Conditions: Knee Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but effects are short lived. This has led to the development of additional injection options such as autologous derived blood products which have been documented to alleviate symptoms related to knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting effect with these blood derived products like platelet rich plasma (PRP) \[2-8\]. One clinically-developed preparation of platelet rich plasma, named autologous conditioned plasma (ACP), has randomized controlled trial data proving efficacy \[4,9\]. Clinical use of platelet rich plasma for knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an injection once a week for three weeks. The main objective of this study is to determine if hyaluronic acid (HA) injected at the same time as autologous conditioned plasma (ACP), a leukocyte-poor platelet rich plasma product, will improve the performance of ACP in the treatment of symptomatic knee osteoarthritis. It is hypothesized that the injection of hyaluronic acid will improve the efficacy of ACP.

Detailed description:
Patients between the ages of 30 and 80 who have documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence grades 1-4) will be screened for participation in this study. Patients must have a documented diagnosis of primary OA for at least six weeks. 80 patients will be recruited through the Andrews Institute physician practices. The study design will be a randomized control trial. Participants who meet the inclusion criteria will have the study explained in detail, and informed consent will be obtained as outlined above. Participants will complete patient-reported outcome questionnaires prior to their injection. The questionnaires will include the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS). Participants will also complete these questionnaires at 1, 3, 6, 12, 18, and 24 months after the final injection. A trained medical professional will draw blood from the patient's arm, and the blood will be spun in a centrifuge for 5 minutes at 1500 RPM. The platelets will then be separated for injection into the patient's knee. The treating physician will then inject the ACP into the involved knee joint following standard aseptic technique per the physician's standard of care. This entire process will be completed in a single patient visit. Any unused portion of a sample in the physician's office will be disposed of through standard biohazard waste disposal systems as required by law. Group 1 \[ACP\]: Will receive three intra-articular injections of autologous conditioned plasma dosed once a week for three weeks. Group 2 \[ACP-HA\]: Will receive two intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for two weeks and a third injection on the third week of ACP.

Arms:
arm 1: Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks. arm 2: Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.

Interventions: intervention 1: Hyaluronan intervention 2: Autologous conditioned plasma
Intervention descriptions: intervention 1: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP. intervention 2: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.

Protocol document:
Prot_SAP_000.pdf: 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of 
Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
 
Date: 06/19/2019 
NCT03889925 
 
 
 


A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis  
Adam Anz, M.D. 
Page 2 of 7 
 
Version 3.0 
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Title:  A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of 
Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
 
Principal Investigator:  
Adam Anz, M.D.  
 
Co-Investigators:  
 
Roger Ostrander, M.D. 
 
 
 
 
Steve Jordan, M.D. 
 
 
 
 
Christopher O’Grady, M.D. 
 
 
 
 
Brett Kindle, M.D. 
Hillary Plummer, PhD, ATC 
 
Funding Mechanism:   
In-House 
 
Institution(s):   
 
Andrews Institute 
 
 
 
 
1040 Gulf Breeze Pkwy. 
 
 
 
 
Gulf Breeze, FL 32561 
 
 
 
 
(850) 916- 8761 
 
 
 
 
 
 
 
 


A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
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Adam Anz, M.D. 
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1 
Background / Scientific Rationale 
In the United States it is estimated that 47 million people have been diagnosed with arthritis. 4.3 
million have been diagnosed with isolated osteoarthritis of the knee and knee arthritis accounts 
for 20% of disability claims [1]. Prevalence of the disease continues to climb and is expected to 
double by 2030. In addition, 4 out of 5 patients with osteoarthritis have movement limitations 
[1]. Currently there are no curative treatments for osteoarthritis. Surgical options include 
arthroscopy, osteotomies, and total joint replacement, but not all patients with knee osteoarthritis 
are candidates for surgical treatments, and others choose non-operative treatments instead of 
undergoing a procedure. Non-surgical treatment options include medications such as non-
steroidal anti-inflammatory’s (NSAIDs), injectables such as corticosteroids and hyaluronic acid, 
or physical treatments such as rehabilitative therapy, unloading braces, and activity 
modifications (i.e. canes or walkers). Additionally, weight loss can help in the battle to reduce 
pain in cases of knee osteoarthritis. 
The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but effects 
are short lived. This has led to the development of additional injection options such as 
autologous derived blood products which have been documented to alleviate symptoms related to 
knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting effect with 
these blood derived products like platelet rich plasma (PRP) [2-8]. One clinically-developed 
preparation of platelet rich plasma, named autologous conditioned plasma (ACP), has 
randomized controlled trial data proving efficacy [4,9].  Clinical use of platelet rich plasma for 
knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an injection once a week 
for three weeks. Currently, all three orthopedic providers in this study use ACP to treat patients 
with knee osteoarthritis in common accepted clinical practice.  
2 
Objectives 
The main objective of this study is to determine if hyaluronic acid (HA) injected at the same time 
as autologous conditioned plasma (ACP), a leukocyte-poor platelet rich plasma product, will 
improve the performance of ACP in the treatment of symptomatic knee osteoarthritis. We 
hypothesize that the injection of hyaluronic acid will improve the efficacy of ACP.  
3 
Participant Eligibility 
Inclusion Criteria: Patients between the ages of 30 and 80 who have documented radiographic 
evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-
Lawrence grades 1-4) will be screened for participation in this study. Patients must have a 
documented diagnosis of primary OA for at least 6 weeks.  


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Exclusion criteria: Patients who have had viscosupplementation in the involved knee in the past 
6 months. Any patient who has had a corticosteroid injection in any joint within 3-months prior 
to screening will be excluded. Patients with gout or rheumatologic disease will be excluded. 
Patients who have had a previous negative experience with HA. Any patient who will have 
difficulty obtaining internet access, does not have an active e-mail address, or is unable to 
comprehend study documents or give informed consent will be excluded.  
4 
Participant Enrollment 
80 patients will be recruited through the Andrews Institute physician practices. Potential 
participants will be prescreened for inclusion and exclusion criteria through standard of care 
medical evaluations. Once a potential participant has agreed to be involved in the study, they will 
go through the described informed consent process. Patients meeting the inclusion criteria will 
have the study explained to them by one of the members of the investigating team, and they will 
be given an opportunity to participate if they are interested. No specific advertising or 
recruitment material will be utilized.  
Participant will also be instructed that they must not take any prescription or over the counter 
non-steroidal anti-inflammatory drugs (NSAIDS) for 1 week prior to the first injection until after 
the final injection. The participants will then be randomly placed in one of the two study groups 
and be scheduled to receive a three-injection series of autologous conditioned plasma injection or 
a two-injection series of autologous conditioned plasma and hyaluronic acid and a third injection 
on the third week of ACP in their involved knee. For The group receiving autologous 
conditioned plasma and hyaluronic acid, HA will be an additional injection on the first two 
injections and the third injection will be ACP alone. This regimen was selected to reflect the 
current evidence-based regimens for ACP and HA independently. 
 
5 
Study Design and Procedures 
Study design will be randomized control trial. Participants who meet the inclusion criteria will 
have the study explained in detail and informed consent will be obtained as outlined above. 
Participants will complete patient reported outcome questionnaires prior to their injection. The 
questionnaires will include the Western Ontario and McMaster University‘s Osteoarthritis Index 
(WOMAC), International Knee Documentation Committee Subjective Knee Evaluation Form 
(IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS). The WOMAC is 24 questions 
and takes approximately 2-5 minutes, the IKDC is 19 questions and takes 3-5 minutes, and the 
KOOS is 42 items and takes approximately 5-10 minutes. Participants will also complete these 
questionnaires at 1, 3, 6, 12, 18, and 24 months after the final injection.   


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Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis  
Adam Anz, M.D. 
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Version 3.0 
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A trained medical professional will draw blood from the patients arm and the blood will be spun 
in a centrifuge for 5 minutes at 1500 RPM. The platelets will then be separated off for injection 
into the patient’s knee. The treating physician will then inject the ACP into the involved knee 
joint following standard aseptic technique per the physician’s standard of care. This entire 
process will be completed in a single patient visit. Any unused portion of a sample in the 
physician’s office will be disposed of through standard biohazard waste disposal systems as 
required by law. 
Group 1 [ACP]: Will receive 3 intra-articular injections of autologous conditioned plasma dosed 
at once a week for 3 weeks. Group 2 [ACP-HA]: Will receive 2 intra-articular injections of 
autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection 
on the third week of ACP. 
  
6 
Expected Risks and Benefits 
 
Risks and Discomforts: Potential risks include those expected with any injection 
including syncope, dizziness, headache, nausea, tachycardia, infection (septic arthritis, phlebitis, 
and osteomyelitis), bleeding, or pain. Additionally, participants may experience knee stiffness or 
inflammation associated with the procedures. These risks would not be any higher with the test 
interventions than those patients are subject to with injection treatments of knee OA. As with 
any research involving patients there is the inherent risk of a breach in patient confidentiality 
though this will be minimized through the use of participant code numbers and adherence to all 
HIPAA guidelines.  
 
Benefits: Direct benefits of the study include injections that may provide potential pain relief, 
improvement of knee function, and improvement of quality of life, which all could lead to the 
avoidance of surgical intervention. It is also believed that the information obtained in this study will 
help advance treatment of osteoarthritis through the use of regenerative medicine. 
 
7 
Data Management Procedures 
All personal information is strictly confidential and no names will be disclosed except as 
required by law. All information and data collected during this research will be recorded in a 
spreadsheet. This spreadsheet will not contain protected health information. The spreadsheet will 
be stored in a secure password protected folder on a laptop that only the study Investigators will 
have access to and will be permanently deleted following publication of any and all manuscripts, 
if any, written as a result of this research. Records related to this study will be securely retained 


A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis  
Adam Anz, M.D. 
Page 6 of 7 
 
Version 3.0 
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in a secure location for a period of 3 years after the completion of the study or longer as required 
by law. At that time, all records will be properly destroyed.  
8 
Data Analysis 
All data will be entered into Surgical Outcomes System (SOS) & Research Electronic Capture 
Database (REDCap) and descriptive data will be compiled. 
9 
Statistical Considerations 
A power analysis was performed to determine sample size based upon recent clinical trials 
comparing PRP to HA for the treatment of osteoarthritis. Analysis utilized the average of 
standard deviation to detect average of group mean effect at 80% power. This determined that 25 
patients per group would be needed to reach statistical significance with the WOMAC.  
Ranges, means and standard deviations for all measures will be determined and calculated. Data 
will be analyzed for differences between groups using a repeated measures ANOVA design, 
using a significant p-value of < 0.05 for rejecting the null hypothesis.   
10  
Quality Control and Assurance 
All protocols will be monitored and analyzed data will be checked for accuracy by the principal 
investigator and /or a designated AREF research team member. All medical data will be kept in 
compliance with HIPAA guidelines. 
11 
Regulatory Requirements 
 
Informed Consent: 
The informed consent process will be performed by one of the study investigators or staff, in the 
office. All participants will have the study described to them and will give as much time as they 
require to read an approved, stamped version of the informed consent document. After signing of 
the informed consent document, participants will be given a copy for their records. This process 
will take place only after the patient has consented to proceed with the study. 
 
Participant Confidentiality: 
Participant confidentiality information is listed above in #7 (Data Management Procedures). All 
medical data will be recorded and stored in compliance with HIPAA guidelines. 
12 
References 


A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis  
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Version 3.0 
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1.  Hootman JM, Helmick CG.  Projections of US prevalence of arthritis and associated activity 
limitations. Arthritis Rheumatology. 2006; 54: 226-9. 
 
2.  Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis 
with autologous Platelet-Rich Plasma in comparison with hyaluronic acid. American Journal of 
Physical Medicine & Rehabilitation. 2012;91(5):411-417. 
 
3.  Kon E, Mandelbaum B, Buda R, et al.  Platelet-Rich Plasma intra-articular injection versus 
hyaluronic acid viscosupplementation as treatments for cartilage pathology: From early degeneration to 
osteoarthritis. Arthroscopy. 2011;27(11):1490-1501. 
 
4.  Cerza F, Carni S, Carcangiu A, et al. Comparison between Hyaluronic Acid and Platelet-Rich 
Plasma, intra-articular infiltration in the treatment of gonarthrosis. American Journal of Sports 
Medicine. 2012;40(12):2822-2827. 
 
5.  Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more 
effective than placebo for knee osteoarthritis: A prospective, double-blind, randomized trial. American 
Journal of Sports Medicine. 2013;41(2):356-364. 
 
6.  Li M, Zhang C, Ai Z, Yuan T, Feng Y, Jia W. Therapeutic effectiveness of intra- knee- articular 
injection of platelet-rich plasma on knee articular cartilage degeneration. Chinese Journal of Reparative 
and Reconstructive Surgery. 2011;25(10):1192-1196. 
 
7.  Filardo G, Kon E, Di Martino A, et al. Platelet-rich plasma vs hyaluronic acid to treat knee 
degenerative pathology: study design and preliminary results of a randomized controlled trial. BMC 
Musculoskeletal Disorders. 2012;13. 
 
8.  Vaquerizo V, Plasenicia M, Arribas I, et al. Comparison of intra-articular injections of plasma rich 
in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with 
symptomatic osteoarthritis: A randomized controlled trial. Arthroscopy. 2013; 29 (10): 1635-1643 
 
9.  Smith P.  Intra-articular Autologous Conditioned Plasma Injections Provide Safe and 
Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, 
Placebo-controlled Clinical Trial.  American Journal of Sports Medicine. 2016;44(4):884.891. 
 

ICF_001.pdf: 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of 
Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
 
Date: 06/27/2019 
NCT03889925 
 


 
 
 
 
Informed Consent Document 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
06/19/19  
 
 
 
 
Page 1 of 7 
 
 
Subject Initials ____________ 
Version 3.0 
RESEARCH SUBJECT INFORMATION, CONSENT FORM, AND HIPAA 
AUTHORIZATION FOR RESEARCH 
 
TITLE OF PROJECT: 
A Randomized, Control Clinical Trial:  The Effect of Different 
Injection Regimens of Autologous Conditioned Plasma for the 
Treatment of Symptomatic Knee Osteoarthritis 
 
 
INVESTIGATOR:  
Adam Anz, M.D. 
 
 
 
 
Andrews Institute 
 
CO-INVESTIGATOR: 
Roger Ostrander, M.D. 
 
 
 
 
Steve Jordan, M.D. 
 
 
 
 
Christopher O’Grady, M.D. 
 
 
 
 
Brett Kindle, M.D. 
Hillary Plummer, PhD, ATC 
 
 SITE(S): 
 
 
Andrews Research & Education Foundation (AREF) 
 
SPONSOR:  
 
In-House 
 
INVESTIGATOR CONTACT INFORMATION:   
 
 
Andrews Institute 
 
1040 Gulf Breeze Pkwy 
 
Gulf Breeze, FL  32561 
 
(850) 916-8796 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BH IRB
By: 100310 Date:06/27/19 9:19


 
 
 
 
Informed Consent Document 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
06/19/19  
 
 
 
 
Page 2 of 7 
 
 
Subject Initials ____________ 
Version 3.0 
 
 
 
 
INTRODUCTION: 
In order to decide whether you wish to participate in this research study, you should understand why 
the study is being done, how the study will be run, the types of study procedures involved, your time 
commitments, and the possible risks and/or benefits associated with your participation to enable you 
to make an informed decision.  This process is known as “informed consent.” 
 
This written consent form and HIPAA Authorization provides detailed information about the research 
study.  This consent form and HIPAA Authorization may contain words that you do not understand.  
Please ask the study doctor (“Investigator” or “Researcher”) or the study staff to explain any words or 
information that you do not clearly understand. Before you decide to take part in this study, you may 
want to think about it more, or discuss it with family or friends. You can take a copy of this form 
home with you before making your decision. Your participation in this study is voluntary. You should 
not join this research study until all of your questions are answered to your satisfaction. 
 
If you wish to participate in this research study, you will be asked to sign this consent form and 
HIPAA Authorization. You must sign before any study procedures are done. You will be given a 
copy of this consent form and HIPAA Authorization to keep for your records. 
 
 
PURPOSE OF THE RESEARCH STUDY: 
You are being asked to participate in research being conducted by the Andrews Institute. The purpose 
of this study is to determine if hyaluronic acid injected at the same time as autologous conditioned 
plasma (ACP), a platelet rich plasma product, will improve the performance of ACP in the treatment 
of symptomatic knee osteoarthritis.  
 
 
SELECTION OF SUBJECTS:  
If you decide to be in this study, you will be one of 80 people in this research study. You must be 
between the ages of 30 and 80 and have documented radiographic evidence of OA in the knee. You 
must have a documented diagnosis of primary OA for at least 6 weeks. If you have had 
viscosupplementation in the involved knee in the past 6 months you will not be able to participate. If 
you have had a corticosteroid injection in any joint within 3-months prior to screening you will be 
excluded. If you have gout or rheumatologic disease or a previous negative experience with HA you 
will be excluded from participating. If you will have difficulty obtaining internet access, do not have 
an active e-mail address, or are unable to comprehend study documents or give informed consent you 
will be excluded. You are being recruited for participation in this study because your doctor thinks 
your knee pain will be improved with a series of injections. 
 
 
RESEARCH PROCEDURES: 
If you agree to be in the study, we will ask you to do the following things:  
 


 
 
 
 
Informed Consent Document 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
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Page 3 of 7 
 
 
Subject Initials ____________ 
Version 3.0 
You will complete patient reported outcome questionnaires prior to your injection. The questionnaires 
will ask you about your knee pain and function and will take approximately 20 minutes to complete. 
You will then be randomly assigned to receive an injection of autologous conditioned plasma either 
with or without hyaluronic acid. A trained medical professional will then draw blood from your arm 
and use a special machine to spin the blood into autologous conditioned plasma. This autologous 
conditioned plasma product will then be injected by your doctor into your knee joint. The same 
procedures will be repeated once a week for two additional weeks. You will receive 3 injections total 
over a 3-week period of time. If you are assigned to the group who gets autologous conditioned 
plasma with hyaluronic acid, you will receive two injections of autologous conditioned plasma and 
hyaluronic acid once a week for 2-weeks and a third injection on the third week of only autologous 
conditioned plasma. You will complete the questionnaires at 1, 3, 6, 12, 18, and 24 months after the 
final injection. 
 
RISKS AND DISCOMFORTS: 
The following risks may be associated with your participation in this study. Potential risks include 
those expected with any injection including syncope, dizziness, headache, nausea, tachycardia, 
infection (septic arthritis, phlebitis, and osteomyelitis), bleeding, or pain. Additionally, you may 
experience knee stiffness or inflammation associated with the procedures. These risks would not be 
any higher with the test interventions than those patients are subject to with injection treatments of 
knee osteoarthritis.  As with any research involving patients there is the inherent risk of a breach in 
patient confidentiality though this will be minimized through the use of participant code numbers and 
adherence to all HIPAA guidelines. 
 
There is a small risk of disclosure of your protected health information, which will be minimized 
where possible, including the removal of all identifiable information from data collection sheets and 
storing study information in secure locations as described in more detail below. 
 
 
ALTERNATIVES: 
You do not have to take part in this study and can choose to proceed without receiving injections to 
treat your symptoms of knee osteoarthritis. Alternative treatment options include activity modification 
and physical therapy. 
   
 
BENEFITS:  
The following benefits may be associated with your participation in this study: include injections that 
may provide potential pain relief, improvement of knee function, and improvement of quality of life, 
which all could lead to the avoidance of surgical intervention. 
 
CONFIDENTIALITY:   
All personal information is strictly confidential, and no names will be disclosed except as required by 
law. Your individual performance or results will not be reported; when/if this study is published, only 


 
 
 
 
Informed Consent Document 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
06/19/19  
 
 
 
 
Page 4 of 7 
 
 
Subject Initials ____________ 
Version 3.0 
the results of all participants as a group will be reported. During the course of this study, your 
information will be de-identified and identified only by a subject number.  
 
All information and data collected during this research will be recorded in a spreadsheet. This 
spreadsheet will not contain protected health information. The spreadsheet will be stored in a secure 
password protected folder on a laptop that only the study Investigators will have access to and will be 
permanently deleted following publication of any and all manuscripts, if any, written as a result of 
this research. Records related to this study will be securely retained in a secure location for a period of 
3 years after the completion of the study or longer as required by law. At that time, all records will be 
properly destroyed. 
 
 
HIPAA and PROTECTED HEALTH INFORMATION: 
We know that information about you and your health is private. We are dedicated to protecting the 
privacy of that information. Because of this promise, we must get your written authorization 
(permission) before we may use or disclose your protected health information, also called “PHI,” or 
share it with others for research purposes. 
 
You are being asked to sign this authorization allowing us to share your PHI for purposes of this 
research study. If you sign this authorization, you give permission to the Investigators to use or 
disclose your PHI for the research study described here. You can decide to sign or not to sign this 
authorization. However, if you choose not to sign this authorization, you will not be able to take part 
in the research study. Whatever choice you make, it will not have an effect on your access to medical 
care. 
 
The United States government has issued a privacy rule to protect the privacy rights of patients 
(“Privacy Rule”). This rule was issued under a law called the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA). The Privacy Rule is designed to protect the confidentiality of 
your health information. Andrews Research and Education Foundation is required by law to protect 
your health information. By signing this document, you authorize Andrews Research and Education 
Foundation to use and/or disclose your health information for this research. Those persons who 
receive your PHI may not be required by Federal privacy laws (such as the Privacy Rule) to protect it 
and may share your information with others without your permission, if permitted by laws governing 
them. 
 
During this study, the Investigators will need to use your PHI. PHI is information about you that 
could be used to identify you, such as your name, address, telephone number, date of birth, new and 
existing medical records, or the types, dates, and results of various tests and procedures. This may 
also include information in your medical record and information created or collected during the study. 
We may also ask other health care providers to give us any information about your health status or 
your health care. If you sign this authorization, you are agreeing to allow the Researchers to use your 
PHI to carry out this study.   
 


 
 
 
 
Informed Consent Document 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
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Subject Initials ____________ 
Version 3.0 
By signing this authorization, and solely for the purposes of completing this research, you also allow 
the research staff to disclose your PHI to outside entities involved in completing the research project, 
such as people who review the research study, their staff, lawyers, government groups (such as the 
Food and Drug Administration), or safety monitors. The study data that the Researchers send to these 
entities will not include your name, address, or social security number, but instead, will be designated 
with a code number. However, your medical records can be reviewed or copied at the study site by 
regulatory authorities or other oversight bodies, including the Institutional Review Board. The 
purpose of these reviews is to make sure the study is being conducted properly and that the data is 
being collected correctly, or for other purposes allowed by law.   
 
Your PHI may no longer be protected by the privacy rule once it is disclosed. Your PHI will be kept 
as confidential as possible under the law; however, absolute confidentiality cannot be guaranteed.   
 
You may cancel this authorization at any time by writing to the Investigator at the Contact 
Information provided above. If you cancel this authorization, the Researchers will no longer use or 
disclose your PHI under this authorization for this study, unless it is needed to preserve the scientific 
integrity of the study. Information obtained before you cancel the authorization may still be used by 
the Researchers.  If you do not cancel this authorization, it will automatically expire at the conclusion 
of the research study. 
 
 
COST AND COMPENSATION:   
There will be no cost to you for participating and you will not receive any compensation for 
participating in this research. In the unlikely event of an emergency, AREF will provide basic first aid 
medical treatment. However, if you were to require additional medical care as a result of participating 
in this study, you would need to contact your personal physician at your own expense.  
 
The Investigators, the employers of the Investigators, and the Research Site do not have programs for 
compensating subjects for injury or complications related to human subjects research. Any treatment 
will be at your expense. 
 
 
VOLUNTARY PARTICIPATION/WITHDRAWAL: 
Taking part in this study is voluntary. Your medical treatment, costs of treatment and eligibility for 
benefits will not be affected if you decide not to sign this Consent Form or participate in the study. If 
you agree to participate, in the event new information becomes available that may affect your 
willingness to participate in this study, this information will be given to you so that you can make an 
informed decision about whether or not to continue your participation. 
 
 
QUESTIONS: 


 
 
 
 
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A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
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Subject Initials ____________ 
Version 3.0 
It is your right, as a research participant, to ask questions at any time regarding the procedures 
involved and any aspects of this study including the potential benefits or risks. For any questions you 
may have for the Investigators, you may contact them at (850) 916-8796. 
 
If you have questions about your rights as a research subject or if you have questions, concerns or 
complaints about the research, you may contact the Baptist Hospital Institutional Review Board* at 
(850) 469-2227. The IRB will not be able to answer some types of questions, such as questions about 
appointment times.   
*The IRB is a group of individuals who independently review research 
 
 
STATEMENT OF CONSENT TO PARTICIPATE IN THIS RESEARCH STUDY:  
By signing this consent form I agree to and acknowledge the following statements: 
 
I agree to participate as a subject with the understanding that my participation is completely 
voluntary, and that I may withdraw at any time without prejudice by sending a written request to the 
Investigator at the Sports Medicine Research Lab, Andrews Research and Education Foundation, 
1020 Gulf Breeze Pkwy, Gulf Breeze, FL 32561.   
 
I have read and understand the above information and have been given the opportunity to discuss it 
and ask questions.  
 
I understand that this authorization does not have an expiration date.   
 
I have received a copy of this authorization form for my records. 
 
I have been informed that I may contact the Investigators by phone at (850) 916-8796 in order to 
answer any questions that I may have at any time during my participation.  
 
 
 
_______________________________________ 
Printed Name of Participant 
 
 
_______________________________________ 
 
 
___________________ 
Signature of Participant 
 
 
 
 
 
 
Date 
 
 
_______________________________________ 
 
 
____________________ 
Signature of Person Conducting Informed Consent  
 
 
Date 
and HIPAA Authorization Discussion  
 


 
 
 
 
Informed Consent Document 
A Randomized, Control Clinical Trial:  The Effect of Different Injection Regimens of Autologous 
Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis 
                                     
 
06/19/19  
 
 
 
 
Page 7 of 7 
 
 
Subject Initials ____________ 
Version 3.0