Scorpio NRG Prospective, Open-label, Post-market International Multicentre Outcome Study
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics

CONFIDENTIAL 
 
Protocol #: K-S-002 (SLCRG-001-2007) 
Stryker SA 
Page 1 of 30 
Version 1.3: 2019-01-09 
 
CLINICAL PROTOCOL 
 
 
 
 
TITLE: 
Scorpio NRG® prospective, open-label, post-market international 
multicentre outcome Study  
 
 
 
Protocol #: 
K-S-002 (previous protocol #: SLCRG-001-2007) 
 
NCT#:  
NCT02524730  
 
Version Date: 
2nd Amendment version 1.3 
2019JAN09 
 
 
 
Sponsor: 
Stryker Orthopaedics 
 
325 Corporate Drive 
 
Mahwah, NJ 07430 
 
USA 
 
 
 
 
Local Sponsor 
Representative: Stryker European Operations B.V. 
Herikerbergweg 110 
Amsterdam Zuidoost  
The Netherlands 
 
 
 
 
Confidentiality Statement 
 
This Clinical Investigation Plan contains confidential and proprietary information about a device 
provided by Stryker, for the exclusive use of the Investigator. This information may not be 
disclosed to any other person without the prior written approval of Stryker. 

CONFIDENTIAL 
 
       Protocol #: K-S-002 (SLCRG-001-2007) 
Stryker SA (UPDATE) 
Page 2 of 30 
Version 1.3: 2019-01-09 
 
Protocol Change History 
 
Version 
Description 
Reason 
Changed by 
1.2 
Add EQ-5D 
Introduced as a standard 
quality of life evaluation tool 
Britta von den 
Brincken 
1.2 
Add Exclusion criterion #17 
Severe deformities: 
varus/valgus deformity >10° 
(mech. axis), bowed femur 
>20°, flexion contracture 
>10° 
Requested by Chief 
investigator 
1.3 
Change protocol number 
from SLCRG-001-2007) to 
K-S-002  
Align with general 
nomenclature of European 
Clinical Investigations 
Britta von den 
Brincken 
1.3 
Change Sponsor 
Responsible 
Study is now conducted by 
Stryker Orthopaedics 
Mahwah USA; local 
representative is European 
Operations B.V. 
1.3 
Delete Chief investigator’s 
agreement from signature 
page  
Now covered by the 
contract 
1.3 
Replace ISO14155 Part1 
and Part 2 by ISO14155-
GCP 
All Clinical procedures have 
been updated to ISO14155-
GCP 
1.3 
Remove x-ray analysis from 
objectives 
x-rays will not be analysed 
1.3 
Update section 1.3 Clinical 
data to date 
Interim report December 
2014 available 
1.3 
Terminate study after a 
minimum of 5 years follow-
up for each case (already 
completed 7 years patient 
follow-up will be included in 
the analysis) 
Significant changes in the 
company’s business as per 
section 13 of this procedure 
1.3 
Update responsible roles 
and contact details 
Changes in study 
management and 
procedures 
1.3 
Replaced detailed reporting 
time lines to EC/IRB by “as 
requested by the 
responsible Ethic 
Commission” 
Different requirements by 
ECs/IRBs as notified in 
approval letter. 

CONFIDENTIAL 
 
       Protocol #: K-S-002 (SLCRG-001-2007) 
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Version 1.3: 2019-01-09 
 
1.3 
In section 11 “Personal data 
protection/Confidentiality” 
 The term “anonymized” was 
replaced by 
“pseudonymized”  
Align with General data 
protection regulation  
 
Delete Appendices 
- Patient Information Sheet 
and Informed Consent 
Form  
- Sample Case Report Form 
- Guide to completing CRFs 
- Tables of chemical 
composition 
 
Documents available in 
Trial master file and 
Investigation site files 
 
 
 
 
Table of Contents 
STUDY SUMMARY ...................................................................................................................................... 5 
CLINICAL PROTOCOL PLAN SIGNATURE PAGE ................................................................................... 8 
CONTACT INFORMATION .......................................................................................................................... 9 
1. 
PRELIMINARY INVESTIGATIONS AND JUSTIFICATION OF THE STUDY .................................. 10 
1.1. 
BACKGROUND .............................................................................................................................. 10 
1.2. 
DEVICE DESCRIPTION ................................................................................................................... 11 
1.3. 
CLINICAL DATA TO DATE............................................................................................................... 12 
2. 
OBJECTIVES OF THE CLINICAL INVESTIGATION ....................................................................... 12 
3. 
DESIGN OF THE CLINICAL INVESTIGATION ................................................................................ 12 
3.1. 
STUDY DESIGN ............................................................................................................................ 12 
3.2. 
NUMBER OF CENTERS .................................................................................................................. 12 
3.3. 
NUMBER OF SUBJECTS ................................................................................................................. 13 
3.4. 
ESTIMATED STUDY DURATION ...................................................................................................... 13 
4. 
ELIGIBILITY ....................................................................................................................................... 13 
4.1. 
INCLUSION CRITERIA .................................................................................................................... 13 
4.2. 
EXCLUSION CRITERIA ................................................................................................................... 13 
4.3. 
DISCONTINUATION AND WITHDRAWAL OF SUBJECTS ...................................................................... 14 
5. 
SUBJECT ENROLMENT ................................................................................................................... 15 
5.1. 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 15 
5.2. 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 15 
5.3. 
TREATMENT ASSIGNMENT ............................................................................................................ 16 
5.4. 
RANDOMIZATION PROCEDURES AND UNBLINDING .......................................................................... 16 
5.5. 
SUPPLIES/DEVICE ACCOUNTABILITY .............................................................................................. 16 
6. 
EVALUATIONS .................................................................................................................................. 17 
6.1. 
SURGICAL PROCEDURE ................................................................................................................ 18 
6.2. 
FUNCTIONAL EVALUATION ............................................................................................................ 18 
6.3. 
PATIENT ASSESSMENT EVALUATIONS ............................................................................................ 18 

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7. 
ADVERSE EVENTS ........................................................................................................................... 19 
7.1. 
DEFINITIONS ................................................................................................................................ 19 
7.2. 
RECORDING OF ADVERSE EVENTS ................................................................................................ 20 
7.2.1. Intensity ................................................................................................................................. 20 
7.2.2. Relationship ........................................................................................................................... 20 
7.3. 
REPORTING OF SERIOUS ADVERSE EVENTS AND ADVERSE DEVICE EVENTS ................................... 21 
7.3.1. Study Sponsor Notification by Investigator ........................................................................... 21 
7.3.2. EC Notification by Investigator .............................................................................................. 21 
7.4. 
PERIOD OF OBSERVATION ............................................................................................................ 21 
7.5. 
MEDICAL MONITORING ................................................................................................................. 21 
8. 
RISK ASSESSMENT ......................................................................................................................... 22 
8.1. 
RISK CATEGORY .......................................................................................................................... 22 
8.2. 
POTENTIAL RISK .......................................................................................................................... 22 
8.3. 
PROTECTION AGAINST RISKS........................................................................................................ 22 
8.4. 
POTENTIAL BENEFITS TO THE SUBJECT.......................................................................................... 23 
9. 
STATISTICAL PLAN ......................................................................................................................... 23 
9.1. 
STATISTICAL METHODS ................................................................................................................ 23 
9.2. 
MISSING DATA ............................................................................................................................. 23 
9.3. 
PROTOCOL DEVIATIONS ............................................................................................................... 23 
10. QUALITY MANAGEMENT ................................................................................................................ 24 
10.1. 
STUDY MONITORING PLAN ............................................................................................................ 24 
10.2. 
CASE REPORT FORMS.................................................................................................................. 24 
10.3. 
DATA MANAGEMENT ..................................................................................................................... 25 
10.4. 
QUALITY ASSURANCE/AUDIT ......................................................................................................... 25 
11. ETHICAL CONSIDERATIONS .......................................................................................................... 25 
11.1. 
INTERNATIONAL STANDARDS ........................................................................................................ 25 
11.2. 
DELEGATION OF INVESTIGATOR DUTIES ........................................................................................ 25 
11.3. 
SUBJECT INFORMATION AND INFORMED CONSENT ......................................................................... 25 
11.4. 
PATIENT INSURANCE .................................................................................................................... 26 
11.5. 
PERSONAL DATA PROTECTION/CONFIDENTIALITY ........................................................................... 26 
11.6. 
LEGAL APPROVALS ...................................................................................................................... 26 
12. AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN.......................................................... 27 
13. EARLY TERMINATION OR SUSPENSION OF THE INVESTIGATION ........................................... 27 
14. RECORD RETENTION ...................................................................................................................... 27 
15. STUDY FINANCIAL ARRANGEMENTS ........................................................................................... 28 
16. PUBLICATION POLICY .................................................................................................................... 28 
17. LIST OF ABBREVIATIONS ............................................................................................................... 28 
18. REFERENCES ................................................................................................................................... 29 
APPENDIX 1 ............................................................................................................................................... 30 
 
 
 
 

CONFIDENTIAL 
 
       Protocol #: K-S-002 (SLCRG-001-2007) 
Stryker SA (UPDATE) 
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STUDY SUMMARY 
 
Title 
Scorpio NRG® prospective, open-label, post-market international 
multicentre outcome Study 
Protocol 
Number 
K-S-002 (previous protocol number SLCRG-001-2007) 
Phase 
Post-marketing 
Sponsor 
Stryker Orthopaedics Mahwah, USA 
Study 
design 
Prospective, open-label, international 
Study 
Duration 
12 months enrolment period + up to a minimum of 5 years follow-up for each 
case  
= ~ 6 years total duration. 
Study 
Centre(s) 
5 
Objectives 
To collect basic function and patient satisfaction data for observation and 
analysis. 
Specific objectives include the following: 
Evaluate the effect of component design on functional performance by 
comparing postoperative Knee Society Scores with preoperative.  
Evaluate the effect of component design on patient activity by comparing 
postoperative Lower Extremity Activity Scale (LEAS) with preoperative. 
Evaluate patient satisfaction using SF-36® Health Survey. 
Evaluate quality of life using Knee Injury and Osteoathritis Outcome Score 
(KOOS) and EuroQol 5D (EQ-5D). 
Primary 
endpoint 
Survival (revision rate) 
Indication 
Primary total knee replacement 
Study 
device / 
control 
device 
Scorpio NRG® Total Knee System 
Number of 
Subjects 
250 Patients (Competitive recruitment) 

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       Protocol #: K-S-002 (SLCRG-001-2007) 
Stryker SA (UPDATE) 
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Inclusion and 
Exclusion 
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)    The subject is a male or non-pregnant female between 40 and 75 years of 
age. 
3) The subject requires a primary total knee replacement. 
4) Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid 
arthritis) 
5) The subject has intact collateral ligaments. 
6) The subject is willing and able to comply with postoperative scheduled 
clinical and radiographic evaluations and rehabilitation. 
7) The subject is capable of understanding the patient scores in the national 
language. 
 
Exclusions: 
1) The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 
2) The subject has a history of total or unicompartmental reconstruction of the 
affected joint. 
3) The subject will be operated bilaterally. 
4) 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).  
5) Patients who had a Total Knee Arthroplasty (TKA) on contralateral side 
within the last year that is considered to have an unsatisfactory outcome. 
(Patients with contralateral TKA > 1 year ago with good outcome can be 
included in the study). 
6) Patients who will need lower limb joint replacement for another joint within 
one year. 
7) The subject has had a high tibial osteotomy or femoral osteotomy. 
8) The subject has a neuromuscular or neurosensory deficiency, which would 
limit the ability to assess the performance of the device. 
9) The subject has a systemic or metabolic disorder leading to progressive 
bone deterioration. 
10) The subject is immunologically suppressed or receiving steroids in excess 
of normal physiological requirements. 
11) The subject’s bone stock in compromised by disease or infection which 
cannot provide adequate support and/or fixation to the prosthesis. 
12) The subject has had a knee fusion to the affected joint. 
13) The subject has an active or suspected latent infection in or about the 
knee joint. 
14) Proven or suspected hypersensitivity to one or more than one of the 
device materials. 
15) Female patients planning a pregnancy during the course of the study. 
16) The subject is a prisoner. 
17)  Severe deformities: varus/valgus deformity >10° (mech. axis), bowed   
       femur >20°, flexion contracture >10° 

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Patient evaluations will be performed according to the schedule below: 
 
Table 1 – Evaluation schedule 
Evaluation 
Pre-
OP 
Intra-
OP 
Prior to  
dis-
charge 
3 
months 
(± 
3 
weeks) 
1 year 
(± 
2 
months) 
3 years 
(± 
2 
months) 
5 years 
 (± 
3 
months) 
7 
years** 
 (± 
3 
months) 
Demographics 
x 
 
 
 
 
 
 
 
Medical history 
x 
 
 
 
 
 
 
 
Clinical 
evaluation 
x 
 
x 
x 
x 
x 
x 
x 
Surgical details 
 
x 
 
 
 
 
 
 
KSS 
x 
 
 
x 
x 
x 
x 
x 
Lower Extremity 
Activity Scale 
x 
 
 
x 
x 
x 
x 
x 
KOOS 
x 
 
 
 
x 
 
x 
x 
SF-36 
x 
 
 
x 
x 
x 
x 
x 
EQ-5D 
x 
 
 
x 
x 
x 
x 
x 
*Radiographs: 
ap, lateral 
x 
 
x 
 
x 
 
x** 
x 
*Radiograph: 
merchant view 
x 
 
 
x 
 
 
 
 
*Radiograph:  
long leg 
x 
 
 
x 
 
 
 
 
*Radiographs will not go into analysis 
**optional  

CONFIDENTIAL 
 
       Protocol #: K-S-002 (SLCRG-001-2007) 
Stryker SA (UPDATE) 
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Version 1.3: 2019-01-09 
 
 
 
CLINICAL PROTOCOL PLAN SIGNATURE PAGE 
 
 
TITLE: 
Scorpio NRG® prospective, open-label, post-market international 
multicentre outcome Study. 
 
Protocol #: 
K-S-002 
 
Version Date: 
2nd Amendment, Version 1.3 
2019JAN09 
 
 
 
I confirm correctness of my 
signature from 2019FEB18 
 
 
 
 
 
 
 
 
 
I confirm correct ness of my 
signature from2019Feb19 
 
 
 
 
 
 
 
 
 
 
I confirm correctness of my 
signature from 2019FEB19 
 
 
 
 
 
 
 
 
 
 

CONFIDENTIAL 
 
       Protocol #: K-S-002 (SLCRG-001-2007) 
Stryker SA (UPDATE) 
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Version 1.3: 2019-01-09 
 
 
 
 
 
 
 
CONTACT INFORMATION 
 
 
 
 
Study Sponsor: 
Stryker Orthopaedics 
 
 
 
 
325 Corporate Drive 
 
 
 
 
Mahwah, NJ 07430 
 
USA  
 
Contact: 
 
Britta von den Brincken 
  
 
Clinical Study Manager 
  
 
Stryker GmbH & Co KG  
Dr.-Homer-Stryker-Platz 1 
47228 Duisburg 
Germany 
  
 
 
  
 
Mobile: 0049 (0)1638999202 
  
 
Britta.vondenBrincken@stryker.com 
 
 
Danielle Campbell 
  
 
Manager, Clinical Research  
 
 
 
Orthopaedics – Joint Replacement 
325 Corporate Drive 
Mahwah, NJ 07430 
USA 
 
Phone: 001 201-831-5498  
Mobile: 001 717-676-2589 
Fax: 
001 201-831-4498 
Danielle.Campbell@stryker.com 
 
 
  
 
 
 
 
 
 
 
 
 
 

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       Protocol #: K-S-002 (SLCRG-001-2007) 
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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-GCP, and the applicable regulatory 
requirements. 
1.1. Background 
This document is a protocol for a clinical outcome study. This study will be conducted in 
compliance with the protocol, Good Clinical Practice Guidelines, associated regulations and all 
applicable research requirements. 
Today total knee joint replacements are routinely implanted with total knee arthroplasty being 
one of the most successful joint reconstructions. The number of total knee replacements is 
rising worldwide, and patients are increasingly younger at the time of implantation. The 
developments of the implant design, as well as the improvement of instruments, over the last 
decades enable sound and reliable results. With increasing success of joint replacement and 
decreasing age of patients, the expectations of total knee arthroplasty are constantly on the rise. 
Patients anticipate reduced painkiller, long lifetime of the implant with high functionality and a 
great range of motion to carry out daily activities and sports. Apart from regaining a lifestyle 
without major knee pain, some cultural and religious aspects (e.g. kneeing while praying) where 
deep flexion is required, are a challenge for modern knee-systems. 
The Scorpio NRG® Knee System has been designed with these activities in mind. Scorpio 
NRG® has a greater internal and external rotational freedom throughout the full range of motion 
when compared to other modern knee replacement designs. Traditional insert designs utilize a 
less functional partial rotary arc, thus limiting the overall kinematic function of the knee. The 
Scorpio NRG® tibial insert’s articulating surface uses a Spherical Arc motion in order to realize 
greater freedom. By combining a single M/L radius and a Spherical Arc, Scorpio NRG® allows 
for greater rotational freedom without restricting the tibio-femoral contact area. Freedom of 
rotation is one of the most essential factors in the design of a successful total knee replacement, 
thus allowing the patient’s ligaments to govern motion of the knee. 
Furthermore, the component design can contribute to patient’s activity level by providing joint 
stability and improved function. While traditional knee implants are designed with several axes 
of rotation that may create mid-flexion instability during the transition between radii, a single axis 
and single radius design can provide consistent collateral ligament isometry and stability 
throughout the range of motion. 
In this outcome study of the Scorpio NRG® knee system, we expect improvement of a patient’s 
lifestyle and activities. This study evaluates patients for five (optional seven) years post-surgery. 
The focus of this study is to evaluate the effect of component design on functional performance 
and the patient’s satisfaction. Thus, the Knee Society Score and the SF-36 is used. Further 
measures being used include the comparative postoperative with preoperative Lower Extremity 
Activity Scale (LEAS), Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol 5D 
(EQ-5D) to evaluate the quality of life. 

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1.2. Device Description 
The Scorpio NRG® Knee System has been CE marked in Europe. This evaluation is therefore 
considered a post marketing assessment. 
In this clinical study, all patients will have the femoral, tibial tray and optional patellar 
components implanted with bone cement. The Scorpio NRG® Femoral component will be 
available in Cruciate Retaining (CR) style combined with Scorpio NRG® CR Tibial insert, 
respectively. In all cases the Scorpio NRG® femoral and tibia inserts will be used in combination 
with the Tibia Baseplate from the Scorpio® Knee System. A patella component from the 
Scorpio® Knee System is optional. The components are described below. 
FEMORAL COMPONENT: 
The Scorpio NRG® femoral components are manufactured from cobalt chromium alloy (ASTM 
F75) and are available in left and right configurations. The interior surface of the components 
contains a waffle pattern for the cement interface. 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. The femoral components are available in 9 proportional sizes 3, 
4, 5, 6, 7, 8, 9, 11 and 13 (see product brochure). 
The Scorpio NRG® CR: Intended for use in combination with the Scorpio NRG® cruciate 
retaining tibial inserts and the Scorpio® Total Knee System patella components. 
TIBIAL 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 
(X3) polyethylene inserts are to be used in all study patients. A proprietary rotary machining 
process used on the articulating surface of the tibial insert provides for improved rotation of 
components. In keeping with the design theory, the tibial insert component employs a single 
medial-lateral radius. 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. 
TIBIAL BASEPLATE: 
The cemented Scorpio® Primary Knee System Tibial Baseplate is to be used in all study cases. 
The baseplate is manufactured from cobalt-chromium alloy. The Scorpio® Primary Tibial 
Baseplate is neutral in configuration, and is available in eight proportional sizes (3, 4, 5, 6, 7, 9, 
11, 13). The undersurface of the tibial tray has a waffle structure and is designed for use with 
PMMA bone cement.  The keel of the tibial tray is designed with normalizations for rotational 
stability and cement interdigitation.    
PATELLAR 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 superior/inferior 
medialized offset of 1,5mm.  
- medialized dome patella 
- concentric dome patella 
- universal dome patella 

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INSTRUMENTATION: 
No new instruments have been designed for use with the Scorpio NRG® System. These 
components will use the currently existing Scorpio Total Knee System instrumentation. The 
only exception is the development of the femoral and tibial insert trials that have the same 
geometry as the implants. 
1.3. Clinical Data to Date 
As of the interim analysis completed in December 2014, 220 patients were included across 5 
centres between May 2009 and December 2013. The mean age, height and weight were 65.3 
years, 171.4 cm and 87.9 kg, respectively. All patients received a Scorpio NRG Total Knee 
System. 
The mean assessment and functional components of the Knee Society Score were 57.6 and 
61.7 pre-operatively compared to 83.6 and 88.7 at the 1-year follow-up, respectively. Patient 
scores including the LEAS, KOOS, SF-36 and EQ5D showed an increase between the pre- 
operative visit and 1-year follow-up visit. There were three prosthesis revisions reported during 
the first year of follow-up and three patients have decided to withdraw from the trial. This 
analysis was carried out in the early stages of follow-up, so it is not possible to draw any 
conclusions about the performance of the prosthesis in this report.  
Overall, the patient group showed improved clinical results in early follow-up.  
 
2. Objectives of the Clinical Investigation 
 
The objective of this study is to collect basic function and patient satisfaction data for 
observation and analysis. 
Specific objectives include the following: 
- 
Evaluate the effect of component design on functional performance by comparing 
postoperative Knee Society Scores with preoperative.  
- 
Evaluate the effect of component design on patient activity by comparing postoperative 
Lower Lower Extremity Activity Scale (LEAS) with preoperative. 
- 
Evaluate patient satisfaction using SF-36® Health Survey. 
- 
Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and 
EuroQol 5D (EQ-5D). 
 
3. Design of the Clinical Investigation 
3.1. Study Design 
A prospective, open-label design will be employed. The study is international and multicentre. 
3.2. Number of Centers 
Cases will be enrolled in up to 5 centres in Europe. See also Appendix 1 Investigator Contact 
List. 

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3.3. Number of Subjects 
A total of 250 patients will be enrolled in the study. A competitive recruitment system will be 
used, meaning patients will be enrolled in all sites until the 250 patients have been recruited. 
Enrollment into the study will be stopped when the planned number of patients has been 
reached between all the study sites (a competitive recruitment system). In the ideal case, this is 
50 patients per centre; however, there is no minimum and no maximum number of study 
patients per site. 
3.4. Estimated Study Duration  
The enrolment period is estimated to be 12 months. Cases will be evaluated as per the 
evaluation schedule (Table 1) with follow-up up to a minimum of five years, giving total study 
duration of approximately six years minimum. 
Subjects will be evaluated preoperatively and at follow-up intervals of three months, six months, 
one year, three years, five years and an optional seven years.  
 
4. Eligibility 
 
The following criteria will be used to distinguish patients eligible for enrolment into this study. 
4.1. Inclusion Criteria 
Subjects meeting all the following criteria will be eligible to be enrolled in the study: 
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. 
The subject is a male or non-pregnant female between 40 and 75 years of age. 
3. 
The subject requires a primary total knee replacement. 
4. 
Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis) 
5. 
The subject has intact collateral ligaments. 
6. 
The subject is willing and able to comply with postoperative scheduled clinical and 
radiographic evaluations and rehabilitation. 
7. 
The subject is capable of understanding the patient scores in the national language. 
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. 
The subject has a history of total or unicompartmental reconstruction of the affected joint. 
3. 
The subject will be operated bilaterally. 
4. 
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 

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contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the 
study). 
5. 
Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last year 
that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 1 
year ago with good outcome can be included in the study). 
6. 
Patients who will need lower limb joint replacement for another joint within one year. 
7. 
The subject has had a high tibial osteotomy or femoral osteotomy. 
8. 
The subject has a neuromuscular or neurosensory deficiency, which would limit the ability 
to assess the performance of the device. 
9. 
The subject has a systemic or metabolic disorder leading to progressive bone 
deterioration. 
10. 
The subject is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements. 
11. 
The subject’s bone stock in compromised by disease or infection which cannot provide 
adequate support and/or fixation to the prosthesis. 
12. 
The subject has had a knee fusion to the affected joint. 
13. 
The subject has an active or suspected latent infection in or about the knee joint. 
14. 
Proven or suspected hypersensitivity to one or more than one of the device materials. 
15. 
Female patients planning a pregnancy during the course of the study. 
16. 
The subject is a prisoner. 
17. 
Severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur >20°, flexion 
contracture >10° 
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.  
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: 
• 
Serious Adverse Event  
• 
Patient Withdrawal 
• 
Revision/Removal of study device 
• 
Lost to Follow-Up 
• 
If, in the Investigator’s opinion, continuation in the study would be detrimental to the 
subject’s wellbeing. 
• 
At the specific request of the Sponsor 
• 
Completion of study and final evaluation 
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 

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through three documented phone calls. If 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. 
5. Subject Enrolment 
5.1. Subject Recruitment and Screening 
Patients will be recruited at the study sites during preoperative visits through normal referral 
practice. 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. 
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. 
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. 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  

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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. 
All patients receive information about the limitation of the study duration to five, optional 7 years. 
5.3. Treatment Assignment 
All subjects enrolled in this study are assigned to receive the Scorpio NRG Total Knee System.  
5.4. Randomization Procedures and Unblinding 
This study will enrol under a non-randomized study design. 
5.5. 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. 

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6. Evaluations 
 
Subjects will be evaluated preoperatively and at follow-up intervals of three months, one year, 
three years, five years and an optional seven years (see Tables 1 and 2). Each subject will be 
followed for a minimum of five years post-implantation. All subject evaluations will be 
documented by completion of appropriate Case Report Forms. 
Table 2 – Evaluation schedule (functional and patient assessment) 
Evaluation 
Pre-
OP 
Intra-
OP 
Prior to  
dis-
charge 
3 
months 
(± 3 
weeks) 
1 year 
(± 2 
months) 
3 years 
(± 2 
months) 
5 years 
(± 3 
months) 
7 
years** 
(± 3 
months) 
Demographics 
x 
 
 
 
 
 
 
 
Medical history 
x 
 
 
 
 
 
 
 
Clinical 
evaluation 
x 
 
x 
x 
x 
x 
x 
x 
Surgical details 
 
x 
 
 
 
 
 
 
KSS 
x 
 
 
x 
x 
x 
x 
x 
Lower Extremity 
Activity Scale 
x 
 
 
x 
x 
x 
x 
x 
KOOS 
x 
 
 
 
x 
 
x 
x 
SF-36 
x 
 
 
x 
x 
x 
x 
x 
EQ-5D 
x 
 
 
x 
x 
x 
x 
x 
*Radiographs: 
ap, lateral 
x 
 
x 
 
x 
 
x** 
x 
*Radiograph: 
merchant view 
x 
 
 
x 
 
 
 
 
*Radiograph:  
long leg 
x 
 
 
x 
 
 
 
 
*Radiographs will not go into analysis 
**optional  
 
Basic demographic and medical history information are 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. 

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6.1. Surgical Procedure 
Standard, accepted surgical procedures for total knee arthroplasty will be utilized. The specific 
surgical procedure performed at each 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. Functional Evaluation  
All subjects participating in the study are to be evaluated functionally utilizing the KSS, LEAS, 
KOOS, and EQ-5D preoperatively and at each protocol specified follow-up interval (see Table 
2).  Clinical assessment is based on an evaluation of pain and function. 
Specific parameters include: 
• 
Pain intensity 
• 
Range of motion 
• 
Stability 
• 
Anatomic alignment 
• 
Walking/standing ability 
• 
Stair climbing ability 
• 
Use of walking aids 
To allow for accurate measurement of the range of motion a goniometer should be used. It is of 
particular importance that a sterile goniometer is used during the surgery to measure the 
intraoperative range of motion.  
6.3. Patient Assessment Evaluations  
Data will be obtained from the subjects with the use of standard health status questionnaires. 
The SF-36 is designed to measure overall evaluation of health, functional status and wellbeing 
from the subject’s perspective. The LEAS is designed to measure patient activity. The patient’s 
quality of life will be measured by the KOOS and EQ-5D. Subjects will be asked to complete the 
questionnaires preoperatively and at each follow-up evaluation interval specified in the protocol 
(see Table 2). 
 

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7. Adverse Events 
7.1. 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” 
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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7.2. 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 
7.2.1. 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. 
7.2.2.  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 causal 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 causal 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 occurrence/worsening of the AE a plausible causal chain may be deduced from the 

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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.   
7.3. Reporting of Serious Adverse Events and Adverse Device Events 
7.3.1.  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 the Clinical Study Manager and the site specific 
responsible CRA. 
7.3.2.  EC Notification by Investigator 
Reports of serious adverse events - including follow-up information - must be 
submitted to the Ethics Committee (EC) as requested by the responsible Ethic 
Commission. Copies of each report and documentation of EC notification and 
receipt will be kept in the Investigator Site File and also in the study Master File.  
7.4. 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. 
7.5. 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 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 routine 
x-rays. 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 ultra-high molecular weight polyethylene (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. 
Adverse events may necessitate reoperation, revision and in rare cases arthrodesis of the 
involved joint, girdle stone 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 
wellbeing of the patient, this deviation will be promptly reported to the Ethics Committee and a 
protocol deviation form shall be completed.  

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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 
Descriptive statistics will be computed for all baseline conditions and demographic parameters. 
For parameters represented by continuous variables (e.g., ROM), the summaries will consist of 
the mean, median, standard deviation, minimum, and maximum values. For categorical 
variables, the number and percent in each category will be presented. If appropriate, the data 
will be presented by appropriate subgroups (e.g., centre, gender). Descriptive statistics and 
statistical comparisons for important demographic, efficacy, and safety variables will be 
provided in tables. 
A survival analysis will be performed to according to the number of revision surgeries. 
9.2. 
Missing Data 
No imputation of missing data will be made. If any questionnaire (e.g., KSS) 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 IEC/IRB according to the local IEC/IRB’s reporting 
procedures. 
Protocol Deviations for this study include the following:  
• 
Informed consent process is not carried out according to ISO 14155 
• 
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. 
 

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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, radio graphs, 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. 
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) 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, 

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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.  
10.3. Data Management 
Data will be collected at each site (description of process see paragraph 10.1. study monitoring 
plan) involved in the study and sent to Data Management at Stryker for entry into a database. 
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 documents, data collection instruments, study data etc.). Procedures will 
be followed in order to comply with ISO 14155 guidelines. The investigator will ensure the 
capability for inspections of applicable study-related facilities. 
 
11. Ethical Considerations 
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” and in accordance with local regulations. 
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. 

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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 
are 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. In all data analyses the identity of patients will remain pseudonymous. Pseudonymised 
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 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.  
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. 
All patients remaining in the study receive information regarding data protection according to EU 
2016/679 General Data Protection Regulation. 
11.6. Legal Approvals 
Before the study starts, the Clinical Investigation Plan, Informed Consent Form and any other 
applicable documents will be submitted to the IEC/IRB 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 IEC/IRB. This also applies to 
any communication between the investigator and the authorities. 
The investigator shall submit progress reports, annual reports and a final report to the 
responsible ethics committee, as required by the local IEC/IRB’s reporting procedures.  
 

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12. Amendments to the Clinical Investigation Plan 
 
Amendments are changes made to the clinical investigational plan, after approval from the 
relevant ethics committee.  
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 two 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 
 
The local sponsor representative Stryker European Operations B.V. holds contracts with the 
medical institutions of the investigation sites on behalf of the Sponsor Stryker Orthopaedics 
Mahwah, USA. The financial aspects of the study will be documented in an agreement between 
Stryker European Operations B.V. 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 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
DCF 
 
 
 
Data Clarification Form 
EC 
Ethics Committee 
EQ-5D 
EuroQol 5D questionnaire  
IRB/IEC 
 
 
Institutional Review Board / Independent Ethics Committee 
 

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ISO 
International Organization for Standardization 
KOOS 
Knee Injury and Osteoathritis Outcome Score 
KSS 
Knee Society Score 
LEAS 
Lower Extremity Activity Scale 
ML 
Mediolateral 
PI 
Primary Investigator 
PS 
Posterior Stabilizing 
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 
 
18. References 
 
 
1. World Medical Association Declaration of Helsinki. Ethical Principles for Medical 
research involving Human Subjects. 2002 
 
2. Clinical Investigation of Medical Devices for Human Subjects. ISO 14155. June 2000 
 
3. EC Medical devices directive for post-market surveillance of CE market joint 
replacement implants including guidance to manufacturers on post-market clinical 
studies (September 2000) 
 
4. EU Medical Devices Directive 93/42/EEC concerning Medical Devices. 14 June 1993 
 
5. Guidelines on Post Market Clinical Follow-Up. MEDDEV 2.12-2. May 2004 
 
6. Guidelines on Medical Devices for Evaluation of Clinical Data: a guide for 
Manufacturers and Notified Bodies. MEDDEV 2.7.1. April 2003 
 
7. Guidelines on a Medical Devices Vigilance System. MEDDEV 2.12-1 rev 4. April 
2001 
 

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Appendix 1 
Investigator Contact List 
Information deleted for data protection reason.