A Prospective, Randomised Controlled Trial Evaluating Total Knee Replacement With the Stryker Triathlon Primary Total Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako, Compared to Bicompartmental Knee Replacement With Restoris MCK Multicompartmental Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Sponsor: Stryker South Pacific

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PROTOCOL: MAKORCT-15 
Version:  5.0 
Date: 22nd February 2018 
 
 
A prospective, randomised controlled trial evaluating Total Knee 
Replacement with the Stryker Triathlon Primary Total Knee System 
performed using Stryker’s Robotic-arm assisted surgery system, Mako, 
compared to Bicompartmental Knee Replacement with Restoris MCK 
Multicompartmental Knee System performed using Stryker’s Robotic-arm 
assisted surgery system, Mako 
 
 
Sponsor:  
Stryker Australia Pty Ltd. 
St Leonards NSW 2065 
+61 2 9467 1200 
 
Principal Investigators: Mr Gavin Clark  
Perth Hip and Knee 
Suite 1/1 Wexford Street 
Subiaco WA 6008 
 
Mr Dermot Collopy 
Perth Hip and Knee 
Suite 1/1 Wexford Street 
Subiaco WA 6008 
 
 
 
 
 
 
 
 
 
I have read and agree to follow the NHMRC National Statement on Ethical Conduct in Research 
Involving Humans. 
 
 
Signature ___________________________________   Date________________ 

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TABLE OF CONTENTS 
 
Section 
Title 
Page No. 
1.0 
2.0 
3.0 
4.0 
5.0 
6.0 
6.1 
6.2 
7.0  
8.0 
8.1 
8.2 
9.0 
10.0 
11.0 
12 
12.1 
12.2 
12.3 
12.4 
12.5 
13.0 
14.0 
15.0 
16.0 
17.0 
17.1 
17.2 
18.0 
19.0 
Summary 
Introduction 
Objectives 
Number of Patients 
Length of Study 
Patient Selection Criteria 
     Inclusion Criteria 
     Exclusion Criteria 
Study Design 
Device Description 
     Device Trade Name 
     Device Supply 
Surgical Procedures 
Informed Consent 
Evaluations 
Statistical Methods 
     Enrolment and Randomisation 
     Sample Size Justification 
     Data Capture and Analysis 
     Statistical Analysis 
     Analysis Populations  
Selection Criteria for Investigators and Clinical Monitors 
Admittance of Patient 
Patient Accounting 
Quality Assurance of the Data 
Management of Intercurrent Events 
Concurrent illness/procedures 
Withdrawal from Study 
Modification of The Protocol 
Definition and Reporting of Adverse Events 
4 
6 
8 
9 
9 
9 
10 
10 
11 
12 
12 
15 
16 
16 
17 
19 
20 
20 
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21 
22 
22 
23 
24 
24 
24 
24 
25 
26 
26 

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19.1 
19.2 
20.0 
20.1 
20.2 
20.3 
20.4 
20.5 
21.0 
21.1 
21.2 
22.0 
23.0 
24.0 
 
     Definitions 
     Reporting of Adverse Events 
Ethics Committee 
     Approval 
     Prior to Initiation of the Study 
     Progress Reports 
     Withdrawal of Ethics Committee Approval 
     Final Reports 
Sponsor Responsibilities 
     Reports 
     Clinical Monitoring of the Study 
Use of Information and Publications 
Analysis/Conclusions 
Bibliography 
Appendices 
Appendix I  - Restoris® MCK Planning and Surgical 
Technique Guide  
 
Appendix 2 - Triathlon Knee System - Express Instruments 
Surgical Protocol  
 
Appendix 3 - Questionnaires 
                      a: Oxford Knee Score 
                  b: EQ-5D Questionnaire 
                  c: VAS pain 
d. Forgotten Joint Score 
e. Knee Society Score  
                   
Appendix 4 – Declaration of Helsinki 
Appendix 5 – TGA annotated ICH GCP  
26 
27 
29 
29 
29 
30 
30 
30 
30 
30 
30 
31 
32 
33 
 
 
 
 
 

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1.0 SUMMARY 
 
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee 
Replacement using the Oxford Knee Score (OKS), in patients receiving either 
Bicompartmental Knee Replacement or Total Knee Replacement performed using 
Stryker’s robotic-arm assisted surgery system Mako, Functional and radiographic 
outcomes will be additionally collected as part of this study.  
 
The study will be conducted in patients with non-inflammatory degenerative joint disease 
who are randomised to either the Restoris® MCK Multicompartmental Knee System for 
Bicompartmental Knee Replacement (BKR), or the Triathlon Total Knee System for Total 
Knee Replacement (TKR), with a minimum 2 year patient evaluation period. 
 
All components used in this study are TGA approved, listed on the Australian Register of 
Therapeutic Goods. This study will be a phase IV post-market clinical trial.   
 
A minimum cohort of 70 patients will be enrolled into the study in Australia.  
 
Patients who are eligible for knee replacement surgery and meet the inclusion/exclusion 
criteria, will be enrolled into the study and randomised to receive either the Restoris® 
MCK Multicompartmental Knee System or Triathlon Primary Total Knee System. 
Patients will undergo a series of evaluations both pre-operatively, intra-operatively and 
post-operatively, in accordance with the below schedule: 
 
 
 
 
 
 
 
 
 
 
PATIENT EVALUATON SCHEDULE 
 

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EVALUATION 
History/  
Pre-Op 
Intra-
Op 
Post op 
≤5 days 
after 
surgery 
6 week 
follow-
up 
(± 2 
weeks) 
3 
month 
follow-
up 
(± 2 
weeks) 
12 
month 
follow-
up 
(± 1 
month) 
24 
month 
follow-
up 
(± 2 
months) 
Date of Visit 
 
 
 
 
 
 
 
Pre Op Clinical Data 
 
 
 
 
 
 
 
Inclusion / Exclusion 
Criteria 
 
 
 
 
 
 
 
Randomisation 
 
 
 
 
 
 
 
Surgical Details  
(All surgery, 
Bicompartmental Surgery, 
Total Knee Replacement)  
 
 
 
 
 
 
 
Oxford Knee Score 
 
 
 
 
 
 
 
EQ-5D 
 
 
 
 
 
 
 
VAS Pain 
 
 
 
 
 
 
 
New Knee Society 
Score 
 
 
 
 
 
 
 
Forgotten Joint Score 
 
 
 
 
 
 
 
Length of Stay 
 
 
 
 
 
 
 
MAKO CT  or  
MAKO CT Arthrogram  
** 
 
 
 
 
 
 
Anteroposterior (A/P) 
and Lateral Knee 
Radiographs  
 
 
* 
 
 
 
 
Skyline Knee 
radiographs 
 
 
 
 
 
 
 
Adverse Events 
 
 
 
 
 
 
 
Serious Adverse Events  
 
 
 
 
 
 
 
Protocol Deviations 
 
 
 
 
 
 
 

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 *A/P and Lateral Knee Radiographs collected post op ≤5 days after surgery are non-
weight bearing 
** MAKO CT Arthrogram to be performed if the patient has not had a previous MRI or 
MRI/CT Arthrogram. MAKO CT to be performed if the patient has had a previous MRI or 
MRI/CT Arthrogram. 
 
Please refer to Section 11.0 Evaluations: Radiographs for the coverage specifications of 
each radiograph listed in the patient evaluation schedule. 
 
 
2.0 INTRODUCTION 
 
The number of Total Knee Replacement procedures is increasing due to an older 
demographic and a heavier population group. Individuals have higher expectations of 
their knee replacement surgery and function due to an increasing participation in 
sporting activities. As newer technologies are developing, the use of evidence based 
medicine is critically important (Walker at al. 2009). 
 
The 2014 Australian National Joint Registry Annual Report states 41 250 patients 
underwent Unicompartmental Knee Replacement (UKR), 165 patients underwent 
Bicompartmental Knee Replacement (BKR) and 396 472 patients underwent Total Knee 
Replacement (TKR), with TKR figures increasing by more than 44 500 procedures from 
the previous 2013 report (AOANJRR). 
 
In 2011 the Triathlon Total Knee System was the third most implanted prosthesis in 
England and Wales. In Australia it has been the most implanted prosthesis for Primary 
Total Knee Replacement since 2009 as reported by the National Joint Registry. Five 
year results report good midterm survivorship along with functional outcomes and patient 
satisfaction. (Scott et al. 2014) 
 
Unicompartmental Knee Replacement and Patellofemoral replacement have both shown 
improved function and faster recovery times postoperatively. Interest in Bicompartmental 

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Knee Replacement is increasing as innovation improves results, resulting in higher 
patient function levels (Argenson et al. 2009).  
 
Currently there are a limited number of studies that report on Bicompartmental Knee 
Replacement outcomes, and even fewer prospective Randomised Control Trials (RCT) 
reported on this method. It has been idealised that Bicompartmental Knee Replacement 
may provide better function when compared to Total Knee Replacement, however 
additional studies are required (Engh et al. 2014). 
 
Surgical accuracy in Total Knee Replacement has previously been improved by using 
computer assisted surgical navigation. New robotic arm technology has been developed 
to constrain the motion of the cutting tool used by the surgeon. The robotic arm remains 
under direct control of the surgeon, and the surgeon has the ability to dictate the 
movement constraints to increase reproducibility, accuracy and precision (Conditt et al. 
2009) 
 
Stryker’s robotic arm assisted surgery offers treatment to patients who do not have 
osteoarthritis in all three compartments of the knee. A 3-D plan is created from the 
patients CT scan to provide implant size, placement and alignment. The robotic arm is 
controlled by the surgeon, and benefits of this technology include a smaller incision, live 
feedback, bone sparing capabilities and a shorter length of stay in hospital (Makoplasty) 
 
This study will assess Bicompartmental Knee Replacement using Restoris MCK 
Multicompartmental Knee System, to Total Knee Replacement using Stryker’s Primary 
Triathlon Total Knee System. Both surgeries will be conducted using Stryker robotic arm 
assisted surgery system (MAKO). Clinical and functional outcomes will be assessed 
between the two groups using the Oxford Knee Score as the primary endpoint. 
Radiographic outcomes will be collected to measure pre-operative cartilage wear, and 
any incidences of loosening and revision.  
 
As all components used in this study are TGA approved, this will be a phase IV, post-
market study.  

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3.0 OBJECTIVES 
 
PRIMARY 
The primary objective of this study is: 
 To compare the clinical outcomes of Knee Replacement surgery using the Oxford 
Knee Score (OKS) at 24 months, in patients receiving Bicompartmental Knee 
Replacement using Restoris MCK Multicompartmental Knee System with Stryker’s 
robotic-arm assisted surgery system Mako, to Total Knee Replacement using the 
Triathlon Total Knee System performed  with Stryker’s robotic-arm assisted 
surgery system Mako. 
 
SECONDARY 
The secondary objectives of this study are: 
• 
To determine functional and clinical outcomes of Bicompartmental  Knee 
Replacement (BKR) and Total Knee Replacement (TKR) (including pain, function 
and health-related quality of life) with Restoris MCK Multicompartmental Knee 
System and Triathlon Primary Total Knee System at 24 months via: 
o EQ-5D: The EQ-5D is a standardised instrument for use as a measure of 
health outcome. 
o VAS Pain: A graphical Visual Analog Scale that patients use to indicate 
their level of pain. 
o New Knee Society Score 2011 (KSS): A validated score assessing 
surgeon generated objective measures based on technical outcomes, 
and subjective measures based on patient satisfaction, patient 
expectations and functional activity of the knee (Noble et al. 2012) 
(Scuderi et al. 2012). 
o Forgotten Joint Score (FJS): The Forgotten Joint Score is a newly-
developed twelve-item, self-reported assessment of how aware recipients 

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of hip and knee joint replacement are of their joint in everyday life 
(Behrend et al, 2011). 
• 
To compare incidence of loosening, reoperation and revision in patients receiving 
Restoris MCK Multicompartmental Knee System, compared to Triathlon Total 
Knee System. 
• 
To determine length of hospital stay in patients receiving Restoris MCK 
Multicompartmental Knee System, compared to Triathlon Total Knee System. 
 
4.0 NUMBER OF PATIENTS 
This study will enrol a total of 70 cases, of which 35 will be randomised to receive the 
Restoris MCK Multicompartmental Knee System and 35 will be randomised to receive 
the Triathlon Primary Total Knee System. See section 12.2 for sample size justification.  
 
Additional patients will be recruited to compensate for early withdrawals and 
terminations. 
 
5.0 LENGTH OF STUDY 
Individual study patients will be followed up for a period of 2 years after surgery.  
 
The enrolment period is expected to be 6-9 months or until the required sample size is 
reached; it is therefore anticipated that the entire study will take a further 33 months 
(minimum) to complete. 
 
6.0 PATIENT SELECTION CRITERIA 
The Investigator is responsible for evaluating each patient against the following criteria 
and assuring that the patient meets the requirements to be enrolled in this clinical 
investigation.  Each patient enrolled in this investigation must meet each of the following 
inclusion criteria and have none of the exclusion criteria. The Investigator must notify the 
Ethics Committee of any patient enrolled in this study who does not meet the inclusion 

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and exclusion criteria. Inclusion/Exclusion criteria have been limited to reflect the actual 
patient population for this post-market assessment. 
Investigators are also expected to follow the instructions for use of all devices involved in 
this study, in accordance with their usual clinical practice. 
 
 
 
6.1 
Inclusion Criteria 
1. The patient is a suitable candidate for a Bicompartmental Knee Replacement and 
has moderate to severe patellofemoral wear and medial compartment wear 
(surgeons discretion) 
2. The patient has no fixed flexion greater than 10 degrees. 
3. The patient has maximal flexion greater than 100 degrees 
4. The patient has a passively correctable varus deformity 
5. The patient has a functionally Intact ACL. 
6. The patient has no significant patellofemoral malalignment 
7. The patient has negligible lateral compartment degeneration with no appreciable 
loss of cartilage height (surgeon’s discretion). 
8. The patient has pain that is not localised to the medial compartment only  
9. The patient is a male or non-pregnant female.  
10. The patient has signed the study specific, HREC-approved, Informed Consent 
document and is willing and able to comply with the specified pre-operative and 
post-operative clinical and radiographic evaluations. 
 
6.2 
Exclusion Criteria 
1. The patient has a clinically deficient ACL and cruciate and collateral ligament 
insufficiency on MRI or MRI/CT Arthrogram. 
2. The patient is undergoing revision surgery  
3. The patient has greater than 10° of hyperextension, greater than 10° of varus or 
valgus deformity, greater than 10° Flexion Contracture 
4. The patient has active, local infection or previous intra-articular infection 
5. The patient has skeletal immaturity 
6. The patient is without  sufficient bone stock to allow appropriate insertion and 
fixation of the prosthesis 

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7. The patient’s weight, age or activity level might cause extreme loads and early 
failure of the system (surgeons discretion). 
8. The patient has a systemic or local condition that would limit the ability to assess 
the performance of the device e.g. neuromuscular or neurosensory deficiency, 
disorder leading to progressive bone deterioration (including rheumatoid arthritis 
and osteoporosis), or patient is immunologically suppressed. 
9. Patient has a cognitive impairment, an intellectual disability or a mental illness that 
is considered by the investigator to inhibit the patient’s capacity to consent to 
research and the ability to participate in it 
10. Patients with tricompartmental disease are contraindicated from the study 
 
7.0 STUDY DESIGN 
This is a prospective, randomised, study with patients treated at multiple hospitals. 
 
Prior to each surgeon enrolling their first study patient, they must be accredited to 
perform Stryker’s Robotic-arm Assisted Surgery. Accreditation includes attending a 
Surgical Skills training course provided by Stryker and led by a surgeon experienced 
with using Mako, review of the planning and surgical technique guides, surgical 
observation and consultation with current Mako users. 
 
All potential study patients will be assigned a MAKORCT-15 study ID.  
If a patient has previously had a MAKO CT Arthrogram and wishes to participate in the 
study, the patient is required to sign the study approved consent form and the previous 
MAKO CT Arthrogram will be used for study purposes.  
If the patient has previously had a MRI or MRI/CT Arthrogram (within 6 months of 
planned study surgery date), the patient is required to sign the study approved consent 
form and the previous MRI or MRI/CT Arthrogram will be used for study purposes. Once 
the study consent form is signed, the patient will be referred for a MAKO CT for surgical 
planning purposes. 
If a patient has not had a MAKO CT Arthrogram, MRI or MRI/CT Arthrogram and wishes 
to participate in the study, the patient is required to sign the study approved consent 
form, and once signed the patient will be referred for a MAKO CT Arthrogram.  

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If the patient meets the Inclusion and Exclusion criteria and has signed the study 
consent form, the patient will be enrolled onto the study. If the patient does not meet the 
Inclusion and Exclusion criteria and has signed the study consent form, the patient will 
be terminated from the study as a Screen Failure. 
Enrolled patients will be randomised to one of two equally sized groups either; the 
Restoris® MCK Multicompartmental Knee System group or the Triathlon Primary Total 
Knee System group. Randomisation will take place via the Investigator or designee 
using the central randomisation system within Inform for allocation to either group. Block 
randomisation will be performed by a statistician using specialised randomisation 
software with a block size of 4.  
 
Any deviation from the assigned treatment will be reported as a deviation from Protocol. 
 
8.0 DEVICE DESCRIPTION 
All implant components to be used in this trial have been approved for sale and use 
throughout Australia.  
In addition, Stryker’s Robotic Arm, comprising of surgical arm guidance module and 
cameras will be used for intraoperative assessment of implant and limb position. This 
system is commercially available, and has been approved for sale and use throughout 
Australia.  
 
8.1 
Device Trade Name 
 
The Restoris® MCK Multicompartmental Knee System 
The Restoris® MCK Multicompartmental Knee System is a commercially available, 
ARTG listed device. The Restoris® MCK Multicompartmental Knee System is 
manufactured by MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL, 33317 
USA. 
The prosthetic components under study in this protocol include: 
o RESTORIS® MCK Multicompartmental Knee System 
o RESTORIS® MCK Femoral Condyle 

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o RESTORIS® MCK Patellofemoral 
o RESTORIS® MCK Tibial base plate 
o RESTORIS® MCK Tibial insert onlay 
o RESTORIS® MCK  Patella Dome (cemented)  
 
 
 
 
 
 
 
 
 
Figure 1: The RESTORIS® MCK system, Family of implants 
 
The components of the RESTORIS® MCK system are used to individually treat the 
components of the knee when showing osteoarthritis.  The medial unicondylar and 
patellofemoral components may be combined to perform a bicompartmental knee 
arthroplasty. These surgical options are shown below in Figure 2. 
                                                
     
 
 
 
 
 
 
                                                        
Figure 2: Stryker robotic-arm assisted surgery solutions.  
 

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Figure 3: The Mako System consists of the RIO® 
Surgical Arm, RIO® Guidance Module, and the 
Camera as pictured.  The system utilizes tactile 
robotic arm technology with integrated intelligent 
surgical instruments and navigation visualization 
system to pre-plan and treat each patient uniquely.  
After the implant plan is confirmed the system 
prevents resection outside of the defined spatial 
boundaries through an established relationship 
between the cutting burr and the patient’s anatomy.  
The end effector of the robotic arm is controlled by 
the surgeon as shown while the system provides the 
surgeon with real-time visual, tactile and auditory 
feedback.[7] 
 
 
 
The comparator (Stryker Triathlon Primary Total Knee System) group: 
The Stryker Triathlon Primary Total Knee System is a commercially available, ARTG 
listed device. The Triathlon Primary Total Knee System is manufactured by Stryker 
Orthopaedics (Mahwah, New Jersey).  
 
The prosthetic components to be implanted as part of this study will collectively be referred 
to as the Stryker Triathlon Primary Total Knee System. Within this system, various 
Figure 4: Surgeon holding Stryker’s Robotic Arm  
 

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individual implants of different designs, sizes and thicknesses are included. The required 
components to be used in this study group include: 
• 
CR Femoral Cementless Component – Beaded with Peri-Apatite 
• 
CR Femoral Cemented Component  
• 
Primary Tibial Baseplate – Cemented 
• 
CR Tibial Insert – X3 
• 
CS Tibial Insert – X3 
• 
Triathlon X3 Patella (cemented asymmetric/symmetric) 
 
 
 
 
 
 
 
 
Figure 3: The Triathlon® Knee system, Family of implants 
 
In addition, the Stryker Precision Knee Navigation System, comprising of computer 
hardware and software and associated instrumentation, will be used for intra-operative 
assessment of implant and limb position. This system is a commercially available, TGA 
(Therapeutic Goods Administration) listed device, and has been approved for sale and 
use throughout Australia.  
 
8.2 
Device Supply 
All device components will be supplied by the local supplier in Australia in accordance 
with usual commercial supply. 
 
The Restoris® MCK Multicompartmental Knee System, Triathlon Primary Total Knee 
System, and Precision Navigation System are supplied by Stryker Australia Pty Ltd.  
 

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9.0 SURGICAL PROCEDURES   
The Restoris® MCK Multicompartmental Knee System will be implanted using the 
corresponding instrumentation systems supplied by the manufacturer, as approved for 
use with this system, and as described in the surgical technique provided by the 
manufacturer (Appendix 1).  
 
The Triathlon Primary Total Knee System will be implanted using the corresponding 
instrumentation system supplied by the manufacturer, as approved for use with this 
system, and as described in the surgical technique provided by the manufacturer 
(Appendix 2).  
 
Appropriate post-operative care will be given and is at the discretion of the physician.  
 
10.0 
INFORMED CONSENT 
 
The Investigator will inform the patient of the purpose of the study, proposed duration of 
the study, follow-up schedule, method of application and randomisation of study groups.  
The Investigator will discuss foreseeable risks involved, as well as potential benefits that 
result from the use of the device.  The Investigator will also inform all patients that, 
should an unanticipated adverse device-related effect occur during the study which, in 
their opinion presents unreasonable risks to the patients, all patients will be notified and 
patient enrolment will be terminated. Patient information will be used during the analysis 
of the results of the clinical study but the confidentiality of the patient will be maintained 
at all times. 
 
The patients will be informed by the Investigator that they are free to refuse participation 
in this Investigation; and if they should participate, that they may withdraw from the study 
at any time without compromising further medical care. 
 
A signed and dated Informed Consent must be obtained by the Investigator or his/her 
designee from the patient prior to enrolment into this study. The original signed and 

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dated information sheet and patient consent will be kept by the Investigator.  A copy will 
be provided to the patient.   
 
11.0 
EVALUATIONS 
All data will be recorded on Case Report Forms or via Electronic Data Capture (EDC). 
The surgeon or study coordinator will complete and sign forms at the time of each 
protocol required visit.  
 
The following data will be collected for all patients:  
• 
Patient Demographics: A record of the patient’s date of birth, gender, height, and 
weight will be obtained pre-operatively. 
• 
Medical History: Relevant medical history will be recorded pre-operatively. 
• 
Surgical Details: A summary of the surgical procedure will be collected during the 
operation. This will include details of the prosthetic components implanted, operating 
time and comments. 
• 
Patient outcome measurements: Surgeon assessment of patient clinical outcomes 
will be recorded at various study visits. The following outcome scores will be recorded 
at time points as set out in the patient evaluation schedule. These include pre-
operative, 6 week, 3 month, 12 month and 24 month follow-up visits (see Appendix 3): 
 
Oxford Knee Score (OKS):  A 12 item questionnaire was developed to 
measure outcomes of patients undergoing total knee replacement (Dawson et 
al. 1998). The score is a self-completed questionnaire that asks patients to 
answer questions on their pain levels and function (Whitehouse et al. 2005).     
 
 
EQ-5D Euro-Qol (EQ-5D-5L): The EQ-5D-5L is a standardised patient-
completed instrument for use as a measure of health outcome (Fransen and 
Edmonds, 1999). It consists of 5 dimensions: mobility, self care, usual 
activities, pain/discomfort, and anxiety/depression. There are 5 levels of 
severity to select from within each dimension. 
 

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 
VAS Pain: A graphic Visual Analogue Scale (VAS) used as measurement 
instrument for patients to indicate their level of pain. The amount of pain that a 
patient feels is believed to range across a continuum from none to an extreme 
amount of pain i.e. from the patient's perspective this spectrum appears 
continuous - their pain does not take discrete jumps, as a categorization of 
none, mild, moderate and severe (Wewers et al. 1990).  
 
 
Forgotten Joint Score (FJS): The Forgotten Joint Score is a newly-developed 
twelve-item, self-reported assessment of how aware recipients of hip and knee 
joint replacement are of their joint in everyday life (Behrend et al, 2011). These 
scores have been further validated to demonstrate reproducibility when 
repeated (Roe et al, 2014). A computer-adaptive test version called FJS-CAT 
has been developed from the original version which consists of a reduced test 
length, and had a strong level of acceptance by patients when administered 
(Giesinger et al. 2013)   
 
 
New Knee Society Score (KSS):  A validated score assessing surgeon 
generated objective measures based on technical outcomes such as ROM, 
alignment and stability, and subjective measures based on patient satisfaction, 
patient expectations and functional activity of the knee (Noble et al. 2012), 
(Scuderi et al. 2012). 
 
 
Radiographs: A MAKO CT Arthrogram or MAKO CT will be used for 
surgical planning and study purposes. Anteroposterior (A/P), and Lateral 
Knee radiographs will be obtained pre-operatively and ≤5 days 
postoperatively for immediate assessment.  Anteroposterior (A/P), and 
Lateral knee post-operative radiographs will also be collected 3 months, 12 
months and 24 months, as outlined in the Patient Evaluation Schedule. 
Skyline knee x-rays will be obtained pre-operatively and at 12 months and 24 
months post-operatively. The pre-operative radiographs will be compared to 
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cartilage wear. All radiographs will be independently reviewed and assessed 
to quantify any radiographic changes within the region of the study device.  
 
Outlined below are the specifications required for the radiographic images as per 
the Patient Evaluation Schedule. 
 
A/P Knee: To be performed as a weight bearing A/P x-ray using a 24x30 or 35x43 
cassette plate at a 100cm FFD. When using a CR system, please ensure 
magnification is defaulted to 100%. Coverage to include 3cm above the patella and 
3cm below the tibial tuberosity. X-rays collected post op ≤5 days post-surgery will 
not be performed as weight bearing.   
 
Lateral Knee: To be performed as a weight bearing lateral x-ray using a 24x30 or 
35x43 cassette plate at a 100cm FFD. When using a CR system, please ensure 
magnification is defaulted to 100%. Coverage to include 3cm above the patella and 
3cm below the tibial tuberosity. X-rays collected post op ≤5 days post-surgery will 
not be performed as weight bearing.   
 
Skyline Knee: To be performed in the supine position with the knee flexed at 45 
degrees using a 24x30 cassette plate at a 100cm FFD. When using a CR system, 
please ensure magnification is defaulted to 100%. Coverage to include whole 
patella and trochlear groove. 
 
 
Adverse Events: All information on general medical, operative and device related 
complications will documented and tabulated (see section 19.0 for Adverse Event 
description and handling).  
 
12.0 
STATISTICAL METHODS 
 
12.1 
Enrolment and Randomisation 
At least 35 patients per study group will be enrolled.  Enrolment is defined as meeting 
the study Inclusion and Exclusion criteria.  

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The randomisation procedure by which the Knee System for the individual operation will 
be chosen (Restoris® MCK Multicompartmental Knee System versus the Triathlon 
Primary Total Knee System) will be centrally organised for all investigators, and 
allocated via block randomisation. At the time the patient meets the Inclusion and 
Exclusion criteria to take part in the study, the surgeon or designee will use the  
central randomisation system (via Inform) to obtain a randomised allocation. The block 
randomisation scheme will be performed using randomisation software with a block size 
of 4. The randomisation scheme will ensure that during the enrolment period the ratio of 
the number of cases in the two groups remains approximately constant and that surgical 
kits are available for each case.  
 
12.2 
Sample Size Justification 
The change in the Oxford Knee Score (OKS) from pre-op to post-op assessments has a 
standard deviation of approximately 8.0 (Scott et al, SD=9.8; Walker et al, Table 2, SD=6 
for UKR, and SD=8 for TKR). The parameters of the sample size calculation were set as 
follows: level of significance 0.05, 2-sided test, and postulated difference and standard 
deviation of 6.0 and 8.0 respectively. For these settings a sample of 29 patients in each 
arm is required to achieve a power of 80%. The sample size was increased by 20% to 
35 in each arm, so 70 in total, in order to allow for withdrawals.  
 
12.3 
Data Capture and Analysis 
At the commencement of the study, data may be recorded on 2-part NCR paper Case 
Report Forms (CRFs). Electronic Data Capture (EDC) will be implemented for this study, 
at which time the sponsor will enter all paper data collected to date and all new patient 
data will be captured via EDC. Investigators and study coordinators will be trained on 
EDC completion. 
 
The surgeon or designated signatory will complete and sign forms at the time of 
completion.  
 

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Original paper CRFs will be collected by Stryker for data entry. Copies will remain at the 
Investigator site. Archiving will be undertaken in accordance with ICH/GCP guidelines 
(Appendix 5).  
 
Any unclear or ambiguous data will be queried, either via paper queries or electronic 
queries as applicable and all cleaned data will be analysed. 
 
12.4 
Statistical Analysis 
For each treatment group the demographic data will be summarised as number of 
observations, mean, standard deviation, minimum, median, maximum for continuous 
variables such as age, and as frequency and percentage for categorical variables such as 
gender. 
 
For the test of the treatment effect the null hypothesis is no difference between the means 
of the 2 treatment groups, and will be tested against the alternative hypothesis that there 
is a difference between the means of the treatment groups.  
 
The primary and continuous secondary efficacy variables will be analysed with a mixed 
model for repeated measurements (MMRM). The model will include factors for treatment 
group, time, and the interaction between treatment group, and time. For each variable the 
baseline values will be included in the model as covariate. The treatment effect will be 
tested against between patient variance. The time effect, and the interaction between 
treatment group and time will be tested against within patient variance. The results will be 
summarised as mean, and 95% CI by treatment group, and time. The least squares means 
will be reported for the treatment difference at each time, and overall with 95% CI. The 
results will be presented in tabular format, and graphically by treatment group, and time. 
The continuous variables of change from baseline, and percentage change from baseline 
will be reported as mean, and 95% CI for each treatment group. 
 
Adverse events will be tabulated separately and reviewed for any commonalities. 
The data will be summarised and comparisons presented according to: 

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• 
Treatment group : Restoris® MCK Multicompartmental Knee System or Triathlon 
Primary Total Knee System 
• 
Adverse events: General complications, local complications, device-related 
complications, revisions/removals, loosening and pain. 
 
In the event of errors in randomisation, the patient will be classified according to the 
treatment received. All randomisation inconsistencies will be listed. 
 
12.5 
Analysis Populations 
Intent to Treat Populations  
An intent-to-treat analysis will be performed using all patients who were randomised and 
received a study device. Patients missing the measure of the primary end point (i.e. 
completed surgery and did not attend the 24 month visit) will be considered missing in 
the intent to treat analysis; no imputation of missing data will be conducted for any 
variables.  
 
13.0 
SELECTION CRITERIA FOR INVESTIGATORS AND CLINICAL MONITORS 
• 
The Investigator/s selected to participate in this study is/are qualified Orthopaedic 
surgeon/s. 
• 
Research assistants and study staff will be representatives of the Institute under 
the direction of the Principal Investigator.   
• 
Any conflicts of interest (including financial assistance from other parties) will be 
declared by Investigators and research personnel before the commencement of 
the trial. 
• 
Investigators must maintain a list of any delegated duties with respect to the trial, 
and the persons and qualifications of those persons to whom the duties are 
assigned. 
• 
Sites must be able to demonstrate that adequate subject recruitment is likely to be 
possible, with necessary time available to conduct the study to GCP requirements, 
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• 
Investigators must provide medical care to a trial participant that is necessary as 
a result of any adverse event experienced during or following the trial that is 
deemed related to the trial. 
• 
Investigators must possess, prior to trial commencement, a favorable Ethics 
Committee endorsement of trial protocol, Patient Information and Consent forms 
and any other information given to subjects. 
• 
All trial related documents are subject to Ethics Committee review. A regular trial 
report is also mandatory for provision to the Ethics Committee (in accordance with 
local requirements). 
• 
The Investigator/Institution shall permit trial related monitoring, audits, Ethics 
review and regulatory inspections, by providing direct access to source 
data/documents and any other trial related documentation. 
• 
The trial MUST be conducted according to the approved protocol. 
• 
Any deviation from the protocol must be documented for later review. 
• 
No deviation from protocol may occur without Ethics Committee endorsement, 
unless it is required to prevent imminent harm to participants 
• 
Investigators must ensure subjects have given informed, written consent, with all 
trial procedures and risks adequately explained. 
 
14.0 
ADMITTANCE OF PATIENT 
The Investigator must wait for written Ethics Committee and Governance approval prior to 
beginning the study or enrolling participants.  
 
A patient will be identified as a patient in this clinical trial upon signing a Patient Information 
Sheet and Consent form. 
 
A review of the inclusion and exclusion criteria must be completed by the Investigator pre-
operatively for each patient.   
 

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15.0 
PATIENT ACCOUNTING  
The Investigator or designee will complete an informed consent log with details (patient 
number and initials) of any patient signing a consent form to participate in this study.  
 
Clinical trial data will be monitored regularly to identify any trends and adverse events.  
Documentation of participants who voluntarily withdraw from the study or who are lost to 
follow-up will be obtained on a Study Termination Form. 
 
16.0 
QUALITY ASSURANCE OF DATA 
Case Report Forms (CRFs) or electronic Case Report Forms (eCRFs) will be routinely 
reviewed by the Principal Investigator for completeness and accuracy as well as any 
evidence which may be indicative of patient risk.  When any discrepancies are noted, they 
will be resolved with the Investigator and/or individual designated by the Investigator.  
When the data are incomplete, attempts will be made to obtain the data whenever 
possible.  
 
Clinical Research staff from Stryker Australia will monitor the investigational site at regular 
intervals to ensure compliance with the protocol and capture of any data or complications 
not already documented. Verification of the data from source documents will also be 
conducted by the Stryker monitors. 
 
17.0 
MANAGEMENT OF INTERCURRENT EVENTS 
 
17.1 
Concurrent illness/procedures 
Participants requiring concurrent procedures or medications for inter-current illnesses or 
adverse events will not be restricted throughout the study. Given the typical patient 
population receiving knee joint replacements, it can reasonably be expected that 
concurrent illnesses or procedures may be experienced by study participants.  
 
 

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17.2 Withdrawal from Study 
Participants will be advised that they may voluntarily withdraw from the study at anytime, 
for any reason and they are not obligated to reveal the reason to the Investigator and it 
will not affect their medical care. However, in such cases, appropriate effort will be made 
to determine the reason for withdrawal from the study.  The Investigator may request a 
letter from the patient noting his or her desire to withdraw from the study.  All attempts to 
locate participants lost to follow up will also be documented. 
 
Participants will be informed that should they withdraw from the study they should remain 
under the care of an appropriately experienced physician until the physician deems further 
follow-up unnecessary. 
 
The following are circumstances for which a patient would be identified as not continuing 
their participation in the study: 
• 
Study Completed / Terminated 
• 
Screen Failure 
• 
Death 
• 
Unable to Return  
• 
Unwilling to Return 
• 
Concurrent Illness  
• 
Lost to follow-up 
• 
Re-operation of the affected knee joint, including revision of knee replacement 
components 
• 
Incorrect implant(s)/device(s) used, device not included in protocol  
• 
Other 
 
Additionally, the patient may be withdrawn by the Investigator, if he/she is unable to 
continue participation in the study due to some condition unrelated to this study. 
 
A Study Termination Form will be completed for all participants who withdraw from the 
study. 

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18.0 
MODIFICATION OF PROTOCOL 
No changes to this protocol will be permitted without the written approval of the 
applicable Ethics Committee.  
 
Protocol deviation details, including the type of deviation (e.g. informed consent, 
inclusion/exclusion criteria, treatment, tests or visits not performed) should be recorded 
on a Protocol Deviation Form as soon as identified and notification will be made to the 
applicable Ethics Committee according to the Ethics Committee requirements.  
 
19.0 
DEFINITIONS AND REPORTING OF ADVERSE EVENTS 
19.1 Definitions 
 
Adverse Events: 
Any undesirable clinical occurrence in a subject, whether it is considered to be device 
related or not, that includes a clinical sign, symptom or condition and/or an observation of 
an unintended technical performance or performance outcome of the device. 
 
Expected: An adverse event is expected when the specificity and severity of the event is 
consistent with a complication that is not related to the device but may be related to the 
surgical procedure. 
 
Unexpected: An adverse event is unexpected when the specificity or severity of an 
adverse event is not consistent with the standard. It refers to an adverse event that has 
not been observed before. 
 
Adverse Device Event 
A clinical sign, symptom or condition that is causally related to the product, implantation 
procedure, the presence of product or the performance of the device system.  
 
Serious Adverse Advent (SAE):  
Any untoward medical occurrence that: 

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• 
Results in death, 
• 
Is life threatening, 
• 
Requires inpatient hospitalization or prolongation of hospitalization*, 
• 
Results in persistent or significant disability/incapacity, 
• 
Is a congenital anomaly/birth defect, or; 
• 
Is a medical or surgical intervention to prevent life-threatening illness and injury 
or permanent impairment to a body structure or a body function. 
 
*Planned (elective) hospitalization for a preexisting condition (a condition that is captured 
on the pre-op clinical data/medical history CRF), or a procedure required by the protocol, 
without serious deterioration in health, is not considered a Serious Adverse Event for this 
study. 
 
Examples of such elective procedures include, but are not limited to, the following 
commonly seen events: 
• 
Contralateral Total Knee Replacement or Partial Knee Replacement 
• 
Total Hip Replacement  
• 
Cataract Surgery 
 
Such events should not be categorized as SAEs on the Stryker AE/SAE Reporting Form, 
but rather should be classified as Adverse Events.  
 
Cancer should be captured as one SAE per diagnosis. All related follow up treatments 
for the primary cancer diagnosis, including  in-patient Chemotherapy or Radiotherapy 
should be captured as new information for the same SAE (the SAE can be left as 
unresolved with status date changed each times updates are made to the treatment 
section.) All metastasized (secondary) cancer diagnoses and associated treatments 
should be captured on a new SAE form. 
 
19.2 Reporting of Events 
 

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Any serious adverse event that occurs between patient consent and end of study, or 
adverse event that occurs from surgery to end of study will be recorded as such.  
 
Additionally, any adverse event identified during radiographic review, will be recorded as 
such. 
 
Adverse Events: 
 
Any adverse event should be recorded as follows: 
 
All information on general medical, operative and device related complications (adverse 
events) will be documented on Case Report Forms (CRFs) or electronic Case Report 
Forms (eCRFs). Information should include date of occurrence, description, severity, 
relationship to study device, treatment and date of resolution.  
 
The Investigator must determine if the event is related to the device. Any adverse event 
in a study patient must be monitored until the event is resolved or considered non-clinically 
significant by the Investigator.  
 
Expected Events: Should be reported to the Sponsor soon as possible, but not later 
than ten working days after the Investigator first learns of the effect.  
 
Adverse Device Events 
Should any adverse device events occur, the study staff will ensure that these are 
documented by the Investigator and reported immediately to the Sponsor. They should 
also be reported to the reviewing Ethics Committee and Institution as soon as possible, 
but not later than fifteen working days after the Investigator first learns of the effect, unless 
an earlier timeline is specified by individual study sites.  The Investigator with the Sponsor 
will conduct an evaluation of such effects. Following this evaluation, if the Investigator 
determines that an unanticipated adverse device effect presents an unreasonable risk to 
participants, the Investigation will be terminated as soon as possible.  Termination shall 
occur no later than five working days after the Investigator makes this determination and 

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no later than fifteen working days after the Investigator first receives notice of the 
unanticipated adverse effect.  
 
Serious Adverse Events:  
Any adverse event that is considered to be of serious nature and occurs at any time 
point from the signing of Informed Consent Form until either the patient is 
terminated from the study, or 30 days post-completion, should be recorded as 
follows: 
 
All Serious Adverse Events (SAEs) should be reported immediately to the Sponsor by 
email or fax, no later than 24 hours after becoming aware of the event. The immediate 
reports should be followed promptly by detailed, written reports. Reports should identify 
subjects by unique code numbers assigned to the trial subjects rather than by the subjects' 
names and/or addresses. The Investigator should also comply with the applicable 
regulatory requirement(s) related to the reporting of serious unexpected adverse device 
reactions to the regulatory authority (TGA) and the Ethics Committee. All other SAEs that 
are NOT related to the device will be reported to the Ethics Committee in a table with the 
annual reports, or as otherwise directed by the relevant Ethics Committee. 
 
20.0 
ETHICS COMMITTEE  
20.1 
Approval 
The Investigator is responsible for obtaining Ethics Committee approval to conduct this 
study.  
 
20.2 
Prior to Initiation of the Study 
The Investigator must wait for written approval by the Ethics Committee and Governance 
Officer prior to beginning the study. The Investigator may discuss the study with 
prospective participants; however, the Investigator may not obtain written Patient 
Informed Consent, nor perform study procedures on prospective study participants, until 
all required approvals are granted. 
 

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20.3 
Progress Reports 
The Investigator will also submit, at intervals requested by the Ethics Committee, 
progress reports on this study.  These progress reports will be submitted both to the 
Sponsor and to the Investigator’s Ethics Committee. 
 
20.4 
Withdrawal of Ethics Committee Approval 
Should the Ethics Committee withdraw its approval, the Investigator will notify the 
Sponsor no later than five working days following such withdrawal. 
 
20.5 
Final Reports 
Upon completion of the study, the Investigator will submit a Final Report on the 
Investigation within three months of completion of the Investigation.  This report will be 
submitted both to the Sponsor and the Investigator’s Ethics Committee. 
 
21.0 
SPONSOR RESPONSIBILITIES 
21.1 Reports 
The Sponsor, upon completion of the study, will prepare a comprehensive Final Report. 
These reports will be submitted to the Investigator/s, and ethics committee/s. 
 
21.2 Clinical Monitoring of the Study 
The Sponsor will monitor and ensure that this study is conducted in accordance with the 
signed Investigator Clinical Investigation Research Agreement, the Protocol, conditions 
imposed by the Ethics Committee, as well as other applicable regulations. Prior to initiating 
any study related activities, the Sponsor will conduct an appropriate pre-investigational 
visit and further communication to ascertain that: 
• 
The Investigator/s understand and accept his/her obligation in conducting the 
study 
• 
The Investigator/s understand the use of the device 
• 
The Investigator/s and staff have sufficient time and access to the adequate 
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• 
The Investigator/s understand that the study does not begin until written approval 
of the protocol is obtained from the ethics committee and all conditions of the ethics 
committee approval have been met 
• 
The Investigator/s and study staff understand and can complete the required case 
report forms 
• 
The Investigator/s have signed a Clinical Investigation Research Agreement and 
have a current curriculum vitae on file 
• 
The Investigators ethics approval is on file. 
 
During the course of the study, the clinical monitors conduct periodic visits at intervals and 
maintain regular contact with the Investigator/s and his/her staff to ascertain completeness 
and accuracy of data being collected as well as any evidence which may be indicative of 
subject risk. When any discrepancies are noted in the data, they will be resolved with the 
Investigator/s or his/her designee. When data are incomplete, they will be obtained 
whenever possible. 
 
The Monitor will report to the Stryker Clinical Research Manager any non-compliance by 
the Investigator with the signed Clinical Investigation Research Agreement, the Protocol, 
the requirements of any TGA regulation, or any condition imposed by the reviewing ethics 
committee. The Sponsor will secure compliance from the Investigator or terminate the 
Investigator’s participation in the study. Ethics Committee approval will be obtained prior 
to resuming a terminated Study. Should any deviations from the Protocol occur, these will 
be reviewed by the monitor for their clinical significance and appropriately documented 
and reported. 
 
22.0 
USE OF INFORMATION AND PUBLICATIONS 
Investigators must respect the confidentiality of data, especially regarding its use by 
potential competitors and must abide by conditions as agreed to in the Clinical 
Investigation Research Agreement.   
 

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The information gathered during this study will be disseminated in journals and 
conferences. Anonymity of the participants involved in the study will be maintained at all 
times. 
 
23.0 
ANALYSIS/CONCLUSIONS 
The data obtained in this Investigation will be maintained and periodically assessed 
throughout the study.   
 
A formal interim analysis will take place following all patients’ completion of the 12 month 
post-operative visit. The interim analysis will aim to review functional outcomes out to 12 
months post-surgery.  
 
The final analysis will take place following all 24 month follow-up visits. 
Based on the above design and planned analysis, we believe this protocol is 
scientifically sound and that the clinical evaluation of the experimental procedure is 
justified. 

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24.0 
BIBLIOGRAPHY 
 
1. Walker PS, Yildiri, G, Arno S, Heller Y. Future directions in knee replacement. 
Institution of Mechanical Engineers. 2009; 224(J): 393-414. 
 
2. Australian Orthopaedic Association. National Joint Replacement Registry Annual 
Report 2014. Available: 
https://aoanjrr.dmac.adelaide.edu.au/documents/10180/172286/Annual%20Repo
rt%202014  
 
3. Argenson JNA, Parratte S, Bertani A, Aubaniac JM, Lombardi AV, Berend KR, 
Adams JB, Lonner JH, Mahoney OM, Kinsey TL, John TK, Conditt MA.  The New 
Arthritic Patient and Arthroplasty Treatment Options. The Journal of Bone and 
Joint Surgery. 2009; 5:43-48. 
 
4. Engh GA, Parks NL, Whitney DPT. A Prospective Randomized Study of 
Bicompartmental vs. Total Knee Arthroplasty with Functional Testing and Short 
Term Outcome. The Journal of Arthroplasty. 2014; 29:1790-1794 
 
5. Scott CEH, Colement ND, MacDonald DJ, Hamiliton DF, Gaston P, Howie CR, 
Burnett R. Five-year survivorship and patient-reported outcome of the Triathlon 
single-radius total knee arthroplasty. Knee Surgery, Sports Traumatology, 
Arthroscopy. 2014; DOI 10.1007/s00167-014-2922-8 
 
6. Conditt MA, Roche MW. Minimally Invasive Robotic-Arm-Guided 
Unicompartmental Knee Arthroplasty. The Journal of Bone and Joint Surgery 
Incorporated. 2009; 91 Suppl 1:63-68 
 
7. Makoplasty Partial Knee Resurfacing. A Minimally Invasive Alternative for 
Patients with Isolated Osteoarthritis of the Knee. Available: 
http://www.makosurgical.com/physicians/products/rio  
 
8. Whitehouse, Sarah L and Blom, Ashley W and Taylor, Adrian H and Pattison, 
Giles T R and Bannister, Gordon C (2005) The Oxford Knee Score; Problems 
and Pitfalls. The Knee 2005 12(4):pp. 287-291. 
 
9. RESTORIS MCK Planning and Surgical Technique (Appendix 1) 
 
10. Noble PC, Scuderi GR, Brekke AC, Sikorskii A, Benjamin JB, Lonner JH, Chadha 
P, Daylamani DA, Scott WN, Bourne RB. Development of a New Knee Society 
Scoring System. Clinical Orthopaedics and Related Research 2012; 470:20-32 
 
11. Roe J, Webb J, Salmon L. ‘The Forgotten Joint Score’ Construct Validity and 
Test-Retest Reliability. 2014 APKASS meeting Kobe, Japan 

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12. Giesinger JM, Kuster MS, Holzner B, Giesinger K. Development of a Computer-
Adaptive Version of the Forgotten Joint Score. The Journal of Arthroplasty 2013; 
28: 418-422. 
 
13. Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The 
New Knee Society Knee Scoring System. Clinical Orthopaedics and Related 
Research 2012; 470:3-19. 
 
14. Dawson J, Firzpatrick R. Murray D, Carr A. Questionare on the perceptions of 
patients about total knee replacement. The Journal of Bone & Joint Surgery (Br) 
1998; 80-B:63-9 
 
15. ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects – 
Good Clinical Practice. Second edition 2011-02-01 
 
16. Behrend H, Giesinger K, Giesinger J, and Kuster M. The “Forgotten Joint” as the 
ultimate goal in joint arthroplasty: Validation of a new patient-reported outcome 
measure. J Arthroplasty [Epub ahead of print] 2011.   
 
 
 
 
 
 
 
 

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APPENDIX 1 
 
Restoris® MCK Planning and Surgical Technique Guide 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 2 
 
Triathlon Knee System – Express Instruments Surgical Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 3 
 
QUESTIONNAIRES 
a) Oxford Knee Score 
b) EQ-5D Questionnaire 
c) VAS pain 
d) Forgotten Joint Score 
e) Knee Society Score 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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MAKORCT-15 Final version 5.0  22 February 2018 
 
 
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APPENDIX 4 
 
DECLARATION OF HELSINKI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

CONFIDENTIAL
 
 
MAKORCT-15 
http://sspintranet/sites/raqa/qms/documents/FM-CRD-029.docx 
MAKORCT-15 Final version 5.0  22 February 2018 
 
 
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APPENDIX 5 
TGA ANNOTATED ICH GCP