Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
Conditions: Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
Sponsor: The University of Tennessee, Knoxville

#17830041.0 
 
 
Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining 
Total Knee Replacements  
 
Harold E. Cates, M.D. 
 Tennessee Orthopaedic Clinics 
9430 Park West Blvd 
Knoxville, TN 37923 
 
Mark Freeman, M.D. 
Erlanger Orthopaedics 
979 East 3rd St. 
Chattanooga, TN 37403 
 
In vivo knee kinematics will be assessed for 80 subjects that have been implanted with either a 
Smith & Nephew Journey II posterior cruciate retaining (PCR) [40 subjects] or bi-cruciate 
retaining (BCR) [40 subjects] total knee arthroplasty (TKA) who are patients of Dr. Cates or Dr. 
Freeman.   Enrollment and testing will be increased to 45 patients per implant model to ensure 
the necessary 80 usable datasets are acquired and also to account for any subjects that may drop 
out of the study. All TKAs should be judged clinically successful (KSS > 80).  A KSS score of 
greater than 90 is deemed to be excellent by the Knee Society.  Each subject should have a well-
functioning prosthesis, be at least three months post-operative, and should have good-to-
excellent post-operative passive flexion.  
    
Deciding which patients received which kind of implant was up to the discretion of Dr. Harold 
Cates or Dr. Mark Freeman, according to their professional opinions. The determination as to 
which type of implant patients received is outside the scope of this particular study. Subjects will 
already have the knee implants and must be at least three months post-operative. Bilateral 
subjects will not be included in the study populations. 
 
Inclusion criteria: 
1. Subjects will have either a Smith & Nephew Journey II posterior cruciate retaining (PCR) 
[45 subjects] or bi-cruciate retaining (BCR) [45 subjects] TKA. 
2. Patients must be at least three months post-operative. 
3. Participants must be judged clinically successful with their most recent new Knee Society 
score equal to or greater than 80. 
4. Weigh < 250  
5. BMI < 40 
6. Must be >40 years of age 
7. Participants must be able to perform the required activities without concern.  
8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the 
study.  
 
Exclusion criteria: 
1. 
Pregnant, potentially pregnant, lactating females or of childbearing age. 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. 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019
20180745
IRB Approved at the 
Protocol Level 
Jul 08, 2019

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3. 
Cannot not have pain in other parts of the body that would prohibit the patient from 
performing the activities 
4. 
Cannot have ligamentous pain and/or laxity. 
5. 
Unwilling to sign IC form. 
6. 
Does not speak English. 
 
Study locations 
Subject Recruitment:  
Research Foundation of Dr. Harold Cates 
9330 Park West Blvd., Suite 208B 
Knoxville, TN 37923 
Phone: (865) 373-1811 
 
Erlanger Orthopaedics 
979 East 3rd St. 
Chattanooga, TN 37403 
Phone: (423) 778-4900 
 
Fluoroscopic exams:  
Tennessee Orthopaedic Clinic 
9430 Park West Blvd. 
Knoxville, TN 37923 
Phone: (865) 690-4861 
 
Study data analysis: 
Science and Engineering Research Facility 
1414 Circle Dr. 
Knoxville, TN 37996 
 
CMR Administrative offices: 
310 Perkins Hall 
1506 Middle Dr. 
Knoxville, TN 37996 
(865) 974-2093 
 
Recruitment 
Up to forty-five patients will have been implanted with a Smith & Nephew Journey II posterior 
cruciate retaining (PCR) and 45 patients will have been implanted with a bi-cruciate retaining 
(BCR) whose post-operative conditions permit them to capably perform the study activities. 
Research staff from Dr. Cates’ Research Foundation or Dr. Freeman’s practice at Erlanger 
Orthopaedics will determine potential participants for the study by reviewing medical files. The 
surgeon’s research staff will review the patient’s KSS, clinical dictation, and electronic health 
record (EHR), and he will approve or reject the patient as a candidate for the study. During 
review of medical files, the research staff will utilize the CMR Recruitment/Enrollment checklist 
(Attachment 6) to ensure that each potential subject meets all eligibility requirements prior to 
being contacted. This sheet included a checklist of the inclusion criteria, as well as a field for the 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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research staff to include a subject identifier so the subject’s eligibility can once again be 
confirmed on the day of data collection. Once this sheet has been completed by the staff, it will 
be submitted to a UT Research Coordinator, lead researcher or PI/Co-PI/Sub-I to review and 
authorize recruitment and enrollment. After a potentially eligible subject has been identified and 
authorized to be enrolled in the study, s/he will be contacted for a visit to the surgeon’s office to 
be consented. The subject will then be consented and scheduled for fluoroscopy data collection 
at the Tennessee Orthopaedic Clinic in Knoxville, TN.  All testing collection at Tennessee 
Orthopaedic Clinic will be scheduled after normal clinic hours so as not to interfere with the 
patient treatments occurring during the day.  
 
Data Collection 
University of Tennessee researchers with experience conducting fluoroscopic research studies, as 
well as either a PI/Co-PI/Sub-I for the study, and possibly Dr. Cates’ staff will be present during 
the fluoroscopy procedure to walk subjects through the activities. A radiation technician (RT) 
employed by the Tennessee Orthopaedic Clinic will collect fluoroscopic video while subjects 
perform the following activities: walking up and down a ramp, deep knee bend and rising from 
the DKB position.  
 
 
 
Prior to starting data collection, UT researchers will complete the second portion of the CMR 
Recruitment/Enrollment checklist to ensure subjects meet eligibility requirements to document 
inclusion criteria for compliance purposes. Age and weight will be verified at the time of 
fluoroscopy to ensure eligibility. If a subject does not meet the inclusion criteria, s/he will not be 
tested. If the participant still meets all study criteria, s/he will be asked to practice the activities 
to ensure s/he can comfortably complete them and experience no pain with the clinic 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.  
 
Multiple trials of each activity may be conducted to ensure usable images have been acquired 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. 
 
The fluoroscopic footage for these activities will be stored on digital video files on a secure 
computer workstation, uploaded onto the secure CMR database by the UT researcher that 
attended data collection, where identifiable data will be removed and substituted for data that 
cannot identify the subject (e.g., dates of birth will be removed and replaced with number of 
months the individual has been alive). Subjects will be assigned study and subject-specific 
identifiers which is how the system will distinguish the datasets.   
   
SPECIFIC RISKS AND PROTECTION MEASURES 
 
1. Fluoroscopic Procedures 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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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 (0.0083 rem per min) (Verdun1).  Mettler, 
et al have reported that the typical effective dose for a conventional knee procedure is 0.005 mSv 
(0.00005 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 
shows that the average effective dose was 0.14 mSv (0.0014 rem) with a maximum dose of 0.27 
mSv (0.0027 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 less than 4 rem.  4 rem is considered 
"Very Low" risk.  It is unlikely that anyone in this study will approach the 4 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 4.0 rems of radiation. This means that the maximum total 
exposure rate will be less than 4 rems per subject for the entire experiment (Attachments 3 and 
4).  The participant's knee joint will be fluoroscoped using minimal risk levels of radiation 
according to published literature (Attachment 2).  
  
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 she/he feels that there is no risk to her/his surgical procedure or 
recuperation.  
 
We are estimating a total maximum time of 45 minutes to permit the subject time to complete the 
IC form, ask any questions s/he may have, practice the activities or repeat any activities that 
could not be completed, and collect all necessary fluoroscopy data from each subject.  
 
2. Participant Confidentiality  
The investigator will ensure subject confidentiality to the extent that is permissible by law is 
maintained throughout the study and after. Complete confidentiality cannot be guaranteed. 
 
Hard Copy 
In compliance with HIPAA regulations, all participants will have their identities withheld from 
all public files. The personnel in the following list will have access to participant PHI for the 
purposes of recruitment or compliance and/or may have contact with patients: 
 
                                                          
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 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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List of Persons Involved in Research affiliated with Covenant Health: 
• Dr. Harold Cates, Study Doctor/Co-PI, Tennessee Orthopaedic Clinics 
• Ms. Jane Smith, Research Director, Tennessee Orthopaedic Foundation for Education 
and Research 
• Clinical Research Staff, including Ms. Peggy Adams and Mr. Johnny Campbell, 
Tennessee Orthopaedic Foundation for Education and Research 
• Radiation technician(s) will operate the fluoroscopy machine. 
• Western Institutional Review Board 
 
List of Persons Involved in Research affiliated with Erlanger Health System: 
• Dr. Mark Freeman, study doctor/Sub-Investigator, Erlanger Orthopaedics 
• Selected research staff, Erlanger 
• University of Tennessee College of Medicine, Chattanooga IRB 
 
List of Persons Involved in Research affiliated with the University of Tennessee: 
• Richard D. Komistek, PI, UT Professor  
• Michael LaCour, Ph. D., Sub-I, UT Research Assistant Professor 
• William Hamel, Ph. D., Sub-I, UT Professor 
• Researchers present during data collection at the University of Tennessee and/or the lead 
graduate student(s) appointed by Dr. Komistek.  
• * Undergraduate student researchers employed by the Center for Musculoskeletal 
Research (CMR) will be involved in analyzing the data after it has been collected, 
transferred to a computer workstation and stored in CMR’s digital data collection. Since 
participant information will be removed and replaced with identifiers (a code that is 
assigned to each individual research subject) before the data is transferred to the secure 
server, it will not be possible for these undergraduate students to be able to identify 
subjects. These student researchers will never have contact with subjects, unless they are 
part of the data collection team. 
• Rebecca Robertson, Research Coordinator, UT staff 
• Institutional Review Board of the University of Tennessee 
 
 
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. It is not anticipated 
that the imaging collected during this study would potentially provide benefit to specific subjects 
by influencing the surgeon’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.  
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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• There is no intention of any direct benefit to participants of the study accept they will be 
able to see their implant on the video monitor and the fluoroscopic video will be assessed 
by the research team.  
 
The researchers have been conducting fluoroscopic exams for 25 years.  In those previous 
studies, subjects participated and the findings from those studies have led to implant design 
improvements with the knee implant systems.  Therefore, like those subjects who participated in 
previous studies, data from this study will lead to results that will continue to improve the 
longevity of future knee implants. 
 
METHODS TO OBTAIN "INFORMED CONSENT" FROM PARTICIPANTS 
Once a patient is identified as potentially eligible by the surgeon’s staff (TOC: Ms. Smith, JJ 
Campbell or Peggy Adams; Erlanger Orthopaedics - TBD), the patient’s KSS, clinical dictation, 
and EHR will be reviewed by the surgeon and he will approve or reject the patient as a candidate 
for the study. As indicated in the Recruitment section of this protocol, in order to ensure and 
document compliance of eligibility, during review of medical files, the research staff will utilize 
the CMR Recruitment/Enrollment checklist to ensure that each potential subject meets all 
eligibility requirements prior to being contacted. This sheet includes a checklist of the inclusion 
criteria, as well as a field for research staff to include a subject identifier so the subject’s 
eligibility can once again be confirmed on the day of data collection. Once this sheet has been 
completed by the Research Foundation staff, it will be submitted to a UT Research Coordinator, 
lead researcher or PI/Co-PI/Sub-I to review and authorize recruitment and enrollment. After a 
potentially eligible subject has been identified and authorized to be enrolled in the study, the 
research staff will then contact the subject, and if interested, the subject will be scheduled for a 
meeting with the research staff at their office.  After a thorough explanation of the study and the 
activities that the subject will be doing, making sure the subject has asked all questions and 
received answers, if the subject agrees to participate, s/he will sign the Informed Consent and the 
HIPAA release. A research staff member will then schedule the fluoroscopic testing session 
during after-hours at the Tennessee Orthopaedic Clinic. These consent forms will be securely 
transmitted and stored at the University of Tennessee, as well as the Research Foundation and 
Erlanger Orthopaedics and will be accessible by only the aforementioned personnel.  
 
Dr. Cates nor Dr. Freeman will be present during the consenting process to avoid possible 
subject coercion to participate. Subjects may contact their surgeon’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 UT researchers to guide the subject through the steps of the procedure, allow the 
subject to practice the activities and then to actually perform the activities under fluoroscopic 
surveillance; actual radiation exposure will be up to, but not more than two minutes. Fluoroscopy 
on-time and any fluoroscopy unit measurements will be indicated on each subject’s IC/HIPAA 
form.  
 
Compensation 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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Since study participants who are patients of Dr. Freeman will be traveling from the Chattanooga 
area to Knoxville for data collection, the sponsor of the study has allocated a $100.00 stipend for 
these individuals. This payment will be made through the University of Tennessee. Subjects will 
be asked to complete necessary paperwork during their consenting visit for them to receive this 
payment. An invoice will be created for each subject on the day that they complete their data 
collection and the payment will be processed through the University’s system. It could take up to 
two weeks for payment to be received. Local subjects of Dr. Cates did/will not receive this 
compensation as their travel is not as substantial. 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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ATTACHMENT 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. 
 
 
 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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ATTACHMENT 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 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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ATTACHMENT 3 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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ATTACHMENT 4  
_______________________________________________ 
* The Health Physics Society is a nonprofit scientific professional organization whose mission is 
excellence in the science and practice of radiation safety. Since its formation in 1956, the Society has 
grown to approximately 6,000 scientists, physicians, engineers, lawyers, and other professionals 
representing academia, industry, government, national laboratories, the Department of Defense, and other 
organizations. Society activities include encouraging research in radiation science, developing standards, 
and disseminating radiation safety information. Society members are involved in understanding, 
evaluating, and controlling the potential risks from radiation relative to the benefits. Official position 
statements are prepared and adopted in accordance with standard policies and procedures of the Society. 
The Society may be contacted at 1313 Dolley Madison Blvd., Suite 402, McLean, VA 22101; phone: 
703-790-1745; fax: 703-790-2672; email: HPS@BurkInc.com. 
 
 
Who We Are 
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Home • Latest News • Ask the Experts • Experts' Answers • 
Radiation Facts • HPS Papers • Meetings • Membership • Affiliates 
Answer to Question #708 Submitted to "Ask 
the Experts" 
Category: Medical and Dental Issues — Nuclear Medicine and PET 
The following question was answered by an expert in the appropriate 
  
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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News & Events 
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field: 
Q: Do you know a source or Web site where I can find a listing of 
typical whole-body doses for common nuclear medicine, 
radiography, CT, mammo, and fluoro exams? I'm just looking for 
average doses.
A: There are numerous sources for some of this information. While 
that is nice for those of us who know where to look, there really 
isn't one source of information on doses for all types of typical 
exams. I've put together, in the tables below, some of the 
information you requested. I've also included the references I used 
in the event you might want to go to the library to look at them or 
to order a copy for yourself. Table 1 is a list of x-ray exams and 
I've given a single-film effective dose. 
 
 
Table 1. Effective doses for single x-ray films 
Single radiographs 
Effective Dose (mrem)
Skull (PA or AP)1 
3 
Skull (lateral)1 
1 
Chest (PA)1 
2 
Chest (lateral)1 
4 
Chest (PA and lateral)5 
6 
Thoracic spine (AP)1 
40 
Thoracic spine (lateral)1
30 
Lumbar spine (AP)1 
70 
Lumbar spine (lateral)1
30 
Abdomen (AP)1 
70 
Abdomen6 
53 
Pelvis (AP)1 
70 
Pelvis or hips6 
83 
Bitewing dental film6 
0.4 
Limbs and joints6 
6 
Table 2 shows the dose an individual might receive if undergoing 
an entire procedure, e.g., a lumbar spine series typically consists of 
five films. 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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Table 2. Effective doses for complete x-ray 
procedures 
Complete exams 
Effective Dose 
(mrem) 
Intravenous Pyelogram (kidneys, 6 films)1 
250 
Barium swallow (24 images, 106 sec 
fluoroscopy)1 
150 
Barium meal (11 images, 121 sec 
fluoroscopy)1 
300 
Barium follow-up (4 images, 78 sec 
fluoroscopy)1 
300 
Barium enema (10 images, 137 sec 
fluoroscopy)1 
700 
CT head1 
200 
CT chest1 
800 
CT abdomen1 
1,000 
CT pelvis1 
1,000 
CT (head or chest)5 
1,110 
PTCA (heart study)6 
750 - 5,700 
Coronary angiogram6 
460 - 1,580 
Mammogram6 
13 
Lumbar spine series6 
180 
Thoracic spine series6 
140 
Cervical spine series6 
27 
 
 
Table 3 gives examples of typical nuclear medicine procedures. 
Table 3. Effective doses for routine nuclear 
medicine studies 
Nuclear Medical 
Scan 
Activity 
(mCi) Radiopharmaceutical 
Effective 
Dose 
(mrem)
Brain2 
20 
99m+Tc DTPA 
650 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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Brain3 
50 
15O water 
170 
Brain4 
20 
99mTc HMPAO 
690 
Hepatobiliary2 
5 
99mTc SCO 
370 
Bone2 
20 
99mTc MDP 
440 
Lung 
Perfusion/Ventilation2 5 & 10
99mTc MAA & 133Xe 
150 
Kidney2 
20 
99mTc DTPA 
310 
Kidney3 
20 
99mTc MAG3 
520 
Tumor2 
3 
67Ga 
1,220 
Heart3 
30 
99mTc sestimibi 
890 
30 
99mTc pertechnetate 
1,440 
Heart4 
2 
201Tl chloride 
1,700 
30 
99mTc tetrofosmin 
845 
Various3 
10 
18F FDG 
700 
References: 
1. Wall BF, Hart D. Revised radiation doses for typical x-ray 
examinations. The British Journal of Radiology 70: 437-
439; 1997. (5,000 patient dose measurements from 375 
hospitals) 
  
2. National Council on Radiation Protection and 
Measurements. Exposure of the U.S. population from 
diagnostic medical radiation. Bethesda, MD: National 
Council on Radiation Protection and Measurements; NCRP 
Report 100; 1989. 
  
3. International Commission on Radiation Protection. 
Radiation dose to patients from radiopharmaceuticals: 
addendum to ICRP 53. New York, NY: Pergamon Press; 
ICRP Publication 80; 1999. 
  
4. International Commission on Radiation Protection. 
Radiological protection in biomedical research. New York, 
NY: Pergamon Press; ICRP Publication 62; 1993. 
  
5. National Council on Radiation Protection and 
Measurements. Sources and magnitude of occupational and 
public exposures from nuclear medicine procedures. 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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Bethesda, MD: National Council on Radiation Protection 
and Measurements; NCRP Report 124; 1996. 
  
6. United Nations Scientific Committee on the Effects of 
Atomic Radiation. Sources and effects of ionizing radiation, 
Vol. 1: Sources. New York, NY: United Nations 
Publishing; 2000. 
Kelly Classic,  
Certified Medical Health Physicist 
  
Answer posted on March 30, 2001. The information and 
material posted on this Web site is intended as general 
reference information only. Specific facts and 
circumstances may alter the concepts and applications of 
materials and information described herein. The 
information provided is not a substitute for professional 
advice and should not be relied upon in the absence of 
such professional advice specific to whatever facts and 
circumstances are presented in any given situation. 
Answers are correct at the time they are posted on the 
Web site. Be advised that over time, some requirements 
could change, new data could be made available, or 
Internet links could change. For answers that have been 
posted for several months or longer, please check the 
current status of the posted information prior to using 
the responses for specific applications.  
 
Ask a Question  •  Search ATE & ATE Categories  •  If you 
have Web-related problems, contact our Webmaster. If you 
are lost, see our site map. This page last updated December 
31, 2003. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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ATTACHMENT 5  
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

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5/3/2019 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

Page 25 of 29 
Cates Freeman Journey II PCR vs BCR Protocol 
V2.3 NA 6.20.19 
5/3/2019 
 
 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

Page 26 of 29 
Cates Freeman Journey II PCR vs BCR Protocol 
V2.3 NA 6.20.19 
5/3/2019 
 
 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

Page 27 of 29 
Cates Freeman Journey II PCR vs BCR Protocol 
V2.3 NA 6.20.19 
5/3/2019 
 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

Page 28 of 29 
Cates Freeman Journey II PCR vs BCR Protocol 
V2.3 NA 6.20.19 
5/3/2019 
 
ATTACHMENT 6 
 
 
 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019

Page 29 of 29 
Cates Freeman Journey II PCR vs BCR Protocol 
V2.3 NA 6.20.19 
5/3/2019 
 
 
IRB NUMBER: UTK IRB-16-03187-FB
IRB APPROVAL DATE: 07/30/2019