Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty
Phase: NA
Conditions: Osteoarthritis of the Knee
Sponsor: DePuy Orthopaedics

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PROTOCOL SIGNATURE PAGE 
Principal Investigator: I have read this protocol and agree to conduct this clinical investigation in 
accordance with the design and specific provisions outlined herein. I understand the protocol, and 
I understand I am solely responsible to ensure the investigation is conducted accordance with Good 
Clinical Practices (GCP), applicable country regulations, the Declaration of Helsinki, applicable local 
regulations, the signed clinical study contract with Sponsor and with the protocol outlined herein.  
I will conduct this study as outlined therein and will make reasonable effort to complete the study within 
the time period designated by the Sponsor. 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who 
will assist in the conduct of this study. I will discuss this material with them to ensure they are fully 
informed regarding the device and the conduct of the study.  
I will fulfill the requirements of my Institutional Review Board (IRB) / Ethics Committee (EC), or other 
oversight committee, to ensure complete and continual oversight of this clinical investigation.  
I will use an Informed Consent Document approved by the Sponsor and my reviewing IRB/EC (where 
required).  
I agree to report all information or data in accordance with the protocol and, in particular, I agree to report 
any serious adverse events, device related adverse events, or procedure related adverse events as defined 
in this protocol to the Sponsor and comply with all adverse events reporting requirements of my reviewing 
IRB/EC. 
I agree to permit the Sponsor, its authorized representatives, my reviewing IRB/EC, and any regulatory 
authority/body access to all records relating to the clinical investigation.  
The below signature confirms I have read and understood this protocol and its associated amendments 
or attachments and will accept respective revisions or amendments provided by the Sponsor. 
 
PRINTED OR TYPED NAME 
 
SIGNATURE 
 
DATE 
 
 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
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Table of Contents 
1 
SUMMARY ....................................................................................................................................... 7 
2 
INTRODUCTION ............................................................................................................................. 12 
2.1 
Summary of Preclinical Experience ......................................................................................... 13 
3 
RATIONALE .................................................................................................................................... 13 
3.1 
Study Rationale ...................................................................................................................... 13 
3.2 
Study Design Rationale ........................................................................................................... 13 
3.3 
Rationale of Endpoints ........................................................................................................... 14 
3.4 
Rationale of Study Population ................................................................................................ 14 
4 
STUDY RISK / BENEFIT ANALYSIS .................................................................................................... 14 
4.1 
Potential Risks to the Subject ................................................................................................. 14 
4.2 
Minimization of Risk ............................................................................................................... 14 
4.3 
Benefit Analysis ...................................................................................................................... 15 
5 
SUBJECT DEFINITION...................................................................................................................... 15 
5.1 
Inclusion Criteria .................................................................................................................... 15 
5.2 
Exclusion Criteria.................................................................................................................... 16 
5.3 
Definition of Subject Enrolment ............................................................................................. 16 
6 
OBJECTIVES.................................................................................................................................... 17 
6.1 
Primary Objective................................................................................................................... 17 
6.2 
Secondary Objectives ............................................................................................................. 17 
6.3 
Tertiary Objectives ................................................................................................................. 17 
7 
STUDY DESIGN ............................................................................................................................... 18 
8 
PROTOCOL ..................................................................................................................................... 19 
8.1 
Subject Enrolment .................................................................................................................. 19 
8.1.1 
Subject Screening ........................................................................................................... 19 
8.1.2 
Subject Informed Consent .............................................................................................. 20 
8.1.3 
Subject Identification Numbering ................................................................................... 22 
8.2 
Study Procedures ................................................................................................................... 22 
8.2.1 
Detailed Instructions on Data Collection ......................................................................... 22 
8.2.2 
Pre-operative Management ............................................................................................ 25 
8.2.3 
Operative Management.................................................................................................. 26 
8.2.4 
Post-operative Management .......................................................................................... 28 
8.2.5 
Radiographic Procedures ................................................................................................ 29 
8.2.6 
Protocol Deviations ........................................................................................................ 29 
8.3 
Adverse Events ....................................................................................................................... 29 
8.3.1 
Adverse Event Determination ......................................................................................... 30 
8.3.2 
Adverse Events Not Required to be Reported to the Sponsor ......................................... 30 
8.3.3 
Adverse Event Definitions ............................................................................................... 30 
8.3.4 
Adverse Event Reporting Guidelines ............................................................................... 33 
8.3.5 
Safety Oversight ............................................................................................................. 36 
8.4 
Discontinuation of Subject Participation ................................................................................. 36 
8.4.1 
Enrolment Replacement Rules ........................................................................................ 36 
8.5 
Post-operative Withdrawal of Enrolled Subjects ..................................................................... 37 
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8.6 
Revisions ................................................................................................................................ 38 
8.7 
Lost to Follow-up ................................................................................................................... 39 
8.8 
Medical Care Following Study End .......................................................................................... 39 
9 
STATISTICAL METHODOLOGY ......................................................................................................... 40 
9.1 
Study Design .......................................................................................................................... 40 
9.2 
Treatment Assignment ........................................................................................................... 40 
9.3 
Interval Windows ................................................................................................................... 40 
9.4 
Levels of Significance.............................................................................................................. 41 
9.5 
Handling of Missing Data ........................................................................................................ 41 
9.6 
Analysis Sets .......................................................................................................................... 41 
9.6.1 
ITT Analysis Set ............................................................................................................... 41 
9.6.2 
Safety Analysis Set .......................................................................................................... 41 
9.6.3 
PP Analysis Set................................................................................................................ 41 
9.7 
Sample Size Justification......................................................................................................... 41 
9.8 
Analyses to be Conducted ...................................................................................................... 42 
9.8.1 
General Conventions ...................................................................................................... 42 
9.8.2 
Disposition of Study Subjects .......................................................................................... 42 
9.8.3 
Demographics and Baseline Characteristics .................................................................... 43 
9.8.4 
Primary and Secondary Endpoints and Associated Hypotheses ....................................... 43 
9.8.5 
Plans for Interim Analysis ............................................................................................... 45 
10 DEVICE DESCRIPTION ..................................................................................................................... 45 
10.1 
Fixation .................................................................................................................................. 45 
10.2 
Devices .................................................................................................................................. 45 
10.3 
Use of the Study Devices ........................................................................................................ 48 
10.4 
Device Management .............................................................................................................. 48 
10.4.1 
Reporting on Deficient Devices ....................................................................................... 48 
11 INVESTIGATOR RESPONSIBILITES AND GOOD CLINICAL PRACTICES................................................. 49 
11.1 
Qualification of Principal Investigator and Investigational Site ................................................ 49 
11.2 
Institutional Review Board (IRB)/Ethics Committee (EC) Approval .......................................... 49 
11.3 
Informed Consent .................................................................................................................. 50 
11.4 
Protected Health Information ................................................................................................ 50 
11.5 
Subject Completion/Discontinuation from the Clinical Investigation ....................................... 50 
11.6 
Source Documentation........................................................................................................... 50 
11.7 
Case Report Form Completion and Data Submission .............................................................. 51 
11.8 
Protocol Adherence ............................................................................................................... 52 
11.9 
CIP Amendments.................................................................................................................... 52 
11.10 Reports .................................................................................................................................. 53 
11.11 Investigator Site File ............................................................................................................... 54 
11.12 Investigator Study Termination .............................................................................................. 54 
12 SPONSOR OBLIGATIONS................................................................................................................. 54 
12.1 
IRB/EC Approval ..................................................................................................................... 54 
12.2 
Investigator Training, Study Initiation ..................................................................................... 54 
12.3 
Study Monitoring ................................................................................................................... 55 
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12.4 
Sponsor Study Termination .................................................................................................... 56 
12.5 
Insurance ............................................................................................................................... 56 
12.5.1 
Sites ............................................................................................................................... 56 
12.5.2 
Financial Agreement ....................................................................................................... 57 
13 INVESTIGATIONAL PLAN EXHIBITS .................................................................................................. 57 
EXHIBIT A: Listing of Non-Reportable Adverse Events ........................................................................ 58 
EXHIBIT B: Preferred Terms for Select TKA Related Adverse Events .................................................... 59 
EXHIBIT C: Component Product Codes ............................................................................................... 60 
EXHIBIT D: Glossary of Terms ............................................................................................................. 71 
EXHIBIT E: Summary of CIP Versions/Revisions .................................................................................. 72 
EXHIBIT F: Non-Clinic Contact Visit Documents .................................................................................. 75 
14 References ..................................................................................................................................... 79 
 
The Sponsor maintains an updated list of Principal Investigators, Sites and Institutions within the Medidata 
RAVE system. The definitive list shall be integrated into the study report.  
 
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2
INTRODUCTION
Primary total knee arthroplasty (TKA) is a common, elective surgical procedure performed frequently to 
alleviate pain most frequently due to osteoarthritis, with factors such as age (older being more frequently 
replaced) and gender (females being more frequent sufferers of knee OA) influencing the patient 
demographics1. The clinical demand for TKA use is increasing, with demand for primary total knee 
replacement in the United States alone being forecast to rise by over 600% to 3.48M from 2005 to 20302.   
TKA components can be fixed to the bone with or without cement. Whilst cemented fixation remains the 
gold standard 3-8, the optimal implant fixation remains a debate.  Aside from the choice of implant system, 
the clinical decision relating to implant fixation is heavily influenced by surgeon training and regional 
preferences. For example, comparing the results of 2 national joint registries of all the primary TKAs 
performed in 2018, in Australia 9.9% of these procedures used fully cementless fixation9  whilst in the UK 
3.8% of TKAs were fully cementless10. Lastly, even if a given surgeon utilizes cementless TKA routinely, 
patient to patient differences may cause a surgeon to deviate from their standard of care based on the 
needs of the patient. Surgeons’ fixation choice can also vary treatment from patient to patient due to 
factors such as intraoperatively observed bone quality and patient expectations. According to Fricka et. 
al.11 “the potential benefits of cementless fixation include preservation of bone stock, shorter operating 
room time, ease of revision, and the elimination of complications associated with cemented fixation, 
including third body wear and retained loose fragment.”  Designs using cementless fixation are also 
preferred by some surgeons often in their treatment of younger patients due to the fact that the 
procedure preserves more of the bone stock than cemented fixation designs and the fixation achieved is 
physiologic and can respond to stresses in a physiologic manner12. It has been shown that the survivorship 
of cemented TKA in younger patients is not as good as in the older population13 and the younger patients 
(<50) have a 4.7 times higher likelihood of revision due to aseptic loosening in the first year compared to 
patients over the age of 6514. Despite the excellent long term survivorship of cemented TKA3-7, several 
authors have also raised concerns about the long term durability of bone cement, particularly for younger 
patients15,16.  
Cementless knee prostheses have been on the market for 30 years, with designs evolving over that time 
period. Cementless TKA that achieves a good initial fixation, sufficient to allow good bone ingrowth, has 
the ability to deliver a reliable long term fixation, as evidenced by a number of publications on long term 
follow-up of cementless TKAs17-20.  
As knee arthroplasty overall has evolved (both by implant design and surgical technique), patients have 
become more demanding and the mean age at which patients are receiving a primary knee replacement 
is decreasing with the proportion of patients younger than 65 increasing2,9. Younger patients generally 
want to live a more active lifestyle and to meet this demand; prostheses that enable higher flexion are 
now available on the market.   
In 2011, DePuy Synthes Joint Reconstruction introduced the ATTUNE Knee System with a goal of 
addressing the unmet needs of patients, surgeons, and hospital providers. The initial offering was only 
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available for cemented fixation. The high-level system goals were to improve function through motion 
with stability, improve patient fit, improve patellofemoral function, improve design/materials for 
durability, and advance surgical process for implant positioning and OR efficiency. In order to bring the 
ATTUNE Knee System design principles to those surgeons who prefer to treat their patients with 
cementless fixation, the 3-D printed ATTUNE Cementless Fixed Bearing (FB) Tibial Base has been 
developed and is the focus of this study. These components are to be used in conjunction with the ATTUNE 
Cementless Cruciate Retaining (CR) and Posterior Stabilized (PS) femoral components (already 
commercially available in the markets to be included in this clinical study) and ATTUNE FB CR, MS and PS 
Tibial Inserts. 
All implant components are commercially available for use in the United States. 
 
2.1
Summary of Preclinical Experience
There are numerous in vitro publications available regarding the design of the ATTUNE knee system.  The 
key areas of research included: anthropometrics and kinematics21-29.   The in vitro results are encouraging 
and reflect the design goal of improving patient satisfaction. The ATTUNE Cementless FB Tibial Base has 
been designed to incorporate 3D printed technology and a titanium porous surface structure, which have 
been shown to increase pull-out force and optimize bone ingrowth30,31.  
 
3
RATIONALE
3.1
Study Rationale
The ATTUNE Cementless Knee System includes both a rotating platform (RP) and fixed bearing (FB) option. 
Currently, the RP configuration is on the market and being used worldwide.  Data on the RP configuration 
is being gathered through a post-market clinical study of 498 enrolled subjects with over half of the 
subjects past their 2-year follow-up visit.  The early signs from that study support the system delivers good 
clinical outcomes in terms of Patient Reported Outcome Measures (PROMs) and survivorship. The 
ATTUNE Cementless FB Tibial Base will be investigated through this protocol with the aim of 
demonstrating their safety and effectiveness in the population that they are designed to treat. The 
resultant study data will be used for CE mark registration of the Cementless FB Tibial Base device in Europe 
and other regions.  
3.2
Study Design Rationale
The study is designed as a non-comparative, multi-center study with each site initially having a cohort of 
approximately 30 Subjects to recruit (maximum of 50 per site). The follow-up period of 5 years was 
selected to assess the early period (the first year) when any initial problems may become evident with 
initial fixation and stability associated with cementless fixation, as well as the medium-term period (out 
to five years) which is a good indicator of longer-term survivorship. Longer-term survivorship will become 
available as the product is captured in National Joint Registries in various markets in the absence of any 
other studies being planned at this point in time.  
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3.3
Rationale of Endpoints
The primary endpoint of the Knee Osteoarthritis and Outcomes Score – (KOOS-Activities of Daily Living 
(ADL), Pain and Quality of Life) at 1 year was selected as it is a good benchmark by which the outcomes of 
Total Knee Arthroplasty (TKA) can be measured with the KOOS being one of the three most commonly 
referenced questionnaires in the TKA literature32. The KOOS scores listed above will be used to find the 
Functional Responder Rate (FRR) at 1 year (further defined in Section 9.8.4.1). KOOS is collected as a 
standard of care in many centers, contains sub-scores that encompass symptoms, routine functional 
activities to more advanced activities, can be reported as a WOMAC score for comparisons with published 
literature,  it is a measure of function which is a relevant manner for assessing recovery and there are 
numerous publications supporting its use33-38.   
3.4
Rationale of Study Population
The population described in the Instruction for Use (IFU) is limited. Candidates for this study include 
patients with a severely painful and/or severely disabled knee function resulting from osteoarthritis, post-
traumatic arthritis, or a failed previous implant provided that bone quality is adequate and there is no 
presence of inflammatory joint disease. The rationale for these inclusion criteria is to enhance the ability 
to pool data across patients recognizing bone defects and/or issues with poor bone quality that render a 
cementless procedure unjustifiable and recognizing that inflammatory disease may introduce differences 
in recovery. 
4
STUDY RISK / BENEFIT ANALYSIS
4.1
Potential Risks to the Subject
Any surgical procedure poses a potential risk and the procedures undertaken as part of this clinical 
investigation are no exception. There are known risks associated with the method of anesthesia (general, 
epidural, local). In addition, there are risks associated with implantation of a device. The risks associated 
with the study devices are similar to those of any primary, cementless total knee replacement. A full 
description of the potential risks related to the ATTUNE Cementless FB is included in the Instructions for 
Use.   In addition to the risks provided in the product IFU, bleeding or excessive blood loss, transfusion 
reaction, or death may occur.  These risks may occur with any total knee arthroplasty procedure. 
Since it is anticipated that study subjects would be undergoing total knee replacement with a Cementless 
total knee system whether or not they enroll in the study, there are no foreseeable study-related risks 
involved with study participation except for the possibility of additional radiation exposure and / or 
unintentional disclosure of protected health information.  Participation in this study may require study 
subjects to have between 1 and 3 additional X-ray examination(s) that they otherwise would not receive 
if they did not take part.  
4.2
Minimization of Risk
Risks have been minimized by designing the device under evaluation (ATTUNE Cementless FB Tibial Base) 
to be similar to commercially available total knee arthroplasty implants used for the same indication. The 
ATTUNE Cementless FB implants have been functionally tested to verify performance characteristics and 
biocompatibility. In addition, only trained Orthopaedic Surgeons with expertise in treating this condition 
will implant the study device within this protocol. 
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Investigators should refer to the ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and 
Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Instructions For Use, and the ATTUNE® 
Knee System Surgical Technique Featuring the ATTUNE® Fixed Bearing Porous Knee for additional 
information. 
The Sponsor will further minimize the identified and/or emergent risks throughout the study by reviewing 
the reported complications and Adverse Effects. Any reported Adverse Events and Device Deficiencies will 
be reviewed and evaluated by the Study Safety Lead assigned to this project. 
4.3
Benefit Analysis
The main benefit of this Clinical Study is that the data will enable the introduction of new implants to the 
market that will enable more surgeons to access the ATTUNE Cementless system (those who prefer a FB 
construct). Subjects involved in this Clinical Study may also have more follow-up visits than they otherwise 
would, which then increases the chance of earlier detection of any problems that may arise. The 
knowledge gained from this investigation may also help future TKA patients. 
5
SUBJECT DEFINITION
Male and female subjects, age 22-80 years, inclusive, with a severely painful and/or severely disabled 
knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided 
that adequate bone is present and are determined suitable to receive the ATTUNE Cementless FB Tibial 
Base and the ATTUNE cemented/Cementless Patella (if the patella is resurfaced) implants are eligible for 
enrolment in this study.  
Subjects who do not meet all inclusion criteria and/or who meet any of the exclusion criteria are 
automatically excluded from study consideration and participation.  
5.1
Inclusion Criteria 
Subjects meeting all of the following specific criteria will be considered for participation in the study: 
 
a)
Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive. 
b)
Subject has a severely painful knee and/or severely disabled knee function resulting from 
osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is 
present.   
c)
The subject requires total knee arthroplasty and would receive the study implant independent of this 
research protocol. 
d)
Subject that is willing to give voluntary, written informed consent to participate in this clinical 
investigation and authorize the transfer of his/her information to the Sponsor  
e)
Subject is currently not bedridden. 
f)
Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing 
and able to perform all study procedures and follow-up visits and co-operate with investigational 
procedures. 
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g)
Subject is able to read and comprehend the Informed Consent Document as well as complete the 
required PROMs in either English or one of the available translations2.  
 
5.2
Exclusion Criteria
Subjects will be excluded from participation in the study if they meet any of the following criteria: 
a)
The Subject is a woman who is pregnant or lactating. 
b)
Contralateral knee has already been enrolled in this study3. 
c)
Revision knee that was previously enrolled in the study as a primary knee (ipsilateral). 
d)
Subject has participated in a clinical study with an investigational product (drug or device) in the last 
two (2) years. 
e)
Subject has had surgery on their contralateral knee within six (6) months of study enrolment or has 
surgery planned on their contralateral knee less than six (6) months of the study surgery. 
f)
Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile 
rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).  
g)
Active local or systemic infection. 
h)
Loss of bone or musculature, inadequate bone quality (e.g. severe osteoporosis), neuromuscular 
compromise or vascular deficiency at the bone site in the affected limb in sufficient degree to render 
the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures that could 
lead to implant instability, joint neuropathy). 
i)
Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral 
ligament integrity. 
j)
The inability to make bone cuts (e.g. inadequate bone stock) so as to assure correct component 
position, a firm press fit, and intimate apposition of the cut bone and prosthetic surfaces. 
k)
Subject is currently involved in any personal injury litigation, medical-legal or worker’s compensation 
claims. 
l)
Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last five 5 years) or has a 
psychological disorder that could affect their ability to complete patient reported questionnaires or 
be compliant with follow-up requirements. 
 
5.3
Definition of Subject Enrolment
A patient will be considered enrolled when they have provided written informed consent to participate in 
this Investigation, which includes authorization of the release of their Personal Health Information (PHI). 
 
2 Note the AKS may not be available in all required languages – if there is no translation available for the Subject’s 
primary language then that Subject need not complete that particular eCRF. 
4 This study does not permit enrolment of any subject undergoing simultaneous bilateral knee surgery.  If the 
subject plans staged bilateral knee surgery, the surgeries must be 6 months apart and first knee will be enrolled 
into this study. 
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6
OBJECTIVES
6.1
Primary Objective 
The primary objective of this clinical investigation is to evaluate functional responder rates with an 
objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 
tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision 
procedures) and will be analyzed when these patients have passed the 1 year preferred post-op 
window.  Study success will be determined using the primary TKA (CR FB and PS FB combined) analysis 
group.    
 
 
6.2
Secondary Objectives
The secondary objectives of this study are to establish the surgical effectiveness of the ATTUNE 
Cementless Tibial Base by evaluating: 
 
6.3
Tertiary Objectives
 
The primary and secondary clinical endpoints and the relevant statistical analyses are described in detail 
in Section 9. 
 
x
Type and frequency of Adverse Events and Device Deficiencies.  
x
Functional responder rates with an objective performance criteria (OPC) of 85% as measured by 
the KOOS questionnaire for all subjects at the 1-year timepoint. 
x
The change from preoperative baseline to the 6-week, 6-month, 1-year, 2-year and 5-year 
timepoints in functional outcomes and quality of life assessments, as measured using additional 
patient reported outcomes measures (PROMS):  
o
AKS (2011) 
o
KOOS (all subscores) 
o
FJS-12 (post-op only) 
o
EQ-5D-5L 
x
Implant survivorship of the ATTUNE Cementless FB Tibial Base using Kaplan-Meier survival analysis 
at 1, 2 and 5-year timepoints.  
x
Investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 
months 1, 2 and 5 years after surgery. 
x
Implant survivorship of the ATTUNE Cementless FB Tibial Base using Kaplan-Meier survival 
analysis at 3 and 4-year timepoints.  
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total sample. It is expected that each site will implant approximately 30 subjects (maximum of 50 per site). 
Treatment assignment in this study is not randomized.  Sites are able to enroll subjects with the required 
variants, any allowed configuration until the minimum of 300 cases for that variant (CR FB or PS FB) is 
met.  Once the cases for any particular variant are met, sites will continue to enroll the remaining variants 
until their site maximum of 50 subjects is met.  Details regarding sample size are presented in Section 9.7.  
The Sponsor will monitor overall project enrollment. The Sponsor can authorize a shift of a group of 
Subjects from one site to another to maintain project timelines.   For example, the Sponsor can reduce 
the cohort of a slow-enrolling site to a faster-enrolling site and the faster-enrolling site will assume 
responsibility for the reallocated cohort.  
Primary Endpoint analyses will be conducted after 225 patients who have undergone TKA have passed 
the 1 year preferred window for submission to regulatory authorities. The remaining follow-up through 5 
years will further evaluate mid-term outcomes and support post-market clinical follow-up commitments.  
The Investigator should follow their current standard of care with respect to patellar resurfacing. 
Specifically, the Investigator can choose to: 
x
resurface the patella with a cemented ATTUNE patella. 
x
leave the patella unresurfaced. 
 
When the ATTUNE Cementless Patella becomes available to the Sites, the Investigator can choose to:  
x
resurface the patella with an ATTUNE Cementless Patella. 
x
resurface the patella with a cemented ATTUNE Patella. 
x
Leave the patella unresurfaced. 
 
 
8
PROTOCOL
8.1
Subject Enrolment
No study-specific procedure, eCRF or form associated with this study can be completed using a patient’s 
personal and/or medical information until written Informed Consent is obtained for that Subject (see 
Section 5.3. Definition of Subject Enrolment).   
8.1.1 Subject Screening
All patients who present with osteoarthritis, post-traumatic arthritis, or a failed previous implant  affecting 
the knee, and are candidates for cementless TKA, and who generally meet the study requirements, will 
be screened for eligibility and will be listed on the Screening and Enrolment Log in order to document that 
the Subject selection was unbiased. The date of screening, the results of screening (included or not) and 
if applicable, the primary reason for not including the patient (e.g., does not satisfy eligibility criteria, not 
interested in participating) will be recorded on this log. The original log is to be retained at the Site and a 
copy sent to the Sponsor regularly during enrolment.   
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Eligible patients who agree to participate in the study will be required to sign an Informed Consent 
Document prior to any study-specific procedures being done.  After signing the Informed Consent, study 
Subjects are defined as “enrolled” and site will complete the non-standard of care pre-operative data 
collection. 
It is expected that complete data collection will be obtained for all enrolled Subjects, with the only 
exceptions being a Subject who is subsequently withdrawn (see section 8.4 Discontinuation of Subject 
Participation for details). 
8.1.2 Subject Informed Consent
The Principal Investigator is responsible for ensuring that no Subject is included in the study without 
adequate informed consent being provided.  Failure to obtain and properly document this process is in 
violation of ISO 14155, the Declaration of Helsinki, and this study protocol.   
All Informed Consent Documents (ICD) must have favorable opinion of the responsible IRB/EC and 
reviewing Regulatory Authority, as applicable (Section 12.1). Consent of a Subject needs to be from the 
Subject themselves and documented on an ICD in the primary language of the Subject as well as the 
process of consent documented in the Subject’s source medical records.  Each Subject will be allowed 
sufficient time to decide whether they wish to participate in this clinical investigation. Written informed 
consent from the Subject MUST be obtained before any of the study-specific procedures are performed 
and PRIOR TO the Day of Surgery. Acquiring consent on the day of surgery will be considered a Protocol 
Deviation.  Note:  On review and approval by Sponsor, a CRF completed as part of an investigator’s 
standard of care (e.g. KOOS) can be used as a source document for study required PROMs after the 
study informed consent has been signed. 
Screening, consenting and enrolment are illustrated in Figure 8-1.  The Investigator or trained designee 
preliminarily screens to determine if a patient generally meets the eligibility criteria for the study. If so, 
the Investigator or trained designee shall offer study participation to those patients. Having explained the 
study intent to the Patient, the Investigator or trained designee shall offer to answer any of the Patient’s 
questions. If the Patient then agrees to participate, his or her willingness must be documented via a 
signature and date on the IRB/EC’s approved ICD and this document subsequently countersigned and 
dated by the person taking consent with a copy of the signed consent document being provided to the 
study Subject.  This full consent process must be documented by the Investigator or trained designee. 
Upon successful completion of the consent process, the Patient is enrolled and is identified as a Study 
Subject.   
 
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8.1.3 Subject Identification Numbering 
The database assigns Subject ID numbers after consent is obtained and data are entered into the 
Electronic Data Capture system. 
Each site is identified uniquely, e.g., 
- followed by 
 for the first Subject at the site, 
 
for the second Subject and so on. Together the Site number and the Subject number will then become the 
unique identifier of the Subject and will be recorded on each page of the eCRF and on the Subject 
Screening & Enrolment Log. For example, the first three enrolled patients at site #
 would be: 
. 
In the instance of a Subject being enrolled, a number assigned and subsequently the Subject is deemed 
ineligible prior to receiving the ATTUNE Cementless FB knee, a Subject Completion/Discontinuation eCRF 
should be completed and the Subject will be recorded as a screen failure on the Screening & Enrolment 
log. In the case of pre-operative withdrawals, a further Subject will be enrolled to replace the withdrawn 
Subject in order to ensure a minimum of 600 Subjects are implanted: a minimum of 300 CR FB (CR or MS 
Tibial Insert) and 300 PS FB (PS Tibial Insert) configurations with up to 300 cementless patellae combined 
across both configurations (if market available). Once a Subject identification number is assigned, it may 
not be reused.  Refer to Section 8.4.1 Enrolment Replacement Rules. 
8.2
Study Procedures  
This section is applicable to enrolled study Subjects. The study Surgeons have selected to implant a total 
knee arthroplasty using cementless fixation as their standard of care. Therefore, this study does not limit 
the procedures involved in the treatment of the subject.  The pre-operative, anesthesia, general operative 
procedures post-op care, and follow up are not research procedures, and therefore are not restricted by 
the study and are regardless of the research.  
This section details the study requirements in terms of the pre-operative, operative, and post-operative 
management of Subjects. Visit evaluations include clinical and radiographic evaluations and Subject self-
assessments. eCRFs must be submitted to DePuy Synthes Products Inc. as outlined in Section 11.7 Case 
Report Form Completion and Data Submission.                                  
The patient reported outcome instruments AKS, KOOS, FJS-12, and EQ-5D-5L are compulsory at all sites. 
PROMs are compulsory for those Subjects whose primary language is one in which the tools are available. 
Sites will be advised during training whether validated translations are available in the local language(s) 
applicable to the Site.  
8.2.1 Detailed Instructions on Data Collection
The following evaluation tools are to be used to collect and evaluate study subject outcomes pre-
operatively, intra-operatively and post-operatively as outlined in Table 8-1.  Patient reported outcomes 
(in italics) will be provided in hard copy printed sets for completion by the study subject during a clinic 
type visit.  
The PROM assessments should be the first assessments administered on the visit day. Pre-operative 
PROMs should be performed within the preferred visit window (-90d to -1d prior to surgery).  Note:  The 
required window allows the preoperative assessment to be completed 180 days to 1 day prior to 
surgery.  Each of the questionnaires are to be completed ONLY by the Subject, and usually takes 2-3 
PPD
PP
D
PP
D
PPD
PPD
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NOTE:  If a subject is enrolled in the clinical study prior to 
implementation of this protocol amendment and receives the 
ATTUNE Medial Stabilized Tibial Insert as part of the investigator’s 
standard of care, that subject will remain in the study, but must be 
reconsented with the updated IRB approved ICF which includes the 
Medial Stabilized insert.  A Protocol Deviation must be completed 
for use of a non-study device with the ATTUNE Cementless Tibia.  
Once this protocol is IRB approved, no further Protocol Deviations 
are required for use of the Medial Stabilized Insert from the date of 
IRB approval forward as long as the subject signs the consent 
including the Medial Stabilized Tibial Insert as an option. 
 
In this study, bone cement must not be used with the ATTUNE 
Cementless Femoral or Tibial Base components.  If bone cement is 
used on either of these components, a Protocol Deviation CRF must 
be recorded and the patient will continue in the study as part of the 
Safety Population.  However, if the site is located in the US and uses 
DePuy Synthes Antibiotic Impregnated Bone Cement (off-label use), 
a Protocol Deviation CRF must be recorded and the patient will be 
discontinued from the study (Study Completion/Discontinuation 
eCRF).  The subject will be replaced with another enrolled subject. 
Patellar Treatment 
Study subjects may be implanted with the ATTUNE Cemented 
Patella, ATTUNE Cementless Patella (after product availability), or 
not undergo patella resurfacing as part of their study procedure.   
 
If 
Then 
the site is located in 
the US and the patella 
is resurfaced using an 
ATTUNE 
Cemented 
Patella 
The site is not permitted to use DePuy 
Synthes Antibiotic Impregnated Bone 
Cement (off-label use).  If this occurs, a 
Protocol 
Deviation 
CRF 
must 
be 
completed and the patient will be 
discontinued from the study (Study 
Completion/Discontinuation eCRF).  The 
subject will be replaced with another 
enrolled subject. 
the 
patella 
is 
resurfaced using an 
ATTUNE 
Cementless 
Patella  
In this study, bone cement must not be 
used with the ATTUNE Cementless 
Patella.  If bone cement is used, a 
Protocol Deviation CRF must be recorded 
and the patient will continue in the study 
as part of the Safety Population. 
 
 
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8.2.4 Post-operative Management 
Immediate post-operative management including physical therapy protocol is at the discretion of the 
Surgeon and support staff and should follow each Surgeon’s standard of care. Rehabilitation programs 
are often individualized. 
The methods of data collection and follow-up windows have been selected to achieve the primary 
objective of evaluating functional responder rates from baseline to one year as measured from the KOOS 
questionnaire, as well as providing further data to include survivorship and performance measures out to 
five years. Every effort should be made to schedule the post-operative follow-up within these windows to 
enhance follow-up compliance.  While required interval windows have been designed to be continuous 
to improve follow-up compliance and accommodate various standards of care across sites, this study 
includes preferred windows as well to increase the consistency with respect to the timing of data 
collection, since function is changing with time, particularly in the early recovery phase. 
 
All follow-up visits will be conducted according to the Time and Events Table (Table 1-1), and applicable 
eCRFs must be submitted to DePuy Synthes Products Inc. Data collected during the post-operative 
management of the Subject is listed in Table 8-1.  
 
 
 
8.2.4.1 Postoperative Data Collection Methods:
A postoperative follow-up is to be done ONLY by a clinic visit at the 6 week, 6 month, 1 year, 2 year and 
5 year follow-up windows.  The phone contact visit is to be done only at postoperative years 3 and 4:  
The definition of a Clinic visit as defined by this protocol is either of the below: 
 
 
 
 
x
The Preferred In Clinic Method:  Subject is seen in clinic, receives an assessment of the 
study knee including study required radiographs, the Subject completes the source 
document PROMs and the required data is submitted to the Sponsor as per protocol (See 
Time and Events Table 1-1). 
x
An Alternative PROMS by Mail Method + Phone Contact* (postoperative follow-up only):  
This method is to be done in the event the Subject is either unable or unwilling to be seen 
in the clinic office and agrees to complete and return the study required PROMs by mail 
AND attend a follow-up phone contact visit*. Upon completion of both methods of data 
collection (in the same interval window), an alternative clinic visit will be considered 
completed.  This type of visit allows for the surgeon portion of the AKS and radiographs to 
be optional.  The details associated with administration of PROMs are described in Section 
8.2.1 and apply for this method of data collection A sample cover letter, Contact Form, 
and Phone Script are provided in Exhibit F. 
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The definition of a *Phone Contact visit is defined as: 
 
Phone Contact visits will take the form of a telephone call where a member of the study team, 
typically a Research Coordinator, speaks with the study Subject. The topics to be covered and 
information to be collected during the call will include: confirmation of the Subject’s contact 
information; assessment of whether there has been a revision or any adverse events to the 
Subject’s implanted knee for the study; reminder to the Subject of their next scheduled visit and 
the importance of their continued study participation. As an alternative approach if in keeping 
with sites’ standard of care, the data collected via a phone contact visit can be collected face to 
face (in clinic or virtual) or via mail in lieu of being done over the phone.  
Note:  If a full clinic visit data set is collected at the phone contact intervals (3 & 4 yrs 
postoperatively), the site will only be compensated for a phone contact type visit. 
 
8.2.5 Radiographic Procedures
Radiographs are to be obtained pre-operatively and at either the 6 week or 6 month visit (1st follow-
up/baseline evaluation, timeline as per the Site’s standard of care) and again 1, 2 and 5 years post-
operatively (within the respective windows specified in this protocol). Pre-operative radiographs are to 
be collected as per the Site’s standard of care. AP/PA and Lateral views are required for all Subjects at the 
above post-operative timepoints. Skyline views should also be collected post-operatively for Subjects with 
an implanted patellar component. Investigators will complete questions within the eCRF regarding 
interpretation of the radiographs for each required set of radiographs. 
Radiographic guidelines regarding image collection will be provided to Sites. Sites are also required to 
send all radiographs collected during the course of the study to an external image analysis facility; training 
on the process to transfer images will be provided prior to study start. 
8.2.6 Protocol Deviations
Any deviations from the procedure outlined in this Protocol should be recorded as Protocol Deviations in 
the eCRF (see Section 11.8 for further detail). 
8.3
Adverse Events
For this study, all SAEs, all Device and/or Procedure-Related AEs and all Device Deficiencies must be 
reported for all Subjects.   
x
A telephone call with the Study Subject (See Time and Events Table 1-1). In order to 
optimize the accuracy of survivorship data, enable timely capture of AEs and maximize the 
chance of good long- term follow-up, contact will be made with each Subject at 3 and 4 
years post-operatively. These telephone contact visits will occur in between the 2yr and 
5yr clinic visits and will ideally occur within the preferred window.  No PROMs are to be 
completed. 
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Figure 8.2 AE Reporting Flowchart 
 
 
 
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8.3.4.2 Institutional Review Board (IRB) / Ethics Committee (EC) Reporting 
In any instances of Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Adverse Device 
Effects, Unanticipated Serious Adverse Device Effect, the Clinical Investigator is responsible for informing 
the IRB/EC in accordance with their local procedures. The Clinical Investigator should institute appropriate 
therapeutic and follow-up measures in accordance with good medical practice and record them in the 
subject’s source documentation.  
8.3.4.3 Regulatory Reporting Requirements 
All reported protocol-required AEs will be reviewed by DePuy Synthes and reported if applicable to the 
appropriate regulatory bodies.  
 
8.3.5 Safety Oversight
Safety oversight will be conducted by the study Safety Lead. Study data will be reviewed periodically 
throughout the Study in order to promptly identify new issues or trends which may have an impact on the 
conduct of the study and/or Subject safety. 
 
8.4
Discontinuation of Subject Participation
Study participation may be discontinued through screen failure, not receiving the tibial base implant, 
revision of the femoral and/or tibial component(s), withdrawal of consent, or death. Table 8-8 describes 
how data will be captured on Subjects that are discontinued prior to receiving the study device while Table 
8-9 describes post-op withdrawal scenarios. In all cases, once a subject is enrolled (per Figure 8-1), if they 
discontinue study participation, the Subject Completion/Discontinuation eCRF must then be completed. 
8.4.1 Enrolment Replacement Rules
Since Subjects are enrolled at the time of consent, any Subject that is withdrawn pre-operatively and or 
does not receive the study required tibial / femoral implants will be replaced with a subsequent Subject.  
Overall, the number of Subjects who receive a TKA procedure with the study required tibial / femoral 
components across all sites must meet the minimum sample size of 300 patients per configuration (CR 
Femoral with CR or MS Tibial Insert or PS Femoral with PS Tibial Insert) and up to 300 cementless patellae 
(across both configurations). Intra-operative withdrawals will also be replaced with a subsequent Subject 
and will be assessed to understand reasons why the implant was not appropriate for use in that subset of 
Subjects. 
 
 
 
 
 
 
 
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9.4
Levels of Significance
Where estimated, all confidence intervals will be 95% confidence intervals. For the primary endpoint 
hypothesis test an alpha = 0.05 will be used to determine statistical significance. No adjustments will be 
made for multiplicity as this is the only hypothesis in the study. 
9.5
Handling of Missing Data
Only actual data will be analyzed; there will be no imputation of missing data.   
9.6
Analysis Sets
The following analysis sets are defined for the purpose of analysis: an Intent to Treat (ITT) analysis set, a 
Safety analysis set, and a Per Protocol (PP) analysis set.  The analyses of adverse events and the Kaplan-
Meier analysis of revisions will be carried out on the Safety analysis set. The primary endpoint analysis 
and all secondary endpoint analyses will be carried out on the Per Protocol analysis set.  The analysis of 
the tertiary endpoints will be carried out on the PP analysis set unless otherwise stated in the final clinical 
summary report. 
9.6.1 ITT Analysis Set  
The ITT analysis set consists of all subjects who are consented and enrolled into the study. Subjects in the 
ITT analysis set who do not undergo surgery to implant the ATTUNE Cementless FB tibial base will be 
withdrawn from the study without any further data collection.  The purpose of this analysis set is to 
provide accountability for these subjects who do not receive the ATTUNE Cementless FB tibial base 
system.  There are no other analyses which are planned for this dataset. 
9.6.2 Safety Analysis Set  
The Safety analysis set consists of all ITT subjects who undergo surgery to implant the ATTUNE Cementless 
FB tibial base.  Subjects who withdraw from the study prior to surgery will not be included in the Safety 
analysis set. 
9.6.3 PP Analysis Set
The Per Protocol (PP) analysis set is a subset of the Safety analysis set that includes all subjects who meet 
the following criteria:  
x
There are no clinically meaningful deviations from the protocol eligibility criteria, and 
x
The subject receives an ATTUNE Cementless FB tibial base,  
x
The subject has at least one post-operative evaluation in the 6 week or later time window. 
9.7
Sample Size Justification
The primary endpoint in this study will be to estimate the Functional Responder (defined below in Section 
9.8.4.1) rate at 1 year and demonstrate superiority to the 85% objective performance criteria. Functional 
Responder rates are anticipated to be between 91-94% in primary TKA based on a previous study of 
ATTUNE Cemented and ATTUNE Cementless CR RP knees. Using the lowest anticipated rate of 91%, a 
sample size of 191 knees will provide at least 80% power to show superiority of the Functional Responder 
rate compared to the objective performance criteria of 85%, with 95% confidence using a one-sided, 
normal approximation, one-proportion test and associated confidence interval. Accounting for up to 15% 
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attrition at 1 year, the sample size population for analysis of the primary endpoint was increased to the 
first N=225 knees enrolled. 
Due to various global requirements and anticipated regulatory submissions the sample size is increased 
to N=300 per configuration. 
9.8
Analyses to be Conducted
9.8.1 General Conventions 
All analysis will be performed using SAS v9.4 or higher. Statistical summaries (tallies and percentages for 
categorical variables, and sample size, mean, standard deviation, minimum and maximum (and others as 
needed) for continuous variables) at each respective time point, or cumulatively for safety endpoints. 
9.8.2 Disposition of Study Subjects 
A detailed account of all enrolled subjects will be presented in a dataset flow diagram to display the 
analysis datasets, beginning with the set of ITT subjects and explicitly listing the subjects with 
distinguishing reasons for exclusion from the other datasets. A template of this dataset flow diagram is 
given in Figure 8-1 below. 
Figure 9-1: Analysis Set Flow Diagram 
 
 
 
 
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9.8.3 Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be summarized overall and by configuration. The 
demographics characteristics will not be compared statistically. 
9.8.4 Primary and Secondary Endpoints and Associated Hypotheses
Each endpoint below will be analyzed for all knees and separately for primary and revision procedures 
and CR FB (CR or MS Tibial Inserts) and PS FB configurations, unless otherwise specified. 
 
9.8.4.1 Primary Endpoint and Associated Hypotheses
The primary endpoint is the Functional Responder Rate (FRR) at 1 year. A Functional Responder is defined 
as: 
x
A subject that shows at least 20% improvement from baseline and at least a 10-point 
improvement from baseline in at least 2 of the following categories: 
o
KOOS (ADL) 
o
KOOS (Pain) 
o
KOOS (Quality of Life) 
 
Functional Responder rates are expected to be between 91%-94%. The objective performance criteria 
for study success is 85%. 
 
ܪ଴: ܨܴܴ ൑85% 
 
ܪ஺: ܨܴܴ> 85% 
 
The primary endpoint will be performed on the first 225 tibia implanted with the ATTUNE Cementless FB 
tray (primary and revision procedures, CR FB and PS FB combined) and will be analyzed when these 
patients have passed the 1 year preferred post-op window (395 days). This analysis will be done on the 
Per Protocol (PP) population.  Study success will be determined using the primary TKA (CR FB and PS FB 
combined) analysis group.  
 
 
 
 
 
 
 
 
 
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9.8.4.2 Secondary Endpoints and Associated Hypotheses
The secondary endpoints in this study are: 
 
All secondary endpoint analyses may be conducted after all patients have passed the recommended study 
window (ex. with a 2-year follow-up analysis conducted after all subjects have passed 790 days post-op).  
All analyses at these time points will be conducted again with final data, along with endpoints which have 
a 5-year follow-up time point, with locked data at the close of the study.   
A Kaplan-Meier survivorship model will be used to estimate survivorship rates (where a revision is defined 
in Section 8.6) along with a two-sided, log-log based 95% confidence intervals; this analysis will be 
conducted on the Safety analysis set.    
The types and frequencies of adverse events that occur throughout the study will be tabulated by 
MedDRA system organ class (SOC) and preferred term (PT) for all Subjects in the Safety analysis set. The 
proportion of Subjects experiencing each complication (PT within SOC) will be presented, and a 95% 
confidence interval will be estimated with the binomial exact method. 
All other specified secondary endpoints will be presented with statistical summaries at each respective 
time point; these secondary endpoint analyses will be carried out with all data on subjects in the Per 
Protocol analysis set. 
 
 
 
x
Type and frequency of Adverse Events and Device Deficiencies.  
x
Functional responder rates with an objective performance criteria (OPC) of 85% as 
measured by the KOOS questionnaire for all subjects (CR FB and PS FB combined) at the 1 
year timepoint.   
x
The change from preoperative baseline to the 6 week, 6 month, 1 year, 2 year and 5 year 
timepoints in functional outcomes and quality of life assessments, as measured using additional 
patient reported outcomes measures (PROMS):  
o
AKS 2011 
o
KOOS (all subscores) 
o
FJS-12 (changes post-operatively only) 
o
EQ-5D-5L 
x
Implant survivorship of the ATTUNE Cementless FB Tibial Base using Kaplan-Meier survival analysis 
at 1, 2 and 5 year timepoints.  
x
Investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 
months, 1, 2 and 5 years after surgery. 
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9.8.4.3
Additional Endpoints
Additional endpoints include: 
 
Duration of surgery (“skin to skin” time) may be analyzed any time after all subjects have been enrolled 
and undergone surgery.  All other post-operative tertiary endpoints may be conducted after all subjects 
have passed the preferred post-op window.  All analyses at these time points will be conducted again with 
final data, along with endpoints which have a 5-year follow-up time point, with locked data at the close 
of the study.   
9.8.5 Plans for Interim Analysis 
There are no formal interim analyses planned with the intent of early trial closure.   
Interim summaries may be performed as required, for example to provide information to Regulatory 
Authorities or Notified Bodies. 
10 DEVICE DESCRIPTION
 
All implant components are commercially available for use in the United States.  The intended purpose, 
indications, contraindications and population are described in the Instructions for Use (IFU), which is 
contained in the packaging of all products marketed in the United States. 
10.1 Fixation
ATTUNE Cementless Cruciate Retaining (CR) or Posterior Stabilized (PS) Femoral implants are to be used 
in combination with the ATTUNE Cementless Fixed Bearing (FB) Tibial Base implant and appropriate Tibial 
Insert and must be used without bone cement.  If any Cementless components are cemented, a Protocol 
Deviation eCRF must be completed and the subject will continue to be followed as part of the Safety 
Population.  See Table 8-2 Protocol Requirements During Surgery for additional details regarding fixation 
requirements. 
10.2 Devices
A list of devices permitted for Subjects enrolled in the study is presented in Table 10-1.  All Investigators 
will be trained on the use of these devices prior to their first enrolment.  The components permitted for 
each of the two (2) constructs is defined in Table 10-1.  The details of the individual components are 
provided in Table 10-2. Additional, detailed information regarding component product codes are provided 
in Exhibit B. 
 
 
 
x
Implant survivorship of the ATTUNE Cementless FB Tibial Base using Kaplan-Meier survival 
analysis at 3 and 4 year timepoints.   
x
To evaluate the duration of surgery (“skin-to-skin” time) for all surgeries, with analysis 
stratified by cemented/Cementless patella usage. 
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10.3 Use of the Study Devices
In addition to the CIP training provided, all Investigators will receive training with the Study Devices, to be 
arranged by the Sponsor, prior to implanting the ATTUNE FB Tibial Base as part of this clinical investigation. 
10.4 Device Management
Device Deficiency reporting for this clinical study includes both the implantable components and the 
instrumentation.  Specific device accountability is not required for this study as it is entirely post-market.  
Implant catalog and lot numbers will be collected.  
10.4.1
Reporting on Deficient Devices
All study Sites (regardless of Site location) are required to report Device Deficiencies relating to ANY of 
the implantable ATTUNE components, component packaging, and instrumentation to the Sponsor via the 
Device Deficiency eCRF (see Section 8.3).   In the event a device deficiency is associated with a Study 
Subject experiencing an adverse event, the Adverse Event eCRF is also required to be submitted to the 
Sponsor.  
 
 
 
UHMWPE and are available in right and left 
sizes 1-10 and thickness from 5, 6, 7, 8, 10, 
12, 14 and 16.  Tibial inserts are sterilized 
using gamma irradiation. 
CE mark &  
510(k) 
clearance 
Cemented 
Patellaes 
Medial 
Offset 
The patellar components are manufactured from UHMWPE and 
are available in two styles, medialized dome and medialized 
anatomic. They are available in 5 sizes with proportionally 
increasing thicknesses from 8.5 to 10.5 mm. Patellar 
components are sterilized using gamma irradiation. They are 
available for cemented use only. 
Anatomic 
510(k) 
clearance 
Cementless 
Patellaes 
Medial 
Offset 
The cementless patellar components are manufactured from 
UHMWPE overmolded onto 3D printed titanium conforming to 
ASTM standard F-3001 and the bone opposing surfaces are 
comprised of 3D printed porous coating technology. The 
anterior surface is designed to work with currently available 
ATTUNE CR and PS femoral components.  They are available in 
4 sizes with proportionally increasing thicknesses from 9.0 to 
10.5 mm.  Patellar components are sterilized using gamma 
irradiation.
Anatomic (if 
available 
during 
enrolment) 
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11 INVESTIGATOR RESPONSIBILITES AND GOOD CLINICAL 
PRACTICES
In conducting this medical device clinical investigation the Investigator is responsible for:  
x
Ensuring that a clinical investigation is conducted according to the Declaration of Helsinki, 
applicable local regulations, the signed Clinical Trial Agreement, and the Clinical Investigation 
Plan.    
x
Protecting the rights, safety, and welfare of Subjects under the Investigator’s care; and 
x
Ensuring the integrity of the data.  
Prior to the initiation of this clinical investigation at each site, the responsible Principal Investigator will 
acknowledge their understanding of this Clinical Investigation Plan (CIP) by signing the signature page. 
This signature confirms that the clinical investigation will be performed in compliance with the CIP. 
 
11.1 Qualification of Principal Investigator and Investigational Site
The PI shall: 
 
The PI shall be able to demonstrate that the proposed investigational site: 
 
11.2 Institutional Review Board (IRB)/Ethics Committee (EC) Approval
All Principal Investigators must submit to their institution’s IRB/EC for initial review a copy of the clinical 
investigational plan (CIP), a sample Informed Consent Document (ICD) provided by the Sponsor.  Many 
institutions request modification of the ICD to satisfy specific institutional requirements.  The use of a 
modified or unique Informed Consent Document is permitted provided that the document is reviewed 
and approved by the Sponsor.  Additionally, all translated consent forms require IRB/EC approval.  
All Principal Investigators must submit the Clinical Investigation for continuing review and any other 
additional required submissions to their IRB/EC according to their IRB/EC’s policies and procedures.  
x
be qualified by education, training and experience to assume responsibility for the proper 
conduct of the clinical investigation in accordance with ISO14155. Evidence of such 
qualifications of the PI and key members of the investigative site team shall be provided 
to the Sponsor through up-to-date CVs or other relevant documentation. 
x
be experienced in the field of orthopaedics and total knee replacement and trained in the 
use of the investigational device under consideration. 
x
disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation and/or interpretation of results. 
x
be knowledgeable with the method of obtaining informed consent. 
x
has the required number of eligible subjects needed within the agreed recruitment period. 
x
has one or more qualified investigators, a qualified investigational site team and adequate 
facilities for the foreseen duration of the clinical investigation. 
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Initial approval/favorable opinion and all continuing review approvals must be documented; originals of 
correspondence and approvals are to be filed by the Investigator and copies forwarded to the Sponsor.  
 
11.3 Informed Consent
The Principal Investigator is responsible for maintaining source documents evidencing informed consent 
was obtained from study Subjects prior to participation in the study and the process followed to obtain 
consent.  
If an Investigator performs any study-specific procedures and/or data collection without obtaining 
informed consent, the Investigator will report such action(s) to the Sponsor and the reviewing IRB/EC.  
For further details and a description of the Informed Consent process, please refer to Section 8.1.2, 
Subject Informed Consent. 
11.4 Protected Health Information
The Principal Investigator is responsible to inform study Subjects their personal data will be collected, 
processed, and confidentially maintained in accordance with local data privacy regulation and law. 
United States: The Principal Investigator is responsible for taking the necessary steps to collect, process 
and maintain confidentiality of the Subject’s personal data in accordance with data protection legislation 
including the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Subjects will be asked 
to sign an Authorization for Release of Protected Health Information (PHI) for the purpose of this 
investigation. The authorization may be combined with the ICD, depending on local IRB preference. 
 
Results from the Clinical Investigation may be published. However, Subject confidentiality will be 
maintained at all times and it will not be possible to identify individual Subjects from any data presented. 
 
11.5 Subject Completion/Discontinuation from the Clinical Investigation
Any Subject is entitled to discontinue/withdraw from this clinical investigation for any reason without 
obligation and/or prejudice to further treatment. In addition, the Investigator may decide, for reasons of 
medical prudence, to withdraw a Subject.  
The Investigator will clearly document the date and reason(s) for the Subject’s discontinuation from this 
clinical investigation in the Subject Completion/Discontinuation eCRF and submit to DePuy Synthes Products 
Inc.  
Please 
refer 
to 
Section 8.4 
Discontinuation 
of 
Subject Participation 
for further 
details. 
 
11.6 Source Documentation
The Investigator will maintain a complete, current and accurate case history (Source Documentation 
records) on each study Subject according to the usual procedure at the investigational site. Case histories, 
medical records, including progress notes, hospital charts, nurses’ notes etc. Additional documents to be 
retained include: 
x
Signed original Informed Consent Document 
x
Completed Source worksheets (if used) 
x
Results of relevant diagnostic and laboratory tests 
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x
Intraoperative and post-operative complications and treatment, and 
x
Any other relevant information or documentation pertaining to the condition of the Subject. 
Monitors may verify data reported in the electronic data capture (EDC) system against Subject source 
documents. The Investigator agrees that the Sponsor’s employees or designees will have the right to audit 
and review pertinent medical records relating to this clinical investigation and the Subject will grant 
approval for such access to their medical records via the Informed Consent process. 
11.7 Case Report Form Completion and Data Submission
Data will be captured within an electronic data capture system provided by DePuy Synthes Products Inc.  
Electronic Case Report Forms (eCRFs) will be used to collect and submit all Subject data once a Subject is 
enrolled in the study. Investigative study sites are asked to transfer Subject data from the source PROMs 
into the eCRFs preferably within 2 weeks from the time the Subject was seen for their scheduled study 
visit. 
Role-specific training on eCRF completion is required to be completed by the Investigator(s) and study 
support staff prior to initiating Subject enrolment. 
 
The personal data recorded on all documents, including copy documents, and within the EDC system, will 
be regarded as confidential. The Investigator will be responsible for the timing, completeness and 
accuracy of the details entered within the electronic data capture system. All data entered in the database 
must have source documents in the Subject’s medical records or source worksheets.  
 
The respective eCRFs must be fully completed for each Subject. The Investigator’s electronic signature will 
be obtained within the EDC system once all study data has been entered, cleaned and coded (and at 
interim analysis if applicable). Sign off can occur on a per form or per casebook level. Any changes to the 
data will break the Investigator’s signature and sign off will need to be obtained again on the relevant 
data.  
 
The patient-reported outcome measures (AKS, KOOS, EQ5D-5L, and FJS-12) will be recorded on paper-
based or other validated electronic questionnaires. The data will then be transferred into the respective 
eCRF within the electronic data capture system by the Investigator or designee.  The patient-reported 
outcomes measures captured on paper-based questionnaires must be stored in the Subject’s binder as 
these will be considered to be the source document. Any errors on paper forms should be crossed out 
with a single stroke, initialed and dated. Typing correction fluid must not be used. The Investigator will 
retain one copy of each completed paper CRF in the medical notes.  
 
The Investigator must record the Subject’s participation in this clinical investigation in the Subject’s 
medical notes.  In addition, the Investigator must keep a separate list of all Subjects entered into this 
clinical investigation showing each Subject’s name, date of birth and assigned Subject number (for 
identification purposes).  A Patient Information log will be provided in the Investigator Site File for this 
purpose and remain at the site. 
 
The Investigator should retain copies of all documents pertaining to this clinical investigation (including 
source documentation, the informed consent document and any other documents to identify the 
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Subjects) per the applicable retention period in your region4 or per your IRB/EC/RA after this clinical 
investigation is completed. In addition, if the Investigator moves/retires, etc., he should provide the 
Sponsor with the name and address of the person who will be responsible for the Subjects’ clinical 
investigation related records. 
 
Data queries will be generated by the system at the time of data entry, if applicable.  Resolution of the 
queries will be the responsibility of the Investigator and investigation team members. Following 
completion of all data queries on each eCRF, the Investigator will be responsible for reviewing and 
confirming agreement to the data within the system. 
 
The platform software has been validated in accordance with 21 CFR Part 11, European Commission’s 
Directive on Data Protection and EU General Data Protection Regulation. Prior to being released for data 
entry, validation of the study level components (i.e., data entry screens, associated edit checks and 
workflow) will be conducted in accordance with approved user acceptance testing procedures. Access to 
this system will be controlled so that only authorized users will have the ability to enter into the system. 
The system is considered a closed system according to 21 CFR Part 11 Electronic Records; Electronic 
Signatures.  
  
11.8 Protocol Adherence
The Investigator(s) agrees to conduct the study in accordance with this protocol.  An Investigator must 
not make any changes in a study without first receiving approval from the Sponsor and IRB/EC, except 
when necessary to eliminate apparent immediate hazards to a Subject. 
 
With the exception of emergency situations, no deviations to this CIP will be permitted.  In the event of 
an emergency situation, the Investigator must notify the Sponsor immediately. The Site will be responsible 
for completing a Protocol Deviation eCRF within the EDC system, which will serve as Sponsor notification.  
IRB/EC/RA notification will be the responsibility of the Investigator.     
 
If serious or repeated protocol deviations are found at a Site, either through study monitoring, data review 
or audit (internal or external), the Sponsor is able to take one, or more of the following actions: 
 
11.9 CIP Amendments
If it becomes necessary to amend the Clinical Investigation, the nature of the amendment will be agreed 
between the Sponsor and the Principal Investigator(s) and this will be recorded with a justification for the 
amendment. The appropriate IRBs/ECs will be informed of any amendments. 
 
4 for at least 5 years in the UK and for at least 3 years in the United States 
x
Issue Site retraining. 
x
Issue Corrective and Preventative Actions. 
x
Temporary Site suspension (see Section 12.4). 
x
Site termination (see Section 12.4). 
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11.11 Investigator Site File
Each Investigator and all personnel from the investigational site must maintain accurate, complete, and 
current information about all aspects of this Clinical Investigation. This includes documentation relating 
to the Investigator’s participation, Subject information and correspondence: electronic, written, and 
verbal, relating to any aspect of the clinical investigation. The records are maintained in the Investigator 
Site File consisting of, but not limited to, correspondence with other participating Investigators, the 
reviewing IRB/EC, and the Sponsor.  
 
Upon receipt of copies of changes or revision updates to the Clinical Investigation Plan (otherwise known 
as the Study Protocol) from the Sponsor, the Investigator will add the updated document and Revision 
Log to the Investigator Site File. The outdated version will be filed.  
 
11.12 Investigator Study Termination
The Investigator may prematurely terminate the clinical investigation at any time. Should this be 
necessary, the procedures will be arranged on an individual clinical investigation basis after review and 
consultation by both parties.  In terminating the clinical investigation, the Sponsor and the Investigator 
will assure that adequate consideration is given to the protection of the Subject’s interests, all 
documentation is archived per Section 11.7 and the appropriate bodies such as the IRB/EC/RA are 
informed as appropriate.   
 
12 SPONSOR OBLIGATIONS
12.1 IRB/EC Approval
The Sponsor requires this Clinical Investigation Plan to be submitted to the IRB/EC for initial review and 
approval before implementation at each site.  Additionally, all protocol amendments must be submitted 
to the IRB/EC for review and approval before implementation. 
 
Each site is required to submit a copy of the IRB/EC initial approval, and any subsequent renewals to the 
Sponsor for filing in the study’s Trial Master File.  The site is to maintain the original documentation of the 
initial approval and renewals in the site’s Investigator Site File.   
12.2 Investigator Training, Study Initiation
Prior to enrolling Subjects in this study, the Investigator(s) and/or appropriate Site personnel will be 
trained on this Clinical Investigation Plan to include: 
x
All general aspects of study administration,  
x
Content and manner of administration of the questionnaires,  
x
All procedures in the protocol, and  
x
The procedure for e-data acquisition and transmission.   
The Sponsor will provide hands on training to supplement the professional education and experience of 
the surgeon regarding the implant and surgical instruments when deemed necessary by the Sponsor.   
 
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12.3 Study Monitoring
Monitoring activities will follow the Sponsor standard operating procedures (SOPs), Clinical Monitoring 
Plan, applicable regulations and good clinical practices (GCPs).  Monitoring will include onsite monitoring 
visits unless prevented by a global pandemic (e.g. COVID-19) or other unforeseen crisis. Remote 
monitoring may be conducted if deemed appropriate by the Sponsor (e.g., global pandemic).   
During the visit, the Sponsor and authorized Sponsor representatives shall be given access to all study 
records, including study Subject medical records to ensure proper monitoring of this clinical investigation. 
The monitor’s duties are to verify that: 
a) compliance with the CIP, any subsequent amendment(s) and regulatory requirements is 
maintained; deviations shall be discussed with the Principal Investigator(s) or authorized 
designee, documented and reported to the Sponsor. 
b) only authorized individuals, as detailed on the Delegation Log, are participating in the Clinical 
Investigation. 
c) the study device is being used according to the CIP or IFU. 
d) investigational site resources and the investigation site team remain adequate throughout the 
duration of the Clinical Investigation. 
e) the Principal Investigator continues to have access to an adequate number of subjects and study 
devices. 
f) signed and dated informed consent forms have been obtained from each subject at the point 
of enrolment or before any Clinical Investigation-related procedures are undertaken. 
g) source documents and other Clinical Investigation records are accurate, complete, up to date, 
stored and maintained appropriately. 
h) CRFs and queries are complete, recorded in a timely manner, and consistent with source 
documents. 
i) appropriate corrections, additions or deletions are made to the CRFs, dated, explained if 
necessary and initialed by the Principal Investigator or by his/her authorized designee; the 
monitor shall not make corrections, additions or deletions to the CRFs. 
j) all device- and procedure-related AEs, SAEs and Device Deficiencies are reported to the Sponsor, 
and all SAEs and Device Deficiencies that could have led to a SADE are reported to the sponsor 
without unjustified delay. 
k) all SAEs and deviations are reported to the EC, if required. 
l) all other required reports, notifications, applications, submissions and correspondence are 
maintained in the investigator's files and are accurate, complete, timely, legible, dated and 
identify the Clinical Investigation. 
m) subject withdrawal has been documented; the monitor shall discuss this with the Principal 
Investigator or his/her authorized designee. 
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n) subject non-compliance with the requirements stated in the informed consent has been 
documented; the monitor shall discuss this with the Principal Investigator or his/her authorized 
designee. 
o) the Principal Investigator and investigation site team are informed and knowledgeable of all 
relevant document updates concerning the clinical investigation. 
p) any corrective and preventive actions, as needed, have been implemented and are effective. 
The Monitor, or representatives from the Sponsor, will be responsible for establishing the schedule and 
procedures to be followed for monitoring this clinical investigation and may also include the monitoring 
of the surgical procedure. The Clinical Investigator will receive reasonable notification prior to each 
monitoring visit during the course of this clinical investigation.  At each visit, the Clinical Investigator will 
be expected to co-operate with the Monitor (and occasionally other Sponsor personnel) for the review 
and verification of all eCRFs and any additional records as may have been previously arranged between 
the Clinical Investigator and the Monitor.  At each visit the Clinical Investigator will also be expected to 
co-operate with the Monitor for the review and verification of the device supply and device returns. 
If under certain circumstances (i.e. limited access for sponsor study personnel to hospitals due to Covid-
19 pandemic) on site monitoring is not possible, Sponsor may plan for remote monitoring and source data 
review or verification, where applicable. Details will be described in the study specific documents, such as 
monitoring plan, project operations manual etc. 
12.4 Sponsor Study Termination
The Sponsor may prematurely terminate or suspend the clinical study as a whole or at an individual 
investigational site for significant and documented reasons.  Reasons for premature termination or 
suspension include, but are not limited to safety, inadequate recruitment, Principal Investigator 
compliance, device-related problems, alignment with business strategy or administrative issues.  
 
In the event of the study being terminated, any enrolled Subjects that have not yet had the surgical 
procedure would be treated as per their surgeon's standard practice using implants and instruments of 
the surgeon's choice. All enrolled Subjects would continue to be cared for by their surgeon according to 
his/her standard of care. No further study-related procedures or data collection would occur.  
 
 
12.5 Insurance
12.5.1
Sites
The Sponsor will secure and maintain in full force and effect, throughout the duration of the Clinical 
Investigation, clinical trial insurance in line with national regulations. The type of insurance for each 
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EXHIBIT D: Glossary of Terms
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AKS 
American Knee Society Score 
AP 
Anterior-Posterior 
BS EN 
British Standard European Norm 
21 CFR 
Code of Federal Regulation: Title 21 
CE 
Conformité Européenne 
CIP 
Clinical Investigational Plan 
CR  
Cruciate Retaining 
CRF 
Case Report Form (paper) 
 
DVT 
Deep Vein Thrombosis 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EQ-5D-5L 
European Quality of Life 5 Dimensions – 5 Levels 
EU 
European Union 
FB 
Fixed Bearing 
FDA 
Food and Drug Administration 
FJS-12 
Forgotten Joint Score 
GCP 
Good Clinical Practice  
ICD 
Informed Consent Document 
IRB 
Institutional Review Board  
ISO 
International Organization for Standardization 
ITT 
Intent To Treat 
KOOS-ADL 
Knee Injury Osteoarthritis Outcome Score – Activities of Daily Living 
MEDDEV 
Medical Device Guidance Document(s) 
MS 
Medial Stabilized 
NIDJD 
Non-inflammatory Degenerative Joint Disease 
OA 
Osteoarthritis 
OR 
Operating Room 
PHI  
Personal Health Information 
PI 
Principal Investigator 
PMCF 
Post-Market Clinical Follow-up 
Post-op 
Post-operative 
PP 
Per Protocol  
Pre-op 
Pre-operative 
PROs 
Patient Reported Outcomes 
PROM 
Patient Reported Outcome Measure 
PS  
Posterior Stabilized 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAS® 
Statistical Analysis System 
TKA 
Total Knee Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
US 
United States 
VAS 
Visual Analogue Scale 
 
 
 
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EXHIBIT F: Non-Clinic Contact Visit Documents
 
SAMPLE COVER LETTER 
Insert Name of Subject 
Insert Street Address  
Insert City, State, Zip Code 
 
 
 
Insert Date  
 
 
Dear Insert Name of Subject, 
 
I am writing you this letter as part of your follow up to the clinical study titled, Multi-Center Clinical 
Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in 
Total Knee Arthroplasty in which you are taking part with Insert Name of Study Investigator. 
 
The reason for this letter is to obtain follow up information on your ATTUNE Cementless Fixed Bearing 
implant in your (insert either right or left) knee since your last contact with our clinic. Please complete the 
enclosed questionnaire(s) about your (insert right or left) knee implant.  Make sure you share any 
problems you may have had especially with your (insert right or left) since your last visit with Dr. Insert 
Name of Study Investigator.  Once completed, please return the forms to my attention in the enclosed 
postage paid envelope.   
 
If you have any questions regarding the information you have received, please call me at INSERT Phone 
Number and I would be happy to answer your questions. 
 
As a friendly reminder, your next appointment has been scheduled for INSERT Date of next appointment.   
 
Finally, we want to thank you again for continuing to take part in this important study. 
 
Sincerely,  
 
Insert Name of Clinical Research Coordinator 
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With signature below you confirm you have personally completed this packet. 
 
Printed name:  
__________________________________________________________ 
 
Signature:       
__________________________________________________________ 
         
Date:               
__________________________________________________________ 
 
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Contact Visit Form – Mailer to Study Participant  
Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella 
Implants in Total Knee Arthroplasty 
PATIENT INFORMATION  
Last Name: ______________________________   First Name:_______________________    Middle Initial: _____ 
Address: ________________________________City:______________________State: _____  ZIP:_____________ 
Home Phone (____) ______________ Work Phone (____) ______________Cell Phone (_____) _______________ 
Email: _____________________________ 
INFORMATION REGARDING YOUR STUDY KNEE 
Since your last visit have you had any new problems with your study knee (Right or Left knee)? 
                  Yes           No 
 
If yes, please provide details regarding the problem with your study knee, including when the problem started, 
description of the problem, and if you went to a doctor to treat the problem. 
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
 
Since your last visit have you had any surgery to your study knee? (Right or Left Knee) 
                  Yes           No 
 
If yes, please provide details of surgery. 
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
 
Since your last visit have you had any other hospitalizations or surgery not related to your study knee? (Right 
Knee) 
                  Yes           No 
 
If yes, please provide details. 
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
 
 
 
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SAMPLE PHONE SCRIPT 
Subject ID:  ___________________  Date of Phone Call: ___________    Time of Phone Call: __________ 
 
Hello (Name of Subject), 
I am calling you today as part of your follow up for the, Multi-Center Clinical Investigation of the ATTUNE® 
Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty Study in 
which you are taking part with Insert Name of Study Investigator. 
 
The reason for this call is to obtain follow up information on your ATTUNE Cementless Fixed Bearing 
implant in your (insert either right or left) knee since your last contact with our clinic. I am now going to 
ask you a few questions: 
 
__ No  __ 
Yes 
If yes, please describe: 
 
 
 
__ No  __ Yes 
If yes, please describe: 
 
 
 
 
I want to thank you for your time today, and assure you that we will keep your information confidential. 
Your information will not shared outside of this study team except to those groups inside and outside of 
this clinic who are responsible for making sure studies are conducted correctly and ethically.   If you 
decide (now or later) to stop, you need to know that the information already collected will continue to be 
used.  
Do you have any questions? Is there anything else I may assist you with?  Thank you for your call. 
x
Since your last visit, have you had any new problems with your study knee? 
x
Since your last visit, have you had any surgery to your study knee? 
x
Have you had any other new medical problems such as a recent hospitalization or surgery 
not involving the study knee? __ No  __ Yes 
If yes, please describe: 
 
 
 
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14 References
1. 
Knutson K, Robertsson O. The Swedish Knee Arthroplasty Register (www.knee.se): The inside 
story. Acta Orthop 2010; 81(1): 5-7. 
2. 
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee 
arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007; 89(4): 780-5. 
3. 
Berger RA, Rosenberg AG, Barden RM, Sheinkop MB, Jacobs JJ, Galante JO. Long-term followup 
of the Miller-Galante total knee replacement. Clin Orthop Relat Res 2001; (388): 58-67. 
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Font-Rodriguez DE, Scuderi GR, Insall JN. Survivorship of cemented total knee arthroplasty. Clin 
Orthop Relat Res 1997; (345): 79-86. 
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Ranawat CS, Flynn WF, Jr., Saddler S, Hansraj KK, Maynard MJ. Long-term results of the total 
condylar knee arthroplasty. A 15-year survivorship study. Clin Orthop Relat Res 1993; (286): 94-102. 
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Rasquinha VJ, Ranawat CS, Cervieri CL, Rodriguez JA. The press-fit condylar modular total knee 
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Joint Surg Am 2006; 88(5): 1006-10. 
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NJR England, Wales & Nothern Ireland 15th Annual Report, 2019. 
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Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, 
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Brown TE, Harper BL, Bjorgul K. Comparison of cemented and uncemented fixation in total knee 
arthroplasty. Orthopedics 2013; 36(5): 380-7. 
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McCalden RW, Robert CE, Howard JL, Naudie DD, McAuley JP, MacDonald SJ. Comparison of 
outcomes and survivorship between patients of different age groups following TKA. J Arthroplasty 2013; 
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Meehan JP, Danielsen B, Kim SH, Jamali AA, White RH. Younger age is associated with a higher 
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arthroplasty. J Am Acad Orthop Surg 2007; 15(1): 53-64. 
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cemented modular posterior-cruciate-substituting total knee design : five to eight-year follow-up. J Bone 
Joint Surg Am 2002; 84(8): 1362-71. 
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Abram SG, Nicol F, Hullin MG, Spencer SJ. The long-term outcome of uncemented Low Contact 
Stress total knee replacement in patients with rheumatoid arthritis: results at a mean of 22 years. The 
bone & joint journal 2013; 95-b(11): 1497-9. 
18. 
Buechel FF, Sr. Long-term followup after mobile-bearing total knee replacement. Clin Orthop 
Relat Res 2002; (404): 40-50. 
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Efstathopoulos N, Mavrogenis AF, Lallos S, et al. 10-year evaluation of the cementless low-
contact- stress rotating-platform total knee arthroplasty. Journal of long-term effects of medical 
implants 2009; 19(4): 255-63. 
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20. 
Lass R, Kubista B, Holinka J, et al. Comparison of cementless and hybrid cemented total knee 
arthroplasty. Orthopedics 2013; 36(4): e420-7. 
21. 
Abo-Alhol TR, Fitzpatrick CK, Clary CW, et al. Patellar mechanics during simulated kneeling in the 
natural and implanted knee. J Biomech 2014; 47(5): 1045-51. 
22. 
Clary C, Aram L, Deffenbaugh D, Heldreth M. Tibial base design and patient morphology 
affecting tibial coverage and rotational alignment after total knee arthroplasty. Knee Surg Sports 
Traumatol Arthrosc 2014; 22(12): 3012-8. 
23. 
Clary CW, Fitzpatrick CK, Maletsky LP, Rullkoetter PJ. The influence of total knee arthroplasty 
geometry on mid-flexion stability: an experimental and finite element study. J Biomech 2013; 46(7): 
1351-7. 
24. 
Fitzpatrick CK, Baldwin MA, Clary CW, Maletsky LP, Rullkoetter PJ. Evaluating knee replacement 
mechanics during ADL with PID-controlled dynamic finite element analysis. Computer methods in 
biomechanics and biomedical engineering 2014; 17(4): 360-9. 
25. 
Fitzpatrick CK, Baldwin MA, Clary CW, Wright A, Laz PJ, Rullkoetter PJ. Identifying alignment 
parameters affecting implanted patellofemoral mechanics. J Orthop Res 2012; 30(7): 1167-75. 
26. 
Fitzpatrick CK, Clary CW, Cyr AJ, Maletsky LP, Rullkoetter PJ. Mechanics of post-cam engagement 
during simulated dynamic activity. J Orthop Res 2013; 31(9): 1438-46. 
27. 
Fitzpatrick CK, Clary CW, Laz PJ, Rullkoetter PJ. Relative contributions of design, alignment, and 
loading variability in knee replacement mechanics. J Orthop Res 2012; 30(12): 2015-24. 
28. 
Fitzpatrick CK, Clary CW, Rullkoetter PJ. The role of patient, surgical, and implant design 
variation in total knee replacement performance. J Biomech 2012; 45(12): 2092-102. 
29. 
Smoger LM, Fitzpatrick CK, Clary CW, et al. Statistical modeling to characterize relationships 
between knee anatomy and kinematics. J Orthop Res 2015; 33(11): 1620-30. 
30. 
Kane R, Miltner, N., Smith, B., Tong. W. Initial mechanical stability of additively manufactured 
pegs in calcellous bone.  Othropaedic Research Society Annual Meeting; 2020. 
31. 
Tong W, Smith, B., Henninger, D., Kane, R., Muench, T. Bone ingrowth of RTT porous structure.  
Orthopaedic Research Society Annual Meeting; 2020. 
32. 
Jauregui JJ, Banerjee S, Cherian JJ, Elmallah RD, Mont MA. Rating Systems to Assess the 
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