In Vivo Kinematics for Subjects Implanted With Klassic TKA
Conditions: Total Knee Arthroplasty, Osteo Arthritis Knee, Knee Implant, Knee Injuries
Sponsor: The University of Tennessee, Knoxville

  
 
 
 
This is to certify that the information contained herein is true and correct as reflected in the records of this IRB. WE CERTIFY THAT 
THIS IRB IS IN FULL COMPLIANCE WITH GOOD CLINICAL PRACTICES AS DEFINED UNDER THE U.S. FOOD AND DRUG 
ADMINISTRATION (FDA) REGULATIONS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) REGULATIONS, 
AND THE INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) GUIDELINES. 
 
Board Action: 09/04/2018 
  
 
 
Investigator Name: Richard D. Komistek, PhD 
Michael Paul Bolognesi, MD  
 
Board Action Date: 09/04/2018 
Investigator Address: 1506 Middle Drive, 310 Perkins Hall
Knoxville, TN 37996, United States 
Approval Expires: 09/04/2019 
Continuing Review Frequency: Annually 
Sponsor:  University of Tennessee 
Institution Tracking Number:   
Sponsor Protocol Number: None 
Amended Sponsor Protocol Number:    
Study Number: 1189113 
IRB Tracking Number: 20182087 
Work Order Number: 1-1104527-1 
Panel: 1 
Protocol Title: In vivo kinematics for subjects implanted with Klassic TKA 
  
THE FOLLOWING ITEMS ARE APPROVED: 
Investigator  
Investigator  
Confidentiality Pledge #18232267.0 - As Submitted  
Protocol (08-10-2018) Version 1.2  
Consent Form [S0]  
Data and Safety Monitoring plan (DSMP) #18232266.0 - As Submitted  
Klassic TKA Revocation of Consent #18232268.0 - As Submitted  
Subject Inclusion Criteria Checklist #18232265.0 - As Submitted  
 
  
Please note the following information: 
The Board requires that all subjects must be able to consent for themselves to be enrolled in this study.  This means that 
you cannot enroll incapable subjects who require enrollment by consent of a legally authorized representative. 
 
Federal Regulations do not recognize Co-Principal Investigators. Therefore, the Board has approved the two investigators 
for this study as if each is THE Investigator and holds each individually responsible for the conduct of the entire study. 
 
Financial Disclosure (08-23-2018) Michael Bolognesi 
  
THE IRB HAS APPROVED THE FOLLOWING LOCATIONS TO BE USED IN THE RESEARCH: 
Hofmann Arthritis Institute’s  Center for Precision Joint Replacement, 24 South 1100 East, Suite 101, Salt Lake City, Utah  
84102    
 
  
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COA Template 01-03-2018 
Board Action: 09/04/2018   
Page 2 of 2
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DISTRIBUTION OF COPIES: 
Contact, Company 
Richard D. Komistek, PhD, The University of Tennessee  
Rebecca Robertson, The University of Tennessee  
Michael Paul Bolognesi, MD, Duke University Health System - Department of Orthopaedic Surgery  
 

In vivo kinematics for subjects implanted with Klassic TKA 
 
Richard D Komistek, PhD 
University of Tennessee 
1506 Middle Drive 
310 Perkins Hall 
Knoxville, TN 37996 
Phone: (865) 974-2093 
Fax: (865) 946-1787 
Email: rkomiste@utk.edu 
 
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total 
Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis 
Institute’s Center for Precision Joint Replacement (24 South 1100 East, Suite 101, Salt Lake 
City, UT 84102). This is the location from which all participants will be recruited and where 
fluoroscopy data collection will occur. Enrollment will be increased to 24 subjects to ensure that 
researchers acquire the necessary 20 usable datasets for analysis and also to account for any 
subjects that may drop out of the study. There will be 12 subjects with the Klassic TKA in the 
right knee and 12 with the Klassic TKA in the left knee. At present, all TKA available for 
surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left 
knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a 
symmetrical knee implant, where the same femoral and same tibial component can be used for 
either the right or left knee. The kinematics for the 10 left knees vs the 10 right knees will be 
compared. The results from this study will also be compared with previously published results 
for fluoroscopic studies assessing the in vivo kinematics during a deep knee bend that is 
available in the literature to determine if there is a difference. The designers of the Klassic knee 
implant believe this knee implant will function similar to asymmetric knee implants. All TKAs 
should be judged clinically successful (KSS ≥80).  Each subject should have a well-functioning 
prosthesis and be at least six months post-operative.  
    
Deciding which subjects received which type of implant was up to the discretion of Dr. 
Hofmann, according to his professional opinion. The determination as to which type of implant 
subjects received is outside the scope of this particular study. Subjects will already have the knee 
implants and must be at least six months post-operative.  
 
We will use the following inclusion criteria to recruit participants for this study: 
1. Subjects will have a Klassic knee system. 
2. Subjects must be at least six months post-operative. 
3. Participants must be judged clinically successful with their most recent (new) Knee 
Society “Knee Score” (Attachment 7) equal to or greater than 80. 
4. Participants must be able to perform a deep knee bend.  
5. Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate 
in the study.  
6. Must speak English. 
 
Exclusion criteria: 

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1. 
Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each 
female subject will be asked if she is pregnant, or possibly could be pregnant. A 
pregnant person will not be allowed to participate in the study. 
2. 
Subjects without the required type of knee implant. 
3. 
Bilateral subjects (i.e., patients with both knees implanted) 
4. 
Subjects who are unable to perform a deep knee bend. 
5. 
Subjects who are unwilling to sign Informed Consent/ HIPAA documents. 
6. 
Subjects who do not speak English. 
 
Study locations 
Subject recruitment and fluoroscopic exams will take place at of the Hofmann Arthritis 
Institute’s Center for Precision Joint Replacement  
24 South 1100 East, Suite 101 
Salt Lake City, UT 84102 
(801) 355-6468 
 
Analysis will take place at the University of Tennessee’s Center for Musculoskeletal Research 
laboratories, Science and Engineering Research Facility  
1414 Circle Dr. 
Knoxville, TN 37996 
(865) 974-0198 
 
CMR administrative offices 
310 Perkins Hall  
1506 Middle Dr.  
Knoxville, TN 37996 
(865) 974-2093 
 
Recruitment 
Dr. Hofmann will recommend eligible subjects for recruitment from his practice that have been 
implanted with the TJO Klassic knee system whose post-operative conditions permit them to 
capably perform the study activities. A partial waiver of HIPAA authorization will be completed 
so patient medical files may be reviewed to ensure complete eligibility. Dr. Daniel Mangiapani, 
(Sub-Investigator), from the Hofmann Arthritis Institute will review those patients’ medical 
records to determine if they meet the remaining eligibility required for the study according to the 
study-specific criteria. A study-specific Subject Inclusion Recruitment/Enrollment sheet 
(Attachment 4) with eligibility requirements will be used when reviewing the patient medical 
files. The forms will not contain any identifying patient information – only boxes to be checked 
to indicate whether or not a potential subject is completely eligible. The form will be sent to UT 
researchers (e.g., research coordinator, PI, Sub-Investigator), and they will advise Dr. 
Mangiapani as to whether or not the patient may be contacted about participating in the study. 
Dr. Mangiapani will then contact the subjects to explain the study and inquire as to whether or 
not they are interested in participating by one of the following methods: primarily telephone calls 
utilizing a script (Attachment 5), in-office discussion and possibly mail correspondence, if 
necessary, using a  recruitment letter (Attachment 6). If a subject is agreeable to participate, s/he 
will be scheduled for a time to visit the Hofmann Arthritis Institute on the day of data collection. 

3 In vivo kinematics for subjects implanted with Klassic TKA  
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On this scheduled day, University of Tennessee (UT) researchers will travel to the Hofmann 
Arthritis Institute to collect the kinematic data of participant implanted knees at least six months 
post-operatively under fluoroscopic surveillance using a C-arm fluoroscopic unit while subjects 
perform a deep knee bend activity. The fluoroscopy unit to be used is owned by the Hofmann 
Arthritis Institute and will be run by a radiation technician employed by the Hofmann Arthritis 
Institute. The fluoroscopic images will be stored on password protected laptop for subsequent 
analysis. 
 
Data Collection 
University of Tennessee researchers (Milad Khasian, Manh Ta, Jarrod Nachtrab, or Garett 
Dessinger) will travel to Salt Lake City, UT to conduct the fluoroscopic data collection. Any of 
these graduate research assistants, as well as either a PI (R. Komistek, Ph.D.), Co-PI (M. 
Bolognesi, M.D.), or Sub-Investigators (A. Hofmann, M.D., A. Sharma, Ph.D., Daniel 
Mangiapani, M.D.) for the study, will be present during the fluoroscopy procedure to walk 
subjects through the activity. A radiation technician (RT) employed by the Hofmann Arthritis 
Institute will collect fluoroscopic video while subjects perform the deep knee bend.  
  
Dr. Mangiapani and/or UT researchers will consent the participants. They will meet with each 
potential participant individually to make sure s/he has been properly informed of the procedures 
and to help with any of the IC/HIPAA form. CMR researchers will inform all subjects that they 
do not have to participate and are free to leave if they wish and will answer any questions 
subjects may have about the study. Participation is entirely voluntary.  
 
In addition to fluoroscopy video, subjects will be videotaped from the shoulders down (to 
maintain subject anonymity) while performing the activity (live feed perspective). The speed 
level of each trial will be based on the comfort level of the subject. One of the researchers will be 
ready and in close proximity to assist each subject in case the participant requires help. This 
precaution will be practiced for all participants, regardless of physical wellbeing, age or prior 
results; no assumptions will be made as to any participant’s capabilities. 
When both the subject and study team are ready, the following activity will be performed: 
1. 
Deep knee bend 
a) The subject will begin standing in a starting position in which the knee is fully 
extended. When ready the subject will flex the knee through its full weight 
bearing range of motion.  
b) Once maximum weight bearing flexion is achieved the activity is complete, and 
the subject can rise to a comfortable resting position. 
 
 
 
Participants will be asked to practice the activity to ensure they can comfortably complete them 
and experience no pain with the fluoroscopy machine off (no radiation). The practice portion of 
the data collection without radiation will not be video-recorded. During the fluoroscopy 
procedure, the RT will follow the motion of the implanted knee with the fluoroscopy machine; 
only the knee joint (from the fluoroscopy machine) will be recorded on the fluoroscopy footage. 
The participant will be allowed to rest as necessary and be instructed to stop the activity at the 
first sign of pain.  
 

4 In vivo kinematics for subjects implanted with Klassic TKA  
Protocol V1.2 
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Researchers will be at the Hofmann Arthritis Institute during the fluoroscopic exams, serving as 
consultants to the RT on site. They will not operate the fluoroscopy unit, but will be available to 
the RT and the Institute staff if questions arise. Researchers will be on hand to assist the 
participant at any time during the procedure. The participant has the right to stop the procedure at 
any time; researchers or the RT can end the procedures at any time if they feel the participant is 
at risk, but the participant can choose to remain in the study if s/he feels that there is no risk to 
her/his surgical procedure or recuperation. If researchers and the M.D. present during data 
collection concur that a subject is at risk and the subject persists in participating, the researchers 
will ask the subject to discontinue the activities and not to participate in the study. 
 
Multiple trials of the activity may be conducted to ensure researchers have successfully collected 
the raw data required to complete the study. Radiation time will be kept as low as reasonably 
achievable (ALARA) and will not exceed two minutes. The RT will start the fluoroscope just 
prior to the subject beginning each activity trial and will stop the fluoroscope immediately after 
the subject completes each activity trial to ensure that the subject is not exposed during idol 
periods. Fluoroscopy on-time will be recorded on subject IC/HIPAA forms. 
 
The fluoroscopic footage for the activity will be stored on digital video files on a secure 
computer workstation, and participant information will be removed and replaced with identifiers 
by researchers selected by Dr. Komistek to lead the study, which may include any researchers 
that attend data collection. All researchers with access to identifiable subject data will sign 
statements of confidentiality. This study data will then be uploaded onto a secure server that 
University of Tennessee researchers will use to conduct the kinematic analysis.  
   
Private Health Information/Medical Record Data 
The surgeon and his staff will provide subjects’ clinical information from their medical records – 
PHI – to Dr. Komistek and his researchers to aid in the interpretation of the results and correlate 
clinical outcomes versus kinematic results, although only researchers present during data 
collection or those appointed by Dr. Komistek to lead the study will have access to PHI; they 
will sign confidentiality statements. This information can be used to rule out any unique 
kinematic patterns. This information will only be used by the UT researchers and will not be 
provided to any other source.  
 
The clinical/demographic information acquired from the medical records with participant 
authorization obtained as required by HIPAA will include: 
• Post-operative New Knee Society “Knee Score” (that was used to ensure subject met 
inclusion criteria). Researchers need the post-operative NKSS that was acquired prior to 
enrollment that qualified candidates as potential participants. 
• Implant information 
• Date of surgery 
 
On the day of data collection, the list of subject names will be given to UT researchers and the 
researchers will use this to generate subject-specific identifiers. A table will be generated for this 
study, indicating the participant’s name and generated ID number; this table with subject names 
and corresponding ID numbers will be provided to Dr. Mangiapani, so he will be aware of which 
identifier is linked with each subject. Then, Dr. Mangiapani will upload the PHI from medical 

5 In vivo kinematics for subjects implanted with Klassic TKA  
Protocol V1.2 
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files into an excel spreadsheet created by the UT researchers present during data collection or 
those appointed by Dr. Komistek that will only have the generated ID numbers. This spreadsheet 
will be securely transferred to UT researchers via UT’s secure email known as the Vault.  
 
The subject data – fluoroscopy frames, video footage and data from medical files– will be 
uploaded and stored on CMR’s secure server at UT, Knoxville for use in this and future studies 
(if participant permission is obtained via IC) by the researcher(s) who attend data collection or 
appointed by Dr. Komistek. Once data has been uploaded, the database automatically removes 
subject identifiers and assigns an ID for each subject. This ID will coincide with the one assigned 
to each individual on the day of data collection. Only these files of de-identified data (no dates of 
surgery) are now available for researchers to review and analyze. Only Dr. Adrija Sharma (Sub-
Investigator and CMR database administrator) has access to the identifiable data that was 
originally uploaded by the GRA, as it remains in a password-protected portion of the secure 
server. Only Dr. Sharma can grant access to this identifiable password-protected portion of the 
database by changing a user's level of authentication with different privilege levels. Researchers 
would like to retain this study data in our secure database so as to continue to add relevant, 
current data to our digital collection to help us work with manufacturers in the future to create 
better implants that last longer and will not require revision surgery. Participants will be asked if 
their study data may remain a part of the CMR data collection for use in future studies in the IC. 
Likewise, should a subject choose to withdraw from the study, s/he will have the option as to 
whether or not data collected from them at the point of withdrawal may be used for data analysis 
or if their information should be destroyed from CMR records; subjects choosing to withdraw 
will be asked to complete a Revocation of Consent wherein they may indicate their preference 
regarding the data collected from them. 
 
These files will be accessible by only the personnel indicated under Section 5. Depending on the 
subjects’ response to the Archiving Data section of the IC (page 8), these video files may be kept 
indefinitely for the possibility of future use.  
 
SPECIFIC RISKS AND PROTECTION MEASURES 
 
1. Fluoroscopic Procedures 
 
As with every clinical study, there may be some risks.  However, doses of radiation exposure 
received will be much lower than those known to produce detectable health effects.  Previously 
reported literature shows that fluoroscopy-based procedure (angiography) on the lower limb 
result in a typical effective dose of 0.83 mSv per min (0.083 rem per min) (Verdun1).  Mettler, et 
al. have reported that the typical effective dose for a conventional knee procedure is 0.005 mSv 
(0.0005 rem)2.  According to either estimate, the additional risk of a fluoroscopic procedure 
involving the knee ranges between "Negligible" to "Low" for a 2 minute exam (Verdun).  A 
previous fluoroscopy TKA study conducted at another hospital with a 2 minute on-time limit 
 
1 Verdun FR, Bochud F, Gundinchet F, Aroua A, Schnyder P, Meuli R. Quality Initiatives Radiation Risk: What 
You Should Know to Tell Your Patient 1. Radiographics 2008 Nov 28(7):1807-16. 
2 Mettler, et al. “Effective Doses in Radiology and Diagnostic Nuclear Medicine.” Radiology 248.1 (2008): 254-263. 
http://radiology.rsna.org/content/248/1/254.full.pdf+html 
 

6 In vivo kinematics for subjects implanted with Klassic TKA  
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shows that the average effective dose was 0.14 mSv (0.0014 rem) with a maximum dose of 0.27 
mSv (0.027 rem).  The additional risk for all subjects in this previous study would be considered 
"Negligible."  To account for subject variability and differences in imagining techniques, all 
subjects enrolled in this study will receive fewer than 2 rem.  2 rem is considered "Low" risk.  It 
is unlikely that anyone in this study will approach the 2 rem limit. Since the fluoroscopy data 
will be collected in one session, there will only be one day in which the participants will be 
exposed to this amount of radiation. 
 
In conclusion, a participant who will be fluoroscoped for less than two minutes will be exposed 
to a maximum amount of only 2.0 rems of radiation. This means that the maximum total 
exposure rate will be less than 2 rems per subject for the entire experiment (Attachments 3 and 
4).  The participant's knee joint will be fluoroscoped using negligible to low risk levels of 
radiation according to published literature (Attachments 2 and 3).   
 
We are estimating a total maximum time of 45 minutes to permit the subject time to complete the 
IC/HIPAA form, ask any questions s/he may have, practice the activity or repeat the activity that 
could not be completed, and collect all necessary fluoroscopy data from each subject.  
 
2. Participant Confidentiality  
The investigators will ensure subject confidentiality to the extent that is permissible by law is 
maintained throughout the study and after. Researchers not notated as Investigators of this study 
that have access to PHI will sign pledges of confidentiality. Complete confidentiality cannot be 
guaranteed. 
 
Computer Database 
As noted, on the day of data collection, the list of subject names will be given to UT researchers 
and researchers will use this to generate subject-specific identifiers; Dr. Mangiapani will be 
provided with this list of subject names and corresponding generated identifiers. These assigned 
identifiers will be uploaded into an excel spreadsheet created by UT researchers. Dr. Mangiapani 
will be aware of each subject’s respective identifier from the table provided to them on the day 
of data collection after UT researchers generate the subject-specific identifiers. They will upload 
the PHI from subject medical files into the excel spreadsheet and transmit the document back to 
UT researchers via UT’s secure email transmission known as the Vault (https://vault.utk.edu/). 
 
After the study data has been entered into the spreadsheet by the surgeon’s office, researchers 
present during data collection or appointed by Dr. Komistek will upload the subject data, 
including PHI, fluoroscopy, and video footage, into the CMR digital data collection. 
Consequently, student researchers in CMR who assist in data analysis cannot access subject-
specific information. All participant queries (lookups) generate the participant identification 
number (the ID generated by UT researchers) and no subject identifiers.  No identifiable images 
exist in the database. This study data will be kept indefinitely on the secure CMR database for 
possible future research (with the permission of each participant – requested in the IC). In the 
case of participant withdrawal from the study, the Revocation of Consent that the participant will 
be asked to complete requests that the participant indicate whether or not data collected prior to 

7 In vivo kinematics for subjects implanted with Klassic TKA  
Protocol V1.2 
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withdrawal may be used for data analysis purposes, or if it should be removed from the CMR 
data collection completely and destroyed. 
 
Hard Copy 
In compliance with HIPAA regulations, all participants will have their identities withheld from 
all public files. Individuals not indicated as Investigators below will have access to participant 
information and they will sign pledges of confidentiality. The personnel in the following list will 
have access to participant PHI: 
 
List of Persons Involved in Research: 
• Dr. Richard Komistek, PI, University of Tennessee Professor, Biomedical Engineering, 
Knoxville, TN 
• Dr. Michael Bolognesi, Co-PI, Duke Orthopaedics, Orthopaedic Surgeon, Durham, NC 
• Dr. Aaron Hofmann, Sub-Investigator, study surgeon, Hofmann Arthritis Institute, 
Orthopaedic Surgeon, Salt Lake City, Utah 
• Dr. Daniel Mangiapani, Sub-Investigator, Hofmann Arthritis Institute, Adult Joint 
Reconstruction Fellow, Salt Lake City, Utah 
• Dr. Adrija Sharma, Sub-Investigator, UT Research Assistant Professor, Biomedical 
Engineering, Knoxville, TN 
• Clinical research staff from Hofmann Arthritis Institute appointed by Drs. Hofmann or 
Mangiapani, Salt Lake City, Utah 
• Radiation technician(s) from Hofmann Arthritis Institute will operate the fluoroscopy 
machine.  
• Rebecca Robertson, Research Coordinator, UT staff. 
• Researchers present during data collection and/or the lead student researchers appointed 
by Dr. Komistek.  
• Graduate students: 
▪ Garett Dessinger 
▪ Jarrod Nachtrab 
▪ Milad Khasian 
▪ Manh Ta 
• * Undergraduate student researchers employed by CMR will be involved in 
analyzing the data after it has been collected and transferred to CMR’s digital 
data collection. Since subject information will be removed and replaced with the 
assigned identifiers before the data is transferred to the database, it will not be 
possible for these undergraduate students to be able to identify subjects. They 
will only have access to the study data that has been uploaded onto the secure 
CMR digital collection. These undergraduate student researchers will not have 
contact with subjects. 
• Institutional Review Boards 
• The University of Tennessee’s IRB has waived oversight to WIRB for this 
study’s review and approval. The required Reliance Agreement is included with 
this submission. 
• Western Institutional Review Board on behalf of the Hofmann Arthritis Institute. 
 

8 In vivo kinematics for subjects implanted with Klassic TKA  
Protocol V1.2 
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Clinical Observations: 
There are no clinical observations made during this data collection or from the images obtained 
through data collection. There will be no radiology report generated for this procedure conducted 
as a result of this study. Therefore, no RT will review such a report for the procedures, which 
would be the only way such a “significant problem” would be determined. No data will be 
returned to the surgeon’s office for evaluation or surgeon review. However, if researchers see 
anything in the imaging that is extremely out of the ordinary (e.g., floating body, severe 
dislocation, potential tumors [spots of incredibly dense tissue on bones and skin]), they will bring 
this to the attention of Dr. Hofmann or his staff. It is not anticipated that the imaging collected 
during this study would potentially provide benefit to specific subjects by influencing the 
physician’s treatment plan. 
 
BENEFITS 
The potential benefits from this study include, but are not limited to: 
• Better understanding of the joints analyzed with the same technique in the past. 
• Future implant design improvements based on the kinematic findings. 
• New and advanced surgical techniques for TKA based on the results.  
• There is no intention of any direct benefit to participants of the study. Information related 
to the data gathered may be provided to the surgeon by the researchers if something out 
of the ordinary is seen during the imaging. However, researchers are not radiologists and 
cannot interpret anything they may see. If there is something within the imaging that is 
obviously wrong as mentioned above, then this could result in potential modification of a 
subject’s treatment plan if images collected as a result of this study reveal any kind of 
“significant problem.”  
 
METHODS TO OBTAIN "INFORMED CONSENT" FROM PARTICIPANTS 
Informed consent will be obtained prior to any procedures being conducted. Subjects who are 
agreeable to participate will be scheduled to visit the Hofmann Arthritis Institute on the day that 
UT researchers will travel there for data collection. Dr. Mangiapani and/or UT researchers will 
be responsible for consenting the participants, giving them ample time to review and complete 
the forms and assist the participants with review of the documentation, if the participants are 
unable to read the form on their own. Only upon signed consent will the subject be allowed to 
participate in the study. If the subject chooses to be removed from the study after participating, 
his/her video footage and any other demographical data that was collected will be managed 
according to the subject’s response on the Revocation of Consent form. A copy of his/her 
Revocation of Consent will be attached to his/her IC and placed in a separate, secure file for IRB 
review. These consent forms will be stored at UT, Knoxville and will be accessible by only the 
aforementioned personnel.  
 
Dr. Hofmann will not be present during the consenting process to avoid possible subject coercion 
to participate. Subjects may contact Dr. Hofmann’s office with any questions they may have. 
 
From previous studies, we have determined that it takes approximately 15 minutes to consent a 
subject and answer any questions that s/he may have. We have also estimated approximately 30 
minutes for researchers to guide the subject through the steps of the procedure, allow the subject 

9 In vivo kinematics for subjects implanted with Klassic TKA  
Protocol V1.2 
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to practice the activity and then to actually perform the activity under fluoroscopic surveillance; 
actual radiation exposure will be up to, but not more than two minutes. We have estimated a total 
time of approximately 45 minutes for each subject to be consented, complete the KSS survey and 
complete the fluoroscopy procedure.   
 
STATISTICAL ANALYSIS PLAN 
Basic descriptive statistics (mean, standard deviation and range) will be analyzed for the 
condylar movement, axial rotation, and range-of-motion.