on the routine procedures of the institution. 
 
Evaluation 
Pre-op* 
Intra-op 
1 yr 
post-op. 
3 yr 
post-op. 
5 yr 
post-op. 
7 yr 
post-op. 
10 yr 
post-op. 
Time window 
Up to - 4 
months* 
N/A 
± 3 
months 
± 6 
months 
± 6 
months 
± 6 
months 
± 6 
months 
Inc./Ex. Criteria 
X 
Pre-OP 
X 
Surgical Details 
X 
KSS 
X 
X 
X 
X 
X 
X 
KOOS 
X 
X 
X 
X 
X 
X 
EQ-5D 
X 
X 
X 
X 
X 
X 
Adverse Events, 
Termination 
As and when required 
* Pre-OP: Date  of  or any time  post the  date  of written  informed consent  up to  4 months prior  to date    
of surgery. 
 
KSS: The Knee Society Score is usually reported as the two scores, Knee Score and Function Score. The 
Knee Score consists of points given for pain, range of motion, and stability. The Function Score consists 
of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs. 
 
KOOS: KOOS is a patient-administered and developed as an instrument to assess the patients’ opinion 
about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, 
Function in daily living, Function in sport and recreation (Sport/Rec) and knee related Quality of life 
QOL. 
 
EQ-5D: The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D is 
commonly used in health economics as a variable in the quality-adjusted life year calculation to 
determine the cost effectiveness of a health treatment. 

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Stryker NTX Registry 
International Multicentre Outcomes Register 
1 INTRODUCTION 
Knee replacement arthroplasty has consistently shown to be successful in relieving pain and 
improving function for those experiencing difficulties of degenerative joint disease. In recent 
years, patient quality of life and return to function have become of greater importance in 
assessing the success of joint replacement surgery. The higher demands placed on current and 
new implants by the younger, typically more active patient population emphasizes the 
importance for prostheses that show consistent long-term results. 
Knee arthroplasty can either be for Total Knee Arthroplasty (TKA), where there is replacement 
of both tibial and both femoral condyles, or only for Partial Knee Resurfacing (PKR) where only 
one tibial condyle and one femoral condyle are replaced (unicompartmental knee) if one 
compartment is affected. 
Stryker’s Knee System portfolio includes the Scorpio NRG and Triathlon Total Knee Systems 
and the Triathlon Partial Knee Resurfacing (PKR) System. 
Single Radius and Soft Tissue guided motion 
Many knee prostheses have been shown to internally and externally rotate around a lateral 
or central point rather than follow the natural medial pivot that the normal knee exhibits. This 
is probably due to a number of factors such as the shape of the implant, surgical technique 
and the remaining soft tissue pathology. But this high degree of variability of internal-external 
rotation, as with the presence of paradoxical anterior motion, can not only lead to issues with 
wear and longevity but also with function and ultimately a patient’s lifestyle. 
Guided motion knees are designed to try and force the knee to move in a particular way – 
e.g. a medial pivot knee or mobile bearing. The problem with that, though, as the literature 
would suggest, is that quite often the knee wants to work in a different way. The affect is that 
this can create a “kinematic conflict” whereby the soft tissue is fighting against what the 
implant is trying to force it to do. In such cases this has been shown to lead to early wear, 
further pathology of the soft tissue and subsequent failure of the implant. 
The Stryker Knee Systems named above follow the philosophy of Soft Tissue Guided Motion. 
The premise for this is that the knee will “find its own way” in its new kinematic environment 
and engineers and surgeons have to give the soft tissue the best possible environment to 
optimize the situation. By keeping the collaterals tight and the knee stable during the 
functional flexion arc, the Single Radius principle (creates the best environment for the body 
to find its natural internal-external centre of rotation. By allowing the collaterals to work the 
way that they were designed to, the femur is able to rotate in a more “natural” and 
physiological manner. This allows predictable motion pathways which not only have benefits 
for function, but also for longevity as they reduce sliding – a key cause of wear. 
The Single Radius principle is fundamental in providing stability to the knee in its new 
environment and is the major contributor in allowing soft tissue guided motion. 

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There are additional features of Stryker’s 4th generation knees that have been incorporated 
into the implant design features to assist with this principle. 
One of the key features is the introduction of a Rotary- or Spherical Arc machined into the 
insert surface in the Triathlon and Scorpio NRG designs, respectively. This is a 3-dimensional 
approach to creating an articular surface that compliments the femoral design. This concept 
essentially allows greater freedom of rotation without sacrificing conformity. By reducing  the 
rotational constraint inherent in most conventional multi radius designs the replaced knee is 
assisted in adapting to its new environment and allows the soft tissue to dictate the motion 
necessary to achieve the patients’ functional goals. 
The Single Radius of the femoral component provides gap balancing throughout the functional 
ROM which provides the stability and predictable motion required. In addition, the rotary arc 
and Single Radius concepts complement each other to guide the knee and ensure optimization 
of contact areas with minimal sliding (conformity without constraint). 
The Triathlon PKR system has been designed with the same design philosophy and rational as 
the Triathlon and Scorpio NRG Total Knee System and is therefore an alternative solution for 
patients that suffer from isolated compartmental wear. 
The main difference between the Triathlon Total Knee system and the Scorpio NRG Total Knee 
system is beside the use of a single A/P radius also the use of a single M/L radius design for 
the Scorpio NRG realizing a large contact area and higher rotational freedom in the two 
orthogonal planes. 
The Single Radius and Soft Tissue guided motion philosophy, coupled with the latest 
generation highly cross-linked polyethylene (X3) as the material for the articulating surface 
has the potential to offer patients a longterm solution to their knee disability. X3 polyethylene 
preserves the mechanical strength, resists oxidation and shows extremely low wear rates. 
Summary 
The higher demands placed on current and new implants by the younger typically more active 
patient population emphasizes the importance for prostheses that show consistent long-term 
results. As the Stryker Knee systems are evolutionary in design and based on proven concepts 
and prior implant strategies, it is anticipated that they will demonstrate efficacy and safety in 
the long-term, however as for all new technology or design, a close overview of the long term 
performance and outcome is essential to prove this. 
The aim of this Stryker Clinical Registry is to determine the Scorpio NRG, Triathlon and X3 
component survivorship over years within a large European multicentre user group. 
 
 
2 SURVEILLANCE DESIGN 
This is a prospective international multicentre follow-up of a consecutive series of patients. 
The surveillance register will be conducted in accordance to the applicable regulatory 
requirements including local health and personal 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. If a full Ethic 

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Committee approval is not required, then a written confirmation of this is required from the 
responsible EC stating that data can be collected from that particular site. 
All institutions willing to participate in the register, able to recruit at least 20 patients (up to 
100 patients) and fulfilling the local and international applicable regulatory requirements can 
be considered for participation. Sufficient human and technical resources are expected in the 
institution to ensure optimal data collection. 
All patients eligible for a knee arthroplasty surgery involving the Scorpio NRG or Triathlon Total 
Knee System or Triathlon PKR Partial Knee Resurfacing (all with X3 inlay), 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 II will be obtained 
from the patients). 
 
 
3 OBJECTIVES & METHODS 
The objective of this registry is to provide outcomes information with regard to surgical and 
implant performance and patient clinical outcomes of the patients who are eligible for a either 
a Total Knee Arthroplasty (TKA) replacement surgery involving the Scorpio NRG or Triathlon 
Total Knee System or Triathlon PKR Partial Knee Resurfacing (unicompartmental knee 
arthroplasty, UKA), all of which with X3 inlay. 
The register will follow the standard clinical procedures used by the institutions for patient 
selection for knee 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 DESCRIPTION OF THE DEVICES 
All components of the Scorpio NRG System (with CR and PS insert), Triathlon Total Knee 
System (with CR and PS insert and CS insert) as well as the Triathlon Partial Knee Resurfacing 
System (Triathlon PKR) used in this clinical registry have been CE marked (CE0086) according 
to the Medical Device Directive 93/42/EEC and therefore are approved for sale on the 
European market. 
Patients will either receive Scorpio NRG Total Knee, Triathlon™ Total Knee or Triathlon™ PKR 
Partial Knee Resurfacing System, combined with a respective X3 insert. 
 
 
Please note that in the Stryker NTX Registry ONLY X3 inserts are approved! 
 
 
The product component sizes are listed in APPENDIX III - PRODUCT COMPONENT SIZES. 

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4.1 Scorpio NRG Total Knee 
 
4.1.1 Femoral Component 
 
The Scorpio NRG® femoral components are manufactured from cobalt chromium alloy (ASTM 
F75) and are available in CR (cruciate retaining) and PS (posterior stabilising) design, both of 
which are available in cemented and cementless versions and left and right configurations. 
These components have been designed to mimic the normal femoral condylar geometry. 
These components employ a single medial lateral radius, which corresponds with the bearing 
surface of the intended articulating tibial counterpart. This helps to maintain contact between 
the femoral condyles and the tibial insert surface throughout the range of motion. 
In the cemented version, the interior surface of the components contains a waffle pattern for 
the cement interface. In the cementless version, the interior surface is grit blasted plus a HA 
(hydroxyapatite) coating. 
The femoral components are available in nine proportional sizes 3, 4, 5, 6, 7, 8, 9, 11 and 13. 
 
 
4.1.2 Tibia Baseplate 
 
The cemented Scorpio® Primary Knee System Tibial Baseplate is manufactured from cobalt- 
chromium alloy. The Scorpio® Primary Tibial Baseplate is neutral in configuration and the keel 
of the tibial tray is designed with normalizations for rotational stability and cement 
interdigitation. The tibial component has a central delta keel with normalizations to improve 
stability and facilitate cement pressurization. 
The Scorpio baseplate is available in cemented and cementless versions. 
In the cemented version, the undersurface of the tibial tray has a waffle structure and is 
designed for use with PMMA bone cement and is available in eight proportional sizes (3, 4,  5, 
6, 7, 9, 11, 13). 
The cementless version is also available as either a waffle structure with HA (hydroxyapatite) 
coating, a beaded surface, or a beaded surface with PA (Peri-Apatite) coating. All are available 
in various sizes. 
 
 
4.1.3 Insert 
 
The tibial insert components are available in CR and PS designs. Both designs are 
manufactured from ultra high molecular weight polyethylene (ASTM F648). Highly crosslinked 
sequentially linked X3 polyethylene inserts are to be used in all study patients. 
 
 
X3 polyethylene is manufactured through a proprietary process where the PE receives 30 
kiloGrays of gamma radiation, which generates free radicles and cross-linking in UHMWPE 
prior to machining. The PE is then annealed below melting point to promote cross-linking 

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and maintains mechanical strength, crystallinity, and density. This also stabilises the free 
radicles. This process is repeated three times. 
For Scorpio NRG, a proprietary rotary machining process used on the articulating surface of 
the tibial insert provides for improved rotation of components (Spherical Arc Design). In 
keeping with the design theory the tibial insert component maintains a single medial-lateral 
radius with 5 degrees of freedom. The surface incorporates a posteriorly sloping raised tibial 
eminence. The insert is assembled to the tibial tray component intraoperatively via a locking 
wire mechanism. The locking wire is manufactured from wrought cobalt chromium alloy 
(ASTM F90). The inserts are available in five sizes (3, 5, 7, 9, 11). Each size is available in seven 
thicknesses 8mm, 10mm, 12mm, 15mm, 18mm, 21mm and 24mm. 
 
 
4.1.4 Patella Component 
 
The use of a patellar component is optional. The Scorpio® System Patellar component is 
manufactured from highly crosslinked (X3) polyethylene and is available with a medialized 
dome design in 4 sizes, a concentric dome in 4 sizes and universal dome in 6 sizes. 
 
 
4.2 Triathlon Total Knee 
 
4.2.1 Femoral Component 
 
The femoral component fabricated from cast cobalt-chromium-molybdenum alloy. 
The femoral component is available in CR (cruciate retaining) or Triathlon PS (Posterior 
Stabilising) design, both of which are available in cemented and cementless (beaded or 
beaded with Peri-Apatite) versions. 
The interior surface of the femoral component intended for use with bone cement is grit- 
blasted to increase the surface roughness, which is entended to promote interdigitation of the 
Polymethylacrylate (PMMA) bone cement with the surface texture and the opposing bone. 
The CR femoral design features cast-in pegs to help in femoral component placement, and to 
provide rotational stability. 
The Triathlon CR: intended for use in combination with the Triathlon CR (cruciate retaining) or 
Triathlon CS (Cruciate Substituting) tibial inserts. The Triathlon PS: intended for use in 
combination with the Triathlon PS (Posterior Stabilising) tibial inserts 
There are 8 sizes available in both CR and PS designs (#1-8). All designs are available in left and 
right configurations. 
The femoral component is a Single Radius design with a deepened trochlea; bevelled 
intercondylar region; and shortened, flared posterior condyles to facilitate fit, stability, and 
motion. The femoral component has a Single Radius of curvature centered about the 
epicondylar axis and is constant from 10° to 110°, promoting ligament balance and stability 
and rotation. The Triathlon femoral component has a narrowed M/L dimension with a 7° 

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anterior flange. There are various instruments available suitable for all approaches (Medial 
Parapatellar, Mid-vastus, Sub-vastus, Triathlon MIS approach). 
 
 
4.2.2 Tibia Baseplate 
 
Patients will receive either Triathlon Primary Tibial Baseplate or Triathlon Universal Tibial 
Baseplate. Both are fabricated from cast cobalt chrome molybdenum alloy and are neutral in 
configuration. 
The Triathlon Primary Tibial Baseplate is available in cemented and cementless (beaded or 
beaded with Peri-Apatite) versions. The undersurface of the tibia baseplate intended for use 
with bone cement is grit-blasted for interdigitation with PMMA bone cement. The tibial 
component has a central delta keel with normalizations to improve stability and facilitate 
cement pressurization. The tibia baseplate has an Anti-Rotation Island to facilitate assembly 
and reduces micromotion. There is a robust locking mechanism (locking wire) with precision 
locking geometry. There are 8 sizes available (# 1-8). 
The Triathlon Universal Tibial Baseplate is available as cemented version and in 8 sizes (# 1- 
8). 
 
 
4.2.3 Insert 
 
The Triathlon tibial insert components are available in CR (Cruciate Retaining), CS (Cruciate 
Substituting) and PS (Posterior Stabilising) designs. All designs are manufactured from ultra 
high molecular weight polyethylene UHMWPE (ASTM F648), highly crosslinked (sequentially 
linked) X3™ polyethylene inserts. 
The Triathlon polyethylene insert is milled in a rotary arc, rather than in a linear fashion. This 
facilitates conformity, congruity, and stability, as well as rotation and flexion, to minimize wear 
and improve longevity. 
The Triathlon CR insert is available in 8 sizes (#1-8), and in 5 thicknesses (9, 11, 13, 16, 
19mm).  The Triathlon CS insert  is  available in 8 sizes  (#1-8), and in 7 thicknesses  (9, 11, 13, 
16, 19, 22, 25mm). The Triathlon PS insert is available in 8 sizes (#1-8), and in 7 thicknesses 
(9, 11, 13, 16, 19, 22, 25mm). 
 
 
4.2.4 Patella Component 
 
The use of a patella component is optional. The Triathlon System patella component is also 
manufactured from Highly crosslinked sequentially linked X3™ polyethylene and is available 
in symmetric and asymmetric design. The asymmetrical patella component is anatomic in 
shape to improve bone coverage and is available in sizes that vary in outer dimensions as well 
as in thickness. A simple symmetric dome implant is also available. 
The cemented symmetric X3 component is available in 6 sizes. The cemented asymmetric X3 
component is available in 5 sizes. 

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4.3 Triathlon PKR Partial Knee Resurfacing System 
 
4.3.1 Femoral Component 
 
The Triathlon PKR femoral component is fabricated from cast-cobalt-chromium- molybdenum 
alloy and has two fixation pegs. The system is intended for cemented fixation. The 
bone/cement facing surface of the component is grit blasted and the articulating surface is 
highly polished. 
 
The Triathlon PKR femoral component was designed with the same philosophy and rational at 
the Triathlon Total Knee System to have a Single Radius to recreate the natural movement of 
the epicondyle (in 10°-110° range). Triathlon PKR Partial Knee Resurfacing System 
incorporates a simple two-step gap balancing system to help balance the flexion and extension 
gaps so the femoral component is positioned well and normal physiologic ligament tension 
may be restored. 
It is available in 6 sizes ranging from Size 1 to Size 6 in right lateral/left medial and left 
lateral/right medial configurations. 
 
 
4.3.2 Tibia Baseplate 
 
The Triathlon PKR tibia baseplate is fabricated from cast-cobalt-chromium-molybdenum alloy. 
The system is intended for cemented fixation. 
 
The underside of the tibial component contains a cement recess, a round peg and an angled 
peg for cement fixation and to provide stability. The inside of the tray has tabs and lip for 
locking the tibial insert in place. The surface finish of the underside of the baseplate is grit 
blasted and the topside is bead blasted. 
 
It is available in 6 sizes ranging from Size 1 to Size 6 in right lateral/left medial and left 
lateral/right medial configurations. 
 
 
4.3.3 Insert 
 
The Triathlon PKR inserts are manufactured from ultra high molecular weight polyethylene 
(ASTM F648). Highly crosslinked (sequentially linked) X3™ polyethylene inserts. 
The articular surface of the Triathlon PKR insert is designed to allow the following 
kinematics: Range of Motion 0° hyperextension to 135° flexion. 
The Triathlon PKR insert is available in six sizes with thicknesses of 8mm, 9mm, 10mm and 
12mm for the right lateral/left medial and left lateral/right medial compartments. 

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5 SELECTION OF PATIENTS 
5.1 Participating Institutions 
 
Up to sixteen institutions willing to participate in the Stryker Registry need to recruit at least 
20 patients and maximum 100 patients. Institutions must fulfil the local and international 
applicable regulatory requirements. Sufficient human and technical resources in the centre 
are expected to ensure optimal data collection. Site selection will be performed according to 
Stryker Clinical procedures. 
 
 
5.2 Number of patients 
 
Up to 1600 patients who will receive a Total Knee Arthroplasty (TKA) replacement surgery 
involving either: 
• Scorpio NRG Total Knee System with X3 insert 
• Triathlon Total Knee System with X3 insert 
or Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA) involving: 
• Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 
will be enrolled in the register. Patients will be enrolled prospectively. 
 
 
5.3 Patient selection criteria 
 
All patients in a participating centre matching all of the inclusion criteria (no specific exclusion 
criteria) and who receive either the (TKA) surgery involving the Scorpio NRG or Triathlon Total 
Knee System with X3 inlay or a partial knee resurfacing (unicompartmental knee) involving the 
Triathlon PKR (Partial Knee Resurfacing) System will be recorded in the Stryker Registry. 
5.3.1 Inclusion criteria 
 
Patients suitable for inclusion in the outcomes registry will be those fulfilling all the following 
selection criteria: 
1. Patients requiring primary TKA, suitable for the use of the Scorpio NRG with X3 insert 
or Triathlon Total Knee System with X3 insert, or, patients requiring partial knee 
resurfacing (unicompartmental knee) suitable for the use of the Triathlon PKR (Partial 
Knee Resurfacing) System with X3 insert 
2. Patients who understand the conditions of the outcomes registry and are willing and 
able to comply with the standard post-operative evaluations and the prescribed 
rehabilitation. 

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3. Patients who signed the Informed Consent Form (approved by Ethics Committee if 
required) prior to surgery. 
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 
II - PATIENT INFORMATION SHEET AND INFORMED CONSENT). 
 
5.3.2 Exclusion criteria 
 
There are no exclusion criteria for the NTX Registry 
 
 
5.4 Patient ID 
 
Each patient participating in the registry will be allocated a unique number for the duration of 
the surveillance. The investigator will maintain a personal subject identification list (subject 
numbers with the corresponding subject names) to enable records to be identified. 
 
 
6 STUDY DURATION 
It is anticipated that the patients shall be recruited within a 12 month period at each 
participating centre. 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 pre- 
operative, intra-operative and 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 
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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6.1 Patient Evaluations 
 
Patients will be assessed pre-operatively, per-operatively and post-operatively. The follow- 
up intervals will be the normal routine of the institutions. 
6.1.1 Pre-operative Evaluation 
 
- Clinical History 
• Patient ID (Register, Site, Subject) e.g. TRI-01-001 
• Date of birth, weight, height, Gender 
• Visit Date 
• Cigarette and Alcohol use 
• Previous surgery to knee planned for operation 
• Primary diagnosis 
• Pain medication (in last 48 hours) 
 
- Clinical Evaluation 
• Patient ID (Register, Site, Subject) 
• Operative side 
• Date of informed consent signed 
• Inclusion / Exclusion criteria 
• KSS (Knee Society Score) 
• Knee Injury and Osteoarthritis Outcome Score (KOOS) and EQ5D 
 
 
6.1.2 Intra-operative Evaluation 
 
- Surgical details 
• Patient ID (Register, Site, Subject) 
• Surgery Date 
• Operative Side 
• Surgical approach 
• Navigation used 
• Soft tissue release 
• Type of Anesthesia 
• Duration of surgery 
• Intra-operative adverse events 
• Components used and sizes 
• Systemic antibiotic prophylaxis 

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6.1.3 Post-operative Evaluation 
 
Patients will be assessed post operatively as the schedule for follow-up routine of the 
participating centre. 
 
- Clinical Evaluation 
• Patient ID (Register, Site, Subject) 
• Date of assessment 
• Adverse events 
• Pain medication (in last 48 hours) 
• KSS 
• KOOS and EQ5D 
 
 
6.1.4 Adverse events and device removal events 
 
• Patient ID (Register, Site, Subject) 
• Onset date 
• When Did the event occur (Intra-op, Post-op) 
• Operative site events 
• Systemic events 
• Device/procedure related 
• Seriousness 
• Treatment 
o Revision/Removal of the entire system or system components 
o Reoperations without component exchange 
o Other treatment 
• Resolution of event 
 
6.1.5 Termination 
 
• Date of termination of Surveillance 
• Reason for termination 
 
 
7 ADVERSE EVENTS 
The investigator is required to document all operative site and general medical adverse events 
as well as elective surgery involving other joints over the course of the 10 year surveillance 
period. Data to be collected includes date of occurrence, date diagnosed, type of complication 
and treatment. 

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7.1 Definitions 
 
The following definitions are according to ISO 14155 from 2011. 
7.1.1 Adverse event (AE) 
“Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other parties, whether or not 
related to the investigational medical device 
NOTE : 
This definition includes events related to the procedures involved.” 
 
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. 
7.1.2 Serious adverse event (SAE) 
“Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, resulting in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse 
event.” 
7.1.3 Adverse device effect (ADE) 
“Adverse event related to the use of an investigational medical device 
NOTE 1 
This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. 
NOTE 2 
This definition includes any event resulting from an error use or from 
intentional misuse of the investigational medical device.” 
7.1.4 Serious adverse device effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event 
7.1.5 Unanticipated serious adverse device effect (USADE) 
“Serious adverse device effect which by its nature, incidence, severity or outcome has not 
been identified in the current version of the risk analysis report 
 
NOTE Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report.” 

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7.2 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 following causal relationships will be assessed: 
i) 
Event related to specific study device? 
ii) 
Event related to surgery procedure? 
This will be reported by the surgeon as: 
- 
Yes* 
- 
No 
- 
Uncertain* 
*If Yes or Uncertain, the Adverse Event form shall be sent to Stryker within 24 hours. 
 
All serious adverse events, serious adverse device effects, 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 Stryker Clinical Adverse Event 
Report Form (according to Stryker Clinical procedures). Subsequent follow-up reports will be 
provided to the sponsor. 
 
A Stryker Clinical Adverse Event Report Form should be completed by the investigator and sent 
by email or fax within 24 hours to the sponsor either: 
• 
local clinical contact by email or fax or 
• 
Clinical Study Manager 
ntx.registry@stryker.com 
Phone: +49 2065 837-0 
 
If at the time of sending the report, all details are not available by the investigator; the partially 
completed form must be sent with the available data and then the investigator will seek to 
obtain complementary information. The complementary information will be sent by the 
investigator to the sponsor as soon as it will be available. 
 
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 adverse event CRF and in the 
termination CRF pages. 
 
Moreover the investigator should send to the Sponsor a copy of the imaging exam when 
performed at the time of the adverse event, as part of the standard post-marketing vigilance 
system for the CE certified Stryker products. The investigator will evaluate the adverse event 
and determine the most appropriate actions. 
The sponsor will report adverse events to Competent Authorities and Ethic Committees that 
occur in accordance with applicable regulations. 

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no 
 
 
 
yes 
 
Figure: Adverse Events Categorization chart (from ISO 14155:2011) 
 
 
8 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 reason for their withdrawal recorded on the termination case report forms (CRF’s), 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. 
 
 
9 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 NTX Registry. 
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 
SAE 
Is it device/ 
procedure related? 
yes 
yes 
Anticipated SADE 
SADE 
Is it anticipated? 
no 
 
SADE 
Adverse 
event 
Does it meet 
seriousness 
criteria? 
AE 
Is it device/ 
procedure 
related? 
no 
yes 
ADE 

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each patient by the surgeon(s). The EDC system 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). 
The upmost best will be done to maintain confidentiality and anonymity at all times by use of 
the unique registry patient ID code. Only this patient ID code (no patient names, addresses, 
hospital numbers) will be recorded in the database. 
 
 
10 SURVEILLANCE MONITORING 
During the course of the Stryker NTX 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 following persons can be contacted at any time concerning any problems 
or queries. 
• 
local clinical contact by email or fax 
or 
• 
Clinical Study Manager 
ntx.registry@stryker.com 
Phone: +49 2065 837-0 
 
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 
patient’s integrity as described in section 14.4. 
 
 
11 ANALYSIS OF RESULTS AND REPORTS 
Results obtained from the NTX Registry will be tabulated and statistically analysed by Stryker’s 
Clinical Department using an appropriate statistical software package. An interim analysis of 
the data will be made once appropriate patients are included in the Outcomes Registry. 

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There will be 2 types of annual reports on register data. i) Stryker Clinical will prepare a report 
on the overall dataset ii) each Investigator will receive a confidential report from data from 
their own institute including benchmarks relative to the average without disclosure of the 
results of other departments. 
Possible analyses of the data include: 
 
• 
Safety during follow-up and Survivorship as described by Kaplan-Meier survival 
curves: 
o 
Adverse events: All intra-operative and post-operative adverse events will be 
recorded. 
o 
Survivorship with regard to the revision of the entire system or system 
components (e.g. insert only, tibia base plate only) 
o 
Survivorship with regard to re-operation without component exchange 
 
• 
Patient clinical outcome 
o 
Standard clinical parameters and KSS (Knee Society Score) as well as patient 
questionnaires (EQ5D (EuroQol Group) and KOOS (Knee Injury and Osteoarthritis 
Outcome Score)) preoperatively and each follow-up visit. 
 
 
11.1 Statistical Methodology 
 
The patient’s safety and survivorship of the implants during the follow-ups will be described 
by Kaplan-Meier survival curves: 
o 
Survivorship with regard to the revision of the entire system or system 
components (e.g. insert only, tibia base plate only) 
o 
Survivorship with regard to re-operation without component exchange 
o 
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: 
o 
Demographic and pre-operative assessments 
o 
Intra-operative assessments 
o 
KSS (pain/motion score, function score). 
o 
Patient questionnaires: KOOS, EQ5D Quality of Life assessment 
o 
Adverse events and device-related adverse events 
o 
Revisions/removals 
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. 

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12 PUBLICATION OF RESULTS 
By signing the Clinical Contract, the investigator agrees to the results of the outcomes registry 
being used for publication and for informing medical professionals. If necessary, names, 
addresses, qualifications and the role of the investigator in the outcomes registry shall be 
notified to the authorities. 
The sponsor shall compile a final outcomes 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 outcomes 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. 
 
 
13 RISK BENEFIT ANALYSIS 
13.1 Risk 
 
There is no additional risk associated in participating in this outcomes register over and above 
that of the primary knee total arthroplasty or partial knee resurfacing (unicompartmental 
knee) procedure. 
As in any surgical procedure, certain risks are associated with 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. 
Adverse Events may necessitate re-operation, revision, arthrodesis of the involved joint, 
girdlestone or amputation of the limb. 
 
 
13.2 Minimization of Risks 
 
All components of the Scorpio NRG Total Knee System (with CR and PS insert), Triathlon Total 
Knee System (with CR and PS insert and CS insert) as well as the Triathlon Partial Knee 
Resurfacing System (Triathlon PKR) used in this post-market clinical registry have been CE 
marked (CE0086) according to the Medical Device Directive 93/42/EEC and therefore are 
approved for sale on the European market. 

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Pre-clinical, clinical, and mechanical testing of the above listed implants indicate that the 
above mentioned risks should not occur at a rate greater than that for any other type of knee 
arthroplasty reported in the literature. 
Patients will be treated in the best medical judgement of the investigator, regardless of the 
outcomes registry. 
 
 
13.3 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 knee prostheses. This will increase 
the current scientific body of knowledge concerning total and unicompartmental knee 
arthroplasty. 
 
 
14 ETHICAL CONSIDERATIONS 
14.1 Declaration of Helsinki 
 
The Surveillance will follow the guidelines as laid down by the “Declaration of Helsinki” 
(Declaration of Helsinki, October 2008) (APPENDIX I - DECLARATION OF HELSINKI). 
In accordance with the Declaration of Helsinki, where applicable, all centres will gain written 
Ethics Committee approval prior to enrolling patients in the Surveillance either from the local 
responsible Ethics Committee at the investigator site or from an adequately constituted 
(according to ISO14155: 2011) independent Ethics Committee. 
If a full Ethic Committee approval is not required, then a written confirmation of this is 
required from the responsible EC stating that data can be collected from that particular site. 
 
 
14.2 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 outcomes registry. 
 
14.3 Patient Insurance (product liability) 
 
Participating patients in this Surveillance are covered by Stryker SA product liability insurance. 

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14.4 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 Clinical 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 Clinical and health 
authorities will have allowed access to personal medical records for the sole purpose of 
checking the accuracy of data collected in the registry. 
 
 
15 GLOSSARY 
A 
ASA 
 American Society of Anaesthesiology scoring system for grading the overall 
physical condition of the patient, as follows: P1 – fit and healthy; P2 – mild 
disease, not incapacitating; P3 – incapacitating systemic disease; P4 – life 
threatening disease; P5 – not expected to survive 24 hours. 
B 
Bilateral operation 
Operation performed on both sides, e.g. left and right knee procedures carried 
out during a single operation. 
 
BMI 
 Body mass index. A statistical tool used to estimate a healthy body weight 
based on an individual’s height. The BMI is calculated by dividing a person’s 
weight (kg) by the square of their height (m²). 
 
C 
Case mix 
 Term used to describe variation in surgical practice, relating to factors such as 
indications for surgery, patient age and sex. 
 
Cement 
 The material used to fix cemented joint replacements to bone - polymethyl 
methacrylate (PMMA). 
 
Cemented 
Prostheses designed to be fixed into the bone using cement. 
 
Cementless 
 Prostheses designed to be fixed into the bone by bony ingrowth or ongrowth, 
without using cement. 
 
CI 
 A confidence interval (CI) gives an estimated range of values which is likely to 
include the unknown population parameter (e.g. a revision rate) being 
estimated from the given sample. If independent samples are taken repeatedly 
from the same population, and a confidence interval calculated for each 
sample, then a certain percentage (confidence level: e.g. 95%) of the intervals 
will include the unknown population parameter. 
E 
EQ-5D 
 EQ-5D is a standardised measure of health status developed by the EuroQol 
Group in order to provide a simple, generic measure of health for clinical and 
economic appraisal. The EQ-5D descriptive system comprises the following 5 

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dimensions: mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression. 
F 
Femoral component (knee) 
Portion of a knee prosthesis that is used to replace the articulating surface of 
the femur (thigh bone). 
H 
HA 
hydroxyapatite 
 
Hazard ratio 
 A comparative statistical measure of the instantaneous risk of experiencing the 
event of interest (e.g. implant revision) between two groups (e.g. two different 
products). 
 
Hybrid procedure 
 Joint replacement procedure in which cement is used to fix one prosthetic 
component while the other is cementless. 
I 
Image/computer guided 
Surgery performed by the surgeon, using real time images to assist alignment 
surgery 
and positioning of prosthetic components 
 
Indication (for surgery) 
The reason for surgery. 
K 
Kaplan-Meier 
 A statistical method of carrying out a survivorship analysis that can take into 
account ‘censored’ data, i.e. patient losses from the sample before the final 
outcome is observed (for instance, if a patient dies). 
 
KOOS 
Knee Injury and Osteoarthritis Outcome Score 
 
KSS 
Knee Society Score 
 
O 
Outlier 
 Data for a surgeon, unit or implant brand that falls outside of the defined 
control limits. 
P 
PA 
Peri-Apatite 
 
Patella resurfacing 
Replacement of the surface of the patella (knee cap) with a prosthesis. 
 
Patient consent 
 A patient can only be included in the Stryker Clinical Registry where explicit 
informed patient consent has been given. 
 
Patient physical status 
See ASA. 
 
PKR 
Partial Knee Resurfacing (Unicompartmental knee, UKA) 
 
Primary knee 
First total joint replacement operation performed on any individual patient. 
replacement 
 
Prosthesis 
 Orthopaedic implant used in joint replacement procedures, e.g. a total hip or a 
unicondylar knee. 
 
p-value 
 A p-value is reported as a result of a statistical hypothesis test. It represents the 
probability that any observed differences are due to chance. If the p-value is 
below a pre-determined cut-off (traditionally 0.05) the result is called 
“statistically significant” and it can be concluded that the observed differences 
are unlikely to be due to chance. 

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R 
Revision knee replacement 
Operation performed to remove and replace one or more components of a 
total joint prosthesis for whatever reason. 
 
S 
Standard Deviation (SD) 
The standard deviation is a measure of the spread of the data about the 
average. The smaller the standard deviation, the less spread out the data. 
Surgical approach 
Method used by a surgeon to gain access to, and expose, the joint. 
Survivorship analysis 
A statistical method that is used to determine what fraction of a population, 
such as those who have had a particular hip implant, has survived unrevised 
past a certain time. See Kaplan-Meier. 
 
T 
Thromboprophylaxis 
 Drug or other post-operative regime prescribed to patients with the aim of 
preventing blood clot formation in the post-operative period. 
 
THA 
Total hip arthroplasty. 
 
TKA 
 Total knee arthroplasty (total knee replacement). Replacement of both tibial 
and both femoral condyles, with or without resurfacing of the patella and with 
or without cement. 
 
Total condylar knee 
 Type of knee prosthesis that replaces the complete contact area between the 
femur and the tibia of a patient’s knee. 
 
Trochanter 
Bony protuberance of the femur, found on its upper outer aspect. 
 
Type (of prosthesis) 
Type of prosthesis is the generic description of a prosthesis, e.g. modular 
cemented stem (hip), patello-femoral joint (knee). 
 
U 
Uncemented 
See cementless. 
 
Unicondylar arthroplasty 
Replacement of one tibial condyle and one femoral condyle in the knee, with or 
without resurfacing of the patella. 
 
Unicondylar knee replacement See Unicondylar arthroplasty. 
 
Unilateral operation 
Operation performed on one side only, e.g. left knee. 

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Li MG, Yao F, Joss B, Ioppolo J, Nivbrant B, Wood D. Mobile vs fixed bearing unicondylar knee arthroplasty: a 
randomised study on short term clinical outcomes and knee kinematics. The Knee. 13, 2006, pp. 365-370. 
Mahoney, OM, et al: The Effect of Total Knee Arthroplasty Design on Extensor Mechanism Function. Journal of 
Arthroplasty, Vol. 17 No. 4, 2002, pp 416-421. 
Mahoney OM, McClung CD, de la Rosa MA, Schmalzried. The effect of total knee arthroplasty design on 
extensor mechanism function. J Arthroplasty. 2002, 17, pp. 416-421 
Mahoney OM, Tomita T et al: Reduction in Articular Rotational Constraint in TKA Prosthetic Design Improves in 
vivo knee kinematics. AAOS 2008 Poster presentation 

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Naal FD, Fischer M, Preuss A, Goldhahn J, von Knoch F, Preiss S, Munzinger U, Drobny T. Return to sports and 
recreational activity after unicompartmental knee arthroplasty. Americal Journal of Sports Medicine. 35, 2007, 
10, pp. 1688-1695. 
Pinskerova V, Johal P, Nakagawa S, Sosna A, Williams A, Gedroyc W, Freeman MA. Does the femur roll-back 
with flexion? J Bone Joint Surg Br 2004;86-6:925-31. 
Wang H, Simpson KJ, Chamnongkich S, Kinsey T, Mahoney. A biomechanical comparison between the single- 
axis and multi-axis total knee arthroplasty systems for stand-to-sit movements. Clin Biomech. 2005, Vol. 20, pp. 
428-433. 
Weiss J, Noble P, Conditt M, Kohl H, Roberts S, Cook K, Gordon M, Mathis K. What Functional Activities Are 
Important to Patients with Knee Replacements? Clinical Orthopaedics and Related Research. 404, 2002, pp. 172-
188. 

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APPENDIX I - DECLARATION OF HELSINKI 
DECLARATION OF HELSINKI WORLD MEDICAL ASSOCIATION (DoH 2008) 
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. 
 
4. The Declaration of Geneva of the WMA binds the physician with the words, “The 
health of my patient will be my first consideration,” and the International Code of 
Medical Ethics declares that, “A physician shall act in the patient's best interest when 
providing medical care.” 
 
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. 
 
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 events. No change to the protocol may 
be made without consideration and approval by the committee. 

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16. Medical research involving human subjects must be conducted only by individuals with 
the appropriate scientific training and qualifications. Research on patients or healthy 
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 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 subject’s freely-given 
informed consent, preferably in writing. If the consent cannot be expressed in writing, 
the non-written consent must be formally documented and witnessed. 

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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 potential subject’s dissent 
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 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. 
 
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 

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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: 
• The use of placebo, or no treatment, is acceptable in studies where no current 
proven intervention exists; or 
• Where for compelling and scientifically sound methodological reasons the use of 
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 or the patient’s 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 - PATIENT INFORMATION SHEET AND INFORMED CONSENT 
 
PLEASE NOTE: This is a template document and may need to be adapted to meet local Ethical 
Committee requirements. 
 
 
PATIENT INFORMATION SHEET AND INFORMED CONSENT 
Stryker NTX Registry 
 
My surgeon informed me that he/she is participating in collaboration with 
Stryker SA, the manufacturer of my knee prosthesis, in a surveillance register of 
the type of knee implant I will be receiving, in order to document the long term 
safety and survivorship of these implants. I’ve understood that many patients 
from different European hospitals/clinics will freely take part in this register. 
 
I also understood that the clinical visits for this register are considered to be 
within the scope of normal clinical practice required for the follow-up of my knee 
in the hospital/clinic where I will be operated. It is anticipated that data will be 
collected before and during surgery, as well as follow-up visits up to 10 years 
after surgery. There are also two patient questionnaires to be filled-out at each 
of these visits. No additional x-rays will be performed for the registry. 
 
I agree that Stryker SA, the manufacturer of my new knee, receives my 
anonymous coded clinical information which is related to my new knee. I 
understand that the knee implant, that I am going to receive, has continuously 
been developed and improved over the last years and that my clinical data, 
together with the data from other patients taking part in this registry study, will 
be 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, this 
data may be stored and electronically processed by Stryker SA 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 (the 
attachment to the patient information – is the legal description of the extent of 
data protection, which is a requirement of the implant 

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manufacturer to include). Only authorized representatives of Stryker SA and 
health authorities will have allowed access to personal medical records for the 
sole purpose of checking the accuracy of data collected in the knee register. 
 
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. 
 
Patient name ……………………………………………….. 
 
Signature ………………………………… Date …………………. 
 
 
 
Surgeon name ………………………………………………. 
 
Signature ………………………………… Date …………………. 
 
 
OPTIONAL 
Witness name (optional) ……………………………………. 
 
Signature 
…………………………………… 
Date …………………. 
Relative/ Representative/Other 
 
Attachment to Patient Information 
This research will involve the collection of data, perhaps including personal 
information. These data may be held by Stryker or subsidiaries of Stryker. By 
consenting to the research I agree that Stryker may, if appropriate for scientific 
purposes, transfer data both internally (common ownership with Stryker) and 
externally (contracted third parties). If data is conveyed to a third party outside 
EU / EEA the receiving party must comply with the data protection laws of 
Switzerland, a country for which the European Commission considers data 
protection laws to be adequate. This consent can be withdrawn at any time 
without influence on the contract governing your place in the clinical trial. 

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APPENDIX III - PRODUCT COMPONENT SIZES 
 
1. Scorpio NRG Total Knee System 
1.1. Femoral Components 
1.1.1. Cemented 
• NRG CR 
• NRG PS 
 
81-4403L 
SCP NRG Fem PS # 3 left, cemented with Pegs 
81-4403R 
SCP NRG Fem PS # 3 right, cemented with Pegs 
81-4404L 
SCP NRG Fem PS # 4 left, cemented with Pegs 
81-4404R 
SCP NRG Fem PS # 4 right, cemented with Pegs 
81-4405L 
SCP NRG Fem PS Waffel # 5 left, cemented with Pegs 
81-4405R 
SCP NRG Fem PS Waffel # 5 right, cemented with Pegs 
81-4406L 
SCP NRG Fem PS # 6 left, cemented with Pegs 
81-4406R 
SCP NRG Fem PS # 6 right, cemented with Pegs 
81-4407L 
SCP NRG Fem PS Waffel # 7 left, cemented with Pegs 
81-4407R 
SCP NRG Fem PS Waffel # 7 right, cemented with Pegs 
81-4408L 
SCP NRG Fem PS # 8 left, cemented with Pegs 
81-4408R 
SCP NRG Fem PS # 8 right, cemented with Pegs 
81-4409L 
SCP NRG Fem PS Waffel # 9 left, cemented with Pegs 
81-4409R 
SCP NRG Fem PS Waffel # 9 right, cemented with Pegs 
81-4411L 
SCP NRG Fem PS Waffel # 11 left, cemented with Pegs 
81-4411R 
SCP NRG Fem PS Waffel # 11 right, cemented with Pegs 
81-4413L 
SCP NRG Fem PS Waffel # 13 left, cemented with Pegs 
81-4413R 
SCP NRG Fem PS Waffel # 13 right, cemented with Pegs 
80-4403L 
SCP NRG Fem CR # 3 left, cemented 
80-4403R 
SCP NRG Fem CR # 3 right, cemented 
80-4404L 
SCP NRG Fem CR # 4 left, cemented 
80-4404R 
SCP NRG Fem CR # 4 right, cemented 
80-4405L 
SCP NRG Fem CR # 5 left, cemented 
80-4405R 
SCP NRG Fem CR # 5 right, cemented 
80-4406L 
SCP NRG Fem CR # 6 left, cemented 
80-4406R 
SCP NRG Fem CR # 6 right, cemented 
80-4407L 
SCP NRG Fem CR # 7 left, cemented 
80-4407R 
SCP NRG Fem CR # 7 right, cemented 
80-4408L 
SCP NRG Fem CR # 8 left, cemented 
80-4408R 
SCP NRG Fem CR # 8 right, cemented 
80-4409L 
SCP NRG Fem CR # 9 left, cemented 
80-4409R 
SCP NRG Fem CR # 9 right, cemented 
80-4411L 
SCP NRG Fem CR # 11 left, cemented 
80-4411R 
SCP NRG Fem CR # 11 right, cemented 
80-4413L 
SCP NRG Fem CR # 13 left, cemented 
80-4413R 
SCP NRG Fem CR # 13 right, cemented 

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1.1.2. Cementless 
• NRG CR 
 
80-6403L 
SCP NRG HA CR Fem #3 L 
80-6403R 
SCP NRG HA CR Fem #3 R 
80-6404L 
SCP NRG HA CR Fem #4 L 
80-6404R 
SCP NRG HA CR Fem #4 R 
80-6405L 
SCP NRG HA CR Fem #5 L 
80-6405R 
SCP NRG HA CR Fem #5 R 
80-6406L 
SCP NRG HA CR Fem #6 L 
80-6406R 
SCP NRG HA CR Fem #6 R 
80-6407L 
SCP NRG HA CR Fem #7 L 
80-6407R 
SCP NRG HA CR Fem #7 R 
80-6408L 
SCP NRG HA CR Fem #8 L 
80-6408R 
SCP NRG HA CR Fem #8 R 
80-6409L 
SCP NRG HA CR Fem #9 L 
80-6409R 
SCP NRG HA CR Fem #9 R 
80-6411L 
SCP NRG HA CR Fem #11 L 
80-6411R 
SCP NRG HA CR Fem #11 R 
80-6413L 
SCP NRG HA CR Fem #13 L 
80-6413R 
SCP NRG HA CR Fem #13 R 
 
• NRG PS 
 
81-6403L 
SCP NRG HA PS Fem #3 L 
81-6403R 
SCP NRG HA PS Fem #3 R 
81-6404L 
SCP NRG HA PS Fem #4 L 
81-6404R 
SCP NRG HA PS Fem #4 R 
81-6405L 
SCP NRG HA PS Fem #5 L 
81-6405R 
SCP NRG HA PS Fem #5 R 
81-6406L 
SCP NRG HA PS Fem #6 L 
81-6406R 
SCP NRG HA PS Fem #6 R 
81-6407L 
SCP NRG HA PS Fem #7 L 
81-6407R 
SCP NRG HA PS Fem #7 R 
81-6408L 
SCP NRG HA PS Fem #8 L 
81-6408R 
SCP NRG HA PS Fem #8 R 
81-6409L 
SCP NRG HA PS Fem #9 L 
81-6409R 
SCP NRG HA PS Fem #9 R 
81-6411L 
SCP NRG HA PS Fem #11 L 
81-6411R 
SCP NRG HA PS Fem #11 R 
81-6413L 
SCP NRG HA PS Fem #13 L 
81-6413R 
SCP NRG HA PS Fem #13 R 

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1.2. Tibia Component 
1.2.1. Cemented 
• Scorpio® Primary Knee System Tibial Baseplate 
 
7115-0003 SCP Tibia Waffel # 3 cemented 
7115-0004 SCP Tibia Waffel # 4 cemented 
7115-0005 SCP Tibia Waffel # 5 cemented 
7115-0006 SCP Tibia Waffel # 6 cemented 
7115-0007 SCP Tibia Waffel # 7 cemented 
7115-0009 SCP Tibia Waffel # 9 cemented 
7115-0011 SCP Tibia Waffel # 11 cemented 
7115-0013 SCP Tibia Waffel # 13 cemented 
1.2.2. Cementless 
• Scorpio® Primary Knee System Tibial Baseplate 
 
75150003 
SCP TIB HA cementless #3 
75150005 
SCP TIB HA cementless #5 
75150006 
SCP TIB HA cementless #6 
75150007 
SCP TIB HA cementless #7 
75150009 
SCP TIB HA cementless #9 
75150011 
SCP TIB HA cementless #11 
 
7125-0003 
SCP Tibia beaded # 3, cementless 
7125-0004 
SCP Tibia beaded #4 cementless 
7125-0005 
SCP Tibia beaded # 5, cementless 
7125-0006 
SCP Tibia beaded #6 cementless 
7125-0007 
SCP Tibia beaded # 7, cementless 
7125-0009 
SCP Tibia beaded # 9, cementless 
7125-0011 
SCP Tibia beaded # 11, cementless 
7125-0013 
SCP Tibia beaded # 13, cementless 
 
7145-0003 
SCP Tibia beaded PA #3 cementless 
7145-0005 
SCP Tibia beaded PA #5 cementless 
7145-0007 
SCP Tibia beaded PA #7 cementless 
7145-0009 
SCP Tibia beaded PA #9 cementless 
7145-0011 
SCP Tibia beaded PA #11 cementless 
7145-0013 
SCP Tibia beaded PA #13 cementless 
 
1.3. Insert 
• CR 
 
82-6-0308 
SCP NRG Tib Ins CR X3 #3 Thickness 8mm 
82-6-0310 
SCP NRG Tib Ins CR X3 #3 Thickness 10mm 
82-6-0312 
SCP NRG Tib Ins CR X3 #3 Thickness 12mm 
82-6-0315 
SCP NRG Tib Ins CR X3 #3 Thickness 15mm 
82-6-0318 
SCP NRG Tib Ins CR X3 #3 Thickness 18mm 

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82-6-0321 
SCP NRG Tib Ins CR X3 #3 Thickness 21mm 
82-6-0324 
SCP NRG Tib Ins CR X3 #3 Thickness 24mm 
82-6-0508 
SCP NRG Tib Ins CR X3 #5 Thickness 8mm 
82-6-0510 
SCP NRG Tib Ins CR X3 #5 Thickness 10mm 
82-6-0512 
SCP NRG Tib Ins CR X3 #5 Thickness 12mm 
82-6-0515 
SCP NRG Tib Ins CR X3 #5 Thickness 15mm 
82-6-0518 
SCP NRG Tib Ins CR X3 #5 Thickness 18mm 
82-6-0521 
SCP NRG Tib Ins CR X3 #5 Thickness 21mm 
82-6-0524 
SCP NRG Tib Ins CR X3 #5 Thickness 24mm 
82-6-0708 
SCP NRG Tib Ins CR X3 #7 Thickness 8mm 
82-6-0710 
SCP NRG Tib Ins CR X3 #7 Thickness 10mm 
82-6-0712 
SCP NRG Tib Ins CR X3 #7 Thickness 12mm 
82-6-0715 
SCP NRG Tib Ins CR X3 #7 Thickness 15mm 
82-6-0718 
SCP NRG Tib Ins CR X3 #7 Thickness 18mm 
82-6-0721 
SCP NRG Tib Ins CR X3 #7 Thickness 21mm 
82-6-0724 
SCP NRG Tib Ins CR X3 #7 Thickness 24mm 
82-6-0908 
SCP NRG Tib Ins CR X3 #9 Thickness 8mm 
82-6-0910 
SCP NRG Tib Ins CR X3 #9 Thickness 10mm 
82-6-0912 
SCP NRG Tib Ins CR X3 #9 Thickness 12mm 
82-6-0915 
SCP NRG Tib Ins CR X3 #9 Thickness 15mm 
82-6-0918 
SCP NRG Tib Ins CR X3 #9 Thickness 18mm 
82-6-0921 
SCP NRG Tib Ins CR X3 #9 Thickness 21mm 
82-6-0924 
SCP NRG Tib Ins CR X3 #9 Thickness 24mm 
82-6-1108 
SCP NRG Tib Ins CR X3 #11 Thickness 8mm 
82-6-1110 
SCP NRG Tib Ins CR X3 #11 Thickness 10mm 
82-6-1112 
SCP NRG Tib Ins CR X3 #11 Thickness 12mm 
82-6-1115 
SCP NRG Tib Ins CR X3 #11 Thickness 15mm 
82-6-1118 
SCP NRG Tib Ins CR X3 #11 Thickness 18mm 
82-6-1121 
SCP NRG Tib Ins CR X3 #11 Thickness 21mm 
82-6-1124 
SCP NRG Tib Ins CR X3 #11 Thickness 24mm 
 
• PS 
 
82-7-0308 
SCP NRG Tib Ins PS X3 #3 Thickness 8mm 
82-7-0310 
SCP NRG Tib Ins PS X3 #3 Thickness 10mm 
82-7-0312 
SCP NRG Tib Ins PS X3 #3 Thickness 12mm 
82-7-0315 
SCP NRG Tib Ins PS X3 #3 Thickness 15mm 
82-7-0318 
SCP NRG Tib Ins PS X3 #3 Thickness 18mm 
82-7-0321 
SCP NRG Tib Ins PS X3 #3 Thickness 21mm 
82-7-0324 
SCP NRG Tib Ins PS X3 #3 Thickness 24mm 
82-7-0508 
SCP NRG Tib Ins PS X3 #5 Thickness 8mm 
82-7-0510 
SCP NRG Tib Ins PS X3 #5 Thickness 10mm 
82-7-0512 
SCP NRG Tib Ins PS X3 #5 Thickness 12mm 
82-7-0515 
SCP NRG Tib Ins PS X3 #5 Thickness 15mm 

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82-7-0518 
SCP NRG Tib Ins PS X3 #5 Thickness 18mm 
82-7-0521 
SCP NRG Tib Ins PS X3 #5 Thickness 21mm 
82-7-0524 
SCP NRG Tib Ins PS X3 #5 Thickness 24mm 
82-7-0708 
SCP NRG Tib Ins PS X3 #7 Thickness 8mm 
82-7-0710 
SCP NRG Tib Ins PS X3 #7 Thickness 10mm 
82-7-0712 
SCP NRG Tib Ins PS X3 #7 Thickness 12mm 
82-7-0715 
SCP NRG Tib Ins PS X3 #7 Thickness 15mm 
82-7-0718 
SCP NRG Tib Ins PS X3 #7 Thickness 18mm 
82-7-0721 
SCP NRG Tib Ins PS X3 #7 Thickness 21mm 
82-7-0724 
SCP NRG Tib Ins PS X3 #7 Thickness 24mm 
82-7-0908 
SCP NRG Tib Ins PS X3 #9 Thickness 8mm 
82-7-0910 
SCP NRG Tib Ins PS X3 #9 Thickness 10mm 
82-7-0912 
SCP NRG Tib Ins PS X3 #9 Thickness 12mm 
82-7-0915 
SCP NRG Tib Ins PS X3 #9 Thickness 15mm 
82-7-0918 
SCP NRG Tib Ins PS X3 #9 Thickness 18mm 
82-7-0921 
SCP NRG Tib Ins PS X3 #9 Thickness 21mm 
82-7-0924 
SCP NRG Tib Ins PS X3 #9 Thickness 24mm 
82-7-1108 
SCP NRG Tib Ins PS X3 #11 Thickness 8mm 
82-7-1110 
SCP NRG Tib Ins PS X3 #11 Thickness 10mm 
82-7-1112 
SCP NRG Tib Ins PS X3 #11 Thickness 12mm 
82-7-1115 
SCP NRG Tib Ins PS X3 #11 Thickness 15mm 
82-7-1118 
SCP NRG Tib Ins PS X3 #11 Thickness 18mm 
82-7-1121 
SCP NRG Tib Ins PS X3 #11 Thickness 21mm 
82-7-1124 
SCP NRG Tib Ins PS X3 #11 Thickness 24mm 
 
1.4. Patella (optional) 
 
 
Medialized: 
73-20-0110 
Scorpio X3 Patella #11 medialized Dome 
73-20-0510 
Scorpio X3 Patella # 5 medialized Dome 
73-20-0710 
Scorpio X3 Patella # 7 medialized Dome 
73-20-0910 
Scorpio X3 Patella # 9 medialized Dome 
 
Concentric: 
73-20-2510 
SCORPIO C-DOME X3 PATELLA #5-10mm 
73-20-2710 
SCORPIO C-DOME X3 PATELLA #7-10mm 
73-20-2910 
SCORPIO C-DOME X3 PATELLA #9-10mm 
73-20-2110 
SCORPIO C-DOME X3 PATELLA #11-10mm 
 
Universal: 
73-20-3308 
SCORPIO U-DOME X3 PATELLA #3-8mm 
73-20-3508 
SCORPIO U-DOME X3 PATELLA #5-8mm 
73-20-3708 
SCORPIO U-DOME X3 PATELLA #7-8mm 
73-20-3710 
SCORPIO U-DOME X3 PATELLA #7-10mm 
73-20-3910 
SCORPIO U-DOME X3 PATELLA #9-10mm 
73-20-3110 
SCORPIO U-DOME X3 PATELLA #11-10mm 

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2. Triathlon Total Knee System 
2.1. Femoral Components 
2.1.1. Cemented 
 
• Triathlon CR 
 
 
Component thickness 
Component thickness 

• Triathlon PS 
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2.1.2. Cementless 
 
Width of box 
Component thickness 
Component 
thickness 
Height of box 
Triathlon CR 

• Triathlon PS 
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2.2. Tibia Component 
 
2.2.1. Cemented 
• Triathlon Primary Tibial Baseplate / Universal Tibial Baseplate 
Baseplate 
A/P 
Kiel length 
Width 
of kiel 
Kiel thickness 
Thickness 
baseplate 
Baseplate M/L 

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2.2.2. Cementless 
• Triathlon Primary Tibial Baseplate 
 
 
 
2.3. Insert 
• CR Tibial Insert – X3 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
tibial 
insert 
(incl. Tibia baseplate) 

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• PS Tibial Insert – X3 
 
 
 
 
Height tibial 
insert (incl. Tibia 
baseplate) 

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• CS Tibial insert – X3 
 
 
Size 
Part Number 
Thickness 
Description 
1 
5531-G-109 
9mm 
Triathlon CS Lipped Insert 
1 
5531-G-111 
11mm 
Triathlon CS Lipped Insert 
1 
5531-G-113 
13mm 
Triathlon CS Lipped Insert 
1 
5531-G-116 
16mm 
Triathlon CS Lipped Insert 
1 
5531-G-119 
19mm 
Triathlon CS Lipped Insert 
1 
5531-G-122 
22mm 
Triathlon CS Lipped Insert 
1 
5531-G-125 
25mm 
Triathlon CS Lipped Insert 
2 
5531-G-209 
9mm 
Triathlon CS Lipped Insert 
2 
5531-G-211 
11mm 
Triathlon CS Lipped Insert 
2 
5531-G-213 
13mm 
Triathlon CS Lipped Insert 
2 
5531-G-216 
16mm 
Triathlon CS Lipped Insert 
2 
5531-G-219 
19mm 
Triathlon CS Lipped Insert 
2 
5531-G-222 
22mm 
Triathlon CS Lipped Insert 
2 
5531-G-225 
25mm 
Triathlon CS Lipped Insert 
3 
5531-G-309 
9mm 
Triathlon CS Lipped Insert 
3 
5531-G-311 
11mm 
Triathlon CS Lipped Insert 
3 
5531-G-313 
13mm 
Triathlon CS Lipped Insert 
3 
5531-G-316 
16mm 
Triathlon CS Lipped Insert 
3 
5531-G-319 
19mm 
Triathlon CS Lipped Insert 
3 
5531-G-322 
22mm 
Triathlon CS Lipped Insert 
3 
5531-G-325 
25mm 
Triathlon CS Lipped Insert 
4 
5531-G-409 
9mm 
Triathlon CS Lipped Insert 
4 
5531-G-411 
11mm 
Triathlon CS Lipped Insert 
4 
5531-G-413 
13mm 
Triathlon CS Lipped Insert 
4 
5531-G-416 
16mm 
Triathlon CS Lipped Insert 
4 
5531-G-419 
19mm 
Triathlon CS Lipped Insert 
4 
5531-G-422 
22mm 
Triathlon CS Lipped Insert 
4 
5531-G-425 
25mm 
Triathlon CS Lipped Insert 
5 
5531-G-509 
9mm 
Triathlon CS Lipped Insert 
5 
5531-G-511 
11mm 
Triathlon CS Lipped Insert 
5 
5531-G-513 
13mm 
Triathlon CS Lipped Insert 
5 
5531-G-516 
16mm 
Triathlon CS Lipped Insert 
5 
5531-G-519 
19mm 
Triathlon CS Lipped Insert 
5 
5531-G-522 
22mm 
Triathlon CS Lipped Insert 
5 
5531-G-525 
25mm 
Triathlon CS Lipped Insert 
6 
5531-G-609 
9mm 
Triathlon CS Lipped Insert 
6 
5531-G-611 
11mm 
Triathlon CS Lipped Insert 
6 
5531-G-613 
13mm 
Triathlon CS Lipped Insert 
6 
5531-G-616 
16mm 
Triathlon CS Lipped Insert 
6 
5531-G-619 
19mm 
Triathlon CS Lipped Insert 
6 
5531-G-622 
22mm 
Triathlon CS Lipped Insert 
6 
5531-G-625 
25mm 
Triathlon CS Lipped Insert 
7 
5531-G-709 
9mm 
Triathlon CS Lipped Insert 
7 
5531-G-711 
11mm 
Triathlon CS Lipped Insert 
7 
5531-G-713 
13mm 
Triathlon CS Lipped Insert 
7 
5531-G-716 
16mm 
Triathlon CS Lipped Insert 
7 
5531-G-719 
19mm 
Triathlon CS Lipped Insert 
7 
5531-G-722 
22mm 
Triathlon CS Lipped Insert 
7 
5531-G-725 
25mm 
Triathlon CS Lipped Insert 
8 
5531-G-809 
9mm 
Triathlon CS Lipped Insert 
8 
5531-G-811 
11mm 
Triathlon CS Lipped Insert 
8 
5531-G-813 
13mm 
Triathlon CS Lipped Insert 
8 
5531-G-816 
16mm 
Triathlon CS Lipped Insert 
8 
5531-G-819 
19mm 
Triathlon CS Lipped Insert 
8 
5531-G-822 
22mm 
Triathlon CS Lipped Insert 
8 
5531-G-825 
25mm 
Triathlon CS Lipped Insert 

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• Asymmetric – X3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patella (optional), cemented 
Symmetric – X3 
Diameter 
Length of peg 
Cement 
thickness 
(1,5mm) 
Diameter of peg 
Thickness 
Length of peg 
Cement 
thickness 
(1,5mm) 
Diameter of peg 
Thickness 

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3. Triathlon PKR 
 
 
3.1. Femoral Components, cemented 
 
 
 
 
Femoral 
Component 
 
 
X3 Insert 
 
Tibial Baseplate 
 
 

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3.2. Tibia Baseplate, cemented 
 

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3.3. Insert