A Prospective, Non-randomized, Longitudinal Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Phase: NA
Conditions: Arthroplasties, Replacement, Knee
Sponsor: Stryker South Pacific

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PROTOCOL: TriShapeMatch-10 
(with ShapeAUSEx-12 Extension Study) 
Version: 8.0  
Date: 21 August 2012 
 
A prospective, non-randomized, longitudinal study of the clinical outcomes of 
participants that receive the Stryker Triathlon Total Knee System for Total Knee 
Arthroplasty implanted using ShapeMatch® Cutting Guides. 
With Extension Study: 
A follow-up, longitudinal study of the clinical and radiographic outcomes of 
participants that receive a Triathlon Custom Fit Knee® using Stryker 
ShapeMatch® Technology: 
 
 
Sponsor:  
 
 
Stryker Australia Pty Ltd (ABN: 48002 873 850) 
8 Herbert Street, St Leonards, NSW 2065 
Contact: Tim Barker PhD, Director of Clinical Research 
Ph: 02 9467 1000 
 
I have read and agree to follow this protocol and the NHMRC National 
Statement on Ethical Conduct in Research Involving Humans: 
 
  
Principal Investigators:  
 
 
 
 
Dr Gavin Clark  
_____________      __/__/__ 
Signature   
 
Date 
 
Dr Ton Tran  
_____________      __/__/__ 
Signature   
 
Date 
 
Dr Adrian Trivett 
_____________      __/__/__ 
Signature   
 
Date 
 
 
 
 
 
Dr Bob Steele 
_____________      __/__/__ 
Signature   
 
Date 
 
 
 
 
 
Dr Peter McEwen 
_____________      __/__/__ 
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 
12.0 
12.1 
12.2 
13.0 
14.0 
15.0 
16.0 
17.0 
17.1 
17.2 
18.0 
19.0 
19.1 
19.2 
20.0 
Summary 
Introduction 
Objectives 
Number of Participants 
Length of Study and Patient Participation 
Patient Selection Criteria 
     Inclusion 
     Exclusion 
Study Design 
Device Description 
     Device Trade Name 
     Device Supply 
Surgical Procedures 
Informed Consent 
Evaluations 
Statistical Methods 
     Sample Size Justification 
     Data Capture and Analysis 
Selection Criteria for Investigators/Sites 
Admittance of Patient 
Patient Accounting 
Quality Assurance of the Data 
Management of Concurrent Events 
     Concurrent illness/procedures 
     Withdrawal from Study 
Modification of The Protocol 
Definitions and Reporting of Adverse Events 
     Definitions 
     Reporting of events 
Human Research Ethics Committee (HREC) 
4 
8 
11 
13 
13 
14 
14 
14 
15 
17 
17 
18 
18 
20 
21 
24 
24 
25 
26 
27 
27 
27 
28 
28 
28 
29 
29 
29 
30 
32 

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20.1 
20.2 
20.3 
20.4 
20.5 
21.0 
21.1 
21.2 
22.0 
23.0 
24.0 
 
 
Appendix 1
 
 
Appendix 2
 
Appendix 3
 
Appendix 4
 
Appendix 5
 
Appendix 6
 
     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 
OtisMed Custom Fit Total Knee Replacement 
Using ShapeMatch® Technology 
 
MRI scan protocol 
 
CT scan protocol 
 
Outcome Assessment Tools 
 
Declaration of Helsinki 
 
ICH Good Clinical Practice (GCP) Guidelines 
 
32 
32 
32 
32 
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33 
34 
34 
34 
 
 
 
 
 
 
 

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1.0 SUMMARY 
This is a prospective, non-randomized, longitudinal study of the clinical outcomes of 
participants that receive the Stryker Triathlon® Total Knee System for Total Knee 
Arthroplasty implanted using ShapeMatch® Cutting Guides. Health status and 
functional outcome measures will be recorded to quantify functional status of subjects 
before surgery and at each follow-up interval. 
 
There will be 4 sites and 6 investigators for this study. A maximum of 160 cases will 
be enrolled in the study and it is expected that participants will be recruited over a 6 
month period. Total duration of the study is expected to be 1.5 years. 
 
The study consists of two groups:  
Group A: Assessment of the intra-operative reproducibility of placement of the 
ShapeMatch® Cutting Guides onto the distal femur and proximal tibia bone surfaces; 
 
Group B: Assessment of the placement of the ShapeMatch® Cutting Guides intra-
operatively combined with an assessment of post-operative patient outcomes 
compared to pre-operative status and post-operative implant placement. 
 
Pre-operatively, all participants will be required to undergo medical imaging 
assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb. 
These images will then be used to manufacture the patient-specific cutting guides for 
preparation of the bones prior to implantation of the total knee replacement.  
 
For Group A, participants will only undergo intra-operative assessments to determine 
repeatability of the placement of the cutting guides onto the distal femur and proximal 
tibia. No post-operative evaluations will be specifically required of participants due to 
their involvement in this study. 
 
For Group B, participants will be requested to attend visits pre-operatively and post-
operatively at 6 weeks, 3 months and 6 months. At these visits will complete 
assessments relating to quality of life, pain and functional outcome. In addition, 
participants will have standard knee X-rays taken pre-operatively and post-

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operatively. A post-operative CT scan will be obtained for all participants in order to 
assess implant position and orientation. 
 
All implanted prosthetic components (Stryker Triathlon Primary Total Knee System) 
used in this study are TGA approved for sale and use in Australia. This study was 
originally to be undertaken via the Clinical Trial Notification (CTN) Scheme of the 
Therapeutic Goods Administration (Therapeutic Goods Act, 1989); however the 
ShapeMatch® Cutting Guides are now also listed on the Australian Register of 
Therapeutic Goods (ARTG) for sale and use in Australia. 
 
This study will adhere to all relevant requirement and guidelines in relation to the 
conduct of clinical trials, including the Declaration of Helsinki (Appendix 5) and ICH 
Good Clinical Practice Guidelines, as implemented in Australia (Appendix 6). 
 
An Extension Study will be undertaken to follow Group B patients who consent to 
continued follow-up. These patients will be followed out to 5 years post-surgery with 
follow-up visits at 12 months, 2 years and 5 years in order to collect longer term data 
on radiographic and patient outcomes. 
 
Visit Windows 
Definition – Since it is not always possible for subjects to come in for a study visit on 
the exact date, most protocols allow a certain time period before or after the calendar 
date; this is known as the visit window. If a subject is not seen during the visit window, 
that visit will be regarded as a missed visit. Visit windows are calculated in reference 
to the baseline date, which is the surgery date (intra-op) for this study.  
 

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Patient Evaluation Schedule 
Part A: Reproducibility sub-study 
 
EVALUATION 
History/ 
Pre-Op 
 
Intra-Op 
Demographics 
 
 
Medical History 
 
 
MRI 
 
 
Surgical Details 
 
 
 
Note: No post-op visits required for participants in Part A. 
 
The visit windows for this study are: 
 
Pre-Op = Within 2 months before the date of surgery 
 
Part B: Functional outcome sub-study 
 
EVALUATION 
History/ 
Pre-Op 
 
Intra-Op 
6 week 
3 MO 
6MO 
Demographics 
 
 
 
 
 
Medical History 
 
 
 
 
 
MRI 
 
 
 
 
 
Surgical Details 
 
 
 
 
 
International Knee 
Society Score 
 
 
 
 
 
KOOS 
 
 
 
 
 
SF-12 v2 
 
 
 
 
 
VAS Pain 
 
 
 
 
 
AP and ML X-rays 
 
 
 
 
 
Perth CT Protocol 
 
 
 
 
* 
 
 
The visit windows for this study are: 
 
Pre-Op = Within 2 months before the date of surgery 
 
Intra-op = Baseline time point  
 
6 Weeks = +/- 2 weeks 
 
3 Months = +/- 1 month (+/- 6 weeks for CT only – except WA site) 
 
6 Months = +/- 1 month(+/- 6 weeks for *CT WA site Only and X-ray only) 
 
 

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Extension Phase: 
 
EVALUATION 
12 month   
follow-up 
2 year   
follow-up 
5 year 
follow-up 
Demographics 

 
 
BMI 

 
 
Medical History Review 
 
 
 
Surgical Details 
 
 
 
Knee Society Score 
 
 
 
KOOS 
 
 
 
SF-12 v 2 
 
 
 
VAS Pain 
 
 
 
Forgotten Joint Score 
 
 
 
Anteroposterior (A/P) 
and Lateral Knee 
Radiographs 
 
 
 
Long leg (A/P) weight 
bearing x-ray 
 
 
 
Adverse Events 
 
 
 
 
 
The visit windows for this study are: 
 
12 Months = +/- 3 months 
 
2 years = +/- 3 months 
 
5 years = +/- 4 months 
 
 
 

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2.0 INTRODUCTION 
 
Total knee replacement has evolved to a point where implant design combined with 
instrumentation and surgeon skill results in excellent implant survival. Over 30,000 
total knee replacement procedures are performed each year in Australia and are used 
to treat a range of conditions including osteoarthritis, rheumatoid arthritis, avascular 
necrosis and secondary arthritis resulting from trauma. 
 
Current surgical techniques make use of generic, re-usable instrumentation, 
consisting of intra- and/or extra-medullary rods on the femur and tibia to determine 
alignment in relation to anatomical landmarks, combined with bone resection guides 
which ultimately determine position and orientation of the definitive implant 
components. 
 
Traditionally, the goal of total knee replacement has been to position the components 
such that the post-operative alignment goal is a straight limb, or a mechanical axis of 
0° (Insall & Scott, 2001). The mechanical axis is defined by lines joining the centre of 
the femoral head, centre of the knee joint and the centre of the ankle. Despite the 
best efforts of the surgeon, the resulting limb alignment varies away from 0° by a 
small amount (typically ±3° in 80% of cases).  
 
More recently, the use of computer navigation systems has been introduced to 
surgical practice with the aim of improving the ability to obtain post-operative limb 
alignment as close as possible to 0° (Chauhan et al, 2004). 
 
Whilst achievement of neutral limb alignment has been considered desirable from an 
engineering point-of-view – to maximize implant longevity through minimizing the 
deleterious effects of polyethylene insert wear and particle-induced osteolysis and 
implant loosening – patient satisfaction of total knee replacement has not always 
been ideal. Despite surgery being performed technically correct by surgeons, up to 1 
in 5 patients express dissatisfaction in the functional result (Bourne et al, 2009). 
Patient expectations after surgery are also increasing due in part to the adoption of 
more active lifestyles amongst total knee replacement recipients where return to 
function can be of primary importance. 

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The opportunity exists to provide an alternative approach to total knee replacement 
surgery which may result in improved patient outcomes. One such approach is to 
determine the optimal placement of components based on the individual anatomy of 
patients, rather than a generic limb alignment philosophy (Coughlin et al, 2003; 
Eckhoff et al, 2005). This approach relies on the creation of a pre-arthritic model of 
the bone and cartilage structures of the knee. A single, 3-D axis of rotation is then 
determined which takes into account the 3-D shape and orientation of the femoral 
condyles during the weight-bearing portion of gait. This is in contrast to traditional 
surgical techniques which set femoral component orientation and position using one 
or more of the trans-epicondylar axis, posterior-condylar axis and/or the anterior-
posterior (or Whiteside’s) line. This new axis is then the basis of determining the so-
called natural alignment goal for the joint replacement procedure. 
 
A comprehensive three-dimensional description of the anatomy can be obtained by 
magnetic resonance imaging (MRI) scans obtained pre-operatively. Through a 
proprietary process, it is possible to pre-operatively develop a model of the arthritic 
bone and cartilage, adapt that model to take into account degenerative process, and 
generate a model of the pre-arthritic anatomy (Appendix 1, Fig. 1). The pre-arthritic 
state then becomes the surgical goal in terms of limb alignment. Custom cutting 
guides are generated for each individual patient to enable the surgeon to perform the 
bone resections in such a way that the resultant construct with the total knee 
replacement components reproduces the pre-disease limb alignment (Fig. 2). Early 
experience of applying this technique indicates that patient outcomes and function 
assessed during the early post—operative phase are superior to conventional 
approaches to total knee replacement (Howell et al, 2008; Spencer et al, 2009). Other 
potential advantages of this technology include a reduction in blood loss (as no 
intramedullary rod is used), and a reduction in ligament releases (as the total knee 
components effectively resurface the knee with restoration of the natural alignment) 
(Howell et al, 2008). 
 
 

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Figure 1: Workflow and data transfer process used for preparation of ShapeMatch® Cutting Guides. 
 
 
Figure 2: Intra-operative image of ShapeMatch® Cutting Guides positioned on distal femur and 
proximal tibia. Femoral cutting guide has been pinned in place, ready for bone resection. Tibial cutting 
guide being positioned prior to pinning. 
 

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This protocol outlines a study for the systematic assessment of this new approach to 
total knee replacement. 
 
This study consists of two distinct parts: 
Group A: This sub-study aims to quantify the reproducibility of positioning the cutting 
guides onto the affected femoral and tibial joint surfaces.  
 
Group B: This sub-study aims to assess certain aspects of the operative procedure, 
as well as measure parameters relating to quality of life, pain and functional outcome 
using standard orthopaedic scoring methods. 
 
Following on from Group B, an extension study will be undertaken. This study aims to 
determine the clinical and radiographic outcomes out to 5 years post surgery, in patients 
receiving a Triathlon Custom Fit Knee featuring Stryker ShapeMatch  
 
3.0 OBJECTIVES 
 
The primary endpoints of this study are: 
 
1. Repeatability of cutting guide position on the distal femur and proximal tibia 
assessed by repeated measures using computer navigation system for total 
knee replacement, assessed intra-operatively (Group A). 
 
2. Radiographic implant location, consisting of multi-parameter assessment of the 
relative position and orientation of the femoral and tibial components and 
overall limb alignment, assessed by the Perth CT protocol 3 months after 
surgery (Group B). 
 
The secondary endpoint of this study is: 
3. Knee function, quality of life and pain assessed 6 months after surgery (Group 
B). 
 
The study objectives are: 
1. Repeatability of the cutting guide position will be no worse than that obtained 
for manual instruments used for total knee replacement (Group A).  

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2. Participants will have higher knee function scores and increased quality of life 
as compared to pre-operative state and equal or better as compared to other 
surgical techniques using historical controls (Group B) 
 
The objectives of the Extension Study are: 
 
1. The primary objective is to determine the clinical and radiographic outcomes at 
12 months, 2 years and 5 years post surgery, in patients receiving a Triathlon 
Custom Fit Knee featuring Stryker ShapeMatch. 
2. The secondary objective is to determine the revision rate (yearly cumulative 
percent revision), device-related adverse events and reoperation rates. 
 
 
RESEARCH OBJECTIVES 
The use of patient-specific cutting guides for total knee joint replacement is being 
developed and introduced to clinical practice by a number of orthopaedic device 
companies. Each system differs in the way in which the cutting guides are designed, 
the material which they are made from, the alignment philosophy and the radiological 
information on which they are based (e.g. X-ray, CT, MRI). 
 
The overall goal of this study is to assess the impact of a new surgical technique 
developed by Stryker on the functional outcome of participants undergoing primary 
total knee joint replacement.  
 
The repeatability in placing the cutting guides relies on the reference points used in 
the design of the block, and the ability of the surgeon to position it on the diseased 
joint surfaces of the knee without the availability of traditional alignment jigs (femoral 
intra-medullary rod, tibial extra- or intra-medullary alignment guide). Hence, the first 
objective of this study is to quantify the reproducibility of this new technique by 
assessing cutting guide position using a repeated-measures methodology. The 
results will be described as a standard error of measurement. 
 
Early reports indicate that improved post-operative functional outcomes may result 
from the use of this new technology when used in combination with particular designs 
of total knee joint prosthetic components (Howell et al, 2008; Spencer et al, 2009). 
The second objective is to assess and quantify such changes in the short-term (6 

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months) post-operative period. Potential benefits may be seen in the general quality 
of life experienced by participants, reduced pain levels, and specific improvements in 
activities of daily living affected by knee function. Other parameters related to the 
procedure, such as operating time, blood loss and length of stay in hospital will also 
be assessed to determine if perceived benefits with the use of this new surgical 
technique can be realised in routine clinical practice. Comparison of the study findings 
will be made to published literature on the clinical outcomes of total knee replacement 
(e.g. Kolisek et al, 2007; Matziolis et al, 2007; Harwin et al, 2008). 
 
In addition, a cadaver study is being planned to further explore the precision analysis 
including quantification of intra- and inter-observer variation in placement of the 
cutting guides. Subsequent clinical studies such as randomised, controlled trials 
(RCTs) are envisaged to provide higher levels of evidence. The results of the case 
series outlined in this proposal will allow future studies to be designed in a sound 
manner, ensuring patient numbers and study design are sufficient to provide 
statistically-significant outcomes. 
 
4.0 NUMBER OF PARTICIPANTS 
Group A: Six investigators will recruit a minimum of 5 cases per investigator and a 
maximum of 60 cases in total. 
Group B: Four hospitals and five investigators will recruit a total of 100 cases. 
Extension Study: Participants from Group B will be invited; a maximum of 100 cases 
will be included. 
 
5.0 LENGTH OF STUDY AND PATIENT PARTICIPATION 
The enrolment period for Group A is expected to be 3 months or until the required 
sample size is reached. For Group B, individual study participants will be seen for at 
least 6 months after surgery. The enrolment period is expected to be 6 months. 
Therefore it is anticipated that the entire study will take approximately 1.5 years to 
complete.  
 
At the completion of the 6 month follow-up visit patients will receive an invite to 
continue participation in the study via enrollment into the Extension Study. Patients 

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will be required to give informed consent and will need to meet the Extension study 
inclusion and exclusion criteria (see sections 6.3 and 6.4). 
 
6.0 PATIENT SELECTION CRITERIA 
Each 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. Any patient 
enrolled in this study who does not meet the inclusion and exclusion criteria will be 
considered a protocol deviation.  
 
6.1 Inclusion Criteria 
 The patient is a male or non-pregnant female between the ages of 50-90. 
 The patient requires a primary total knee replacement and is indicated for 
computer-assisted surgery. 
 The patient has a primary diagnosis of osteoarthritis (OA). 
 The patient has intact collateral ligaments. 
 The patient is able to undergo MRI scanning of the affected limb. 
 The patient has signed the study specific, HREC-approved, Informed Consent 
document. 
 The patient is willing and able to comply with the specified pre-operative and 
post-operative clinical and radiographic evaluations. 
 
6.2 Exclusion Criteria 
 The patient has a history of total, unicompartmental reconstruction or fusion of 
the affected joint. 
 Patient has had a high tibial osteotomy or femoral osteotomy. 
 The patient is morbidly obese (BMI ≥ 40). 
 The patient has a deformity which will require the use of stems, wedges or 
augments in conjunction with the Triathlon Total Knee System.  
 The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical 
axis). 
 The patient has a fixed flexion deformity ≥ 15°. 

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 The patient has a neuromuscular or neurosensory deficiency, which would limit 
the ability to assess the performance of the device. 
 The patient has a systemic or metabolic disorder leading to progressive bone 
deterioration. 
 The patient is immunologically suppressed or receiving steroids in excess of 
normal physiological requirements. 
 Patient has a cognitive impairment, an intellectual disability or a mental illness. 
 The patient is pregnant. 
 The patient has metal hardware present in the region of the hip, knee or ankle 
(as this is known to create geometrical distortion in the region of the implant). 
 The patient has any known contraindications for undergoing assessment by 
MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted 
devices such as cardiac pacemakers, etc). 
 
6.3 Extension Study: Inclusion Criteria (applicable to patients electing to 
continue participation in the Extension study). 
 Patient was enrolled in TriShapeMatch-10 study and completed 3 month 
follow-up visit. 
 Patient is willing and able to give informed consent to participate in the study. 
 Patient is willing and able to comply with the specified clinical and radiographic 
evaluations. 
 
6.4 Extension Study: Exclusion Criteria (applicable to patients electing to 
continue participation in the Extension study). 
 Patient no longer has the Triathlon Custom Fit Knee featuring Stryker 
ShapeMatch in situ, including patients that have had revision surgery. 
 Patient has a cognitive impairment, an intellectual disability or a mental illness. 
 Patient no longer resides in a geographical location that would reasonably 
permit clinic visits at protocol specified intervals. 
 
7.0 STUDY DESIGN 
Group A: This is a repeatability study of ShapeMatch® patient-specific cutting guides 
designed for participants undergoing total knee arthroplasty with the Triathlon® Total 

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Knee System (Stryker Orthopaedics, Mahwah NJ, USA) and Stryker eNact Knee 
Navigation System (Stryker Navigation, Kalamazoo MI, USA). Participants will 
undergo pre-operative assessment using MRI of the affected limb according to the 
scan protocol (see Appendix 2 for example). At the time of surgery, a repeated-
measures methodology will be implemented in which the position of the femoral and 
tibial cutting guides will be measured using the Navigation system. The same surgeon 
will position each cutting guide a total of 3 times for each patient. Multiple participants 
will be assessed by each surgeon. No bone resections will take place using the 
patient-specific cutting guides. After the study-specific measurements have been 
taken, the total knee procedure will resume using the Navigation system and 
associated instruments being used to prepare the distal femur and tibia prior to 
implantation of the Triathlon® total knee components. No post-operative evaluations 
will be undertaken as part of this sub-study. However, participants will have routine 
visits, as per the investigators’ standard-of-care for such participants. 
 
Approximately30 participants (5 per investigator) up to a maximum of 60 participants 
will contribute to this sub-study. 
 
Group B: This is a consecutive sample survey of participants undergoing total knee 
arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, 
NJ USA) utilizing ShapeMatch® patient-specific cutting guides to prepare the bony 
resections on the distal femur and proximal tibia. Health status and functional 
outcome measures will be recorded to quantify functional status of subjects before 
surgery and at each follow-up interval. 
 
Participants suitable for primary total knee arthroplasty and indicated for computer-
assisted surgery will be booked for surgery. Recruitment will be subject to gaining 
suitable informed consent from the patient.  
 
Participants will undergo pre-operative assessment using MRI of the affected limb 
according to the scan protocol (Appendix 2). 
 
Appropriate total knee replacement components from the Stryker Triathlon® Total 
Knee System will be used.  

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All patients undergoing total knee replacement routinely have anterior-posterior (AP) 
and medio-lateral (ML) X-rays taken of the affected knee pre-operatively and post-
operatively. In addition, a more comprehensive assessment of total knee replacement 
component position and orientation will be obtained using the Perth CT protocol 
(Appendix 3; Chauhan et al, 2004). 
 
Demographic details, diagnosis, coexistent disease and concomitant medications will 
be collected preoperatively and adverse events will be collected during and after 
surgery. Surgeons will monitor participants following surgery as per their standard of 
care for such participants. 
 
Participants will follow the standard postoperative rehabilitation program established 
by the investigator at the study site.  
 
Subjects 
Subjects will be screened using the inclusion and exclusion criteria, and enrolled from 
the clinic after informed consent has been obtained. Their personal information and 
co-morbidities will be recorded from the chart and functional status will be assessed 
using the International Knee Society Score, SF-12 v2, Knee Osteoarthritis Outcome 
Score (KOOS), and Pain Visual Analog Scale. All information will be kept strictly 
confidential.  
 
Demographic details and body mass index will be collected preoperatively and 
complications will be collected after surgery.  
 
8.0 DEVICE DESCRIPTION  
 
8.1 Device Trade Name 
 
The instruments used to resect the distal femur and proximal tibia as part of this study 
will be referred to as the Stryker ShapeMatch® Cutting Guides. These devices are 
single-use, patient-specific instruments, approved for use in Australia by the 
Therapeutic Goods Administration.  
 

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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 individual implants of different designs, sizes and thicknesses are 
included, including: 
 CR Femoral Component – Cemented 
 CR Femoral Cementless Component – Beaded with Peri-Apatite 
 PS Femoral Component – Cemented 
 PS Femoral Cementless Component – Beaded with Peri-Apatite 
 Primary Tibial Baseplate – Cemented 
 Primary Tibial Baseplate – Beaded with Peri-Apatite 
 CR Tibial Insert – X3 
 CS Tibial Insert – X3 
 PS Tibial Insert – X3 
 
The Stryker Triathlon Primary Total Knee System is a commercially available, 
TGA (Therapeutic Goods Administration) listed device, and has been approved for 
sale and use throughout Australia. 
 
In addition, the Stryker eNact 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 
 
The Triathlon Primary Total Knee System, ShapeMatch® Cutting Guides and eNact 
Knee Navigation System will be supplied by Stryker Australia Pty Ltd.  
 
9.0 SURGICAL PROCEDURES   
Group A: 
Each patient will be prepared to undergo a primary total knee replacement using the 
Triathlon Primary Total Knee System and Stryker eNact Knee Navigation System. A 
standard skin incision and joint exposure will be performed according to the surgeon’s 

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preference. Navigation trackers will be secured to the femur and tibia and registration 
of the limb will be undertaken according to the surgical technique. 
 
The appropriate Stryker ShapeMatch® Cutting Guide will be positioned onto the distal 
femur. A Navigation tracker with Resection Plane Probe attached will be placed into 
the cutting slot of the cutting guide. The location (position and orientation) of the 
probe is displayed on the computer screen of the Navigation system. The screen will 
be diverted from the surgeon’s view and a recording will be made of the position once 
the surgeon has indicated that the cutting guide is positioned appropriately. The 
cutting guide will then be removed from the femur, and the process repeated until a 
total of three measurements have been recorded. The same procedure will be 
performed on the proximal tibia using the appropriate Stryker ShapeMatch® Cutting 
Guide. This entire process should take no longer than 5 minutes. 
 
Once these measurements have been performed, the surgeon will resume the 
surgical technique for implantation of the Stryker Triathlon Primary Total Knee 
System using Stryker eNact Knee Navigation System, as per their own instrument 
and implant preferences. 
 
Appropriate post-operative care will be provided according to the preference of the 
treating physician. No further evaluations will be required by study participants. 
 
Group B: 
Each patient will be prepared to undergo a primary total knee replacement using the 
Triathlon Primary Total Knee System and Stryker eNact Knee Navigation System. A 
standard skin incision and joint exposure will be performed according to the surgeon’s 
preference. Navigation trackers will be secured to the femur and tibia and registration 
of the limb will be undertaken according to the surgical technique. 
 
The appropriate Stryker ShapeMatch® Cutting Guide will be positioned onto the distal 
femur, and secured in place using fixation pins. A Navigation tracker with Resection 
Plane Probe attached will be placed into the cutting slot of the cutting guide. The 
location (position and orientation) of the probe will be displayed on the computer 
screen of the Navigation system and stored for future reference. The distal femoral 

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bone resection will be completed and the block removed. Completion of the bone 
preparation of the distal femur will be undertaken using manual instruments. 
 
The same procedure will be performed on the proximal tibia using the appropriate 
Stryker ShapeMatch® Cutting Guide.  
 
Trial components will be inserted into the joint and measurements of limb alignment 
and joint kinematics will be performed using the Navigation system. 
 
Each of these measurements form routine assessments performed during total knee 
replacement surgery using the Stryker eNact Navigation System. 
 
Once these measurements have been performed, the surgeon will resume the 
surgical technique for implantation of the Stryker Triathlon Primary Total Knee 
System using either CR or CS components. If the surgeon identifies intra-operatively 
that treatment using PS components is deemed more suitable, then this will be 
carried out. The final choice of components used will be noted on the relevant Case 
Report Form. 
 
Appropriate post-operative care will be provided according to the preference of the 
treating physician. Post-operative assessments will be undertaken according to the 
study protocol. 
 
10.0 INFORMED CONSENT 
 
The Investigator will inform potential study candidates of the purpose of the study, 
proposed duration of the study, including the study-specific procedures and 
evaluations.  The Investigator will discuss foreseeable risks involved, as well as 
potential benefits that may result for future participants through the outcomes of this 
study.  Following this verbal discussion with the Investigator, participants will then be 
given time to read, understand, and, if agreeable, sign the study-specific Participant 
Consent Form indicating their agreement to participate in the study.   
 

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De-identified patient information will be used during the analysis of the results of the 
clinical study and the confidentiality of the participants will be maintained at all times.  
Patient records will be stored with the surgeon’s normal secure record storage 
system.  
 
The participants will be informed by the Investigator that they are free to refuse 
participation in this Investigation, and if they decline or withdraw from the study at any 
time this will not compromise further medical care. 
 
A signed and dated Participant Consent must be obtained by the Investigator from the 
patient prior to enrolment into this study. The original signed and dated information 
sheet and patient consent will be kept by the Investigator.  A copy will be provided to 
the patient, and another copy placed in the patient’s hospital medical record.   
 
Should a patient undergo any study procedure without signing a Participant 
Information and Consent Form, the Investigator must notify the applicable Ethics 
Committee and study sponsor of the deviation, detailing the circumstances which 
resulted in the failure to obtain informed consent.  The Investigator will then follow 
Ethics Committee instructions on how to handle patient/situation and obtaining 
consent. 
 
Patients willing to participate in the extension study will undergo a second consent 
process with a new patient information sheet detailing the additional study-specific 
procedures. This process will be carried out in the same manner as the original 
consent. 
 
11.0 EVALUATIONS 
 
All data will be recorded on the Case Report Forms. The designated signatory (e.g. 
investigator, delegated authority, participant, etc) will complete and sign forms at the 
time of each required visit specified by the study protocol. 
 
Only participants in Group B will have detailed information collected pre- and post-
operatively as part of their involvement in this study. Participants will have Anterior-

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Posterior (AP) and Medio-Lateral (ML) X-rays taken pre-operatively and post-
operatively as part of their standard-of-care. In addition, a CT scan according to the 
Perth CT protocol will be taken post-operatively. Participants will be assessed at 6 
weeks, 3 months and 6 months after surgery. 
 
The following data will be captured throughout the study:  
 
Patient Demographics (Groups A & B): A record of the patient’s date of birth, 
gender, height, weight, and medical history will be obtained pre-operatively. 
 
Operative Details (Groups A & B): A summary of the surgical procedure will be 
collected during the operation. This will include details of the surgical approach, 
prosthetic components implanted, operating time and comments. In addition, 
measurements will be taken intra-operatively using the Stryker eNact Knee 
Navigation System. This will quantify cutting guide position, limb alignment and limb 
kinematics during the procedure. 
 
Medical Imaging (Group B and Extension Study participants only) 
Standard AP and ML X-rays of the affected limb will be obtained pre-operatively and 
post-operatively. A CT scan according to the Perth CT protocol (Appendix 3; 
Chauhan et al, 2004) will also be undertaken to obtain detailed three-dimensional 
descriptions of the position and orientation of the implant components. This position 
will be compared to the pre-operative plan to assess the efficacy of the customized 
bone cutting guides to implement the alignment goal. 
 
In the Extension Study, participants will undergo two Long Leg AP weight bearing x-
rays to evaluate alignment of the limb; one at 12 months and one at 5 years post 
surgery.  
 
Patient outcome measurements (Group B only) 
 
The International Knee Society System (IKSS) separates findings in the operated 
knee with findings in the patient's function. As such the Knee Score is not artificially 
affected by co-morbid conditions. The Knee Score consists of points given for pain, 
range of motion, and stability in both the coronal and sagittal planes, with deductions 

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for fixed deformity, and extensor lag. The Function Score consists of points given for 
the ability to walk on level surfaces, and the ability to ascend and descend stairs, with 
deductions for the use of external supporting devices (Appendix 4; Insall et al; 1990).  
 
SF-12 v2: is a multi-purpose, short-form health survey with only 12 questions, derived 
from the original SF-36. It yields an 8-scale profile of functional health and well-being 
scores as well as psychometrically-based physical and mental health summary 
measures and a preference-based health utility index (Appendix 4; Ware, 2000). It is 
a generic measure, as opposed to one that targets a specific age, disease, or 
treatment group. Accordingly, the SF-12 has proven useful in surveys of general and 
specific populations, comparing the relative burden of diseases, and in differentiating 
the health benefits produced by a wide range of different treatments.  
 
KOOS: Self administrating survey form which assesses the patient’s opinion about 
their knee and associated problems. It is designed to assess subjects with relatively 
high-level of knee joint function and hence can be used to minimize ceiling effects 
resulting from other less-discriminating knee outcome scores. It consists of 5 
subscales: pain; symptoms; function in daily living; function in sport and recreation 
and knee-related quality of life (Appendix 4; Roos et al; 1998). The original and 
complete WOMAC Osteoarthritis Index (more typically used for assessment of 
osteoarthritic knee function) is also contained within KOOS, and can be calculated as 
a sub-scale. 
 
VAS: A Visual Analogue Scale (VAS) is a measurement instrument that tries to 
measure a characteristic or attitude that is believed to range across a continuum of 
values and cannot easily be directly measured. For example, the amount of pain that 
a patient feels ranges across a continuum from none to an extreme amount of pain. 
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).  
 
FJS-12: 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, 2012).  

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Medical History Review: For participants in the extension study, details of any 
significant medical events from time of surgery to 12 month visit will be recorded to 
ensure no adverse events have occurred between termination from Group B study 
and re-enrolment into Extension study. 
 
All information on general medical, operative and device related complications will be 
documented and tabulated on case report forms (CRF). 
 
All information on complications (date of occurrence, description, severity, related to 
study device, treatment and resolution) will be recorded at the time of occurrence. 
 
All information on protocol deviations including the type of deviation (informed 
consent, inclusion/exclusion criteria, treatment, tests not performed and follow-up) will 
be recorded at the time of occurrence. 
 
12.0 STATISTICAL METHODS 
 
12.1 Sample Size Justification 
Group A 
No published data currently exists on the reliability and repeatability of the ability of 
surgeons to position the patient-specific cutting guides on the femoral and tibial bone 
surfaces. This is an observational case series with no sample size calculation. The 
study uses a sample size of convenience, based on the number of study sites and 
anticipated recruitment rate at each site.  
 
Group B 
Howell et al (2008) reported improvements in post-operative Knee Society Score 
resulting from the use of ShapeMatch® Cutting Guides for total knee replacement. A 
comparison of these results with those reported by Matziolis et al (2007) when using 
computer-assisted surgery for total knee replacement suggests that such differences 
may be clinically significant. An improvement of 15 points in the Knee Society Score 
(from 150 to 165 points, out of a maximum of 200) with a standard deviation of 35 can 
be assumed as representing a clinical significant improvement. Using these figures, 

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with 80% power, power analysis indicates that 87 patients per group are required. 
This does assume comparison of two independent groups with the t-test. Allowing for 
patient drop out, a minimum of 100 cases is recommended. 
 
All 100 cases will be invited to participate in the Extension Study. 
 
12.2 Data Capture and Analysis  
All data will be recorded on 2-part NCR paper Case Report Forms (CRFs). The 
surgeon will complete and sign forms at the time of completion. Original 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 6). 
 
Any unclear or ambiguous data will be queried and all cleaned data will be entered 
into a database for tracing purposes.  
The primary outcome data gathered from Group A will be assessed using a repeated-
measures analysis (Hopkins, 2009) to determine the mean and standard error of 
measurement between successive pairs of trials. Multiple surgeons gathering 
repeated measures on individual patients will be pooled to take into account varying 
knee anatomies and intra-observer variation. 
 
The data from Group B and the Extension Study will be summarised and descriptive 
statistics will be utilised for analysis of the primary and secondary outcomes. The 
mean, median, standard deviation, minimum and maximum will be presented for 
quantitative variables. Statistical tests will be employed as deemed appropriate by a 
biostatistician. A significance level of 0.05 will be used for comparative tests. 
 
Adverse events will be tabulated separately and reviewed for any commonalities.  
Revision surgery data from the Extension Study will be compared to the revision rates 
reported in the National Joint registry Report at 12 months, 2 years and 5 years. A 
cost benefit analysis will be undertaken with the use of data from the Australian 
Government Hospital Casemix Protocol Annual Report.  
 
A formal interim analysis will take place following completion of each Group A and 
Group B sub-studies.  Additionally, formal interim analyses will take place following all 

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participants’ completion of the 12 month visit, again following completion of all 
participants’ 2 year visit and final analysis will take place following completion of all 
participants’ 5 year follow-up visits.  
 
13.0 SELECTION CRITERIA FOR INVESTIGATORS/SITES 
 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, and with adequate facilities and trial staff. 
 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 Human 
Research Ethics Committee (HREC) endorsement of trial protocol, patient 
information and consent forms and any other information given to subjects. 
 All trial related documents are subject to HREC review. A regular trial report is 
also mandatory for provision to the HREC (in accordance with local HREC 
requirements). 
 The investigator/institution shall permit trial related monitoring, audits, HREC 
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. 

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 No deviation from protocol may occur without HREC 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 review of the inclusion and exclusion criteria must be completed by the Investigator 
pre-operatively for each patient.   
 
A patient will be identified as a patient in this clinical trial upon signing a study 
informed patient consent form. 
 
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 Completion Form. 
 
16.0 QUALITY ASSURANCE OF DATA 
Case Report Forms 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.  
 
Stryker Australia will monitor each investigational site at regular intervals to ensure 
compliance with the protocol and capture of any data or complications not already 

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documented. Verification of the data from source documents will also be conducted 
by the Stryker monitors. 
 
17.0 MANAGEMENT OF CONCURRENT 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 total knee joint replacements, it can reasonably be expected that 
concurrent illnesses or procedures may be experienced by study participants.  
 
 
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 
 Death 
 Unable to Return  
 Unwilling to Return 
 Concurrent Illness  
 Lost to follow-up 

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 Re-operation of the affected knee joint, including revision of total knee 
replacement components 
 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 Completion Form will be completed for all participants who withdraw from the 
study. 
 
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 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. 
 

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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: 
 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 medically important event or reaction. 
 
19.2 Reporting of Events 
 
Adverse Events: 
 
Any adverse event that occurs at any time point from the beginning of the 
surgical procedure until either the patient is terminated from the study, or 30 
days post-completion, 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). Information 
should include date of occurrence, description, severity, relationship to study device, 
treatment and date of resolution.  
 

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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 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 

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committee. All other Serious Adverse Events 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 HUMAN RESEARCH ETHICS COMMITTEE (HREC) 
20.1 Approval 
The Investigator is responsible for obtaining Ethics Committee and Governance 
approval to conduct this study.  
 
20.2 Prior to Initiation of the Study 
The Investigator must wait for written approval by their 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. 
 
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 to the 
sponsor and to the Investigator’s Ethics Committee. 
 
20.4 Withdrawal of Ethics 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 Investigation, each Investigator will submit an Ethics Close-
Out Report on his/her part of 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 RESPONSIBILITES 
 
21.1 Reports 

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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. 
Any significant results from interim analyses will be communicated to the 
Investigator/s and ethics committee/s, and any required changes to the protocol as a 
result of these analyses will be submitted as protocol amendments to the reviewing 
HREC. 
 
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 Trial 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 
number of subjects required for the study 
 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 Trial 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. 

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The Monitor will report to the Stryker Clinical Research Manager any non-compliance 
by the Investigator with the signed Clinical Trial 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.   
 
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.  Based on the above design and planned analysis, we believe 
this Case Series Protocol is scientifically sound and that the clinical evaluation of the 
experimental procedure is justified. 
 
24.0 BIBLIOGRAPHY 
1. Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint 
arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-
436.e1. 
 
2. Bourne RB, Chesworth BM, Davis AM, et al. Patient satisfaction after total knee arthroplasty: who is satisfied 
and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. 
 
3. Chauhan SK, Clark GW, Lloyd S et al. Computer-assisted total knee replacement – A controlled cadaver 
study using a multi-parameter quantitative CT assessment of alignment (The Perth CT Protocol). JBJS (Br) 
2004; 86-B:818-23. 
 
4. Chauhan SK, Scott RG, Breidahl W. Computer-assisted knee Arthroplasty versus a conventional jig-based 
approach. JBJS (Br) 2004; 86-B:372-7. 
 
5. Coughlin KM, Incavo SJ, Churchill DL et al. Tibial axis and patellar position relative to the femoral epicondylar 
axis during squatting. J Arthroplasty 2003; 18(8):1048-55. 

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6. Eckhoff DG, Bach JM, Spitzer VM et al. Three-dimensional mechanics, kinematics, and morphology of the 
knee viewed in virtual reality. JBJS (Am) 2005; 87-A:71-80. 
 
7. Hopkins WG. A new view of statistics [online] http://www.sportsci.org/resource/stats/ Accessed 1/7/2010. 
 
8. Harwin SF, Greene KA, Hitt K. Triathlon total knee arthroplasty – 4-year outcomes with a high-performance 
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Development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;78(2): 88-96. 
 
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Res Nurs Health 1990; 13: 227-36.  

CONFIDENTIAL                                                                                         ShapeAUSEx-12 
Protocol TriShapeMatch-10(with ShapeAUSEx-12 Extension Study) V8.0- 21August2012                         
 
 
APPENDIX 1 
 
OtisMed Custom Fit Total Knee Replacement  
Using ShapeMatch® Technology 
 

CONFIDENTIAL                                                                                         ShapeAUSEx-12 
Protocol TriShapeMatch-10 (withShapeAUSEx-12 Extension study) -V8.0 21August2012  
 
APPENDIX 2 
 
MRI Scan Protocol 

CONFIDENTIAL                                                                                         ShapeAUSEx-12 
Protocol TriShapeMatch-10 (withShapeAUSEx-12 Extension study) -V8.0 21August2012  
 
APPENDIX 3 
 
CT Scan Protocol 

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Protocol TriShapeMatch-10 (withShapeAUSEx-12 Extension study) -V8.0 21August2012  
 
APPENDIX 4 
 
Outcome Assessment Tools 

CONFIDENTIAL                                                                                         ShapeAUSEx-12 
Protocol TriShapeMatch-10 (withShapeAUSEx-12 Extension study) -V8.0 21August2012  
 
APPENDIX 5 
 
Declaration of Helsinki 

CONFIDENTIAL                                                                                         ShapeAUSEx-12 
Protocol TriShapeMatch-10 (withShapeAUSEx-12 Extension study) -V8.0 21August2012  
 
APPENDIX 6 
 
ICH Good Clinical Practice (GCP) Guidelines