Polyethylene Wear Study on the Triathlon Total Knee Prosthesis A Prospective Randomized Single Centre Roentgen Stereophotogrammetric Analysis (RSA) Study
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT:  
       02525588 

CONFIDENTIAL 
 
Protocol #: TriathlonX3vsN2Vac 
Stryker SA 
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Table of Contents 
STUDY SUMMARY ...................................................................................................................................... 4 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE ............................................................................ 5 
CONTACT INFORMATION .......................................................................................................................... 6 
1. 
PRELIMINARY INVESTIGATIONS AND JUSTIFICATION OF THE STUDY .................................. 10 
1.1. 
INTRODUCTION ............................................................................................................................. 10 
1.2. 
DESCRIPTION OF THE DEVICES ..................................................................................................... 11 
2. 
OBJECTIVES OF THE CLINICAL INVESTIGATION ....................................................................... 13 
3. 
DESIGN OF THE CLINICAL INVESTIGATION ................................................................................ 13 
3.1. 
STUDY DESIGN ............................................................................................................................ 13 
3.2. 
NUMBER OF SUBJECTS ................................................................................................................. 13 
3.3. 
RANDOMISATION .......................................................................................................................... 14 
4. 
ELIGIBILITY ....................................................................................................................................... 14 
4.1. 
INCLUSION CRITERIA .................................................................................................................... 14 
4.2. 
EXCLUSION CRITERIA ................................................................................................................... 14 
4.3. 
DISCONTINUATION AND WITHDRAWAL OF SUBJECTS ...................................................................... 15 
4.3.1 
Specific Criteria for Withdrawal /Termination ........................................................................ 15 
5. 
SUBJECT ENROLMENT ................................................................................................................... 16 
5.1. 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 16 
5.2. 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 16 
5.3. 
RANDOMIZATION, BLINDING AND TREATMENT ALLOCATION ............................................................. 17 
5.4. 
THE OPERATIVE PROCEDURE ....................................................................................................... 17 
5.5. 
THE POSTOPERATIVE TREATMENT ................................................................................................ 18 
5.6. 
SUPPLIES/DEVICE ACCOUNTABILITY .............................................................................................. 18 
6. 
METHODS AND EVALUATIONS ...................................................................................................... 18 
6.1. 
STUDY PARAMETERS/ENDPOINTS .................................................................................................. 21 
6.1.1 
Clinical outcome .................................................................................................................... 21 
6.1.2 
Durability of the device .......................................................................................................... 21 
6.1.3 
Patient success or failure ...................................................................................................... 21 
6.1.4 
Surgical Procedure ................................................................................................................ 22 
6.2. 
STUDY PROCEDURES ................................................................................................................... 22 
6.3. 
THE RSA PROCEDURES ............................................................................................................... 22 
7. 
ADVERSE EVENTS ........................................................................................................................... 23 
7.1. 
SECTION 10 WMO ....................................................................................................................... 23 
7.2. 
DEFINITIONS ................................................................................................................................ 23 
7.3. 
RECORDING OF ADVERSE EVENTS ................................................................................................ 25 
7.4. 
REPORTING OF SERIOUS ADVERSE EVENTS AND ADVERSE DEVICE EVENTS ................................... 26 
Study Sponsor Notification by Investigator ........................................................................................ 26 
METC Notification by Investigator ...................................................................................................... 27 
7.5. 
PERIOD OF OBSERVATION ............................................................................................................ 27 
7.6. 
MEDICAL MONITORING ................................................................................................................. 27 
8. 
RISK / BENEFIT ASSESSMENT ....................................................................................................... 28 
8.1. 
RISK CATEGORY .......................................................................................................................... 28 
8.2. 
POTENTIAL RISK .......................................................................................................................... 28 
8.3. 
PROTECTION AGAINST RISKS........................................................................................................ 29 

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8.4. 
POTENTIAL BENEFITS TO THE SUBJECT.......................................................................................... 29 
9. 
STATISTICAL PLAN ......................................................................................................................... 29 
9.1. 
STATISTICAL METHODS ................................................................................................................ 29 
9.2. 
MISSING DATA ............................................................................................................................. 29 
9.3. 
PROTOCOL DEVIATIONS ............................................................................................................... 29 
10. 
QUALITY MANAGEMENT ............................................................................................................ 30 
10.1. 
STUDY MONITORING PLAN ............................................................................................................ 30 
10.2. 
CASE REPORT FORMS.................................................................................................................. 31 
10.3. 
DATA MANAGEMENT ..................................................................................................................... 31 
10.4. 
QUALITY ASSURANCE/AUDIT ......................................................................................................... 31 
11. 
ETHICAL CONCIDERATIONS ...................................................................................................... 32 
11.1. 
INTERNATIONAL STANDARDS ........................................................................................................ 32 
11.2. 
DELEGATION OF INVESTIGATOR DUTIES ........................................................................................ 32 
11.3. 
SUBJECT INFORMATION AND INFORMED CONSENT ......................................................................... 32 
11.4. 
PATIENT INSURANCE .................................................................................................................... 32 
11.5. 
PERSONAL DATA PROTECTION/CONFIDENTIALITY ........................................................................... 32 
11.6. 
LEGAL APPROVALS, ANNUAL PROGRESS REPORT AND END OF STUDY REPORT .............................. 33 
11.6.1. Submission of Documents at Study Start .............................................................................. 33 
11.6.2 Annual Progress Report ........................................................................................................ 33 
11.6.3 End of Study Report .............................................................................................................. 33 
12. 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN ..................................................... 33 
13. 
EARLY TERMINATION OR SUSPENSION OF THE INVESTIGATION ...................................... 34 
14. 
RECORD RETENTION .................................................................................................................. 34 
15. 
STUDY FINANCIAL ARRANGEMENTS ....................................................................................... 35 
16. 
PUBLICATION POLICY ................................................................................................................ 35 
17. 
LIST OF ABBREVIATIONS .......................................................................................................... 35 
18. 
REFERENCES ............................................................................................................................... 36 
 
 
 
 
List of Appendices 
 
APPENDIX 1 
 
PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM  
APPENDIX 2 
 
SAMPLE CASE REPORT FORM 
 

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STUDY SUMMARY 
 
Title 
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis_A 
Comparison of a Highly-crosslinked and a Crosslinked PE in-vivo 
Protocol Number 
TriX3_2009 
Phase 
Post-marketing 
Sponsor 
Stryker SA, Montreux, Switzerland 
Study design 
A Prospective Randomized Single Centre RSA Study 
Study Duration 
12 months enrolment period + up to 5 year follow-up for each case  
= 6 years total duration. 
Study Centre(s) 
1 
Objectives 
The primary objective is the assessment of the in vivo wear of the two 
randomized polyethylene inlay types N2Vac and X3 by means of Roentgen 
Stereophotogrammetry.  
The secondary objective is the assessment of prosthetic migration results after 
two years of the Triathlon CS Peri-Apatite coated tibial component by means of 
Roentgen Stereophotogrammetry. 
The third objective will be the prediction of the long-term survival of the 
Triathlon CS Peri-Apatite coated tibial components based on the two-year 
migration patterns combined with clinical factors and radiographic aspects. 
 
Safety data will be collected 
Primary endpoint 
In-vivo wear of N2Vac inlay vs. X3 inlay 
Indication 
Primary total knee replacement 
Study device / control 
device 
Triathlon CS total knee system 
Number of Subjects 
100 Patients 

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Inclusion Criteria 
Inclusions: 
1. 
Patient is able to understand the meaning of the study and is willing to sign 
the EC approved, study specific Informed Patient Consent Form. 
2. 
Patients with a pre-operative knee score of < 70. 
3. 
Patients scheduled to undergo primary total knee replacement with any of 
the following indication. 
- Painful and disabled knee joint resulting from osteoarthritis. 
- One or more compartments are involved. 
4. 
Need to obtain pain relief and improve function. 
5. 
Ability and willingness to follow instructions, including control of weight and 
activity level, and to return for follow-up evaluations. 
6. 
A good nutritional state of the patient. 
7. 
Full skeletal maturity of the patient, patients who are at least 18 years of 
age. 
8. 
Patients of either sex. 
 

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Exclusion Criteria 
Exclusions: 
1. 
The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 
2. 
Skeletal immaturity of the patient, patients who are less than 18 years of 
age. 
3. 
Patient has a flexion contracture of 15° and more. 
4. 
Patient has a varus/valgus contracture of 15° and more. 
5. 
Patients with a pre-operative knee score of >70. 
6. 
The subject has a history of total or unicompartmental reconstruction of the 
affected joint. 
7. 
The subject will be operated bilaterally. 
8. 
Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or 
ipsilateral side within the last year that is considered to have an 
unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 
1 year ago with good outcome can be included in the study). 
9. 
Patients who had a Total Knee Arthroplasty (TKA) on contralateral side 
within the last 6 months that is considered to have an unsatisfactory 
outcome. (Patients with contralateral TKA > 6 months ago with good 
outcome can be included in the study). 
10. The subject has an active or suspected latent infection in or about the knee 
joint 
11. Osteomyelitis 
12. Sepsis 
13. Patients who will need lower limb joint replacement for another joint within 
one year. 
14. The subject has a neuromuscular or neurosensory deficiency, which would 
limit the ability to assess the performance of the device. 
15. The subject has a systemic or metabolic disorder leading to progressive 
bone deterioration. 
16. The subject is immunologically suppressed or receiving steroids in excess 
of normal physiological requirements. 
17. The subject’s bone stock in compromised by disease or infection which 
cannot provide adequate support and/or fixation to the prosthesis. 
18. The subject has had a knee fusion to the affected joint. 
19. Female patients planning a pregnancy during the course of the study. 
20. The patient is unable or unwilling to sign the Informed Consent specific to 
this study 

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Patient evaluations will be performed according to the schedule below: 
 
Table 1 – Evaluation schedule 
 
 
Pre
-op 
Op 
< 1wk 
(prior to 
discharge) 
6wk 
3m 
6m 
1yr 
2yr 
5 yr 
Range (weeks) 
 
 
 
±4d 
±1wk 
±2wks 
±4wks 
±4wks 
±6ks  
Demographic Information 
P 
 
 
 
 
 
 
 
 
Historical Record 
P 
 
 
 
 
 
 
 
 
Clinical Evaluation 
 
 
P 
P 
P 
P 
P 
P 
P 
Operative Record 
 
P 
 
 
 
 
 
 
 
Knee Society Score 
P 
 
 
P 
P 
P 
P 
P 
P 
SF-36 
P 
 
 
P 
P 
P 
P 
P 
P 
EQ 5-D 
P 
 
 
P 
P 
P 
P 
P 
P 
Lower-Extremities Activity 
P 
 
 
P 
P 
P 
P 
P 
P 
RSA analysis 
 
 
P 
P 
P 
P 
P 
(double) 
P 
P 
Radiographic imaging 
P 
AP/
Lat 
 
P 
Lat 
P 
P 
Lat 
P 
P 
Lat 
P 
Lat 
P 
Lat 
Adverse Events 
(including revision) 
 
Anytime 

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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
 
 
TITLE: 
Polyethylene Wear Study on the  
Triathlon Total Knee Prosthesis 
 
Protocol #: 
Triathon X3vsN2Vac 
 
Version Date: 
Version 0.5: 2010-03-10 
 
 
Prepared by:  
____________________________  
 
_________________________ 
 
Eric H. Garling, Ph.D. 
 
 
 
 
 
 
Clinical Research Manager 
 
 
 
Stryker GmbH & Co.KG, Germany 
 
 
 
 
 
 
Approved by: 
_____________________________ 
Hanna Schlyter 
 
Director Clinical Research Europe  
Stryker SA 
 
I agree: 
· 
To conduct the trial in compliance with ISO 14155 guidelines, with the applicable regulatory 
requirements, and with the protocol agreed to by the sponsor and given approval/favourable 
opinion by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) 
 
 
 
· 
To comply with procedures for data recording/reporting 
· 
To permit monitoring, auditing and inspection 
· 
To retain the essential documents that should be in the investigator/institution files until the 
sponsor informs the investigator/institution these documents are not longer needed 
 
 
 
Signed by:  
____________________________________________________ 
 
 
 
H. Kaptijn, MD  
Department of Orthopaedics  
‘t Langeland Ziekenhuis Zoetermeer 
 
 

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CONTACT INFORMATION 
 
Principal investigator 
H. Kaptijn, MD 
 
Department of Orthopaedics  
‘t Langeland Ziekenhuis Zoetermeer 
 
Co-investigator  
 
 
            R. de Ridder, MD 
Department of Orthopaedics  
‘t Langeland Ziekenhuis Zoetermeer 
 
 
 
Orthopaedic surgeons 
P. Langendijk, MD 
Department of Orthopaedics  
‘t Langeland Ziekenhuis Zoetermeer 
 
V. Rudolphy, MD 
Department of Orthopaedics  
‘t Langeland Ziekenhuis Zoetermeer 
 
 
Radiology 
J. Kuiper, MD 
 
Department of Radiology 
 
 
 
‘t Langeland Ziekenhuis Zoetermeer 
 
R. Olsthoorn 
Department of Radiology 
‘t Langeland Ziekenhuis Zoetermeer 
 
 
RSA analysis (CRO) 
ClinFact, a Medis specials b.v. company 
Hans Reiber, CEO 
Leiden, The Netherlands 
 
Research Coordinators  
A. van Dam 
Clinical Research Associate 
Stryker Nederland 
 

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1. 
Preliminary Investigations and Justification of the Study 
This document is a protocol for a clinical investigation. This clinical investigation will be conducted in 
compliance with this protocol, ISO 14155 Part 1 and 2 Guidelines, and the applicable regulatory 
requirements. 
1.1. 
Introduction 
The most common causes for failure after more than 2 years after primary total knee surgery are 
polyethylene wear and aseptic loosening (Dennis, 2004; Fehring et al., 2001; Sharkey et al., 2002). 
Cumulative 10 year revision rates of total knee arthroplasty (according to the Swedish Knee register 
report) have generally decreased over the past 25 years probably due to improvements in implant design, 
more accurate instrumentation and polyethylene quality. However, there is a general trend towards 
treating younger patients and these younger and probably more active patients are likely to generate 
more wear and hence this may contribute to a new increase of wear and revision rates seen in (younger) 
patients. 
The Posterior Stabilized (PS) knee prosthesis is the most implanted total knee prosthesis design in the 
world. In PS knees articulation of the femoral component is facilitated by the use of a post and cam 
interaction providing the anterior-posterior sliding necessary to reach optimal (high) flexion. Research 
indicates that the high degree of tibial-femoral conformity and stability, which characterizes PS knees, 
plays an important role in the long-term durability and survivorship of 90% after 15 year of this design 
(Aglietti et al., 1999, Stern & Insall, 1992). However, it has also been shown that posterior stabilized 
implants contribute to additional wear debris. Especially at anterior and posterior locations of the post 
severe wear has been observed (Puloski et al., 2001).  
Ultra high molecular weight polyethylene (UHMWPE) is nowadays the standard material used for the 
articulating surface. Recently a cross-linking process improved the mechanical properties of polyethylene 
with double or even triple cross-linking procedures arising. An example of a triple cross-linked 
polyethylene is X3 (Stryker, Warsaw, USA). Theoretically and in vitro X3-polyethylene has improved wear 
resistance over conventional and current generation cross-linked polyethylene. It improves wear 
reduction over conventional polyethylene with 97%; the mechanical properties are maintained so that 
structural fatigue, yield strength and ultimate tensile strength are equivalent to virgin polyethylene and it 
resists oxidation. However, so far no clinical in vivo data has shown the benefits of this new material for 
tibial bearings. Combining this new material with a PS design should theoretically lead to superior wear 
characteristics and consequently long-term durability and survivorship of the prosthesis. 
Therefore, it would seem logical to develop an alternative bearing surface in total knee replacements to 
attempt to reduce wear by applying the newest generation of polyethylene in combination with the 
successful characteristics of a PS knee. On theoretical ground this knee prosthesis will potentially further 
improve survivorship and function of these implants. The Triathlon CS insert (Stryker, Warsaw, USA) 

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substitutes the posterior cruciate function (like normal PS knees) without the use of a post. This will 
remove the additional wear observed in PS knees without compromising function and stability. The insert 
is available in a conventional polyethylene (N2Vac) and the newest generation polyethylene (X3). 
To test new bearing concepts on a large scale in a general population, using national registries as the 
primary benchmarking tool, is by definition not a good idea. Firstly, the main endpoint in registers is 
usually revision and all tribological failures, radiological or clinical, do not have to lead to revision. 
Secondly, due to the relatively low observed revision rate, the size of the population to be studied has to 
be large (several thousands) and to be followed over an extended period of time (5-10 years) in order to 
detect statistically significant differences (Robertsson, 2007). Therefore to study wear and fixation of new 
implants accurate outcome parameters have to be used. 
Roentgen Stereophotogrammetric Analysis (RSA) is a very accurate measurement technique used to 
obtain micromotion of the implants relative to inserted tantalum markers in the surrounding bone. The 
accuracy of RSA mentioned in the literature ranges from 0.01 to 0.7 mm for displacement. It has been 
applied in many studies, mostly in Sweden (Kärrholm, 1989). In 2000, the Orthopaedic Department of the 
Leiden University Medical Center developed a Model-based RSA system (Model-based RSA, Medis 
specials BV, Leiden, The Netherlands). The accuracy of this software in clinical studies is about 0.25 mm 
for translations and 0.2° for rotations in the 95% confidence interval (Hurschler et al., 2006; Kaptein et al., 
2003; Vrooman et al, 1998). Kärrholm et al. (1994) and Ryd et al. (1995) showed that with RSA a long-
term prediction can be made of prosthetic loosening based on a two years follow-up.  
The goal of this study is to compare conventional UHMWPE with X3 highly cross-linked polyethylene in a 
CS fixed bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA) by means of RSA 
and clinical evaluation. 
1.2. 
Description of the Devices 
The Triathlon® Knee System (Stryker, Warsaw, USA) is designed to help provide patients more  
natural-like motion, a better anthropometric fit and the potential for greater implant longevity, e.g. in 
reduction of Polyethylene related wear. The design goal was to optimize rotation in deep flexion while 
providing stability. The unique design of the Triathlon Knee with its anatomic single-radius replicates 
proper tracking of the epicondyles, creating natural soft-tissue tension that promotes stability, allows for 
deep flexion and facilitates the tibial rotation necessary to support deep flexion activities. This will mimic 
natural knee motion, enhancing stability and mobility during daily activities. These design characteristics 
offer the potential for enhanced long-term component durability.  
 
Triathlon Peri-Apatite coated Tibial component: 
All tibial components are Peri-Apatite coated. The crystals deposited from the Peri-Apatite form a 
Hydroxy- Apatite coating with an overall average thickness of 20 μm which allows for bone in-growth. 
Prostheses are available in eight different (1-8) so the best suited size is used for the patient based on 
the pre-operative evaluation and planning.  

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The participating surgeons will use Stryker instruments for prosthesis placement. The instruments will be 
used conform the instructions of the manufacturer. 
(Cat. # 5526-B-X00 Triathlon Primary PA coated) 
 
Triathlon Peri-Apatite coated Femoral component: 
All femoral components are Peri-Apatite coated. The crystals deposited from the Peri-Apatite form a 
Hydoxy- Apatite coating with an overall average thickness of 20 μm which allows for bone in-growth. 
Prostheses are available in eight different (1-8) so the best suited size is used for the patient based on 
the pre-operative evaluation and planning.  
The participating surgeons will use Stryker instruments for prosthesis placement. The instruments will be 
used conform the instructions of the manufacturer. 
(Cat. # 5517-F-XXX Triathlon CR PA coated) 
 
Polyethylene insert N2Vac: 
Ultra high molecular weight polyethylene (UHMWPE) is a linear polymer with a molecular weight of 4 – 6 
Daltons. In solid form the crystallinity is about 50%. The numerous tie molecules connecting the 
crystalline regions give this polymer high impact and wear resistance. For over 40 years UHMWPE has 
been used as a bearing surface for total hip or knee joint replacement. 
Packaging and sterilisation techniques are important factors affecting for the longevity of this material. 
The N2Vac packaging process consists of two steps: Nitrogen packaging and Gamma irradiation to limit 
the risk of oxidation during irradiation. 
(Cat. #: 5531-P-XXX Triathlon CS N2Vac Insert) 
 
Polyethylene insert X3TM: 
X3 polyethylene offers advanced mechanical strength, improved wear reduction and resistance to 
oxidation by placing the material through a sequentially irradiation and annealing progressive crosslinking 
process. This patented process preserves the polyethylene´s microstructure for optimal strength and 
fatique benefits. It makes X3TM suitable for higher stress applications such as knees, so these patients 
may benefit from the potentially longer wearing properties of a highly crosslinked material. 
(Cat. # 5531-G-XXX Triathlon CS X3 Insert) 
 
1.3. Beads 
To evaluate the motion of the polyethylene bearing and micromotion of the prosthesis, at least three well-
scattered tantalum balls (ø 1.0 mm) have to be inserted into the tibia and femoal bone. To this end a 
special designed Ta-marker insertion device will be used according to instructions of the manufacturer 
(Halifax Biomedical, NS, Canada). The beads are not part of the Knee system itself. The bead inserter 

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device will be loaned to the hospital by Stryker for the duration of the clinical study (covered in study 
contract).  
2. 
Objectives of the Clinical Investigation 
· 
The primary objective is the assessment of the in vivo wear of the two randomized polyethylene 
inlay types N2Vac and X3 by means of Roentgen Stereophotogrammetry. It is expected that the 
X3 group will show significantly less wear after 5 years compared to the conventional N2Vac 
polyethylene group. 
· 
The secondary objective is the assessment of prosthetic migration results after two years of the 
Triathlon CS Peri-Apatite coated tibial and femoral components by means of Roentgen 
Stereophotogrammetry. It is expected that due to the superior wear qualities of X3 polyethylene 
this group will show significantly less migration of the prosthesis’ components after two-years 
compared to the components in the N2Vac group. 
· 
The third objective will be the prediction of the long-term survival of the Triathlon CS Peri-Apatite 
coated tibial and femoral components based on the two-year migration patterns combined with 
clinical factors and radiographic aspects. In order to identify other clinical parameters besides 
wear influencing the fixation of the prosthesis components, clinical scores and radiographic 
aspects will be correlated with the RSA outcome. Subsequently, a long-term prediction can be for 
the Triathlon CS Peri-Apatite coated tibial and femoral components.      
 
 
3. 
Design of the Clinical Investigation 
3.1. 
Study Design 
Single-Center Randomized Controlled Trial (RCT) to compare conventional UHMWPE with X3 highly 
cross-linked polyethylene in a CS fixed bearing total knee prosthesis. 
All Patient recruitment and RSA image acquisitions will take place in: ‘t Lange Land Ziekenhuis, 
Zoetermeer. 
The Quality Control of the RSA images and RSA image analysis will be carried out by the CRO (ClinFact, 
Leiden, the Netherlands). 
3.2. 
Number of Subjects 
RSA is able to measure wear with high accuracy. Previous RSA wear studies show that the expected 
wear rate is 0.13 ± 0.08 mm a year (Short et al., 2005; Kellett et al., 2004). A clinical relevant difference to 
detect differences in wear would be a standard deviation of 0.1 mm a year.  
Group sample sizes of 27 patients in each group would achieve 95% power to detect a difference of -0.1 
mm wear between the null hypothesis that both group means are 0 and the alternative hypothesis that the 
mean of group 2 is 0.1 with estimated group standard deviations of 0.1 and with a significance level 
(alpha) of 0.05 using a two-sided two-sample t-test.  
However, in order to also achieve the third objective of this protocol whereby clinical parameters will be 
correlated with RSA results, more patients are needed to obtain stronger correlations with the important 

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clinical outcome parameters. Taking the latter in account and to compensate for possible lost to follow up, 
50 patients will be recruited per study group. 
 
3.3. 
Randomisation 
After signing Informed Consent, the patients will be randomised in one of the two groups, the day before 
surgery. Randomization envelopes will be provided by Stryker to the primary investigator. The patient will 
receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. . 
The principal investigator and the participating surgeons may dissent from the randomisation scheme 
based on intra-operative findings. This patient will be excluded from the study.   
4. 
Eligibility 
General inclusion/exclusion criteria for patients undergoing primary total knee arthroplasty will be used as 
guidelines for this study. Subjects selected for this evaluation must meet the following criteria in order to 
be enrolled in to the study: 
4.1. 
Inclusion Criteria 
Subjects meeting all the following criteria will be eligible to be enrolled in the study: 
9. 
Patient is able to understand the meaning of the study and is willing to sign the EC approved, 
study specific Informed Patient Consent Form. 
10. Patients with a pre-operative knee score of < 70. 
11. Patients scheduled to undergo primary total knee replacement with any of the following 
indication. 
- 
Painful and disabled knee joint resulting from osteoarthritis. 
- 
One or more compartments are involved. 
12. Need to obtain pain relief and improve function. 
13. Ability and willingness to follow instructions, including control of weight and activity level, and to 
return for follow-up evaluations. 
14. A good nutritional state of the patient. 
15. Full skeletal maturity of the patient, patients who are at least 18 years of age. 
16. Patients of either sex. 
4.2. 
Exclusion Criteria 
Subjects meeting any of the following criteria will not be included in the study: 
1. 
The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 
2. 
Skeletal immaturity of the patient, patients who are less than 18 years of age. 
3. 
Patient has a flexion contracture of 15° and more. 
4. 
Patient has a varus/valgus contracture of 15° and more. 

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5. 
Patients with a pre-operative knee score of >70. 
6. 
The subject has a history of total or unicompartmental reconstruction of the affected joint. 
7. 
The subject will be operated bilaterally. 
8. 
Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within 
the last year that is considered to have an unsatisfactory outcome (Patients with contralateral 
and/or ipsilateral THA > 1 year ago with good outcome can be included in the study). 
9. 
Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months 
that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 
months ago with good outcome can be included in the study). 
10. The subject has an active or suspected latent infection in or about the knee joint 
11. Osteomyelitis 
12. Sepsis. 
13. Patients who will need lower limb joint replacement for another joint within one year. 
14. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to 
assess the performance of the device. 
15. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 
16. The subject is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements. 
17. The subject’s bone stock in compromised by disease or infection which cannot provide 
adequate support and/or fixation to the prosthesis. 
18. The subject has had a knee fusion to the affected joint. 
19. Female patients planning a pregnancy during the course of the study. 
20. The patient is unable or unwilling to sign the Informed Consent specific to this study 
4.3. 
Discontinuation and Withdrawal of Subjects 
The subject’s participation in this investigation is voluntary, and the subject has the right to refuse further 
participation or withdraw from this investigation at any time and without providing a reason.  
4.3.1 
Specific Criteria for Withdrawal /Termination 
In the event that a subject is discontinued from the study for any reason, the site will complete a Study 
Termination form. Subjects may be withdrawn for the following reasons: 
· 
Patient failure – defined by the requirements at the two- year follow-up interval see section 6.1.3. 
· 
Any Serious Adverse Event that effects the outcome of the study 
· 
Any Serious Adverse Event related to the test device 
· 
Revision/Removal of study device 
· 
Patient withdrawal (patients own request 
· 
Lost to Follow-Up 

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· 
If, in the Investigator’s opinion, continuation in the study would be detrimental to the subject’s well 
being (a written explanation is required) 
· 
Completion of study and final evaluation 
· 
Death of the subject 
If the patient fails to return for their follow-up appointments, every effort should be made to contact the 
subject to assess their health status. If after attempting to contact the patient through 3 documented 
phone calls and a certified (i.e., return-receipt) letter, the patient still does not respond, the patient will be 
considered as “lost to follow-up”. A Study Termination Form will be completed after notifying Stryker of the 
patient’s status.   
In the event that the subject is discontinued by the investigative site prior to the final study evaluation, the 
subject is notified that they are no longer in the study and a Study Termination form will be completed.  
Following discontinuation, the subject will be seen regularly as considered clinically appropriate. If the 
discontinuation was caused by an adverse event the subject will be seen regularly until the symptoms 
have disappeared or are under control, or until feasible treatment has been undertaken. Refusal to 
participate or early withdrawal from this investigation will not affect the quality or availability of the 
subject’s medical care.  
Subjects withdrawn from the study will keep their subject number. New subjects must always be assigned 
a new subject number. In the event that the subject withdraws from this investigation, the information that 
has already been collected will be included in the database and in the final analyses. The subject’s 
medical records will also be available for monitoring, auditing and inspection purposes. 
After withdrawal subjects will not be replaced to the study. 
5. 
Subject Enrolment 
5.1. 
Subject Recruitment and Screening 
Patients will be recruited during preoperative visits through normal referral practice.  
If the patient fulfills the study criteria, the surgeon informs the patient concerning the study and gives the 
information letter. The surgeon will answer remaining questions at the next visit. If the procedure is clear 
and the patient agrees to participate, the informed consent is signed and the preoperative questionnaires 
are obtained. All patients recruited for this study will have the capacity to give their informed consent on 
the ethics committee approved, study specific Informed Patient Consent Form. If the patient does not 
want to participate or does not fulfill the inclusion criteria, he/she will obtain the normal clinical follow-up. 
5.2. 
Patient Informed Consent and Guidelines 
The subject will be informed by the Investigator (or his designated representative) of the purpose of the 
study, study duration, and follow-up schedule. All foreseeable risks and potential benefits, which might 
occur during and after total knee arthroplasty, will be discussed with the subject. 
 

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The subject will be informed that his/her medical records are subject to review by representatives of the 
sponsor as necessary. The confidentiality of the subject will be maintained at all times.  The subject will 
be told that he/she is free to refuse study participation or to withdraw from the study at any time without 
compromising future medical care. 
 
All subjects for this study will be provided with a consent form describing this study giving sufficient 
information for subjects to make an informed decision about their participation in the study. 
 
The informed consent must contain all elements required by local and institutional policies.  See Appendix 
1 for a copy of the Patient Information Sheet and Informed Consent Form. The document must be 
translated into the local language(s) applicable in each study site, be understandable to the subject and 
must specify who informed the subject. When required by local regulations, the person informing the 
subject must be a physician. This consent form will be submitted with the protocol for review and approval 
by the IEC/IRB for the study. 
 
All subjects must provide written consent of their willingness to participate in the study after having had 
adequate time to consider their decision. The formal consent of a subject, using the EC-approved consent 
form, must be obtained before that subject is submitted to any protocol related procedures that are not 
part of the subject’s normal care. Written documentation of consent must be provided on the consent’s 
signature page in addition to a note in the patient medical records indicating the date that consent was 
obtained. The investigator obtaining the consent must also sign this consent form. The subject or their 
legal representative should receive a signed copy of the consent. 
5.3. 
Randomization, Blinding and Treatment Allocation 
The patients will be randomized to receive N2Vac polyethylene inlay or the X3 polyethylene inlay (see 
section 3.3). The randomization will occur via a random number generator (manual or computer). The 
doctor or other health care professional does not choose the participants for each group. For patients 
satisfying inclusion criteria, randomisation will occur by retrieving the next randomly generated group 
assignment. The patient, physiotherapist (for the clinical evaluation) and data analyzers (RSA data, 
clinical data, radiographic data and statistics) will be blinded. The PI and other participating surgeons 
have no influence on the collection of the (clinical) data and the data analysis. 
 
5.4. 
The Operative Procedure 
The prosthesis is placed according to the instruction manual (see appendix) by an experienced knee 
surgeon using a standard approach and instrumentation. 

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5.5. 
The Postoperative Treatment 
The patient will rehabilitate at home with help of a physiotherapist. At the regular visits at the outpatients 
the questionnaires will be obtained by a physiotherapist (blinded to which patient received which type of 
inlay). The physiotherapist was not present at the operation. The patients will complete the patient 
questionnaires by himself/herself. In case of a complication or adverse event, the surgeon will be called. 
5.6. 
Supplies/Device Accountability 
The study devices must be stored and handled in accordance with the manufacturer’s guidelines. The 
Investigator will also keep accurate records of the devices assigned to each subject. 
The investigator will be asked to attach the labels (with the lot device number), where possible, of the 
implanted devices to the corresponding patient CRF page in order to keep a tracking of the devices. 
6. 
Methods and Evaluations 
Subjects will be evaluated preoperatively, prior to discharge and at follow-up intervals of 6 weeks, 3 
months, 6 months, 1, 2 and 5 years. Each subject will be followed for five years post-implantation. At the 
1-year follow-up a double examination will be made in order to assess the clinical RSA precision. All 
subject evaluations will be documented by completion of appropriate Case Report Forms (see Appendix 
2). 
 
Table 1 – Evaluation schedule (functional and patient assessment) 
 
 
Pre
-op 
Op 
< 1wk 
(prior to 
discharge) 
6wk 
3m 
6m 
1yr 
2yr 
5 yr 
Range (weeks) 
 
 
 
±4d 
±1wk 
±2wks 
±4wks 
±4wks 
±6ks  
Demographic Information 
P 
 
 
 
 
 
 
 
 
Historical Record 
P 
 
 
 
 
 
 
 
 
Clinical Evaluation 
 
 
P 
P 
P 
P 
P 
P 
P 
Operative Record 
 
P 
 
 
 
 
 
 
 
Knee Society Score 
P 
 
 
P 
P 
P 
P 
P 
P 
SF-36 
P 
 
 
P 
P 
P 
P 
P 
P 
EQ 5-D 
P 
 
 
P 
P 
P 
P 
P 
P 
Lower-Extremities Activity 
P 
 
 
P 
P 
P 
P 
P 
P 
RSA analysis 
 
 
P 
P 
P 
P 
P 
(double) 
P 
P 
Radiographic imaging 
P 
AP/
 
P 
Lat 
P 
P 
Lat 
P 
P 
Lat 
P 
Lat 
P 
Lat 

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Lat 
Adverse Events 
(including revision) 
 
Anytime 
 
Basic demographic and medical history information is to be collected at the most two months prior to 
surgery. This information includes age and gender. Height, weight, primary diagnosis, concurrent medical 
condition and prior treatment to the affected joint are also documented at this time. 
 
Prior to surgery (- 2 months) 
Demographic information: 
Date of birth 
Height/ weight 
Gender 
 
Patient’s initial diagnosis 
 
 
Operative side 
 
 
Historical record 
Cigarette Smoker  
Medical History: 
Concurrent Medical condition and 
current treatment according to 
medication category (ATC Class) 
 
Am. Knee Society Score AKSS*  
Pain intensity 
Active and passive range of 
motion (Neutral-zero-method) 
Stability 
Anatomic alignment 
Walking/standing ability 
Stair climbing ability 
Use of walking aids  
 
Patient questionnaires 
SF-36 
EQ-5D 
LEAS (Lower Extremities Activity 
Scale) 
 
Radiographic assessment 
Anterior/posterior 
Lateral 
 
 
 
Surgical Procedure 
Anesthesia 
Type 
ASA 
 
Systemic prophylactic therapy 
Antibiotic 
 

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Anticoagulant 
Bone cement 
 
 
Surgical approach 
 
 
Soft tissue released 
 
 
Navigation 
 
 
Deviation from site-specific 
surgical procedure 
 
 
Bone removed 
Femur 
Tibia 
Slope 
 
Tantalum balls (ø 1.0 mm) 
Position in the tibia bone 
 
Time 
Skin to skin 
Tourniquet 
 
Implant details 
Sizes of components 
Product labels 
 
Intra-operative complications 
 
 
 
 
 
Assessment at on week postoperative 
Clinical evaluation 
Concomitant therapy 
Pain medication 
 
Systemic prophylactic therapy 
Antibiotic 
Anticoagulant 
 
Rehabilitation/mobilization 
Site specific procedure 
Discharged 
Radiographic assessment 
Anterior/posterior 
Lateral 
Radiostereometric analysis 
 
Early post-op complications 
 
 
 
 
Follow-up assessment at 6 weeks, 3 months, 6 months, 1 year, 2 years and 5 years 
Clinical evaluation 
Patient status 
 
 
Concomitant therapy 
Pain medication 
 
AKSS* 
 
 
Patient questionnaires  
SF-36 
EQ-5D 
Radiographic assessment 
Anterior/posterior 
Lateral 
Radiostereometric analysis 
 

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Complications 
 
 
Termination 
Date of evaluation 
 
 
Study completion 
Reason for early termination 
 
Position of study device at last 
contact to patient 
 
 
Problems at last contact 
 
 
 
 
 
 
6.1. 
Study parameters/endpoints 
6.1.1 
Clinical outcome 
· Relief of Pain, measured by an increase in the pain score component of the Knee Society Score 
· Restoration of Function, measured by an increase in the functional score of the Knee Society Score. 
· Patient satisfaction as determined by answers to patient outcomes questionnaires (EQ 5-D, SF-36 and 
Lower Extremity Activity Scale). 
6.1.2 
Durability of the device 
· The absence of revisions/removal due to pain and/or loosening. 
· Radiological integrity. The integrity of the implant / bone interfaces will be assessed. The occurrence of 
radiolucent lines / radiolucency being defined as a clearing or radiolucent line not exceeding 2 mm in 
width at the bone / prosthesis. 
· Progressive radiolucency being defined as radiolucencies which increase no more than 2mm in two or 
more zones in the femoral or tibial implants. 
- Anterior-Posterior (AP) view 
- Skyline (Merchant View) at 30 degree Knee Flexion 
- Lateral View 
6.1.3 
Patient success or failure 
Each patient from the two groups must meet the following criteria at the two-year (± 2 months) evaluation 
in order to be considered as “success”: 
Patient Success - defined by the following requirements at the two-year follow-up interval: 
· A Knee Score of ≥ 80, and 
· No component revisions or removals (femoral, bearing, tibial or patella), and 
· No pending component revisions or removals (femoral, bearing, tibial or patella) and 
· Absence of Osteolysis in any component (femoral, bearing, tibial or patella) and 
· No migration / subsidence of >3mm or >3º in any component (femoral, bearing, tibial or patella) 

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A patient who meets any of the following criteria at the two-year (± 2 months) evaluation will be 
considered as “failure”: 
Patient Failure – defined by the following requirements at the two-year follow-up interval: 
· A Knee Score of < 80, or 
· Revisions or removals of any component (femoral, bearing, tibial or patella), or 
· Pending revisions or removals of any component(femoral, bearing, tibial or patella), or 
· Presence of Osteolysis in any component(femoral, bearing, tibial or patella), or 
· Migration / subsidence of 3 mm or >3º in any component (femoral, bearing, tibial or patella). 
6.1.4 
Surgical Procedure 
Standard, accepted surgical procedures for total knee arthroplasty will be utilized. The specific surgical 
procedure performed at the investigative site is to be documented before study start. All study patients 
are to be operated on according to the relevant site-specific surgical procedure. Any deviations from this 
site-specific surgical procedure are to be documented. 
After surgery, information is to be collected concerning the surgical details and hospital course of the 
subject. Information such as length of surgery (skin to skin, tourniquet, instrumentation, and anesthetic 
times); surgical approach; soft tissue released; ASA Classification; range of motion at discharge; 
intraoperative complications and prosthesis implanted is recorded.  
Appropriate postoperative care will be given and is at the discretion of the physician, as is weight bearing 
schedule.  
Rehabilitation time frame and regimen performed at each investigative site is to be documented before 
study start. All study patients are to be rehabilitated according to the relevant site-specific rehabilitation 
procedure. Any significant deviations from this site-specific rehabilitation procedure are to be 
documented. 
6.2. 
Study Procedures 
Patient packs containing all the necessary Case Report Forms for the duration of the study will be 
supplied to the PI prior to commencing the Study. Samples of the forms are included in the Report Forms 
section of this protocol. 
An Informed Patient consent Form will be completed. Diagnosis may include any confirmatory test as 
deemed necessary by the surgeon, such as x-ray, CT (computerised tomography) or MRI (magnetic 
resonance imaging). Standard pre-operative blood and laboratory tests should be conducted. 
An Operative Record will be completed to record details of each operative procedure. 
6.3. The RSA Procedures  
The fixation and stabilization of the tibia components will be assessed using RSA. During the surgical 
procedure at least three well-scattered tantalum markers are installed (ø 1.0 mm) into the bone around 

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the tibial component to obtain skeletal landmarks. The tantalum markers are locked inside a rotating 
cartridge inside a specially designed insertion instrument (Halifax Biomedical, NS, Canada). 
At the routine control visits (discharge day, 6 weeks, 3, 6, 12, 24 months and 5 years), the radiographs 
will be taken and the physical evaluation will be performed.  
The RSA data of the prostheses components will be compared in terms of subsidence, linear, and 
rotational movements and wear. If the prosthesis is stable and fixed the differences will be zero. 
The RSA set-up consist of two synchronized roentgen tubes positioned approximately 1.5 meter above 
two roentgen cassettes (35*43 cm) at a 20° angle to the vertical. Both roentgen tubes simultaneously 
expose the roentgen film. A carbon fiber calibration box (Medis specials b.v., Leiden, The Netherlands) is 
used to calibrate the experimental set-up (loaned by Stryker to the hospital for the duration of the study, 
covered in study contract).  
The RSA X-rays of the discharge day (4-7 days postoperative) is used as baseline. Since the tantalum 
balls are fixed in the bone around the tibial implant, the position of the implant relative to the bone can be 
calculated. Taking these bone markers as reference points, the spatial translations and rotations of the 
tibial component during follow-up can be calculated (Kaptein et al., 2006; Valstar et al. 2005). The bone 
markers need to be well fixated in the bone. Bone markers are defined unstable when they move more 
than 0.3 mm with respect to the other bone markers. Unstable markers will be excluded from analysis 
(Garling et al. 2005b). 
For the analysis of wear the same principle can be used. Taking the tibial component as a reference, the 
spatial translations and rotations of the femoral component during follow-up can be calculated. The 
relative change in proximal – distal direction of the femur with respect to the tibia will be denoted as 
polyethylene wear. 
7. 
Adverse Events 
7.1. 
Section 10 WMO 
In accordance to section 10, subsection 1of the WMO, the investigator will inform the subjects and the 
reviewing accredited METC if anything occurs, on the basis of which it appears that the disadvantages of 
participation may be significantly greater than was foreseen in the research proposal. The study will be 
suspended pending further review by the accredited METC, except insofar as suspension would 
jeopardize the subjects’ health. The investigator will take care that all subjects are kept informed. 
7.2. Definitions 
Adverse Event (AE) – “Any untoward medical occurrence in a subject whether it is considered to be 
device related or not. An adverse event can therefore be any unfavourable and unintended sign, 
symptom, or disease developed or worsened during the period of observation in the study, whether or not 
related to the investigational product” 
 

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An Adverse Event could be: 
§ 
a new illness 
§ 
worsening of an illness 
§ 
an effect of the study device including the comparator (if any) 
§ 
a combination of two or more of these factors 
 
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 study period. Planned surgery measures permitted by the study and the condition(s) 
leading to these measures are not adverse events. If the condition(s) was (were) known before the 
subject enrolled in the study, this (these) should be recorded in the medical history CRF. 
 
Adverse Device Effect (ADE) – “Any untoward or unintended response to a medical device including 
any event resulting from insufficiencies or inadequacies in the instructions for use or the deployment of 
the device and any event that is a result of user error” 
 
Serious Adverse Event (SAE) – An adverse event that: 
§ 
Led to a death, or 
§ 
Led to serious deterioration in the health of the subject that: 
– resulted in a life-threatening illness or injury. 
– resulted in a permanent impairment of a body structure or a body function. 
– required in-patient hospitalization or prolongation of existing hospitalization. 
– resulted in medical or surgical intervention to prevent permanent impairment to body structure 
or a body function, or 
§ 
Led to foetal distress, foetal death or a congenital abnormality or birth defect. 
The term “life threatening” in the definition refers to an event in which the subject was at risk of death at 
the time of the event. It does not refer to an event that hypothetically might have caused death if it were 
more severe. 
 
Serious Adverse Device Effect (SADE) – “adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event or that might have led to any of these 
consequences if suitable action had not been taken or intervention had not been made or if 
circumstances had been less opportune” 

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7.3. Recording of Adverse Events 
Once the subject has signed the informed consent, information on all adverse events should be recorded 
immediately in the source document.  
Any adverse event which occurs during the reporting period which is related to the device or meets the 
definition of serious should be documented via a Serious Adverse Event Form. AE’s can be documented 
via an Adverse Event Form. All complications will be treated with appropriate medical care. 
Any device-related Adverse Event will be documented in detail as indicated on the CRF. The following 
information is required: 
§ 
Onset date of the AE 
§ 
Description of the event (All clearly related signs, symptoms, and abnormal diagnostic procedure 
results should be recorded in the source document, though they should be grouped under one 
diagnosis on the CRF) 
§ 
Seriousness of the event 
§ 
Intensity of the event (mild, moderate or severe; see definitions below) 
§ 
Relationship of the AE to the investigational device (see definitions below) 
§ 
Any action taken to resolve the AE 
§ 
Outcome of the AE (recovered, recovered with sequela, or on going) 
§ 
Stop date of the AE if not indicated as on going 
 
Intensity 
The investigator is to classify the intensity of an AE according to the following definitions: 
Mild: 
 
Transient symptoms, no interference with the subject’s daily activities. 
Moderate: 
Marked symptoms, moderate interference with the subject’s daily activities. 
Severe: The subject is unable to perform usual activity. 
 
Relationship 
The investigator is to classify the investigational device relationship of an AE according to the following 
definitions: 
Not related: 
The time between implantation of the investigational device and occurrence or worsening 
of the AE rules out a casual relationship, and/or another cause is confirmed and no 
indication of involvement of the investigational device in the occurrence/worsening of the 
AE exists. 
 
Unlikely: 
The time between implantation of investigational device and occurrence or worsening of 
the AE makes a casual relationship unlikely, and/or the known effects of the 
investigational device provide no indication of involvement in occurrence/worsening of the 
AE, and another cause adequately explaining the AE is known, and/or regarding the 

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occurrence/worsening of the AE a plausible causal chain may be deduced from the 
known effects of the investigational device, but another cause is much more probable, 
and/or another cause is confirmed and involvement of the investigational device in the 
occurrence/worsening of the AE is unlikely. 
 
Possibly: 
An AE that might be due to the use of the device. An alternative explanation (e.g. 
concomitant drug(s), concomitant disease(s)) is inconclusive. The relationship in time is 
reasonable; therefore the casual relationship cannot be excluded. 
 
Probably: 
An AE that might be due to the use of the device. The relationship in time is suggestive 
(e.g. confirmed by dechallenge). An alternative explanation is less likely (e.g. concomitant 
drug(s), concomitant disease(s). 
 
Definitely: 
An AE that is listed as a possible adverse reaction and cannot be reasonably explained 
by an alternative explanation, e.g. concomitant drug(s), concomitant disease(s). The 
relationship in time is very suggestive (e.g. it is confirmed by dechallenge and 
rechallenge) 
 
The clinical course of each device-related event should be followed until resolution, stabilisation, or until 
it has been determined that the study treatment or participation is not the cause. 
7.4. 
Reporting of Serious Adverse Events and Adverse Device Events 
7.4.1 
Study Sponsor Notification by Investigator 
Any serious adverse event or adverse device event must be reported by the Investigator to the Safety 
Responsible at Stryker by telephone within 24 hours or at the latest on the following working day. 
 
A Serious Adverse Event Form must be completed by the investigator and faxed to Stryker within 3 
working days. The reporting language is English. The investigator will keep a copy of this SAE form on file 
at the study site. Serious Adverse Events should be reported by phone to: 
Annemarieke van Dam, CRA 
Phone: +31 (0) 418569813 
Mobile: +31 (0) 622741602 
Fax:  
+31 (0) 418 569 777 
Email: annemarieke.vandam@stryker.com 

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7.4.2 
METC Notification by Investigator 
Reports of serious adverse device effects - including follow-up information - must be submitted within 48 
hours to Stryker and the accredited METC that approved the protocol, according to the requirements of 
that MTEC. Copies of each report and documentation of METC notification and receipt will be kept in the 
Investigator Site File and also in the study Master File.  
7.5. Period of Observation 
For the purpose of the study, the period of observation for collection of adverse events extends from the 
time the subject gives informed consent until the date of last study visit or last contact with the subject. 
7.6. Medical Monitoring 
It is the responsibility of the Investigator to oversee the safety of the study at his/her site. This safety 
monitoring will include careful assessment and appropriate reporting of adverse events as noted above. 

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8. 
Risk / Benefit Assessment 
8.1. 
Risk Category 
There is minimal risk associated with participating in this study over and above that of the primary knee 
arthroplasty procedure. 
8.2. 
Potential Risk 
The study involves the routine assessment of a knee arthroplasty procedure. The device under study has 
been cleared for marketing and has the CE mark. It will be used according to its labelling. Assessment 
involves questionnaires, patient and physician assessments, and RSA-radiographs. The effective 
radiation dose per RSA-radiograph is 3 μSv (Teeuwisse et al., 1998). The additional annual radiation 
dose is negligible if the natural annual exposure of 2 mSv is considered and will do the patient no harm 
(Blake et al., 1996). The International Commission on Radiological Protection categorizes the 
corresponding level of risk qualitative due to radiation as ‘trivial’ with a quantitative risk of about one in a 
million or less. The required level of benefit should be related to ‘only increase knowledge’. 
(http://ec.europa.eu/energy/nuclear/radioprotection/publication/099_en.htm) 
The information collected will be kept confidential. 
Serious complications may be associated with any total joint replacement surgery. These complications 
include, but are not limited to: infection, genitourinary disorders, gastrointestinal disorders, vascular 
disorders, including thrombus, bronchopulmonary disorders, including emboli, myocardial infarction and 
death. 
With all implanted devices, asymptomatic, localized progressive bone resorption (osteolysis) may occur 
around the prosthetic components as a consequence of foreign-body reaction to the particulate matter of 
metal or polyethylene (X3, UHMWPE). Particulate is generated by interaction between components as 
well as adhesion, abrasion, and fatigue. Secondarily, particulates can also be generated by third body 
wear. Osteolysis can lead to future complications, including loosening, necessitating the removal and 
replacement of prosthetic components. 
Early and late loosening of total knee components can occur. Early biomechanical loosening may result 
from inadequate initial fixation, latent infection, premature loading of the prosthesis or trauma. Late 
loosening may result from trauma, infection, biological complications including osteolysis or mechanical 
problems, with the subsequent possibility of bone erosion and/or pain. 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
Intraoperative fissure, fracture, or perforation of the femur or tibia can occur due to impaction of the 
component into the prepared femur or tibia. Postoperative femoral or tibial fracture can occur due to 
trauma, the presence of defects, or poor bone stock.  
Metal sensitivity reactions have been reported following joint replacement. 

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Adverse events may necessitate reoperation, revision and in rare cases arthrodesis of the involved joint, 
girdlestone or amputation of the limb.     
8.3. 
Protection Against Risks 
Patients will be treated in the best medical judgment of the investigator, regardless of the study protocol. 
If an investigator must deviate from the written protocol to protect the health or well being of the patient, 
this deviation will be promptly reported to the Ethics Committee and a protocol deviation form shall be 
completed.  
8.4. 
Potential benefits to the Subject 
In addition to the benefits from the primary knee arthroplasty procedure e.g. reduced pain, improved 
range of motion, there is no guarantee that patients will personally benefit from inclusion in this study. 
Patients may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance. This study seeks to provide clinicians information about this 
system/device by comparing this treatment/device to published results for other treatments/devices. 
Information gathered in this study may benefit others undergoing this procedure in the future. 
9. 
Statistical Plan 
9.1. 
Statistical Methods 
Continuous outcome variables and their differences will be analyzed with parametrical statistical 
techniques, such as t-tests, unless the normality assumption does not seem reasonable for the data, in 
which case non-parametric techniques will be considered e.g. Wilcoxon/Mann-Whitney tests. 
Categorical outcome variables will be analyzed with chi-square tests and/or Fisher's exact tests 
(depending on the expected values in the categories). For the relevant parameters (subsidence, survival, 
pain and function) also the 95 percent confidence intervals will be calculated. 
The effect of parameters such as age, sex and operators will be evaluated using multiple variate analysis. 
All data will be analyzed by blinded researchers.  
9.2. Missing Data 
No imputation of missing data will be made. If any questionnaire (e.g., AKSS) has a missing item, the 
total score for that scale will be considered missing. 
9.3. Protocol Deviations 
Any deviation from this protocol will be recorded with an explanation for the deviation and reported to 
Stryker who is responsible for analysing them and assessing their significance. Protocol deviations will be 
reported to the METC according to the local METCs reporting procedures. 
 

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Protocol Deviations for this study include the following:  
· 
Informed consent process is not carried out according to ISO 14155 Part 1. 
· 
Subject enrolled does not meet the inclusion/exclusion criteria. 
· 
Subject is not implanted with study device. 
· 
Subject not seen in the specified follow-up window. 
· 
Surgical protocol not followed. 
 
If the site anticipates a possible protocol deviation, the investigator or study coordinator should contact 
Stryker for guidance. For the examples cited above, it is likely that the patient would be excluded, and a 
Study Termination form completed. 
10. 
Quality Management 
10.1. Study Monitoring Plan 
This investigation will be monitored regularly by monitors appointed by Stryker to review the compliance 
with the clinical investigation plan, ISO 14155 and with applicable regulatory requirements. Proper 
monitoring ensures adequate protection of the rights of human subjects, the safety of subjects involved in 
a clinical investigation and the quality and integrity of data submitted as a result of the investigation. 
 
This study will be monitored depending on the recruitment rate. The first monitoring visit is to take place 
after the recruitment of the first patient and then at least quarterly during the enrolment period and at least 
twice per year during the follow up periods, with additional visits as necessary. The investigator will 
allocate adequate time for such monitoring activities. The Investigator will also ensure that the monitor or 
other compliance or quality assurance reviewer is given access to all study-related documents and study 
related facilities, and has adequate space to conduct the monitoring visit.   
 
The monitor will review the source documents and compare them to the data contained in the case report 
forms, in addition to performing a periodic review of the Investigator Site File. The monitors will need the 
following when they visit: 
· 
An area where they can review records 
· 
Patient case report forms 
· 
Signed Patient Informed Consents 
· 
Source documents (Patient charts, radiographs, etc) 
· 
Investigator Site File 
· 
Time to meet with the study coordinator and the investigator  
Clinical data reports are considered as containing source data and are therefore regarded as confidential 
and available for review only by the sponsor’s authorised representative, clinical investigators and their 
ethics committees or by regulatory authorities if required for audits. 

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The sponsor’s clinical monitor will check data accuracy and quality before taking the case report forms 
and leaving a copy on side. Informed consent and source data relevant to the study are inspected but are 
not be removed from the side. 
10.2. Case Report Forms 
Stryker will provide the Case Report Forms (CRF) (see appendix 2) to the investigators. The investigator 
should ensure the accuracy, completeness, legibility and timelines of the data reported to Stryker in the 
CRFs and in all required reports. 
 
Data reported on the CRF, which is derived from source documents, should be consistent with the source 
documents or any discrepancies should be explained. 
 
All data requested on the CRF must be recorded. All missing data must be explained. If a space on the 
CRF is left blank as a procedure was not performed or the question was not asked, “N/D” should be 
inserted. If the item is not applicable to the individual case, “N/A” should be inserted. All entries should be 
printed legibly in ink. If an error has been made on entering data, corrections should be made by drawing 
a single straight line through the incorrect entry and entering the correct data above it. All such changes 
must be initialled and dated. DO NOT ERASE OR WHITE OUT ERRORS. For clarification of illegible or 
uncertain entries, print the clarification above the item and then initial and date it. 
 
Case report forms should be completed as soon as the information is available, signed by the 
investigator, and be ready for review before the monitor visits the site.  
 
A sample case report form is provided in Appendix 2. 
10.3. Data Management 
Data will be collected (description of process see paragraph 10.1. study monitoring plan) and sent to Data 
Management at Stryker for entry into a database which is held at the Stryker SA offices in Montreux. 
Patient data will be collected, processed and monitored according to the protocol schedule by the clinical 
research group at Stryker. If errors or omissions are identified by Data Management upon receipt, a data 
clarification form (DCF) will be sent to the site for clarification. Completed DCFs should be returned to 
Stryker within two weeks of receipt. 
10.4. Quality Assurance/Audit 
The investigator will permit study-related monitoring, audits and inspections by the IEC/IRB, Stryker 
and/or government regulatory bodies of all study related documents (e.g. source documents, regulatory 
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with ISO 14155 guidelines. The investigator will ensure the capability for inspections of applicable study-
related facilities. 
11. 
Ethical Conciderations 
11.1. International Standards  
This study is to be conducted according to globally accepted standards of ISO 14155, in agreement with 
the “Declaration of Helsinki” (Declaration of Helsinki, October 2002) (see Appendix 8) and in accordance 
with local regulations. 
x 
11.2. Delegation of Investigator Duties 
The investigator should ensure that all persons assisting with the study are adequate qualified, informed 
about the study procedures, any amendments and their study-related duties and functions. 
 
The investigator should maintain a list of co-investigators and other appropriately qualified persons to 
whom he or she has delegated significant study-related duties. 
11.3. Subject Information and Informed Consent 
In accordance with the Declaration of Helsinki all centres must gain written Ethics Committee approval 
prior to enrolling patients in the study. Ethics Committee approval must be gained either from the local 
responsible Ethics Committee at the investigator site or from an adequately constituted (as according to 
ISO14155) independent Ethics Committee. 
11.4. Patient Insurance 
All patients enrolled in this trial are covered by general liability insurance and where required insurance 
according to national regulations is taken out by Stryker. The name address of the relevant insurance 
company, the certificate of insurance, the policy number and the sum insured is provided in the 
Investigator Site File. 
11.5. Personal data protection/Confidentiality 
Stryker affirms and upholds the principle of the patient rights to protection against invasion of privacy. All 
data recorded in the CRFs or data used in further evaluations are coded by patient number, and date of 
birth. In all data analyses the identity of patients will remain anonymous. Anonymous patient data may be 
stored and electronically processed by Stryker 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, Independent Ethics Committee 
(IEC)/Institutional Review Board (IRB) and health authorities will have allowed access to personal medical 
records for the sole purpose of checking the accuracy of data collected in the trial.  

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As such, Stryker will only collect information that is necessary to support the objectives of the clinical trial. 
Stryker will take precautions to ensure that data received is as unidentifiable as possible. If Stryker 
receives information which would allow the identification of a patient, it will ensure that such information 
will be deleted and will not be transferred. Study subjects will authorize Stryker to use their health 
information in support of the clinical trial according to the Informed Consent Process. Should a subject 
choose to withdraw authorization, Stryker may use data collected prior to the withdrawal of authorization 
in order to maintain data integrity.  
The Investigator will maintain a personal subject identification list (i.e. subject numbers with the 
corresponding subject names) to enable records to be identified. 
11.6. 
Legal Approvals, Annual Progress Report and end of Study Report 
11.6.1. Submission of Documents at Study Start 
Before the study starts, the Clinical Investigation Plan, Informed Consent Form and any other applicable 
documents will be submitted to the METC with a cover letter or a form listing the documents submitted 
noting the version dates. If applicable, the documents will also be submitted to the relevant authorities in 
accordance with local regulatory requirements. 
Before the first subject is enrolled in the study, all ethical and legal requirements must be met. 
The investigator must keep a record of all communication with the METC. This also applies to any 
communication between the investigator and the authorities. 
11.6.2 Annual Progress Report 
The principal investigator will submit a summary of the progress of the trial to the accredited METC once 
a year. Information will be provided on the date of inclusion of the first subject, numbers of subjects 
included and numbers of subjects that have completed the trial, serious adverse events/ serious adverse 
reactions, other problems, and amendments.  
11.6.3 End of Study Report 
The principal investigator will notify the accredited METC (and the competent authority) of the end of the 
study within a period of 8 weeks (90 days). The end of the study is defined as the last patient’s last visit.  
In case the study is ended prematurely, the principal investigator will notify the accredited METC (and the 
competent authority within 15 days), including the reasons for the premature termination. 
Within one year after the end of the study, the principal investigator will submit a final study report with the 
results of the study, including any publications/abstracts of the study, to the accredited METC (and the 
Competent Authority). 
12. 
Amendments to the Clinical Investigation Plan 
Amendments are changes made to the clinical investigational plan, after approval from the relevant ethics 
committee.  

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A ‘substantial amendment’ is defined as an amendment to the terms of the ethics committee application, 
or to the protocol or any other supporting documentation that is likely to affect to a significant degree: 
- 
the safety or physical or mental integrity of the subjects in the study, 
- 
the scientific value of the study, 
- 
the conduct or management of the study or 
- 
the quality or safety of any intervention used in the study. 
 
Where necessary, Ethics Committee/Institutional Review Board, competent authorities or the regulatory 
bodies will be informed. 
Non-substantial amendments must not be notified to the accredited ethics committee, but are recorded 
and filed by the sponsor. Examples of non-substantial amendments are typing errors and administrative 
changes like changes in names, telephone numbers and other contact details of involved persons stated 
in the submitted study documentation. 
All amendments to the Clinical Investigation Plan will be agreed between Stryker and the clinical 
investigators. Amendments will be recorded along with a justification for the amendment. 
13. 
Early Termination or Suspension of the Investigation 
At the discretion of Stryker, the entire investigation may be cancelled for medical reasons. In addition, 
Stryker retains the right to end the investigation at any time if the investigation cannot be carried out as 
agreed in the Clinical Investigation Plan or for reasons of significant changes in the company’s business. 
In case of premature termination, Stryker will promptly inform the investigators/institutions. In addition, the 
regulatory authorities and IRBs/IECs will be informed according to the local requirements of the 
termination or suspension and the reason for such termination. 
14. 
Record Retention 
Both administrative and patient related documents are kept by the Sponsor for 15 years after the study 
termination. Administrative and patient data at the clinical investigational site is kept according to site and 
local country regulations. The investigator must obtain approval in writing from the Sponsor before 
destruction of any study records/documentation. 

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15. 
Study Financial Arrangements 
This study is financed by Stryker SA. The financial aspects of the study will be documented in an 
agreement between Stryker SA and the investigator/institution. 
16. 
Publication Policy 
It is anticipated that a publication of the study results will be compiled and submitted to a peer-reviewed 
journal. The primary investigator of the multi-centre study will be chosen by Stryker and will have the 
responsibility of being primary author of such publications.   
 
Each surgeon/investigator shall have publication privileges for their own centre’s results at the completion 
of the study. These manuscripts and abstracts will be delayed until after the multi-centre publication is 
submitted. All publications of the data shall be submitted to Stryker for review at least 60 days prior to 
submission for publication. Stryker shall not edit or otherwise influence the publications other than to 
ensure that confidential information is not disclosed and that the data is accurately represented. 
17. 
List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Anterior-posterior 
ASTM  
American Society for Testing and Materials 
BMI 
Body Mass Index 
CE 
Communauté Européenne 
CR 
Cruciate Retaining 
CRF 
Case Report Form 
DCF 
 
 
 
Data Clarification Form 
EC 
Ethics Committee 
IRB/IEC 
 
 
Institutional Review Board / Independent Ethics Committee 
ISO 
International Organization for Standardization 
KOOS 
Knee Injury and Osteoathritis Outcome Score 
KSS 
Knee Society Score 
LEAS 
Lower Extremity Activity Scale 
METC 
Medisch-ethische toetsingscommissies 
= Medical Research Ethics Committees 
ML 
Mediolateral 
PI 
Primary Investigator 
PS 
Posterior Stabilizing 

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ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SF-36 
Short-Form 36 
THA 
Total Hip Arthroplasty  
TKA 
Total Knee Arthroplasty 
WMO 
Wet medisch-wetenschappelijk onderzoek met mensen  
= Medical Research Involving Human Subjects Act  
WOMAC 
 
 
Western Ontario McMaster Osteoarthritis Index 
18. 
References 
1. Blake , G.M. et al. (1996). New generation Dual X-ray absorptiometry scanners increase radiation 
dose to patients and staff. J Bone Min Res 11: 267. 
2. Ewald,F.C.: The Knee Society total knee arthroplasty roentgenographic evaluation and scoring 
system. Clinical Orthopaedics and Related Research. 248: 9-12, 1989. 
3. Garling, E.H., Valstar, E.R. and Nelissen, R.G.G.H.: Comparison of micromotion in mobile bearing 
and posterior stabilized total knee prostheses. Acta Orthopaedics. 76, (3) 353-361, 2005b. 
4. Hurschler C, Seehaus F, Emmerich J, Kaptein BL. Accuracy and precision of a model-based RSA 
technique for measuring implant migration. J Biomech 2006; 39 Suppl 1: S129. 
5. Insall,J.N., Dorr,L.D., Scott,R.D. and Scott,W.N.: Rationale of the Knee Society clinical rating 
system. Clinical Orthopaedics and Related Research. 248: 13-14, 1989. 
6. Kaptein BL, Valstar ER, Stoel BC, Rozing PM, Reiber JH. A new model-based RSA method 
validated using CAD models and models from reversed engineering. J Biomech 2003; 36(6): 873-
882. 
7. Kärrholm, J. (1989). Roentgen stereophotogrammetry. Review of orthopaedic applications. Acta 
Orthop Scand: 491-503. 
8. Kärrholm, J., Borsen, B., Löwenhielm, B. & Snorrason, F. (1994). Does early migration of femoral 
stem prostheses matter? 4-7 year stereoradiographic follow-up of 84 cemented prostheses. J 
Bone Joint Surg 76b: 912-917. 
9. Kellett CF, Short A, Price A, Gill HS, Murray DW. In vivo measurement of total knee replacement 
wear. Knee 2004;11(3):183-7. 
10. LUMC (1999). Determination of radiation dose in RSA radiographs. Internal study. 
11. Puloski SK, McCalden RW, MacDonald SJ, Rorabeck CH, Bourne RB. Tibial post wear in 
posterior stabilized total knee arthroplasty. An unrecognized source of polyethylene debris. J Bone 
Joint Surg [Am] 2001; 83-A(3): 390-397. 
12. Robertsson O. Knee arthroplasty registers. J Bone Joint Surg 2007; 89-B: 1-4. 
13. Ryd, L., Albrektsson, B.E.J., Carlsson, L., Dansgård, F., Herberts, P.,Lindstrand, A., Regner, L. & 
Toksvig-Larsen, S. (1995). Roentgen stereophotogrammetric analysis as a predictor of 
mechanical loosening of knee prostheses. J bone Joint Surg 77(B): 377-383. 
14. Short A, Gill HS, Marks B, Waite JC, Kellett CF, Price AJ, et al. A novel method for in vivo knee 
prosthesis wear measurement. J Biomech 2005;38(2):315-22 
15. Selvik, G. (1989). Roentgensterophotogrammetric method for the study of the kinematics of the 
skeletal system. Acta Orthop Scand 60 (suppl 232). 
16. Stern, S.H., Insall, J.N. (1992). Posterior stabilized prosthesis: results after follow-up of nine to 
twelve years. J Bone Joint Surg 74A: 980-991. 

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17. Teeuwisse, W., Berting, R. & Geleijns, J. (1998). Stralenbelasting bij orthopediscje radiologie. 
Gamma 8/9: 197-200. 
18. Valstar,E.R., Gill,R., Ryd,L., Flivik,G., Borlin,N., and Karrholm,J.: Guidelines for standardization of 
radiostereometry (RSA) of implants.  Acta Orthopaedics. 76:563, 2005. 
19. Vrooman, H.A., Valstar, E.R., Brand, G., Admiraal, D., Rozing, P.M. & Reiber, H.C. (1998). Fast 
accurate automated measurement in digitized stereophotogrammetric radiographs. J Biomech 31: 
491-498. 
19. 
Appendices 
Appendix 1 
Contact Details 
Appendix 2 
Patient Information and Informed Consent 
Appendix 3 
Case report Form 
 
Appendix 1: Contact Details 
Sponsor (Project management / monitoring) 
 
Principle investigator 
 
 
 
 
 
 
 
 
 
Eric H. Garling, PhD 
Clinical Research Manager 
Stryker GmbH & Co KG 
Dr.-Homer-Stryker-Platz 1 
D-47228 Duisburg 
Fon:       +13 (0) 646713518 
Fax:       +49 (0) 2065/837 419 
E-mail:    eric.garling@stryker.com 
 
 
Annemarieke van Dam 
Clinical Research Associate 
Stryker Nederland 
Koeweistraat 8 
4181 CD Waardenburg 
the Netherlands 
Phone: +31 (0) 418569813 
Mobile: +31 (0) 622741602 
Fax:     +31 (0) 418 569 777 
E-mail:   annemarieke.vandam@stryker.com 
 
 
 
 
H. Kaptijn, MD 
Department of Orthopaedics  
‘t Langeland Ziekenhuis Zoetermeer