Clinical trial NCT04297631
Conditions: Antibotics in Cementless Knees
Sponsor: Washington University School of Medicine
Start date: 2020-02-14; Completion date: 2020-11-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.

Detailed description:
Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.

Arms: arm 1: All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels. arm 2: All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.
Interventions: intervention 1: Tobramycin Powder intervention 2: Vancomyscin
Intervention descriptions: intervention 1: Everyone gets tobramycin powder. intervention 2: Everyone gets the vancomyscin powder.

Protocol documents:
Prot_SAP_000.pdf: 
Version#2 2/10/20 
 
 
 
 
 
11/14 
Human Research Protection Office  
Box 8089 
(314)633-7400 
Fax (314)367-3041 
 
Prospective study investigating antibiotic elution from free intra-articular vancomycin and 
tobramycin powder after cementless total knee arthroplasty 
Principal Investigator:  
Charles Lawrie, MD  
 
 
Co-Investigators:  
J. Chance Miller, MD 
Robert L. Barrack, MD 
Ryan Nunley, MD 
 
Study team members 
Venessa Riegler, BS 
Rondek Salih, MPH 
 
OVERVIEW 
 
Background information:  
Use of intrawound antibiotics to decrease the risk of periprosthetic joint infections (PJI) is standard 
practice in primary total knee arthroplasty (TKA). There is mixed evidence on their role in 
reducing infection rates after TKA. For cementless TKAs, surgeons typically add an antibiotic to 
the knee prior to closure. Previous studies have showed that the systemic absorption of these 
antibiotics is low, and they carry a low risk of toxicity. 
 
Prior studies have shown that many of organisms causing PJI after primary TKA are susceptible to 
vancomycin but resistant to aminoglycosides including tobramycin. These findings have been 
confirmed by our previous study on bacterial isolate patterns from PJIs after TKA. It showed that 
nearly all of the gram negative isolates were susceptible to tobramycin, while 27.8% of the 
gram-positive isolates were resistant. However, the addition of vancomycin covered 100% of these 
tobramycin-resistant gram-positive isolates. Thus, the addition of vancomycin and an 
aminoglycoside together provides broad-spectrum prophylaxis against the most common 
organisms causing PJIs after TKA. 
 
 
 
 


Version#2 2/10/20 
 
 
 
Primary Hypothesis:  
The intra-articular concentration of vancomycin and tobramycin will reach supratherapeutic 
concentrations postoperatively. Serum concentrations will be significantly lower than intraarticular 
concentrations. Use of these antibiotics is an effective way to reduce joint infections.  
Aim(s): 
1. Determine the intra-articular concentration of vancomycin and tobramycin after 
administration of vancomycin and tobramycin powder in primary cementless total knee 
arthroplasty.  
2. Determine the serum concentrations of these antibiotics postoperatively 
 
Potential Contribution:  
The findings of this study will provide evidence for optimal intrawound antibiotic choice in 
cementless total knee arthroplasty.  
 
METHODS 
Timeline: 1 year (6 months of prospective enrollment and 6 months of data analysis.)   
 
Data analysis will begin after this study has received approval. Anticipated end date is December 
2020. 
 
Inclusion/Exclusion Criteria:   
1. Age over 18 
2. Total knee arthroplasty for primary osteoarthritis  Primary diagnosis of knee osteoarthritis 
 
Exclusion criteria: 
1. Diminished mental capacity 
2. Vancomycin allergy 
3. Tobramycin allergy 
4. Chronic kidney disease stage III and stage IV 
 
Recruitment:  
We will be identifying patients from the clinical practice of Dr. Ryan Nunley, Dr. Robert Barrack, 
and Dr. Charles Lawrie.    
 
 
Design:  
This study is a prospective study designed to characterize and quantify the level of antibiotics 
eluted from the knee after administration of intrawound antibiotic powder in primary cementless 
total knee arthroplasty. 


Version#2 2/10/20 
 
 
 
The study will collect 3 samples of postoperative intra-articular drain fluid from the total knee 
arthroplasty, and 3 samples postoperative serum samples the day after surgery. The total amount of 
intra-articular drain fluid and blood drawn will be 15 mLs fluid and 15 mLs blood, respectively. 
(5mL = 1 teaspoonful 15mL=1 tablespoonful) The fluid being used for the study is fluid that is 
drained after surgery and discarded. Data collected will permit clinical evaluation of antibiotic 
powder as it pertains to total knee arthroplasty. This study will collect drug-related or possibly 
drug-related adverse events. Data collected will include the following: Patient demographics (age, 
gender, BMI), implant and surgical information, and medical comorbidities. Each eligible 
participant will be required to execute written informed consent and covers the provisions of this 
study.  
Number of participants: We propose to enroll 20 participants undergoing primary cementless total 
knee arthroplasty. 
There will only be one study group. 
The study patients will not be blinded to their study group. The surgeons and study personnel will 
not be blinded to study group. 
Data collection: 
Data collection for prospective patients will occur preoperatively and postoperatively.  
 
Data analysis: 
A student t-test will be used to compare means and standard deviations between serum and 
intraarticular antibiotic concentrations. Descriptive statistics will be used to analyze the subjective 
data points such as AEs. Analysis methods will be further discussed during data and publication 
review meetings. We will be doing the analysis at pre-operative, intraoperative and postoperative 
time points. An independent statistician, independent of the study team and the orthopedics 
department will analyze the data.  
 
Procedures:  
The study will collect intraarticular drain fluid from the total knee arthroplasty the day after 
surgery. 2 serum samples will also be collected after surgery, and there will be a chart review. 
 
INFORMED CONSENT 
Enrollment and consent will begin in the clinic of Dr. Ryan Nunley, Dr. Robert Barrack, and Dr. 
Charles Lawrie. The treating surgeon will identify patients who are determined to be candidates 
for primary TKA, and who generally meet the study requirements.  
 
The consent process will occur by one of the following means:  
 


Version#2 2/10/20 
 
 
 
1) The study coordinator will meet with each potentially eligible participant to review the study 
requirements (including additional screening for eligibility) and answer any questions the patient 
may have.  
 
If the patient has any clinical questions that cannot be answered by the study coordinator they will 
be answered by the physician or the physician's nurse. The patient will have the opportunity to 
review the consent form, discuss with family/friends, and do his/her own research on the subject if 
desired. Qualified patients who agree to participate in the study will be required to sign an 
Informed Consent Document. Valid enrollment is not granted until after surgery, once it has been 
verified that the participant has had total knee surgery. 
 
2) The consent discussion and review of the Informed Consent Document may occur over the 
phone. In this case, the study coordinator will call the patient to present the study to the participant 
and gauge interest in participation. If the patient expresses interest in participation, the study 
coordinator will e-mail, mail or fax the Informed Consent Document to the participant. The patient 
will be given the opportunity to ask questions. If the patient has any research questions beyond the 
scope of the study coordinator, arrangements will be made for the participant to speak with the 
applicable member of the research team, including the PI. After review of the Informed Consent 
Document, the participant will sign the applicable sections of the Informed Consent Document and 
mail or fax the consent for back to the study coordinator. The Informed Consent Document will be 
signed by the consenting study coordinator upon receipt. Valid enrollment is not granted until after 
surgery, once it has been verified that the participant applicable member of the research team, 
including the PI. After review of the Informed Consent Document, the participant will sign the 
applicable sections of the Informed Consent Document and email, mail or fax the consent for back 
to the study coordinator. 
 
PROCEDURES FOR MAINTAINING CONFIDENTIALITY 
Data Security:  
Protection of confidentiality by the Washington University Coordinating Center will be maximized 
by use of (a) protected and secured data collection, (b) password protected access to data storage, 
and (c) access to patient data limited to the study coordinator or his designate.  
 
ASSESSMENT OF RISKS AND BENEFITS 
Risks 
A potential risk of accidentally disclosing information regarding Washington University patients is 
possible though unlikely. 
Benefits 
The findings of the study will identify areas for improvement in antibiotic choice used for total 
knee arthroplasty and characterize intraarticular and serum antibiotic levels after standard use of 
intrawound antibiotics in cementless total knee arthroplasty.   
 
 
REFERENCES 
 


Version#2 2/10/20 
 
 
 
1. Lux PS, Martin JW, Whiteside LA. Reinfusion of whole blood following addition  
of tobramycin powder to the wound during total knee arthroplasty. The Journal of 
Arthroplasty 1993 Jun;8(3):269-71. 
2. Johnson JD, Nessler JM, Horazdovsky RD, Vang S, Thomas AJ, Marston SB. 
Serum and Wound Vancomycin Levels After Intrawound Administration in 
Primary Total Joint Arthroplasty. The Journal of Arthroplasty 2017 
Mar;32(3):924-928 
3. Eckman JB Jr, Henry SL, Mangino PD, Seligson D. Wound and serum levels of 
tobramycin with the prophylactic use of tobramycin-impregnated 
polymethylmethacrylate beads in compound fractures. Clin Orthop Relat Res. 
1988 
4. Dec;(237):213-5. PubMed PMID: 3191632. 
5. Murray J. Penner MD, BSc, Bassam A. Masri, MD, FRCS(C), Clive P. Duncan, 
MD, MSc, FRCS ( C) (1996) Elution characteristics of vancomycin and 
tobramycin combined in acrylic bone-cement The Journal of Arthroplasty 1996 
Dec;11(8):939-44 
6. Konstantinos Anagnostakos, Jens Kelm (2009) Enhancement of antibiotic elution 
form acrylic bone cement Journal of Biomedical Materials Research Part B: 
Applied Biomaterials 2009 Jul;90(1):467-75, doi:10.1002/jbm.b.31281 
7. Brien WW, Salvati EA, Klein R, Brause B, Stern S(1993) Antiobiotic impregnated 
bone cement in total hip arthroplasty. An in vivo comparison of the elution 
properties of tobramycin and vancomycin Clinical Orthopedics and Related 
Research Nov;(296):242-8 
8. Gonzalez Della Valle A, Bostrom M, Brause B, Harney C, Salvati EA (2001) 
Effective bactericidal activity of tobramycin and vancomycin eluted from acrylic 
bone cement Acta Orthopaedica Scandinavica 2001 Jun;72(3):237-40 
9. Paloma Anguita-Alonso MD, Arlen D Hanssen MD, Douglas R. Osmon MD, 
Andrej Trampuz MD, James M. Steckelberg MD, Robin Patel MD (2005) High rate 
of aminoglycoside resistance among staphylococci causing prosthetic joint 
infection Clinical Orthopaedics and Related Research 2005 Oct;439:43-7 
10. Gregory Vrabec MD, FRCS, Willis Stevenson MD, Sameh Elguizaoui MD, 
Matthew Kirsch MD, John Pinkowski MD (2016) What is the intraarticular 
concentration of tobramycin using low dose tobramycin bone cement in TKA: An 
in vivo analysis  Clinical Orthopaedics and Related Research 2016 
474:2441-2447 doi 10.1007/s11999-016-5006-x 
 

ICF_001.pdf: 
 
FOR IRB USE ONLY 
IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
INFORMED CONSENT DOCUMENT 
 
Project Title: 
Prospective study investigating antibiotic elution from free intra-articular 
vancomycin and tobramycin after cementless total knee arthroplasty 
 
Principal Investigator: 
Charles Lawrie 
 
Research Team Contact: 
Venessa Riegler 314-362-1721 
 
 
 
This consent form describes the research study and helps you decide if you want to participate.  It 
provides important information about what you will be asked to do during the study, about the risks and 
benefits of the study, and about your rights and responsibilities as a research participant. By signing this 
form you are agreeing to participate in this study. 
 You should read and understand the information in this document including the procedures, 
risks and potential benefits.  
 If you have questions about anything in this form, you should ask the research team for more 
information before you agree to participate.   
 You may also wish to talk to your family or friends about your participation in this study. 
 Do not agree to participate in this study unless the research team has answered your 
questions and you decide that you want to be part of this study.  
 
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study.  We invite you to participate in this research study because you are scheduled 
for a total knee arthroplasty (TKA).  
The purpose of this research study is to learn about intra-articular antibiotic use in primary cementless 
total knee arthroplasty. Two types of commonly used antibiotics will be used as part of this study.  
Vancomycin and Tobramycin will be administered into the joint during surgery. 
 
The findings from this study will provide evidence for optimal antibiotic choice in cementless total knee 
arthroplasties. 
 
 Tobramycin and vancomycin are approved by the U.S. Food and Drug Administration to treat serious 
bacterial infections caused by microorganism strains that are susceptible to these drugs.  However, the 
use of tobramycin and vancomycin are considered investigational in this study. 
 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
If you agree to participate you will have the standard procedure of receiving vancomycin and 
tobramycin powder administered to your knee during surgery.  As part of routine care, a drain will be 
placed into your knee during surgery. We will then collect and test the fluid that is drained from your 
knee on the day after surgery.  This fluid is usually discarded.  The study will collect 3 samples of 


 
FOR IRB USE ONLY 
IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
Page 2 of 10 
postoperative intra-articular drain fluid from the total knee arthroplasty, and 3 postoperative serum 
samples the day after surgery. The total amount of drain fluid and blood to be drawn will be 15milliliters 
fluid (3 teaspoonfuls) and  15 milliliters blood (3 teaspoonfuls), respectively.  
 
We will also collect data from your medical records including demographic information (age, gender, 
BMI), implant and surgical information, other medical conditions you might have and joint-related 
findings. 
 
Will you save my research information/samples to use in future research studies? 
 
We would like to use the fluid samples and data, we are obtaining in this study for studies going on right 
now as well as studies that are conducted in the future.  These studies may provide additional 
information that will be helpful in understanding antibiotics used in total knee arthroplasties in knee 
joint fluid immediately following TKA or other diseases or conditions, including research to develop 
investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug 
Administration.  It is unlikely that what we learn from these studies will have a direct benefit to you.  
There are no plans to provide financial compensation to you should this occur.  By allowing us to use 
your data and samples you give up any property rights you may have in the data and samples. 
 
We will share your data and samples with other researchers. They may be doing research in areas similar 
to this research or in other unrelated areas.  These researchers may be at Washington University, at other 
research centers and institutions, or industry sponsors of research.  We may also share your research data 
with large data repositories (a repository is a database of information) for broad sharing with the 
research community.  If your individual research data is placed in one of these repositories only 
qualified researchers, who have received prior approval from individuals that monitor the use of the 
data, will be able to look at your information.   
 
If you change your mind and do not want us to store and use your knee fluid data for future research you 
should contact the research team member identified at the top of this document.  The data will no longer 
be used for research purposes. However, if some research with your knee fluid has already been 
completed, the information from that research may still be used. Also, if data has been shared with other 
researchers it might not be possible to withdraw data to the extent it has been shared. 
 
Please place your initials in the blank next to Yes or No for each of the questions below: 
 
My data and samples may be stored and used for future research as described above. 
 
_____ Yes 
_____ No 
Initials  
Initials 
 
My data and samples may be shared with other researchers and used by these researchers for the 
future research as described above. 
 
_____ Yes  
_____ No 
Initials  
Initials 
 


 
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IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
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 Identifiers may be removed from your private information including fluid samples and data and 
used for future research or shared with others. If this occurs, we will not ask you for additional 
consent.  
 
HOW MANY PEOPLE WILL PARTICIPATE? 
 
Approximately 20 people will take part in this study conducted by investigators at Washington 
University.  
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your involvement will last for the completion of the collection of 
your fluid samples (which will be done on the day after surgery).  
 
WHAT ARE THE RISKS OF THIS STUDY? 
 
You may experience one or more of the risks indicated below from being in this study. In addition to 
these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this 
study.  
 
Risk of Blood samples 
bruising, pain, bleeding, and infection 
 
Risk of Tobramycin  
 
Likely/ Common 
Mild 
 Renal function changes (which can indicate kidney damage) 
 
Less Likely / Less Common 
Mild 
 Anemia 
 Decrease/increase in white blood cells 
 Low blood platelet count 
 Fever 
 Rash 
 Dermatitis (skin inflammation) 
 Itching 
 Nausea 


 
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RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
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 Vomiting 
 Diarrhea 
 Headache 
 Lethargy (sleepiness) 
 Abnormal labs(increased ALT and AST, increased serum LDH and bilirubin, decreased serum 
calcium, magnesium, sodium, and potassium) which could indicate liver damage 
Rare   
Mild 
 Disorientation  
 Dizziness 
 Vertigo (feeling off balance) 
 Tinnitus (ringing in the ears) 
 Roaring in ears 
 Hearing loss 
Risk of Vancomycin 
 
 Likely/ Common 
Mild 
 Renal function changes 
Rare 
Mild 
 Hearing loss 
 Vertigo 
 Dizziness 
 Tinnitus 
 Low blood platelet count 
 Decrease in white blood cells 
 
 Breach of Confidentiality 
One risk of participating in this study is that confidential information about you may be accidentally 
disclosed.  We will use our best efforts to keep the information about you secure.  Please see the section 
in this consent form titled “How will you keep my information confidential?” for more information. 
 
WHAT ARE THE BENEFITS OF THIS STUDY? 
 
You will not benefit from being in this study. 
 
However, we hope that, in the future, other people might benefit from this study because the findings 
will provide evidence for optimal antibiotic choice in antibiotic cement used in total knee arthroplasty, 
as well as determine the effect of using intra-articular antibiotics in cementless total knees. 
 


 
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APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
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WHAT OTHER TREATMENT OPTIONS ARE THERE? 
 
 
Before you decide whether or not to be in this study, your doctor will discuss the other options that are 
available to you.  Instead of being in this study, you could choose not to be in the study. You will still be 
getting a total knee arthroplasty regardless if you are in the study or not. 
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
As part of this study you will receive tests and procedures that are similar to what you would receive 
during routine clinical care of your condition.  Your health plan/insurance company will be billed for 
some or all of these costs, and you will be responsible for any co-pays and deductibles that are normally 
required by your health plan/insurance.  Not all insurance plans cover the costs associated with being in 
a study. Even if they do, you may be responsible for more out-of-pocket expenses, such as co-pays and 
deductibles, when there are more tests and procedures or more expensive tests and procedures involved 
in the study than if you were to receive routine clinical care outside the study.   
 
If you wish to know whether there are more tests and procedures or more expensive tests and procedures 
in the study, you should ask your study doctor.   
 
If you wish to know whether your insurance will pay, you should contact them directly, or speak with 
the study team about obtaining a financial pre-certification prior to enrolling in the study. 
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will not be paid for being in this research study.   
 
 
WHO IS FUNDING THIS STUDY? 
 
The University and the research team are not receiving payment from other agencies, organizations, or 
companies to conduct this research study.  
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
Washington University investigators and staff will try to reduce, control, and treat any complications 
from this research. If you feel you are injured because of the study, please contact the investigator at 
314- 747-2508 and/or the Human Research Protection Office at 1-(800)-438-0445.  
 
Decisions about whether payment for medical treatment for injuries relating to your participation in 
research will be made by Washington University. If you need to seek medical care for a research-related 
injury, please notify the investigator as soon as possible.  
 
 
 


 
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IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
Page 6 of 10 
HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL? 
 
Other people such as those indicated below may become aware of your participation in this study and 
may inspect and copy records pertaining to this research.  Some of these records could contain 
information that personally identifies you. We will keep your participation in this research study 
confidential to the extent permitted by law.   
 Government representatives (including the Office for Human Research Protections) to complete 
federal or state responsibilities 
 The U.S. Food and Drug Administration 
 Hospital or University representatives to complete Hospital or University responsibilities 
 Information about your participation in this study may be documented in your health care records 
and will be available to anyone with access to your health care record, including your health 
insurance company.  This information may also be released as part of a release of information 
request. 
 The last four digits of your social security number may be used in hospital or University systems 
to track billing information for research procedures. 
 Washington University’s Institutional Review Board (a committee that oversees the conduct of 
research involving human participants) and the Human Research Protection Office. The 
Institutional Review Board has reviewed and approved this study.  
 Any report or article that we write will not include information that can directly identify you.  
The journals that publish these reports or articles require that we share your information that was 
collected for this study with others to make sure the results of this study are correct and help 
develop new ideas for research. Your information will be shared in a way that cannot directly 
identify you. 
 
To help protect your confidentiality, we will password protect computer and files containing your 
information. Your study data and samples will be labeled with a code that does not identify you. Data 
that does identify you will be kept separately from the code.  
 
 
Are there additional protections for my health information? 
 
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal 
law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this 
research, you must give the research team permission to use and disclose (share) your PHI for the study 
as explained in this consent form.  The research team will follow state and federal laws and may share 
your health information with the agencies and people listed under the previous section titled, “How will 
you keep my information confidential?” 
 
Once your health information is shared with someone outside of the research team, it may no longer be 
protected by HIPAA.   
 
The research team will only use and share your information as talked about in this form or as permitted or 
required by law.  When possible, the research team will make sure information cannot be linked to you 
(de-identified).  Once information is de-identified, it may be used and shared for other purposes not 


 
FOR IRB USE ONLY 
IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
Page 7 of 10 
discussed in this consent form. If you have questions or concerns about your privacy and the use of your 
PHI, please contact the University’s Privacy Officer at 866-747-4975.  
 
Although you will not be allowed to see the study information, you may be given access to your health 
care records by contacting your health care provider.  
 
If you decide not to sign this form, it will not affect 
 your treatment or the care given by your health provider. 
 your insurance payment or enrollment in any health plans.   
 any benefits to which you are entitled. 
However, it will not be possible for you to take part in the study. 
 
If you sign this form: 
 You authorize the use of your PHI for this research 
 This authorization does not expire. 
 You may later change your mind and not let the research team use or share your information 
(you may revoke your authorization).  
 To revoke your authorization, complete the withdrawal letter, found in the Participant section 
of the Human Research Protection Office website at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the 
investigator send you a copy of the letter.    
 
 
 
o If you revoke your authorization: 
 The research team may only use and share information already collected for 
the study. 
 Your information may still be used and shared as necessary to maintain the 
integrity of the research, for example, to account for a participant’s 
withdrawal from the research study or for safety reasons. 
 You will not be allowed to continue to participate in the study. 
 
IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If 
you decide to be in this study, you may stop participating at any time. Any data that was collected as 
part of your participation in the study will remain as part of the study records and cannot be removed.   
 
If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or 
lose any benefits for which you otherwise qualify.   
 
What if I decide to withdraw from the study? 
 
You may withdraw by telling the study team you are no longer interested in participating in the study or 
you may send in a withdrawal letter. A sample withdrawal letter can be found at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research 
Study. 
 


 
FOR IRB USE ONLY 
IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
Page 8 of 10 
Will I receive new information about the study while participating? 
 
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information. 
 
 
Can someone else end my participation in this study? 
 
Valid enrollment is not granted until after surgery, once it has been verified that the participant has had 
total knee surgery. 
 
Under certain circumstances, the investigator [or the study sponsor] might decide to end your 
participation in this research study earlier than planned.  This might happen for no reason or because in 
our judgement it would not be safe for you to continue, or if your condition has become worse. 
 
 
WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Venessa Riegler at 314-362-1721. If you experience a research-related injury, please contact Dr. 
Charles Lawrie, at 314-747-2508. 
 
If you have questions, concerns, or complaints about your rights a a research participant, please contact 
the Human Research Protection Office at 1-(800)-438-0445, or email hrpo@wustl.edu.   General 
information about being a research participant can be found on the Human Research Protection Office 
web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to 
speak to someone other than the research staff, call the Human Research Protection Office at the number 
above. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
Page 9 of 10 
 
 
This consent form is not a contract. It is a written explanation of what will happen during the study if 
you decide to participate. You are not waiving any legal rights by agreeing to participate in this study. 
As a participant you have rights and responsibilities as described in this document and including: 
 To be given enough time before signing below to weigh the risks and potential benefits and 
decide if you want to participate without any pressure from the research team or others. 
 To understand all of the information included in the document, have your questions answered, 
and receive an explanation of anything you do not understand. 
 To follow the procedures described in this document and the instructions of the research team to 
the best of your ability unless you choose to stop your participation in the research study. 
 To give the research team accurate and complete information. 
 To tell the research team promptly about any problems you have related to your participation, or 
if you are unable to continue and wish to stop participating in the research study. 
 
Your signature indicates that this research study has been explained to you, that your questions have 
been answered, and that you agree to take part in this study.  You will receive a signed and dated copy 
of this form. 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 12/15/20. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Participant) 
 
 
 
 
(Date) 
 
 
____________________________________________ 
(Participant's name – printed) 
 
 
 
Statement of Person Who Obtained Consent 
 
The information in this document has been discussed with the participant or, where appropriate, with the 
participant’s legally authorized representative.  The participant has indicated that they understand the 
risks, benefits, and procedures involved with participation in this research study. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date) 
 
 
___________________________________________ 
(Name of Person who Obtained Consent - printed) 


 
FOR IRB USE ONLY 
IRB ID #: 201911147 
APPROVAL DATE: 02/13/20 
RELEASED DATE: 02/13/20 
EXPIRATION DATE: 12/15/20 
 
 
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