Clinical trial NCT04088227
Conditions: Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Rupture
Sponsor: Andrews Research & Education Foundation
Start date: 2019-09-12; Completion date: 2023-04-21
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis.

The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.

Detailed description:
A non-surgical treatment option for the management of osteoarthritis include injectables such as corticosteroids and platelet rich plasma. These injectables work by positively affecting cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as synoviocytes. Platelet rich plasma is an autologous derived blood product, i.e. a joint injectable made from the patient's own blood at the time and location of injection with simple blood centrifugation. Studies in the bench-top laboratory setting have provided in-vitro evidence that platelet rich plasma decreases synoviocyte production of metallometal proteases, an inflammatory protein with negative effects on cartilage and decreases the effects of inflammatory proteins.

Arms: arm 1: The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury). arm 2: The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
Interventions: intervention 1: Experimental Group intervention 2: Control Group
Intervention descriptions: intervention 1: Patients will receive platelet rich plasma injection two times prior to surgery. intervention 2: Patients will have their knee aspirated at their initial physician visit and at the time of surgery.

Protocol documents:
Prot_SAP_000.pdf: 
Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers 
in Patients with Acute Anterior Cruciate Ligament Tears   
Adam Anz, M.D. 
Page 1 of 7 
 
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Title:  Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative 
Biomarkers in Patients with Acute Anterior Cruciate Ligament Tears   
 
Principal Investigator:  
Adam Anz, M.D.  
 
Co-Investigators:  
 
Steve Jordan, M.D. 
Brett Kindle, M.D. 
Roger Ostrander, M.D.   
 
 
 
 
 
Funding Mechanism:   
In-House 
 
Institution(s):   
 
Andrews Institute 
 
 
 
 
1040 Gulf Breeze Pkwy. 
 
 
 
 
Gulf Breeze, FL 32561 
 
 
 
 
(850) 916- 8570 
 
 
 
 
 
 
 
 
 
1 
Background / Scientific Rationale 


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In the United States, 80,000 anterior cruciate ligament (ACL) ruptures are estimated to 
occur annually, with an increased likelihood of these injuries involving individuals participating 
in sports and aged between 15-25 years [7]. A potential long-term consequence of ACL injuries 
is the development of posttraumatic osteoarthritis (PTOA) in the years following injury [8,9]. 
There are no curative treatments for osteoarthritis, increasing the importance of minimizing the 
occurrence of PTOA following ACL injuries. Current literature has begun to indicate that 
biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can 
contribute to the development of PTOA [10-12]. 
 
A non-surgical treatment option for the management of osteoarthritis include injectables such 
as corticosteroids and platelet rich plasma (PRP). These injectables work by positively affecting 
cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as 
synoviocytes.  PRP is an autologous derived blood product, i.e. a joint injectable made from the 
patient’s own blood at the time and location of injection with simple blood centrifugation.  
Studies in the bench-top laboratory setting have provided in-vitro evidence that PRP decreases 
synoviocyte production of metallometal proteases, an inflammatory protein with negative effects 
on cartilage, decreases the effects of inflammatory proteins such as IL-B on chondrocytes, and 
has an anti-inflammatory effect upon the gene expression of chondrocytes and synoviocytes[14-
16]. While these are mechanisms that can help manage osteoarthritis after it arises, they also are 
mechanisms that could help prevent osteoarthritis before it forms. Recent comparative studies of 
PRP to other injectables in the management of osteoarthritis suggest a greater, long-lasting effect 
of PRP than other injectables [1-6]. 
 
Orthopedic research has focused on methods to prevent PTOA after ACL injury.  Recent 
study involving the post-injury ACL joint milieu suggested that an early intervention of joint 
aspiration and corticosteroid injection has positive effects, including a decrease in biomarkers 
responsible for chondral degeneration [13]. This combined with in vitro study on the effects of 
PRP on chondrocyte and synoviocyte activity suggest that PRP has potential to affect the ACL-
injured joint. However, current literature is lacking in regard to this assertion, and in vivo study 
of PRP to positively affect the joint after following ACL injury is warranted. 
2 
Objectives 
The main objective of this study is to determine if an early intervention of joint aspiration and 
PRP injection will positively affect the biomarkers representative of chondral degeneration in 
patients with ACL injuries. We hypothesize that the intervention will reduce the volume of 
inflammatory and chondrodegenerative biomarkers following ACL injury.  
3 
Participant Eligibility 
Inclusion Criteria: Patients between the ages of 14 and 40 years with closed growth plates as 
visualized on plain radiography, no history of previous traumatic ipsilateral knee injury, and no 


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clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or 
lateral collateral ligament injury.  
Exclusion criteria: Patients without a palpable knee effusion, an injury occurring more than 10 
days before enrollment, previous ipsilateral knee surgery, intra-articular cortisone or PRP 
injection into either knee within 3 months of injury, participation in another clinical drug trial 
within the 4 weeks before injury, and a history of any inflammatory disease or immune-
comprised. 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 
60 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.  
The participants will then be randomly placed in one of the two study groups and be scheduled to 
receive either an injection of PRP or no injection in their involved knee.  
Participants will not be billed for the joint aspirations or PRP injections.  
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.  
Patients will be randomized to 1 of 2 groups. Both groups will have joint aspirations performed 
at an initial visit, within the first 10 days after injury, and at the time of surgery, within 4 weeks 
of injury. Group 1 will receive only joint aspirations as outlined above.  Group 2 will undergo 
aspirations as outlined above and also receive a PRP injection at the initial visit and at a second 
visit 5-12 days after the initial visit.  Joint aspirations and injections will be performed through 
the superolateral, suprapatellar approach Patients will be instructed not to take any prescription 
or over-the-counter nonsteroidal anti-inflammatory medications. Patients will be encouraged to 
rest, ice, and elevate their injured knee. 


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PRP Manufacturing: PRP preparation will involve Autologous Conditioned Plasma disposables 
(Arthrex, Naples, FL, USA), a commercially available kit for the production of PRP.  
Preparation will follow the manufacturer’s instructions. The treating physician will then inject 
the PRP 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. A 0.1-0.5 mL 
sample of the PRP will be inserted into a vacutainer for analysis of cell count.  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.  
Biomarker Analysis: Samples will be prepared and frozen at -80 C until all study sample have 
been obtained. Enzyme-linked immunosorbent assay kits will be used to assess 
chondrodegenerative & synovial fluid biomarkers.  
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 PRP injection. Knee aspiration and injection are standard 
medical procedures used routinely in the management of knee osteoarthritis and acute injury.  
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 potential pain relief, improvement of knee 
function from joint aspiration, and the potential to decrease the risk of PTOA after ACL injury. It is 
also believed that the information obtained in this study will help advance treatment of PTOA 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 
REDCap and exported into 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 


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completion of the study or longer as required by law. At that time, all records will be properly 
destroyed.  
8 
Data Analysis 
This study is anticipated to take 2 years to complete. All data will be entered into REDCap. The 
investigators will meet at appropriate intervals to evaluate and analyze the data.  
9 
Statistical Considerations 
A power analysis was performed to determine sample size based upon recent clinical trials. 
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. 10 additional patients will be account for potential patient withdrawal or lost-to-
follow-up. 
Ranges, means and standard deviations for all measures will be determined and calculated. Data 
will be analyzed for differences between groups using a t-test 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. 


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12 
References 
 
1. 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. 
 
2. 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. 
 
3. 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. 
 
4. 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. 
 
5. 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. 
 
6. 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 
 
7. Griffin L, Agel K, Albohm M, et al. Noncontact anterior cruciate ligament injuries: risk factors 
and prevention strategies. J Am Acad Orthop Surg. 2000;8:1410159 
 
8. Smith T, Postle K. Penny F, et al. Is reconstruction the best management strategy for anterior 
cruciate ligament rupture? A systematic review and meta-analysis comparing anterior cruciate 
ligament reconstruction versus non-operative treatment. Knee. 2014;21:462-470 
 
9. Lohmander L, Englund P, Dahl L, et al. The long-term consequence of anterior cruciate 
ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007;35(10):1756-1769 
 
10. Piscoya J, Fermor B, Kraus V, et al. The dose response relationship of mechanical compression 
on the induction of osteoarthritis-related biomarkers in articular cartilage explants. 
Osteoarthritis Cartilage. 2005;13(12):1092-1099 
 
11. Chaudhari A, Briant P, Bevill S, et al. Knee kinematics, cartilage morphology, and osteoarthritis 
after ACL injury. Med Sci Sports Exerc. 2008;40:215-222 


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in Patients with Acute Anterior Cruciate Ligament Tears   
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12. Chu C and Andriacchi T. Dance between biology, mechanics, and structure: a systems-based 
approach to developing osteroarthritis prevention strategies. J Orthop Res. 2015;33(7):939-947 
 
13. Lattermann C, Jacobs C, Proffitt B, et al. A multicenter study of early anti-inflammatory 
treatment in patients with acute anterior cruciate ligament tear. American Journal of Sports 
Medicine. Doi:10.1177/0363546516666818  
 
14. Sundman, E, Cole, B, Karas, V, et al. The anti-inflammatory and matrix restorative 
mechanisms of platelet-rich plasma in osteoarthritis. American Journal of Sports 
Medicine, 42(1), 2014,35–41. https://doi.org/10.1177/0363546513507766 
 
15. van Buul, G, Koevoet, W, Kops, N, et al. Platelet-rich plasma releasate inhibits 
inflammatory processes in osteoarthritic  chondrocytes. American Journal of Sports 
Medicine, 39(11), 2011,2362–2370. https://doi.org/10.1177/0363546511419278 
 
16. Osterman, C., McCarthy, M, Cote, M, et al. Platelet-Rich Plasma Increases Anti-
inflammatory Markers in a Human Coculture Model for Osteoarthritis. American Journal 
of Sports Medicine, 43(6), 2015,1474–1484. https://doi.org/10.1177/0363546515570463 
 
 
 
 

ICF_001.pdf: 
Informed Consent Document 
Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in 
Patients with Acute Anterior Cruciate Ligament Tears 
Version 5.0 
 
 
RESEARCH SUBJECT INFORMATION, CONSENT FORM, AND HIPAA 
AUTHORIZATION FOR RESEARCH 
 
TITLE OF PROJECT: 
Effect of Platelet Rich Plasma Injections on Inflammatory and 
Chondrodegenerative Biomarkers in Patients with Acute Anterior 
Cruciate Ligament Tears 
 
 
INVESTIGATOR: 
Adam Anz, M.D. 
Andrews Institute 
 
CO-INVESTIGATOR: 
Steve Jordan, M.D. 
Brett Kindle, M.D. 
Josh Hackle, MD 
Christopher O’Grady, MD 
Roger Ostrander, M.D. 
Todd Hayano, DO 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
04/01/2021 
 
Page 1 of 6 
Subject Initials 
_ 
BH IRB
By: 100310 Date:04/08/21 9:25


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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 an early intervention of joint aspiration and platelet rich plasma (PRP) 
injection will positively affect the biomarkers representative of chondral degeneration in patients with 
anterior cruciate ligament (ACL) injuries. 
 
SELECTION OF SUBJECTS: 
If you decide to be in this study, you will be one of 60 people in this research study. You must be 
between the ages of 14 and 40 and have radiographic evidence of closed growth plates in the knee, and 
no clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral 
collateral ligament injury. 
 
If you are without knee joint swelling, sustained your injury more than 10 days before joining the 
study, or have had intra-articular cortisone or PRP injection into either knee within 3 months of injury 
you will be unable to participate. Additionally, if you have participated in another clinical drug trial 
within the 4 weeks before injury, or have a history of any inflammatory disease or are immune- 
comprised then you will be unable to participate. 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. 
 
RESEARCH PROCEDURES: 
If you agree to be in the study, we will ask you to do the following things: 


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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 a joint aspiration either with or without additional PRP 
injections. Both groups will receive joint aspirations at your initial visit within the first 10 days of 
your injury, and within 4 weeks of your injury. Participants receiving PRP injections will have 
injections at their initial visit and again 5-12 days after the initial visit. If you are receiving PRP 
injections, a trained medical professional will draw blood from your arm and use a special machine to 
spin the blood into PRP, which will then be injected by your doctor into your knee joint. You will 
complete the questionnaires again at the time of the final joint aspiration. 
 
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, participants 
may experience knee stiffness or inflammation associated with the PRP injection. Knee aspiration and 
injection are standard medical procedures used routinely in the management of knee osteoarthritis 
and acute injury. 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 joint aspirations 
and PRP injections during your treatment following ACL injury. Alternative treatment options include 
activity modification and physical therapy. 
 
BENEFITS: 
The following benefits may be associated with your participation in this study: potential pain relief, 
improvement of knee function from joint aspiration, and the potential to decrease the risk of 
posttraumatic osteoarthritis (PTOA) after ACL injury. It is also believed that the information obtained 
in this study will help advance treatment of PTOA through the use of regenerative medicine. 
 
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 
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 


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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. 
 
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. 


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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 having the joint aspirations or PRP injections. 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: 
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 


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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