Persona Outcomes Led Assessment Research in Total Knee Arthroplasty
Phase: NA
Conditions: Osteoarthritis, RheumatoId Arthritis, Traumatic Arthritis, Polyarthritis
Sponsor: Zimmer Biomet

 
 
 
 
 
 
Persona™ Outcomes Led  Assessment  Research 
in  Total Knee Arthroplasty 
 
 
POLAR –TKA STUDY 
 
 
 
 
PROSPECTIVE MULICENTER STUDY OF 
  
PERSONA™  KNEE SYSTEM  
 
 
 
 
 
Protocol # CSU2012-10K 
United States 
 
 
September 7, 2012 – Version 1.0 
May 8, 2013 – Version 2.0 
January 3, 2014 – Version 3.0 
 
 
 
 
Zimmer, Inc. 
Clinical Affairs Department 
1800 West Center Street 
Warsaw, IN 46580 
800-613-6131 
 
 
 
 
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Inc. except as otherwise 
agreed to in writing, by accepting or reviewing this document, you agree to hold this information in confidence and 
not  distribute or  disclose it  to  others (except where required by  applicable law) or  use it  for  unauthorized 
purposes. In the event of any actual or suspected breach of this obligation, Zimmer Inc. must be promptly notifie d. 
Duplication and distribution of this document in any form or shape requires prior approval from Zimmer Inc. 

POLAR-TKA: CONFIDENTIAL 
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Table of Contents 
I. 
Study Synopsis ................................................................................................................................... 1 
II. 
Data Collection Overview .................................................................................................................. 4 
III. 
Introduction and Purpose.................................................................................................................. 5 
IV. 
Study Objectives ................................................................................................................................ 5 
V. 
Study Design ...................................................................................................................................... 6 
VI. 
Study Population ............................................................................................................................... 6 
A. 
Inclusion Criteria ....................................................................................................................... 7 
B. 
Exclusion Criteria....................................................................................................................... 7 
VII. 
Study Device Information .................................................................................................................. 7 
VIII. 
Study Procedures............................................................................................................................... 8 
A. 
Offer Study Participation .......................................................................................................... 8 
B. 
Informed Consent Process ........................................................................................................ 8 
C. 
Informed Consent Log............................................................................................................... 8 
D. 
Subject Enrollment.................................................................................................................... 9 
E. 
Determination of Eligibility ....................................................................................................... 9 
F. 
Monitor Log............................................................................................................................... 9 
G. 
Delegation of Authority (Site Signature Log) ............................................................................ 9 
H. 
Baseline/Pre-operative Assessment ....................................................................................... 10 
I. 
Surgical Technique .................................................................................................................. 10 
J. 
Intention to Treat .................................................................................................................... 10 
K. 
Surgical and Immediate Post-surgical Procedures (Data Collection)...................................... 10 
L. 
Post-operative Follow-up Procedures (Data Collection) ........................................................ 11 
M. 
Minimization of Subjects Lost to Follow-up............................................................................ 11 
N. 
Radiographic Definitions and Methods .................................................................................. 12 
O. 
Recommended Revision Procedure ........................................................................................ 12 
IX. 
Reporting ......................................................................................................................................... 12 
A. 
Prior to Initiation of the Study ................................................................................................ 12 
B. 
Clinical Data Collection/Submission........................................................................................ 13 
C. 
Reporting Requirements ......................................................................................................... 14 
D. 
Management of Incurrent Events ........................................................................................... 14 
E. 
Medical Events/Adverse Events Definitions and Classifications............................................. 16 
F. 
Monitoring of the Study.......................................................................................................... 19 
X. 
Risk Analysis..................................................................................................................................... 19 
A. 
General Surgical Risks ............................................................................................................. 19 
B. 
Risks Associated with Total Knee Arthroplasty Procedure/Study Device............................... 20 
XI. 
Statistical Considerations ................................................................................................................ 20 
A. 
General Statistical Methods.................................................................................................... 20 
B. 
Sample Size ............................................................................................................................. 21 
XII. 
References ....................................................................................................................................... 22 

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Appendices: 
 
Appendix A 
Sample Informed Consent 
Appendix B 
Case Report Forms 
Appendix C 
Study Logs 
Appendix D 
Abbreviations 

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STUDY/CONTACT INFORMATION SHEET 
 
 
TITLE: 
Persona Outcomes Led Assessment Research in Total Knee Arthroplasty 
(POLAR Study) 
PROTOCOL NUMBER: 
CSU2012-10K 
STUDY TYPE: 
Post Market 
STUDY SPONSOR: 
Zimmer, Inc 
1800 West Center Street 
Warsaw, IN 46580 
Ph: 800-613-6131 
STUDY SPONSOR CONTACTS: 
Kacy Arnold 
David Fawley 
Associate Director, Clinical Affairs Clinical Project Lead 
Ph:  574-371-8336 
Ph: 574-371-1924 
Cell: 574-551-8417 
Cell: 574-453-6443 
Fax: 574-372-4710 
Fax: 574-372-4710 
kacy.arnold@zimmer.com  
david.fawley@zimmer.com 
 
STUDY MANAGER(S): 
David Fawley 
Clinical Project Lead 
Ph: 574-371-1924 
Cell: 574-453-6443 
Fax: 574-372-4710 
david.fawley@zimmer.com 

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I. 
Study Synopsis 
 
TITLE: 
Persona Outcomes Led Assessment Research in Total Knee Arthroplasty 
(POLAR Study) 
SPONSOR: 
Zimmer Inc., Warsaw, IN 
PROTOCOL NUMBER 
CSU2012-10K 
STUDY OBJECTIVES 
The primary objective of this study is to obtain implant survivorship and 
clinical outcomes data for commercially available Persona fixed bearing 
implants used in primary total knee arthroplasty. 
The assessments will include: 
1.   Implant survivorship based on removal of a study device. 
2.   Safety based on incidence and frequency of adverse events. 
3.   Clinical performance measured by overall pain and function, quality 
of life data, radiographic parameters and survivorship. 
TARGET POPULATION: 
Patients qualifying for primary total knee arthroplasty who meet the 
inclusion/exclusion criteria for study participation 
STUDY DESIGN: 
Prospective multicenter, non-controlled study of commercially available 
Zimmer Persona fixed bearing knee components 
STUDY TYPE: 
Post-market 
SAMPLE SIZE: 
A maximum of 15 U.S. sites contributing a maximum of 100 implanted  
Persona knees per site  
LENGTH OF STUDY: 
Five year study 
Follow-up clinical visits include 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 
years post-op. 

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INCLUSION/EXCLUSION CRITERIA: 
INCLUSION CRITERIA: 
1.   Patient is 18 to 75 years of age, inclusive 
2.   Patient qualifies for a primary total knee arthroplasty based on 
physical exam and medical history, including diagnosis of severe knee 
pain and disability due to at least one of the following: 
a. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, 
polyarthritis 
b. Collagen disorders and/or avascular necrosis of the femoral 
condyle 
c. Post-traumatic loss of joint configuration, particularly when there 
is patellofemoral erosion, dysfunction or prior patellectomy 
d.   Moderate valgus, varus, or flexion deformities 
e.   The salvage of previously failed surgical attempts that did not 
include partial or total knee arthroplasty of the ipsilateral knee 
3.   Patient has participated in this study-related Informed Consent 
process 
4.   Patient is willing and able to provide written Informed Consent by 
signing and dating the IRB or EC approved Informed Consent form 
5.   Patient is willing and able to complete scheduled study procedures 
and follow-up evaluations 
6.   Independent of study participation, patient is a candidate for 
commercially available Persona fixed bearing knee components 
implanted in accordance with product labeling 
 
 
EXCLUSION CRITERIA: 
1.   Patient is currently participating in any other surgical intervention 
studies or pain management studies 
2.   Previous history of infection in the affected joint and/or other 
local/systemic infection that may affect the prosthetic joint 
3.   Insufficient bone stock on femoral or tibial surfaces 
4.   Skeletal immaturity 
5.   Neuropathic arthropathy 
6.   Osteoporosis or any loss of musculature or neuromuscular disease 
that compromises the affected limb 
7.   Stable, painless arthrodesis in a satisfactory functional position 
8.   Severe instability secondary to the absence of collateral ligament 
integrity 
9.   Rheumatoid arthritis accompanied by an ulcer of the skin or a history 
of recurrent breakdown of the skin 
10. Patient has a known or suspected sensitivity or allergy to one or more 
of the implant materials 
11. Patient is pregnant or considered a member of a protected 
population (e.g., prisoner, mentally incompetent, etc.) 
12. Patient has previously received partial or total knee arthroplasty for 
the ipsilateral knee 

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STUDY DEVICE: 
Commercially available Persona fixed bearing knee components 
implanted in accordance with product labeling 
OUTCOMES MEASURES: 
2011 Knee Society Score 
EQ-5D 
Forgotten Joint Score 
PERFORMANCE ASSESSMENTS: 
Pain and function Quality 
of life Radiographic 
parameters Survivorship 
STATISTICAL REPORTING: 
Performance will be evaluated for pain, function, quality of life, and 
survivorship. Data will be summarized descriptively additional to 
evaluation of data on surgical technique and instrumentation. Categorical 
data (e.g., gender or race) will be summarized using counts and 
percentages with 95% Confidence Interval (CI) limit over the time period 
of interest. Continuous data, such as age, will be summarized by using 
means, medians, SD, minimum, maximum, and 95% CI over the time 
period of interest. Implant survival and return to function will be 
summarized using a Kaplan-Meier method and presented with rates (as 
percentages) and CI. Routine summaries of complication data is 
represented by frequencies and percentages.  Sample size is based on a 
longitudinal data collection model and using survivability as the primary 
endpoint of interest. The attrition rate is assumed to be 10% 
 
 
 
This protocol is written based on guidelines from ISO 14155 Standard for Clinical Investigation of Medical Devices 
For Human Subjects – Good Clinical Practice (i) and the ICH Guideline on Good Clinical Practice(ii), and is in 
accordance with US Code of Federal Regulations 21 CFR Parts 11, 50 and 56 (ii) 

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II. 
Data Collection Overview 
 
The following table indicates the necessary case report forms to be completed at the given time 
point: 
 
 
Form Name 
Pre-op 
Surgical & 
Immediate 
Post- 
Surgical 
6 weeks 
6 months 
1 year 
Years 2, 3, 4, 
5 Post- 
Surgical 
Informed Consent 
X 
Inclusion/Exclusion Criteria 
X 
Demographic Evaluation 
X 
Operative Information 
X 
Surgical Device Information 
X 
Discharge Summary 
X 
Physical Exam 
X 
X 
X 
X 
X 
FJS-12 
(Forgotten Joint Score) 
 
 
 
 
 
EQ-5D 
 
 
 
 
 
KSS - Surgeon completed 
X 
X 
X 
X 
X 
KSS – Patient completed 
 
 
 
 
 
Physician Assessment of Post-op Radiographs 
X 
X 
X 
X 
Adverse Event Report 
 
 
 
 
 
Protocol Deviations 
 
 
 
 
 
 
Study Completion 
 
 
 
 
 
 
Independent Radiographic Review 
 
 
 
 
 
X 
Completed by Investigator or Designee 
 Completed by patient 
  Completed by Investigator or Designee as applicable 
 Independent radiographic review may be performed by Sponsor’s designee, if applicable 
at discretion of Sponsor 
 
 
 
The following table indicates the necessary case report forms required to be completed for 
revision patients: 
 
FORM NAME 
REVISION (as applicable) 
COMMENTS 
Physician Assessment of Post-op 
Radiographs 
 
Mark the “pre-revision” exam period. 
Adverse Event Report 
 
Document adverse event resulting in the 
revision 
Study Completion 
 
Complete indicating “Study Prosthesis 
Removed” under Study Completion Status. 
 
  Completed by Investigator or designee as applicable 

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III. 
Introduction and Purpose 
Osteoarthritis (OA) is the most common type of arthritis causing considerable disability across 
broad populations. The economic burden of arthritis, specifically osteoarthritis is enormous with 
an estimated cost of $60 billion in the United States and expected to increase to $100 billion by 
2020.1,2    The knee joint is the most common joint to develop OA and total knee arthroplasty 
(TKA) is the most frequently performed joint arthroplasty procedure for this condition. 3,4   With 
an increase in the prevalence of arthritis, obesity, and old age, a further demand for TKA is 
projected to increase substantially over the next few years. 5-9  In 2005, approximately 523,000 
TKAs were performed nationally. 10    The American Academy of Orthopedic Surgeons (AAOS) and 
Kurtz et al, 11  have provided projections for future demand of TKA. In 2002, the AAOS had 
suggested an annual replacement load of 474,000 by the year 2030. In 2007, Kurtz et al, 11 
described an annual demand of 3.5 million by 2030. While these projections vary widely, both 
suggest a strong increase in demand for TKA, prompting significant interest from surgeons, 
healthcare institutions and orthopedic device manufacturers  interested  to better understand 
the future technological and economic burden of TKA. 
 
Although, TKA has demonstrated effectiveness with substantive and sustained improvement in 
quality of life for individuals with moderate to severe osteoarthritis, 12,13 functional performance 
in patients 1 year after TKA remains lower than for healthy adults, with reports of an 18% slower 
walking speed, 51% slower stair-climbing speed, and deficits of nearly 40% in quadriceps 
strength. 14 Additionally, certain limitations in knee design systems require surgeons to accept 
compromises which can result in surgical inefficiencies and challenges in seizing desired 
outcomes. 15-19  Patient expectations and an ever emerging population with active lifestyle also 
add a new requirement and need for innovative designs that bring advantages over traditional 
implants. Personalized implants with critical features of natural movement, contoured shape, 
and unique anatomic and physiologic composition can address these requirements. The current 
concepts in TKA warrant a personalized orthopedics initiative by offering a finer ability in 
identifying and precisely addressing the unique needs of patients. It is through this introduction 
of high fidelity implants, morphologic designs and intelligent instrumentation that each patient’s 
knee can be distinctively and accurately reconstructed, allowing for clinical outcomes to be 
better  optimized.  Furthermore,  such  personalized  systems  will  empower  the  surgeon  to 
advance performance by providing a leading design that efficiently accommodates surgeons’ 
intraoperative needs with minimizing surgical trade-offs and maximizing efficiency. 
 
To address these clinical challenges and methodologically address new implant characteristics, a 
prospective, multi-center, longitudinal data collection model is being proposed. The objective of 
this study is to determine clinical performance/ outcomes and implant survivorship for 
commercially available Persona® fixed bearing implants used in primary total knee arthroplasty. 
 
 
IV. 
Study Objectives 
The objective of this study is to obtain clinical performance (outcomes) data and survivorship for 
commercially available Persona fixed bearing knee components implanted in primary total knee 
arthroplasty.     This  will  be  done  by  analysis  of  validated  outcome  measurement  tools, 
radiographs and adverse event data. 

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The assessments will include: 
1.    Implant survivorship based on removal of a study device 
2.    Safety based on incidence and frequency of adverse events 
3.    Clinical performance measured by overall pain and function, quality of life data, radiographic 
parameters and survivorship 
 
 
V. 
Study Design 
This is a prospective, multicenter, non-controlled clinical study designed to facilitate the 
collection and evaluation of pain, function, quality of life, radiographic assessment, and adverse 
event data.  A minimum of six U.S. sites will contribute to this study. Maximum enrollment per 
site will not exceed 100 implanted knees.  Each Investigator will be skilled in total knee 
arthroplasty and experienced implanting the devices included in this study. 
 
Each Principal Investigator will be responsible for obtaining Institutional Review Board (IRB) or 
Ethics Committee (EC) approval as required prior to conducting the study.  In order to avoid 
potential selection bias, each Investigator will offer study participation to each consecutive 
patient presenting as a candidate for primary total knee arthroplasty using the commercially 
available (FDA cleared)  Persona fixed bearing knee system.   Candidates who express interest in 
study  participation  will  be  offered  Informed  Consent.    All  potential  study  subjects  will  be 
required to participate in the Informed Consent process and will not be considered enrolled in 
the study until the candidate has signed and dated the IRB/EC approved patient Informed 
Consent.    Study  data  cannot  be  collected until  the  candidate  has  completed the  informed 
consent process and signed and dated the IRB or EC approved Informed Consent. 
 
All study subjects will undergo preoperative clinical evaluations prior to their total knee 
arthroplasty.  The post-operative clinical and radiographic evaluations will be conducted at 6 
weeks, 6 months, 1 year, 2, 3, 4, and 5 years. 
 
The   Investigator  will  review  radiographs  at  each  clinical  evaluation  interval  to  ensure 
radiographic evidence of adverse events is documented and reported to the IRB or EC and 
Sponsor as required.  At Sponsor’s discretion, Sponsor may request copies of these radiographs 
for independent radiologic review.  Sponsor may request one central reviewer for all radiographs 
independent of the surgeon and institution. 
 
 
VI. 
Study Population 
Study population for primary statistical analysis will be comprised of males and females who 
require primary total knee arthroplasty and satisfy the inclusion/exclusion criteria outlined in 
this section of the protocol.   In order to avoid potential selection bias, each Investigator will 
offer study participation to each consecutive patient presenting as a candidate for primary total 
knee arthroplasty using the commercially available (FDA cleared) Persona fixed bearing knee 
system.    Candidates  who  express  interest  in  study  participation  will  be  offered  Informed 
Consent. 

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A.   Inclusion Criteria 
1.   Patient is 18 to 75 years of age, inclusive 
2.   Patient  qualifies  for  a  primary total  knee  arthroplasty  based on physical  exam  and 
medical history, including diagnosis of severe knee pain and disability due to at least one 
of the following: 
a.    Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis 
b.   Collagen disorders and/or avascular necrosis of the femoral condyle 
c. Post-traumatic   loss   of   joint   configuration,   particularly   when   there   is 
patellofemoral erosion, dysfunction or prior patellectomy 
d.   Moderate valgus, varus, or flexion deformities 
e.   The salvage of previously failed surgical attempts that did not include partial or 
total knee arthroplasty of the ipsilateral knee 
3.   Patient has participated in a study-related Informed Consent process 
4.   Patient is willing and able to provide written Informed Consent by signing and dating the 
IRB/EC approved Informed Consent form 
5.   Patient  is  willing  and  able  to  complete  scheduled  study  procedures  and  follow-up 
evaluations 
6.   Independent of study participation, patient is a candidate for commercially available 
Persona fixed bearing knee components implanted in accordance with product labeling 
 
B.   Exclusion Criteria 
1.  Patient is currently participating in any other surgical intervention studies or pain 
management studies 
2.   Previous history of infection in the affected joint and/or other local/systemic infection 
that may affect the prosthetic joint 
3.   Insufficient bone stock on femoral or tibial surfaces 
4.   Skeletal immaturity 
5.   Neuropathic arthropathy 
6.   Osteoporosis or any loss of musculature or neuromuscular disease that compromises 
the affected limb 
7.   Stable, painless arthrodesis in a satisfactory functional position 
8.   Severe instability secondary to the absence of collateral ligament integrity 
9.  Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent 
breakdown of the skin 
10. Patient has a known or suspected sensitivity or allergy to one or more of the implant 
materials 
11. Patient is pregnant or considered a member of a protected population (e.g., prisoner, 
mentally incompetent, etc.) 
12. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee. 
 
 
VII. 
Study Device Information 
Persona knee components included in this study are commercially available (FDA cleared) in 
fixed bearing left and right side configurations and various component sizes to accommodate 
anatomical variation. 
Fixed  bearing  components  may  be  configured  for  use  in  posterior 
cruciate-retaining,  cruciate-sacrificing,  or  cruciate-substituting  knee  arthroplasty  procedures. 

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They are intended for long-term implantation in accordance with product labeling.  Please refer 
to the package insert for additional information and instructions. 
 
 
VIII. 
Study Procedures 
 
A.   Offer Study Participation 
Study participation will be offered to each consecutive patient presenting as a potential 
candidate for primary total knee arthroplasty using the commercially available (FDA cleared) 
Persona fixed bearing knee system.  Candidates who express interest in study participation 
will be offered Informed Consent. Prior to patient enrollment or any further patient 
evaluation for study eligibility, the patient must participate in the Informed Consent process 
and sign and date the IRB or EC approved Informed Consent. 
 
B.   Informed Consent Process 
For candidates that express interest, the Investigator or Designee will describe relevant 
study information, including the purpose, procedures, possible risks, and potential benefits 
associated with study participation.   The Investigator or Designee will also review, along 
with the candidates, the Informed Consent approved by both the governing IRB or EC and 
the study Sponsor.  Candidates shall have sufficient time to read and understand the IRB or 
EC approved Informed Consent and discuss whether they wish to participate in the study. 
Candidates will be asked to acknowledge whether all of their questions and concerns have 
been addressed to their satisfaction. Any questions that candidates may have will be 
addressed appropriately by the Investigator or Designee.   Candidates will be further 
instructed that they are free to obtain additional information from the Investigator or 
Designee at any time, that they are free to decline participation, and that they are free to 
withdraw their consent and discontinue their participation at any time without prejudice. 
 
After completing the Informed Consent process, candidates who agree to enter the study 
must sign and date the IRB or EC approved Informed Consent.  The Informed Consent must 
be signed and dated prior to the date of the study surgery.  For bilateral TKA candidates that 
agree to enroll for both operative sides, a separate Informed Consent must be signed and 
dated for each operative side. 
 
A copy of the signed Informed Consent must be provided to the study subject.  The original 
signed Informed Consent is to be filed in the subject’s medical record, study subject binder, 
or regulatory binder. 
 
Study data will not be collected until the Informed Consent has been signed and dated.  If 
the candidate does not wish to participate (does not sign and date the Informed Consent), 
data for that candidate will not be collected  for this study. 
 
C.   Informed Consent Log 
An Informed Consent Log (Appendix C) will be maintained at the site throughout the course 
of the study.  The purpose of the Informed Consent Log is to provide documentation that all 
enrolled study subjects underwent the Informed Consent process, signed and dated the IRB 
or EC approved Informed Consent, and were provided with a copy of the fully executed 

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consent with all required signatures.   All candidates who sign and date the approved 
Informed Consent for the study must be entered in the log.  If a subject signs and dates 
additional Informed Consent(s) after enrollment (e.g., due to a protocol amendment, 
protocol revisions, etc.), subsequent signings will also be recorded in the log.  The Informed 
Consent Log will be filed in the site Regulatory Binder for the study. 
 
D.   Subject Enrollment 
Once the Informed Consent has been signed and dated by the subject, the subject will be 
considered enrolled in the study.  A unique case identification number (Case ID) will be 
assigned to each participating subject/knee (bilateral subjects will be assigned a unique case 
ID number for each knee).  This unique case ID number will be used throughout the study 
for identification.   Case ID numbers will be assigned consecutively in ascending order per 
site, with the starting number for a given site defined by Sponsor. 
 
E.   Determination of Eligibility 
Once Informed Consent has been obtained, the subject’s eligibility to continue study 
participation will be determined by the study inclusion/exclusion criteria.  This may include 
an interview to assess significant subject medical/surgical history, history of present 
illness/injury, evaluation of present pain and functional capacity, and a radiographic 
assessment.   Evaluation of the inclusion/exclusion criteria will be documented on the 
Inclusion/Exclusion Criteria case report form.    Subjects that do not meet all 
inclusion/exclusion criteria will be terminated from the study and no further study data will 
be collected.  A Study Completion form will be completed and the reason for termination 
must be specified on the form.  These subjects will be excluded from the primary statistical 
analysis for this study. 
 
F. Monitor Log 
The Site Monitoring Visit Log (Appendix C) will be maintained throughout the course of the 
study.  The log will contain the visit date, monitor name/signature and the purpose of the 
visit (i.e. site initiation, onsite interim monitoring (as applicable), site close-out, etc.).  The 
site monitoring visit log will be filed in the site Regulatory Binder for the study. 
 
G.   Delegation of Authority (Site Signature Log) 
A Site Signature Log (Appendix C) will be maintained throughout the study and will contain 
the names, initials, signatures and study responsibilities of all site personnel/designees 
involved in study procedures and data collection. The Site Signature Log will be filed in the 
site Regulatory Binder for the study. 

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H.   Baseline/Pre-operative Assessment 
Baseline/pre-operative data will be collected on the following case report forms: 
1.   Inclusion/Exclusion Criteria 
2.   Demographic Evaluation 
3.   Physical Exam 
4.   EQ-5D 
5.   Knee Society Score 
a.    Surgeon completed 
b.   Patient completed 
6.   Protocol Deviations (as applicable) 
7.   Study Completion (as applicable) 
 
I. 
Surgical Technique 
Standard  operative  procedures  will  be  followed  and  all  surgical  procedures  will  be 
performed under aseptic conditions.  Investigators will implant all commercially available 
Persona fixed bearing components and any other compatible products in compliance with 
corresponding labeling requirements and in accordance with appropriate surgical 
technique(s). 
 
J. 
Intention to Treat 
Subjects who are enrolled in the study with an intention to treat (i.e. underwent the study 
Informed Consent process, signed and dated the Informed Consent, and met the study 
inclusion/exclusion  criteria),  but  do  not  undergo  the  study  surgery  due  to  subject 
withdrawal, investigator withdrawal, or any other reason(s), will be terminated from the 
study.  A Study Completion form will be completed and the reason for termination must be 
specified on the form.  These subjects will be excluded from the primary statistical analysis 
for this study. 
 
K.   Surgical and Immediate Post-surgical Procedures (Data Collection) 
Surgical and immediate post-surgical data will be collected on the following case report 
forms: 
1.   Operative Information 
2.   Surgical Device Information 
3.   Discharge Summary 
4.   Adverse Event Report (as applicable) 
5.   Protocol Deviations (as applicable) 
6.   Study Completion (as applicable) 
 
Post-surgical management for study subjects will follow the investigator’s standard of care 
for patients undergoing total knee arthroplasty (e.g. prophylactic antibiotic therapy, 
prevention of deep vein thrombosis, prevention of pulmonary embolism, etc.). 
Post-surgical rehabilitative therapy will be as prescribed by the investigator. 

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L. Post-operative Follow-up Procedures (Data Collection) 
Post-operative  clinical  evaluations/assessments  will  be  conducted  at  the  following  visit 
intervals: 
 
 
Clinical Interval 
Interval Window in Days Post-op* 
Approximate Window in Weeks 
or Months Post-op* 
6 weeks 
17 to 90 days 
-4 weeks / +7 weeks 
6 months 
91 to 244 days 
-3 months / +2 months 
1 year 
245 to 547 days 
-4 months/ +6 months 
2 years 
548 to 912 days 
-/+ 6 months 
3 years 
913 to 1277 days 
-/+ 6 months 
4 years 
1278 to 1642 days 
-/+ 6 months 
5 years 
1643 to 2007 days 
-/+ 6 months 
*Visit(s) outside of window will be determined based on Days Post-op 
 
 
Post-operative clinical data will be collected on the following case report forms: 
1.   Physical Exam 
2.   FJS-12 (Forgotten Joint Score) 
3.   EQ-5D 
4.   Knee Society Score 
a.    Surgeon completed 
b.   Patient completed 
5.   Physician Assessment of Post-op Radiographs 
6.   Adverse Event Report (as applicable) 
7.   Protocol Deviations (as applicable) 
8.   Study Completion (as applicable) 
 
 
Subjects will be followed post-operatively for up to 5 years.  Unless the study is otherwise 
closed, data will continue to be collected until the subject completes the study per the 
protocol, voluntarily withdraws from the study, is withdrawn from the study by the 
investigator, is lost to follow-up, undergoes revision to remove a study device, or expires. 
See  Management  of  Incurrent  Events  (Section  IX,  Subsection  D  of  this  protocol)  for 
additional details.   Reason(s) for study completion must be documented on the Study 
Completion case report form. 
 
M.  Minimization of Subjects Lost to Follow-up 
Subject follow-up is extremely important for the conduct of a clinical study, and the 
expectation is to maintain the highest possible rate of follow-up compliance throughout this 
study.   At each follow-up interval, subjects should be counseled on the importance of 
completing future study follow-up intervals. 

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N.   Radiographic Definitions and Methods 
All postoperative radiographic evaluations performed according to the protocol will be 
reviewed by the Investigator at the time of the evaluation and documented using the 
Physician Assessment  of  Post-op  Radiographs  case  report  form.     This  includes 
documentation of any significant radiographic findings.  In addition, an Adverse Event 
Report case report form must be completed for those findings indicated by an asterisk on 
the Physicians Assessment of Post-op Radiograph case report form, or for any other findings 
identified as an adverse event. 
 
1.   Required radiographic views 
Standing anteroposterior (AP) and standard lateral radiographs of the operative 
knee are required to be captured at the 6 week, 6 month, 1 year, 2 year, 3 year, 
4 year, and 5 year follow-up visits.   
 
Radiographs  should  have  similar  exposure  and  must  show  the  entire  study 
device and surrounding bone.  For consistency, every effort should be made to 
capture all radiographic views for a given subject using the same institution 
throughout the study.  However, radiographs captured at a different institution 
may be used for the study, provided they meet required study specifications 
and are captured within the required interval window.  The investigative site will 
retain copies (hard copy/CD/digital) of all radiographs referenced for the study. 
 
2.   Submission to Sponsor 
At Sponsor’s discretion, study radiographs may be requested from the sites for 
independent radiographic review and assessment of appropriate parameters. 
 
O.   Recommended Revision Procedure 
See Management of Incurrent Events (Section IX, Subsection D of this protocol) 
 
 
IX. 
Reporting 
The management of all study data received by Sponsor will be the responsibility of Sponsor or 
its Designee.   The use or disclosure of all protected health information will comply with the 
Health Insurance Portability and Accountability Act (HIPAA).  All information will be treated with 
strict adherence to professional standards of confidentiality and will be filed by Sponsor under 
adequate security and restricted accessibility by clinical personnel.  All electronic systems used 
to create, modify, maintain, or transmit study records will be validated according to 21 CFR Part 
11(ii).  Reports and communications relating to study subjects will typically identify each subject 
only by the subject’s initials, assigned study subject Case ID number, date of surgery, operative 
side, and date of birth. 
 
A.   Prior to Initiation of the Study 
1.   Clinical Trial Agreement (CTA) 
A fully executed (signed by all required parties) CTA must be on file with Sponsor 
prior to any investigator participating in this study. 

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2.   Institutional Review Board/Ethics Committee Protocol Approval 
This study protocol must be submitted to and approved by the Investigator’s 
Institutional Review Board (IRB) or Ethics Committee (EC).  A copy of the IRB or EC 
approval letter must be submitted to Sponsor.   The letter should identify the 
following: 
Protocol name and/or number 
Date of IRB or EC meeting (if available) 
Date of approval 
Date of expiration 
Signature of IRB or EC 
 
3.   Informed Consent 
A Sponsor-approved Informed Consent document (Appendix A Sample) will be 
provided along with the study protocol for IRB or EC submission and approval. If the 
IRB or EC requires revisions to the provided Informed Consent, the requested 
revisions must be submitted by the Investigator to Sponsor for review and approval. 
Once Sponsor has reviewed and approved the revision, the Informed Consent will 
be re-submitted to the IRB or EC for final review and approval.  A copy of the final 
IRB or EC approved Informed Consent form (ICF) must be submitted to Sponsor. 
 
B.   Clinical Data Collection/Submission 
1.   Summary of Case Report Form Data Collection 
Study data will be collected on study-specific Case Report Forms (CRFs) provided by 
Sponsor.  For subjects having bilateral knee replacement, separate case report 
forms must be completed for each operative side. 
 
The following CRF guidelines should be followed: 
 
Complete carefully and accurately. 
Complete header information consistently across all case report forms for each 
individual study subject. 
Use the study subject’s initials in header section. 
Use the study subject’s unique Case ID number assigned as instructed. 
Do not provide information that is not requested on the CRFs. 
Ensure that all fields are completed.  For fields completed by the subject, efforts 
should be made to obtain any missing responses prior to the subject completing 
their visit. 
 
2.   Data Submission 
Completed CRFs will be submitted directly to Sponsor by electronic data capture 
and submission via a method approved by Sponsor. Every effort must be made to 
ensure data submission to Sponsor is made within 30 days of the visit completion. 
 
3.   Quality Assurance of Data 
The Investigator should ensure the accuracy, completeness, legibility, and timeliness 
of the data reported to the Sponsor in the CRFs and in all required reports.  Data 
reported  on  the  CRF,  which  are  derived  from  source  documents,  should  be 

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consistent with the source documents or the discrepancies should be explained.  All 
electronic systems used to create, modify, maintain, or transmit electronic study 
records will be validated according to 21 CFR Part 11(ii).   Sponsor will maintain 
quality control systems, in accordance with Sponsor’s policies and procedures. 
 
C. Reporting Requirements 
1.   Investigator Reporting Responsibilities 
The Investigator should ensure the accuracy, completeness, legibility, and timeliness 
of data reported to the Sponsor in accordance with this protocol.  The Investigator 
or Designee will provide periodic reports to their IRB or EC as required to maintain 
IRB or EC approval throughout the study, and will provide any required final 
reporting to the IRB or EC upon study completion/termination.  A copy of all IRB or 
EC re-approval letters must be submitted to the Sponsor.  If the IRB or EC 
terminates or suspends its approval of the study, the Investigator or Designee will 
suspend study-related activities and will promptly notify the Sponsor.  The 
Investigator should also promptly provide written reports to the Sponsor and the 
IRB or EC regarding any changes significantly affecting the conduct of the study, 
and/or increasing risk to the subjects. 
 
2.   Retention of Records 
Study records must be retained by the Investigator or Designee for a minimum of 2 
years from the Investigator’s study termination date, or per applicable regulatory 
and/or IRB or EC requirements (whichever time period is greater). Measures shall 
be taken to prevent accidental or premature destruction. 
 
D.  Management of Incurrent Events 
1. 
Failure to Obtain Informed Consent 
Study data will not be collected until the Informed Consent has been signed and 
dated by the candidate.  If a candidate does not wish to participate (does not sign 
and date the Informed Consent), data for that candidate will not be collected for 
this study. 
 
2.   Adverse Events 
An adverse event is any unfavorable or unintended sign, symptom, or disease 
associated with the use of the study device, whether or not related to the device. 
Adverse event is synonymous with complication or medical event. 
 
See Section IX, Subsection E of this protocol for additional information regarding 
adverse event classifications.  All medical events, regardless of classification, are 
required to be reported on the Adverse Event Report case report form.   The 
completed Adverse Event Report case report form must be submitted to Sponsor in 
a timely manner.  The Investigator or Designee will also promptly provide Sponsor 
with any additional requested information required for Sponsor to comply with 
regulatory requirements.   If applicable per their reporting requirements, the 
Investigator or Designee will also report applicable adverse event(s) to their IRB or 
EC. 

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3.   Revision 
In  the  event  that  removal  of  one  or  more  of  the  study  knee  components  is 
necessary,  the  Investigator  will  determine  the  best  treatment  and/or  revision 
method for the subject. 
 
Prior to revision surgery, the Investigator or qualified Designee must document any 
significant radiographic findings related to the need for revision on the Physician 
Assessment of Postop Radiographs case report form.  An Adverse Event case report 
form  must  be  completed  for  those  findings  indicated  by  an  asterisk  on  the 
Physicians Assessment of Postop Radiograph case report form. 
 
Once  the  revision  surgery  has  been  completed,  the  Investigator  or  qualified 
Designee must complete an Adverse Event case report form as well as a Study 
Completion case report form terminating the subject from the study.  For the study 
completion status, select “Study Prosthesis Removed”.  This procedure also applies 
to partial revisions such as polyethylene exchange. 
 
4.   Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if the subject no 
longer meets study inclusion/exclusion criteria. The reason for the Investigator’s 
withdrawal  of  the  subject  must  be  documented  on  the  Study  Completion case 
report form. 
 
5.   Subject Withdrawal 
Study subjects may choose to withdraw from the study at any time, for any reason. 
If possible, a final evaluation will be completed for any subject who no longer wishes 
to participate in the study.   The reason for the subject withdrawal must be 
documented on the Study Completion case report form. 
 
6.   Lost to Follow-up 
A study subject will be considered lost to follow-up after they have missed a visit 
and attempts to locate and evaluate the subject using the procedure outlined below 
have failed.   All attempts to contact the subject are to be documented in the 
subject’s medical record and on the Study Completion case report form.  Missed 
visit(s) also must be documented using the Protocol Deviations case report form. 
The first three contact attempts should be made by telephone, with additional 
attempts as outlined in the following table: 
 
If 
Then 
a response is not received after three 
(3) phone calls 
the   Investigator   or   Designee   should 
send a   letter to the subject explaining 
the 
follow-up 
agreement 
per 
the 
Informed Consent, and requesting a 
response from the subject. 
all attempts to contact the subject are 
unsuccessful 
or  the 
subject 
is 
contacted and chooses to withdraw 
from the study 
a  Study  Completion  case  report  form 
will be completed and will specify the 
reason 
the 
subject 
is 
no 
longer 
participating in this study. 

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7.   Protocol Deviations 
Investigators should not deviate from the study protocol.   If a protocol deviation 
does occur,  the  deviation must be documented on the Protocol Deviation case 
report form and submitted to Sponsor.    If applicable per their reporting 
requirements, the Investigator or Designee will also report applicable protocol 
deviations to their IRB or EC. 
 
8.   Study Termination 
Study subject participation is expected to end upon completion of the subject’s 5- 
year follow-up visit unless the subject voluntarily withdraws from the study, is 
withdrawn  from  the  study  by  the  Investigator,  is  lost  to  follow-up,  undergoes 
revision to remove a study device, or expires.  Reason(s) for study completion must 
be documented on the Study Completion case report form. 
 
If   Sponsor   decides   to   terminate   the   study   early,   Sponsor   will   inform   the 
Investigators of the reason for early study termination.  It is the responsibility of the 
Investigators to inform their IRB or EC as applicable according to local and national 
laws/regulations. 
 
9.   Modification of the Protocol 
All amendments to this clinical protocol shall be agreed to by Sponsor and be 
recorded with a justification for the amendment prior to implementation. Approval 
of the applicable IRB or EC must be obtained prior to implementation, if required 
according to the local and/or national laws/regulations. 
 
E.   Medical Events/Adverse Events Definitions and Classifications 
An adverse event is any unfavorable or unintended sign, symptom, or disease associated 
with the use of the study device, whether or not related to the device.  Adverse event is 
synonymous with complication or medical event.   All medical events, regardless of 
classification, are required to be reported on the Adverse Event Report case report 
form.    The completed Adverse Event Report case report form must be submitted to 
Sponsor in a timely manner.  The Investigator or Designee will also promptly provide 
Sponsor with any additional requested information required for Sponsor to comply with 
regulatory   requirements.      If   applicable   per   their   reporting   requirements,   the 
Investigator or Designee will also report applicable adverse event(s) to their IRB or EC. 
 
1.   Classification of the Event: 
Adverse Event (AE)(i): 
An Adverse Event is any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the medical device. 

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Serious Adverse Event (SAE)(i): 
A Serious Adverse Event is any adverse event that 
a.    led to death 
b.   led to serious deterioration in the health of the subject, that either 
resulted in 
1.   a life-threatening illness or injury, or 
2.   a permanent impairment of a body structure or a body function, 
or 
3.   in-patient or prolonged hospitalization, or 
4.   medical  or  surgical  intervention  to  prevent  life-threatening 
illness or injury or permanent impairment to a body structure or 
a body function 
c. led to fetal distress, fetal death or a congenital abnormality or birth 
defect. 
Note: Planned hospitalization for a pre-existing condition, or a procedure 
required by the protocol, without serious deterioration in health, is not 
considered a serious adverse event. 
 
Adverse Device Effect (ADE)(i): 
An Adverse Device Effect is an adverse event related to the use of a medical 
device. 
 
Note 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the medical device. 
 
Note 2: This definition includes any event resulting from use error or from 
intentional misuse of the medical device. 
 
Serious Adverse Device Effect (SADE)(i): 
A Serious Adverse Device Effect is an adverse device effect that has resulted in 
any of the consequences characteristic of a serious adverse event. 
 
Sponsor is responsible for determining the final classification of adverse events. 
 
If an Unanticipated Serious Adverse Device Effect (USADE) is identified by Sponsor, it will 
be promptly reported to concerned Investigators and regulatory authorities as required 
by applicable regulatory requirements.  If applicable per their reporting requirements, 
the Investigator or Designee will report the USADE to their IRB or EC. 
 
2.   Intensity of Symptoms 
Mild: 
The subject is aware of the sign or symptom, but finds it easily tolerated.  The 
event is of little concern to the subject and/or little clinical significance.   The 
event is not expected to have any effect on the subject’s overall health or well 
being. 

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Moderate: 
The subject has discomfort enough to cause interference with or change in 
usual activities.   The event is of some concern to the subject’s health or well 
being and may require medical intervention and/or close follow-up. 
 
Severe: 
The event interferes considerable with the subject’s usual activities.  The event 
is  of  definite  concern  to  the  subject  and/or  poses  substantial  risk  to  the 
subject’s  health  or  well- being.     The event is likely to require medical 
intervention   and/or   close   follow-up   and   may   be   incapacitating   or   life 
threatening. Hospitalization and treatment may be required. 
 
NOTE:  The term “severe” refers to the intensity of the event and can be used 
with any event, without regard to whether or not it meets the criteria for being 
classified as “serious” or “unanticipated”.  For example, a subject can have a 
severe headache, but it is not a serious event. 
 
3.   Outcome Definitions 
The outcome is in relationship to the Adverse Event, not the treatment rendered for 
the event (if any). 
 
Resolved: 
The adverse event has been resolved and/or no further treatment is required to 
treat the reported condition or illness. 
 
Tolerated: 
The adverse event will most likely never be resolved.   The subject “tolerates” 
the illness or condition as a matter of life. 
 
Pending: 
Treatment or diagnostic studies were prescribed for the adverse event and the 
outcome of the adverse event is not yet known. 
 
Study Withdrawal: 
Due to the adverse event, the subject was withdrawn from the study. 
 
Device Removal: 
The adverse event resulted in the removal of a study device. 
 
Reoperation of Affected Joint: 
The   adverse  event   resulted   in   reoperation  of   the   study  joint,   but  the 
reoperation did not include removal of a study device. 
 
Death: 
The  outcome  indicates  the  subject  died  as  a  direct  result  of  the  reported 
adverse event. 

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F.  Monitoring of the Study 
Prior to initiating the clinical study, Sponsor will conduct a site initiation visit to ensure 
the Investigator(s) and study staff understand the study protocol and requirements and 
have adequate time and resources to implement and conduct the study.  Prior to study 
initiation, the Investigator must have a fully executed CTA and IRB or EC approval of the 
study protocol and the study Informed Consent. 
 
During the course of the study, Sponsor will conduct periodic central monitoring and 
maintain contact with the study staff to monitor compliance and evidence of adverse 
events, in accordance with Sponsor’s policies and procedures.  Sponsor will address any 
identified non-compliance with the executed CTA, study protocol, and applicable 
regulatory requirements. 
 
If onsite monitoring visit(s) are deemed appropriate by Sponsor, the Investigator will 
permit representatives of Sponsor’s monitoring team to have direct access to inspect all 
source data/documents, study documents/binders, study subject case report forms, 
corresponding sections of study subject medical/hospital records, and any other 
documents relevant to the study.  All Sponsor visits (including site initiation) will be 
documented using the Site Monitoring Visit Log (Appendix C). 
 
 
X. 
Risk Analysis 
This post-market clinical study is classified as minimal risk(ii)  and there are no anticipated risks 
specific to study participation other than the potential loss of confidentiality. There are no 
experimental procedures in this study, and participation in this study is not anticipated to affect 
the medical treatment of enrolled subjects. 
 
When used in accordance with product labeling, the risks associated with the use of Persona 
knee components are similar to those of standard, metal-on-polyethylene knee systems used 
for the same clinical indication or purpose.  These risks are categorized below as either general 
surgical risks or risks associated with the total knee arthroplasty procedure/study device. 
Unanticipated adverse events can also occur. 
 
A.   General Surgical Risks 
General surgical risks and post-operative adverse events can occur with any surgery and 
include, but are not limited to: 
Anesthetic complications/reactions 
Bleeding and/or excessive blood-loss 
Transfusion reaction 
Chronic Pain 
Post-operative infection 
Vascular injury 
Delayed wound healing 
Deep vein thrombosis (DVT) 
Nerve injury 
Death 

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B.   Risks Associated with Total Knee Arthroplasty Procedure/Study Device 
Potential adverse events associated with total knee arthroplasty include, but are not limited 
to: 
Wear of the polyethylene articulating surface 
Progressive bone resorption (osteolysis) as a result of foreign-body reaction to 
wear debris 
Loosening of the prosthetic knee components 
Fracture/damage of the prosthetic knee components 
Soft tissue impingement or damage 
Dislocation and/or joint instability 
Malalignment of the prosthetic knee components 
Bone fracture 
Nerve damage 
Swelling 
Infection 
Leg length discrepancies 
Poor range of motion 
Delayed wound healing 
Temporary or permanent neuropathies 
Pain 
Cardiovascular disorders including venous thrombosis, pulmonary embolism, or 
myocardial infarction 
Histological reactions resulting in inflammation 
Metal sensitivity 
Corrosion of metal components (the significance and long-term implications are 
uncertain and await further clinical evidence and evaluation) 
 
Minimization of Risk 
Investigators should refer to the package insert for additional information and instructions. 
 
 
XI. 
Statistical Considerations 
Performance of commercially available Persona fixed bearing knee components in primary total 
knee arthroplasty will be evaluated for pain, function, quality of life, and survivorship.  Data 
collected in this study will be summarized descriptively and descriptive summaries will be the 
basis of any study reports issued.  These summaries may be used for interim study reports and 
may also be used to support regulatory submissions, presentations, and/or publications. 
Additional surgical technique and instrumentation data may be collected and evaluated. 
 
A.   General Statistical Methods 
Statistical methodology will consist of summarizing collected data descriptively.  Categorical 
data (e.g., gender or race) will be summarized using counts and percentages, and 95% 
Confidence Interval (CI), over the time periods of interest. Continuous data, such as age, will 
be summarized by using means, medians, standard deviation, minimum, maximum, and 
95% CI over the time periods of interest.   Implant survival and return to function will be 

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summarized using a Kaplan-Meier method and presented with rates (as percentages) and 
confidence intervals. 
 
B.   Sample Size 
Sample size is based on a longitudinal data collection model and using survivability as the 
primary endpoint of interest.  The attrition rate is assumed to be 10%. 

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XII. 
References 
 
1.   Mehrotra C, Remington PL, Naimi TS, Washington W, Miller R. Trends in total knee replacement 
surgeries and implications for public health, 1990-2000. Public Health Rep. 2005;120(3):278-82. 
 
2.   CDC. Update: Inpatient surgery: Data for US. Accessed on Sep’ 1, 2012. 
http://www.cdc.gov/nchs/data/nhds/4procedures/2009pro4_numberprocedureage.pdf 
 
3.   Felson DT, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern 
Med. 2000;133:8. 
 
4.   Felson DT, et al. Risk factors for incident radiographic knee osteoarthritis in the elderly: the 
Framingham Study. Arthritis Rheum. 1997;40:4. 
 
5.   Marks R, Allegrante JP. Body mass indices in patients with disabling hip osteoarthritis. Arthritis 
Res 2002;4:112-6. 
 
6.   Mokdad AH, Bowman BA, Ford ES, Vinicor F, Marks JS, Koplan JP. The continuing epidemics of 
obesity and diabetes in the United States. JAMA 2001;286:1195-200. 
 
7.   Stickles B, Phillips L, Brox WT, Owens B, Lanzer WL. Defining the relationship between obesity 
and total joint arthroplasty. Obes Res 2001;9:219-23. 
 
8.   Tennant A, Fear J, Pickering A, Hillman M, Cutts AM, Chamberlain MA. Prevalence of knee 
problems in the population aged 55 years and over: identifying the need for knee arthroplasty. 
BMJ 1995;310:1291-3. 
 
9.   Winiarsky R, Barth P, Lotke P. Total knee arthroplasty in morbidly obese patients. J Bone Joint 
Surg Am 1998;80:1770-4. 
 
10. Iorio R, Robb WJ, Healy WL, Berry DJ, Hozack WJ, Kyle RF, Lewallen DG, Trousdale RT, Jiranek 
WA, Stamos VP, Parsley BS. Orthopaedic surgeon workforce and volume assessment for total 
hip and knee replacement in the United States: preparing for an epidemic. J Bone Joint Surg Am. 
2008;90:1598–1605. 
 
11. 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;89:780–785. 
 
12. Harris WH, Sledge CB. Total hip and total knee replacement (1). N Engl J Med1990; 323:725-31. 
 
13. Harris WH, Sledge CB. Total hip and total knee replacement (2). N Engl J Med1990; 323:801-7. 
 
14. Walsh M, Woodhouse LJ, Thomas SG, Finch E. Physical impairments and functional limitations: a 
comparison of individuals 1 year after total knee arthroplasty with control subjects. Phys Ther. 
1998;78:248–258 

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15. Lemaire et. al. Tibial component positioning in total knee arthroplasty: bone coverage and 
extensor apparatus alignment. Knee Surg. Sports Traumatol, Number 5, pp 251-257. 1997 
 
16. Mahoney et. al. Overhang of the Femoral Component in Total Knee Arthoplasty: risk factors and 
clinical consequences. JBJS, Number 92, pp 1115-1121. 2010 
 
17. David. Two and a half years of navigation of the LCS knee prosthesis using the Brainlab Vector 
Vision system:180 navigations. Eur J Orthop Traummatol, Number 18, pp111-117. 2008. 
 
18. Hanratty et. al. The influence of posterior condylar offset on knee flexion after total knee 
replacement using a cruciate sacrificing mobile-bearing implant. Br JBJS, Number 89, pp 915- 
918. 2007. 
 
19. Arabori et. al. Posterior condylar offset and flexion in posterior cruciate retaining and posterior 
stabilized TKA. J Orthop Sci, Number 13, pp 46-50. 2008 

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Guideline Reference: 
i.  ISO 14155:2011(E). International Standard for Clinical investigation of medical devices for human subjects 
– Good clinical practice 
ii. Barnett Educational Services. 2011 Code of Federal Regulations Reference Guide for Medical Devices. 
Revised April 1, 2011.