Effect of Astaxanthin for Pain, Function, and Inflammation in Patients With Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery
Phase: PHASE2
Conditions: Osteoarthritis, Knee, Osteoarthritis Knees Both, Joint Inflammation
Sponsor: Prisma Health-Midlands

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Effect of Astaxanthin for Pain, Function, and Inflammation in Patients with 
Advanced Osteoarthritis Awaiting Total Knee Replacement Surgery 
1. Principle Investigator: Daniel J. Del Gaizo, MD1
2. Co-Investigators: Corey Hamilton, MD1,2, Mitzi Nagarkatti, PhD3,
J. Benjamin Jackson III, MD, MBA1,2, Christopher Toussaint, MD1,2
3. Study Coordinators: Paisley, Myers1, Cindy Earley1
1 Prisma Health Orthopedics 
2University of South Carolina School of Medicine, Department of Orthopedic Surgery 
3University of South Carolina School of Medicine, Department of Pathology, Microbiology, 
and Immunology 
NCT Number: 05138549 
Document Date: 1/11/2022 

 
Page 2 of 8 
 
1. Background / Justification for Study 
 
Osteoarthritis (OA) is a common degenerative joint disorder that affects a 
significant portion of the population. Over 30 million Americans are currently affected by 
the disease, with prevalence expected to increase 40% by 2025 as a result of the aging 
population and obesity epidemic.1,2,3 Specifically, symptomatic knee OA is a leading cause 
of disability, occurring in 10% of men and 13% of women over the age of 60.1 Patients 
with symptomatic OA often experience pain, swelling, and stiffness of the knee resulting 
in a decrease in physical mobility which can have a drastic impact on quality of life.3,4 In 
addition to the significant impact on affected individuals, OA is associated with an 
enormous economic burden estimated at $136.8 billion annually in the US, surpassing costs 
of tobacco-related health effects, diabetes, and cancer.5  
 
Although originally classified as non-inflammatory arthritis, recent studies suggest 
that a relationship exists between joint inflammation and OA. Specifically, the complex 
interaction between sites of local tissue damage and immune cells leads to a state of chronic 
joint inflammation which may play a key role in disease pathogenesis.2,6,7 The evidence 
suggesting a role of inflammation in disease progression makes anti-inflammatory agents 
ideal candidates for symptom management. Astaxanthin is a keto-carotenoid present in 
many aquatic animals, including salmon, shrimp, and lobster, that has demonstrated 
heightened antioxidant activity and the ability to suppress inflammation.2,8,9 Early evidence 
suggests that astaxanthin may protect against osteoarthritis in vivo, illustrating its potential 
as a therapeutic supplement for patients with OA.2 However, studies illustrating these 
effects in humans have yet to be conducted.  
 
This prospective, blinded, randomized, placebo-controlled pilot study will evaluate 
the effect of astaxanthin in reducing inflammation, controlling pain, and improving 
physical function in patients with advanced knee osteoarthritis awaiting total joint 
replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will 
be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. 
Additionally, patient-reported outcome measurements assessing physical function and pain 
interference will be obtained prior to and following completion of treatment allowing for a 
comparison between treatment groups. Study outcomes will provide evidence to support 
astaxanthin supplementation as a cost-effective, added strategy for symptom management 
in patients with advanced osteoarthritis and will lay the foundation to seek additional 
federal funding to conduct a large-scale clinical trial to further establish the efficacy of this 
treatment strategy. 
 
2. Objectives / Research Aims 
 
The goals of this study are to:  
a. Determine the effect of astaxanthin on pain control and physical function in patients 
with osteoarthritis who are scheduled to undergo a total knee replacement surgery. 
b. Determine the effect of astaxanthin on inflammatory synovial markers in patients 
with osteoarthritis who are scheduled to undergo a total knee replacement surgery. 
 

 
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3. Setting 
 
This study will take place at Prisma Health Orthopedics clinic facilities and Prisma Health 
Baptist Hospital.  
 
4. Resources Available 
 
Documentation will be comprised of a thorough history and physical, clinical progress 
notes, operative reports, anesthesia reports, and post-operative progress notes available on 
the EPIC EMR as well as patient reported outcome measurements collected via PROMIS 
surveys and stored on the Prisma Health REDCap server, a secure data collection platform.  
 
Two fellowship trained orthopaedic surgeons will lead the research team. 
 
The research team will be comprised of practicing orthopaedic surgeons, the Chair of the 
Department of Pathology, Microbiology, and Immunology, resident orthopaedic surgeons 
in training, medical students, clinical nursing staff, and research assistants. 
 
5. Study Design 
 
This will be a prospective, double-blinded, randomized, placebo-controlled pilot study. 
 
a. Recruitment Methods 
 
Adult patients with advanced osteoarthritis who are scheduled to undergo total knee 
replacement surgery, meeting all inclusion/exclusion criteria, will be approached 
by a study team member. The team member will review the study with the patient 
and, if appropriate, obtain their consent to participate in the study. 
 
b.  Inclusion and Exclusion Criteria 
 
Inclusion: 
• ≥ 18 years of age 
• Radiographic evidence of advanced knee osteoarthritis 
• Knee pain 
• Scheduled to undergo a total knee replacement 
 
Exclusion: 
• < 18 years of age 
• Unable to provide written consent 
• Known allergy to fish or astaxanthin 
• Pregnant and/or breastfeeding 
• Received a corticosteroid injection within 3 months of initiating treatment 
with astaxanthin or placebo 
• Currently taking immunosuppressant drugs or drugs which act as a 5-alpha 
reductase inhibitor 

 
Page 4 of 8 
 
• History of any autoimmune condition  
• Known autoimmune etiology for arthritis (e.g. Rheumatoid or Psoriatic 
arthritis) 
 
c. Number of Subjects 
 
160 total patients included in this study, 80 per treatment arm. 
 
d. Study Procedures 
 
Once patients have been enrolled in the study, they will complete a Patient Reported 
Outcome Measurement Information System (PROMIS) Physical Function and Pain 
Interference assessment. This assessment will be administered on an iPad by clinic 
or research staff and data will be recorded in REDCap.   
 
Participants will be randomized to receive a daily oral regimen of either astaxanthin 
(12mg) or placebo over a 6-week period prior to surgery. Patients will record 
compliance with taking the supplement via a log provided to them at the time of 
consent.  
 
Research staff will call participants biweekly over the 6-week period to assess pain 
score, supplement compliance and record any side effects from the astaxanthin or 
placebo. 
 
On the day of surgery, participants will again complete the PROMIS Physical 
Function and Pain Interference assessment when they arrive at the hospital. This 
assessment will be administered on an iPad by clinic or research staff and data will 
be recorded in REDCap.  
 
At the time of surgery, following sedation, an aliquot of synovial fluid will be 
collected from the affected knee by the orthopedic surgeon performing the surgery. 
Obtained samples will be analyzed to measure levels of pro- and anti-inflammatory 
cytokines and chemokines.  
 
e. Study Timelines 
 
Following IRB approval, we will begin prospectively enrolling eligible patients in 
this study. Currently, Dr. Del Gaizo treats approximately 50 patients in clinic per 
week, with nearly 50% suffering from knee osteoarthritis. Overall, he performs 2-
6 knee replacements for advanced osteoarthritis per week. Given the high volume 
of patients treated by Dr. Del Gaizo with advanced osteoarthritis who will 
ultimately undergo total knee replacement surgery, we expect to achieve complete 
enrollment of 160 participants in a 10-12-month period. Additional orthopedic 
surgeons may be included to increase enrollment, if necessary.  
 
Following the completion of participant enrollment and data collection, the 

 
Page 5 of 8 
 
obtained results will be reviewed and statistically analyzed over a 2-month period.  
 
f. Study Endpoints 
 
Pain interference and physical function between the astaxanthin and placebo 
control group as measured by PROMIS Physical Function and Pain Interference 
assessments prior to beginning astaxanthin or placebo treatment regimen and just 
prior to surgery. 
 
Inflammatory profiles of post-treatment synovial fluid from the astaxanthin and 
placebo control group as measured by levels of pro- and anti-inflammatory 
chemokines and cytokines.  
 
g. Medication Treatment protocol  
 
Pre-Operatively: 
12mg Astaxanthin or placebo once daily for 6 weeks prior to surgery 
 
h. Data Collection/Banking 
 
All data will be stored on a password-protected, encrypted spreadsheet. Only 
members of the study team will have access to this information.  
 
Participants will be given a unique study ID and a separate password-protected 
document will be created linking patients to their study ID. 
 
Data recorded via PROMIS and phone surveys will be stored on the Prisma Health 
REDCap sever, a secure web application for managing research databases. 
 
Synovial fluid samples will be stored in a -80C freezer in a locked laboratory and 
will only be accessible to members of the study team. Samples will be labeled with 
study IDs given to participants.  
 
i. Statistical Analysis 
 
PROMIS assessments will be completed at two time points: prior to beginning the 
astaxanthin or placebo treatment regimen and just prior to surgery, at the time of 
completing the treatment regimen. A paired t-test will be performed to detect 
differences in the before and after measurements per group. These differences will 
then be compared for patients in the astaxanthin arm vs. placebo arm to determine 
if participants receiving astaxanthin report a significant difference in pain and 
physical function ability following completion of the treatment regimen. 
 
Synovial fluid will be collected in heparinized tubes at the time of surgery.  A 
quantitative analysis of immune cell infiltration will be performed from the 
synovial fluid collected, using a hematology analyzer. This will provide total and 

 
Page 6 of 8 
 
differential WBC counts. Further studies will be done to estimate the cytokine and 
chemokine levels in synovial fluid. Statistical analysis will be performed and a p 
value < 0.05 between groups will be considered statistically significant. 
 
 
j. Data Management  
 
Data will be maintained on a secure password protected server. Only IRB 
authorized research study members can access this information. The researchers 
involved in this study commit to handle all information with care and to protect 
research subjects’ identity. The data collected will be kept for at least three years 
after publication and then destroyed in accordance with the hospital and federal 
guideline. Participants will be given a unique study ID and a separate password-
protected document will be created linking patients to their study ID. No PHI will 
be disclosed during statistical analysis or subsequent presentations or publications. 
 
k. Confidentiality 
 
All study related data activities will take place on password-protected network 
supported by the home hospital institution. Study team has been educated and 
agrees to uphold the hospital and federal confidentiality laws. 
 
l. Provisions to Monitor the Data to Ensure the Safety of Subjects 
Data will be maintained on a secure server with password protection. Study 
data and signed consent documents will be stored in a locked office in 
Prisma Health Orthopedics. Only authorized research members of this study 
can access this information. The researchers involved in this study commit 
to handle all information with care and to protect research subjects’ 
identities.  
 
6. Risks to Subjects 
 
Possible side effects associated with Astaxanthin supplementation are increased 
bowel movements, red stool color, and stomach pain. 
Astaxanthin has been shown to hinder the 5-alpha reductase enzyme in laboratory 
studies. This may prevent testosterone from changing into the dihydrotestosterone 
(DHT) hormone. While it is unclear the exact effect that astaxanthin may have due 
to this interaction, similar medications that affect the 5-alpha reductase enzyme may 
cause side effects such as lower libido, male breast growth, and erectile dysfunction. 
Patients who are currently taking medication which acts as a 5-alpha reductase 
inhibitor will be excluded from this trial.  
Astaxanthin has the potential to increase the function of your immune system. 
Patients who are currently taking immunosuppressant drugs and/or have an 
autoimmune condition will be excluded from this trial.  

 
Page 7 of 8 
 
 
As this is a prospective study, there is a slight risk of loss of confidentiality of 
protected health information (PHI). Members of the study team commit to handle all 
information with care and protect the identify of research subjects.  
 
7. Potential Benefits to Subject 
 
Patients may potentially benefit by receiving a new regimen of medical care that reduces 
the inflammation associated with advanced osteoarthritis, subsequently reducing pain 
improving physical function. 
 
Indirectly, patients may benefit by providing information for medical professionals to 
better treat patients in the future.  
 
 
8. Consent Process 
 
During the pre-operative phase, in clinic, eligible patients will be identified. A member of 
the study team will explain the purpose of the research and what the patient’s role will be. 
The person obtaining consent will adequately review all potential risks and benefits and 
will not coerce patients to consent. This is outlined on our informed consent document. 
Written informed consent will be obtained on our informed consent document. These 
documents will be stored in a locked office Prisma Health Orthopedics Research 
Department as well as the subject’s electronic medical record. Participants will also be 
provided a signed copy of the informed consent document to keep.  
 
9. Bibliographic References 
1. Zhang Y, Jordan JM. Epidemiology of osteoarthritis [published correction 
appears in Clin Geriatr Med. 2013 May;29(2):ix]. Clin Geriatr Med. 
2010;26(3):355-369. doi:10.1016/j.cger.2010.03.001 
2. Sun K, Luo J, Jing X, et al. Astaxanthin protects against osteoarthritis via Nrf2: 
a guardian of cartilage homeostasis. Aging (Albany NY). 2019;11(22):10513-
10531. doi:10.18632/aging.102474 
3. Farr Ii J, Miller LE, Block JE. Quality of life in patients with knee 
osteoarthritis: a commentary on nonsurgical and surgical treatments. Open 
Orthop 
J. 
2013;7:619-623. 
Published 
2013 
Nov 
13. 
doi:10.2174/1874325001307010619 
4. Vitaloni, M., Botto-van Bemden, A., Sciortino Contreras, R.M. et al. Global 
management of patients with knee osteoarthritis begins with quality of life 
assessment: a systematic review. BMC Musculoskelet Disord 20, 493 (2019). 
https://doi.org/10.1186/s12891-019-2895-3 
5. United States Bone and Joint Initiative. The Burden of Musculoskeletal 
Diseases in the United States (BMUS). In: In. Fourth ed. Rosemont, IL. 2018:  
6. Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of 
osteoarthritis: latest findings and interpretations. Ther Adv Musculoskelet Dis. 
2013 Apr;5(2):77-94. doi: 10.1177/1759720X12467868. PMID: 23641259; 

 
Page 8 of 8 
 
PMCID: PMC3638313.  
7. Scanzello CR, Goldring SR. The role of synovitis in osteoarthritis 
pathogenesis. Bone. 2012;51(2):249-257. doi:10.1016/j.bone.2012.02.012 
8. Guerin M, Huntley ME, Olaizola M. Haematococcus astaxanthin: applications 
for human health and nutrition. Trends Biotechnol. 2003 May;21(5):210-6. 
doi: 10.1016/S0167-7799(03)00078-7. PMID: 12727382. 
9. Higuera-Ciapara I, Félix-Valenzuela L, Goycoolea FM. Astaxanthin: a review 
of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. 
doi: 10.1080/10408690590957188. PMID: 16431409. 
10. Park JS, Chyun JH, Kim YK, Line LL, Chew BP. Astaxanthin decreased 
oxidative stress and inflammation and enhanced immune response in humans. 
Nutr Metab (Lond). 2010;7:18. Published 2010 Mar 5. doi:10.1186/1743-
7075-7-18 
 

Protocol 00113612, Version 1.7, 01/11/2022 
 
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CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
 
EFFECT OF ASTAXANTHIN FOR PAIN, FUNCTION, AND INFLAMMATION IN PATIENTS WITH 
ADVANCED OSTEOARTHRITIS AWAITING TOTAL JOINT REPLACEMENT SURGERY 
 
 
Study to be Conducted at: 
Prisma Health Baptist Hospital 
 
 
 
 
Marion Street 
 
 
 
 
Columbia, SC 29220 
 
 
 
 
 
Prisma Health Baptist Parkridge Hospital 
 
 
 
 
400 Palmetto Health Pkwy 
 
 
 
 
Columbia, SC 29212 
 
 
 
 
 
Prisma Health Richland Hospital 
 
 
 
 
5 Richland Medical Park Drive 
 
 
 
 
Columbia, SC 29203 
 
 
 
 
 
Prisma Health Orthopedics Ambulatory Clinics: 
 
 
 
 
 
 
 
 
 
14 Richland Medical Park Drive 
 
 
 
 
Suite 200 
 
 
 
 
Columbia, SC 29203 
 
 
 
 
 
 
 
 
 
104 Saluda Pointe Drive 
 
 
 
 
Lexington, SC 29072 
 
 
 
 
 
100 Palmetto Health Pkwy 
 
 
 
 
Suite 320 
 
 
 
 
Columbia, SC 29212 
 
 
 
 
 
Funding Sources: 
Prisma Health Grant in Aid Foundation; The Orthopaedic Research and 
Education Foundation 
 
Principal Investigator:  
Daniel Del Gaizo, MD; 803-296-9210 
 
 
 
KEY INFORMATION 
You are being asked to participate in a research study. Participation in a research study is voluntary. The 
information in this consent form is meant to better inform you so you may decide whether or not to participate 
in this research study. Please ask the study doctor to explain anything you do not understand.  
 
The purpose of this study is to determine the effect of astaxanthin on pain, physical function, and inflammation 
in patients with knee osteoarthritis who are scheduled to undergo a total knee replacement surgery. Your 
participation in this study will require you to take the study drug or placebo and complete surveys prior to and 
Prisma Health
 IRB Number: Pro00113612
Date Approved 1/7/2022
Version Valid Until: 1/6/2023

Protocol 00113612, Version 1.7, 01/11/2022 
 
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at the time of your total knee replacement. While under anesthesia for your total knee replacement, a small 
sample of fluid will be removed from your knee for analysis of inflammatory markers. You will be contacted 
by the study team at routine intervals throughout the study to discuss your pain level, physical capabilities, 
and any experienced side effects of the study drug.  
 
Your participation in this study will not require any additional office visits outside of the standard visits 
following a total knee replacement surgery. There is a risk of adverse reactions to these medications such 
as, increased bowel movements, red stool color, and stomach pain. We cannot promise any benefits to you 
or others from your taking part in this research. However, taking part in this study may benefit you as the 
patient directly if you receive astaxanthin by providing decreased pain and improved physical function. 
 
The Institutional Review Board of Prisma Health has reviewed this study for the protection of the rights of 
human participants in research studies, in accordance with federal and state regulations. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this Web site at any time. 
 
 
PURPOSE 
You are being asked to participate in this study because you have advanced osteoarthritis and are scheduled 
to undergo a total knee replacement.  
 
Osteoarthritis causes pain, swelling, and stiffness of the knee resulting in a decrease in physical function. A 
promising treatment option to address swelling associated with this disease includes the use of a naturally 
occurring compound, astaxanthin, which is commonly used as and is approved by the FDA as a dietary 
supplement. The goal of this study is to evaluate the use of this dietary supplement in patients with 
osteoarthritis awaiting total knee replacement surgery. Results from this study may provide an added 
treatment option to improve the quality of life for those individuals.  
 
We expect about 160 people will be in this research study total. All participants will be treated at Prisma 
Health Orthopedics. Your participation will last for 6 weeks prior to your total knee replacement.  
 
 
HOW THE STUDY WORKS 
1. If you agree to be in this study, your surgeon and research staff will review your medical history to make 
sure that you are eligible. Once all of your questions are answered and you are willing to participate, you 
will be asked to sign and date this consent form. 
 
2. You will complete a survey about your current level of pain and how your pain effects your ability to 
perform daily activities.  
 
3. You will randomly be assigned to receive astaxanthin or a placebo. A placebo is a substance that has no 
therapeutic effect and is used as a control when testing new medications in research studies. 
Randomization means that you are put into a group by chance. It is like flipping a coin.  Neither you nor 
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your doctor will choose what group you will be in or know what group you are assigned to. You will have 
an equal chance of being placed in any group. Specific members of the research team will know which 
group you have been assigned to and can provide this information if needed in the event of an 
emergency.  
 
4. You will be given a 6-week supply of medication (astaxanthin or placebo), to be taken once daily for 6 
weeks prior to your total knee replacement surgery. You will record taking your medication on a daily log 
that will be provided to you at the time of consent. You will bring this document back to your surgeon on 
the day of your surgery. 
 
5. A member of the study team will call you biweekly at weeks 1, 3, and 5; During these phone calls, you 
will be asked: 
• To rate your pain level on a scale from 0-10 
• If you have taken any additional medication for pain 
• If you have experienced any side effects such as increased bowel movements, red stool color, 
or stomach pain.   
 
6. On the day of your surgery, at the hospital, you will be asked to complete a survey about your current 
level of pain and how your pain effects your ability to perform daily activities.   
 
7. During your surgery, while under anesthesia, your surgeon will obtain a sample of fluid (approximately 1 
teaspoon) from your knee to be analyzed for markers of inflammation for the purposes of this research.  
  
8. Following your surgery, you will have completed all activities associated with this study and your 
participation in the study will end.  
 
 
RESEARCH USE OF BIOSPECIMENS 
This study involves the collection of biospecimens (bodily substances). At the time of your total knee 
replacement, your surgeon will obtain a sample of fluid from your knee while you are under anesthesia. This 
fluid will be analyzed to determine levels of common markers of inflammation. No genetic testing will be done 
in this study. The biospecimens collected for this study will not be used or distributed for future research 
studies. Findings from this study may be used in publications; however, no identifying information about your 
specimen will be published.   
 
 
POSSIBLE RISKS 
Any treatment has possible side effects. The treatments and procedures used in this study may cause all, 
some, or none of the side effects listed. There is always the risk of very uncommon or previously unknown 
side effects. 
 
You will be receiving the same medical care, and treatment as patients that are not included in this study. 
The supplement you will be taking has minimal known side effects. There is a risk of adverse reactions to 
these medications such as increased bowel movements, red stool color, and stomach pain.  
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Version Valid Until: 1/6/2023

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Astaxanthin has been shown to hinder the 5-alpha reductase enzyme in laboratory studies. This enzyme is 
present in high concentrations in male reproductive organs and is important in male reproductive function.  
Anything that reduces this enzyme may cause side effects such as lower libido, male breast growth, and 
erectile dysfunction. There are medications that are prescribed to reduce this enzyme to treat conditions such 
as enlarged prostate or male pattern baldness.  Patients who are currently taking such medication that are 
intended to reduce this enzyme will be excluded from this study. It is very important that you provide your 
study doctor an accurate list of all medications that you are currently taking so that an appropriate assessment 
can be done prior to consenting to participate in this study.  
 
Astaxanthin has the potential to increase the function of your immune system (the processes that protect 
your body from disease.) Patients who are currently taking immunosuppressant drugs (such as prednisone, 
hydrocortisone and many of the drugs used to treat cancer) and/or have an autoimmune condition (such as 
Lupus, Rheumatoid Arthritis, Graves’ Disease or Inflammatory Bowel Disease) will be excluded from this trial.  
 
As with all medications, side effects may include allergic reactions. Allergic reactions may range from minor 
itching or rash to major reactions, which can lead to death. 
 
It is possible that receiving the study drug with your regular medications, supplements, or some food (for 
example, grapefruit juice) may change how the study drug, your regular medications, or your regular 
supplements work. It is very important that you tell the study doctor about all medications or supplements 
you are taking during the study. Tell the study doctor if you are taking any drugs, or non-prescription 
medications or supplements, including vitamins or herbs, other than those being used in this research study 
because of the risk of possible and/or serious drug interactions. Tell anyone who gives you medical care that 
you are participating in a research study. 
 
 
POSSIBLE BENEFITS 
It is not possible to know whether or not you may benefit from participating in this study. The treatment or 
procedures you receive may even be harmful. The information gained from this study may be useful and may 
help others. 
 
We cannot promise any benefits to you or others from your taking part in this research. However, taking part 
in this study may benefit you as the patient directly if you receive astaxanthin by providing decreased pain 
and improved physical function. Additionally, future patients could benefit from the results of this study if 
astaxanthin becomes part of the standard of care for osteoarthritis.  
 
 
ALTERNATIVE (OTHER) TREATMENTS 
The decision to participate in this study is entirely up to you. The alternative to participating in this study is 
simply not to participate. If you decide not to participate in the study, you will not be penalized in any way. 
 
 
 
 
 
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NEW INFORMATION 
Your doctor will tell you about new information that may affect your willingness to participate in this research 
study. Alternatives, or other choices, concerning your care will be discussed at that time. There are no plans 
to share individual research results with you.  
 
 
COST TO YOU FOR PARTICIPATING IN THIS STUDY 
Subjects will not be responsible for the cost of the study drug or any fees associated with obtaining or 
analyzing the fluid sample. Study funds will pay for all study-related items and services required by the 
research.  
 
We will bill you or your health insurer for items and services that are not part of the research and are part of 
your routine care. You will be responsible for payment of any deductibles and co-payments required by your 
insurer for this routine care or other billed care. You will be responsible for the cost of any care not covered 
by insurance or study funds.   
 
If you have any questions or are unsure about costs from taking part in the research, please speak with the 
study doctor or staff.  
 
 
PAYMENT FOR PARTICIPATION  
To You: 
You will not be paid for participating in this study.  
 
To Investigators: 
The investigators will not be paid above their regular salaries for conducting this study.  
 
 
COMPENSATION FOR INJURY AS A RESULT OF STUDY PARTICIPATION 
Prisma Health will provide you the care needed to treat any injury, or illness, that directly results from taking 
part in this research study.   
 
Injuries sometimes happen in research even when no one is at fault. The study sponsor, Prisma Health, or 
the investigators as part of this study have no plans to pay you or give you other compensation for an injury, 
should one occur. However, you are not giving up any of your legal rights by signing this form.  
 
If you think you have been injured or have experienced a medical problem as a result of taking part in this 
research study, tell the person in charge of this study as soon as possible. The researcher’s name and phone 
number are listed in the ‘Contact for Questions’ section of this consent.  
 
 
VOLUNTARY PARTICIPATION 
Participation in this research study is voluntary. You may refuse to participate or withdraw from the study at 
any time. If you refuse to participate or withdraw from the study, you will not be penalized or lose any benefits 
and your decision will not affect your relationship with your doctor or hospital. 
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You can withdraw from this study at any time it will not affect your care. If you decide to withdraw from the 
study, there are no medical risks. If you agree to participate in the study, and then elect to withdraw, the data 
we have collected up until that point will be maintained for analysis. This data will be handled the same as 
research data; however, no further data will be collected from you after you withdraw. 
 
However, if you decide to stop study participation, you are encouraged to talk with your doctor regarding safe 
removal from the study. Further treatment would be discussed at that time. 
 
If your participation in this research study is stopped, your study doctor will discuss any tests or procedures 
that might be needed for your health and safety, but you may refuse any or all of these tests or procedures.  
Following this discussion with your study doctor, you still have the right to refuse any or all of these tests or 
procedures. 
 
 
AUTHORIZATION TO USE AND DISCLOSE (RELEASE) MEDICAL INFORMATION 
As part of this research study, the study doctor and his/her research team will keep records of your 
participation in this study. These study records may be kept on a computer and will include all information 
collected during the research study, and any health information in your medical records that is related to the 
research study. The study doctor and his/her research team will use and disclose (release) your health 
information to conduct this study. This study may result in scientific presentations and publications, but steps 
will be taken to make sure you are not identified.   
 
Some of the organizations/entities that may receive your information are: 
• The Institutional Review Board, which is a group of people who review research with the goal of 
protecting the people who take part in the study 
• The Food and Drug Administration (FDA) and the groups it works with to review research.  
 
Under federal privacy laws, your study records cannot be used or released for research purposes unless you 
agree. If you sign this consent form, you are agreeing to the use and release of your health information. If 
you do not agree to this use, you will not be able to participate in this study.  Once your health information 
has been released, federal privacy laws may no longer protect it from further release and use.  
 
The right to use your health information for research purposes does not expire unless you withdraw your 
agreement. You have the right to withdraw your agreement at any time. You can do this by giving written 
notice to the study doctor. If you withdraw your agreement, you will not be allowed to continue participation 
in this research study. However, the information that has already been collected will still be used and released 
as described above. You have the right to review your health information that is created during your 
participation in this study. After the study is completed, you may request this information. 
 
If you have any questions about the privacy of your health information, please ask the study doctor. 
 
 
 
 
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 IRB Number: Pro00113612
Date Approved 1/7/2022
Version Valid Until: 1/6/2023

Protocol 00113612, Version 1.7, 01/11/2022 
 
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CONTACT FOR QUESTIONS 
For more information concerning this study and research-related risks or injuries, or to give comments or 
express concerns or complaints, you may contact the principal investigator, whose information is included 
below. 
 
You may also contact a representative of the Prisma Health Office of Human Research Protection for 
information regarding your rights as a participant involved in a research study or to give comments or express 
concerns, complaints or offer input. You may obtain the name and number of this person by calling (864) 
455-8997. 
 
 
 
 
 
Principal Investigator Name: Daniel Del Gaizo, MD 
 
 
Telephone Number: 803-296-9210 
Prisma Health
 IRB Number: Pro00113612
Date Approved 1/7/2022
Version Valid Until: 1/6/2023

Protocol 00113612, Version 1.7, 01/11/2022 
 
Page 8 of 8 
 
 
 
 
 
CONSENT TO PARTICIPATE 
The study doctor, ____________________________________________, has explained the nature and 
purpose of this study to me. I have been given the time and place to read and review this consent form and 
I choose to participate in this study.  I have been given the opportunity to ask questions about this study and 
my questions have been answered to my satisfaction. I have been given the opportunity to review my study 
doctor’s Notice of Privacy Practices. I agree that my health information may be used and disclosed (released) 
as described in this consent form. After I sign this consent form, I will receive a copy of it for my own records. 
I do not give up any of my legal rights by signing this consent form. 
 
 
_____________________________________________ 
Printed Name of Participant 
 
 
 
_____________________________________________   
_____________ 
____________ 
Signature of Participant  
 
 
 
 
Date 
 
 
Time 
 
 
_____________________________________________ 
Printed Name of Investigator 
 
 
_____________________________________________   
_____________ 
____________ 
Signature of Investigator  
 
 
 
 
Date 
 
 
Time 
 
 
Principal Investigator 
 
 
Phone 
Daniel Del Gaizo, MD 
 
 
803-296-9210 
 
Co-Investigators 
The following co-investigators may be reached at 803-296-9210: 
Corey Hamilton, MD 
 
 
 
 
 
 
Prisma Health
 IRB Number: Pro00113612
Date Approved 1/7/2022
Version Valid Until: 1/6/2023