You are being invited to take part in this research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the information in this form carefully, as it may contain words you do not understand. You may wish to discuss it with your doctor, family, and/or friends. If there is anything that you do not understand or you would like more information, please ask questions and the study doctor or study staff will try their best to answer them. Once the study has been explained and you have had all your questions answered to your satisfaction, you will be asked to sign this form if you wish to participate. Before anything is done for this study, you must sign this form. A copy of this signed form will be given to you.
You do not have to take part in this study. You are free to withdraw from this study at any time you choose without giving a reason. This will not affect any future care you will receive. No promises can be made about the outcome of this as far as your current condition, either positive or negative. People who take part in research are called “subjects” instead of “patients”.
Why are you being invited to participate in this study?
You are being asked to take part in this study because you are a patient greater than 18 years of age and are undergoing knee surgery to partially or completely remove a torn meniscus.
What is the purpose of this study?
The purpose of this study is to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. Bone marrow is removed from your body with a needle, processed by an FDA-approved centrifuge (separator) system, and injected into your knee after the torn meniscus is removed. “Autologous” means that you are receiving back your own cells that were collected. This is a prospective, randomized, double-blind clinical trial, which means in advance of participation, you will be assigned by chance, similar to a coin toss, to have bone marrow removed and injected into your knee or not. The study will compare outcomes(as reported by subjects) who receive the BMAC and those who do not. The study will also compare physical examination, X-rays, and BMAC and synovial fluid analysis.
How many study subjects are expected to take part in the study?
50 subjects are expected to be enrolled at Rush-affiliated surgical centers or hospitals.
What will you be asked to do?
As a participant in this study, you will still experience the same routine care you would receive if you were not enrolled. This includes a pre-operative exam, X-rays, and arthroscopic (minimally invasive surgery) removal of the damaged meniscus (meniscectomy), and physical examination at follow-up visits at 7-10 days, 2 weeks, 3 months, 6 months, 1 and 2 years.
Immediately following your normally scheduled meniscectomy, bone marrow may or may not be aspirated (removed with a needle) from your iliac crest (hip bone) and injected into your knee. The bone marrow removal and injection will add approximately 5-10 minutes of additional time to your surgery. You will remain under anesthesia for the duration of the meniscectomy, bone marrow aspiration, and injection. The injection will not require any additional recovery time from the procedure. You have an equal chance of being randomly assigned to either receive the bone marrow injection or to receive a placebo (saline) injection. Being a participant in the study does not guarantee that you will or will not receive the bone marrow injection. All subjects will have a small incision on their hip bone whether or not they receive bone marrow. This is necessary to prevent subjects from knowing which group they are in until after the study which could affect the results.
As part of the study, regardless of whether or not you received the bone marrow aspirate injection, you will also be asked to fill out questionnaires that provide information on your knee pain, function and overall health before your surgery and at each follow-up visit. X-rays will be taken at one and two years post-operatively as well. Synovial fluid (the fluid found in the knee joint) will be drawn from your knee at the time of procedure, 2 weeks, and 12 weeks to test for the presence of certain growth factors to evaluate how your knee is healing. These additional steps (surveys, follow-up X-rays, synovial fluid testing, and follow-up visit at the two year mark) are part of the research study and not part of routine care.
Are you a candidate for this clinical trial?
If you are receiving knee surgery to partially or completely remove a torn meniscus, and are interested in participating in the clinical trial, please contact us today!
How long will you be in the study?
If you agree to participate in this study, you will be enrolled for approximately two years. You may be removed from this study without your consent. Possible reasons may be that the study doctor decides that continued participation in the study will be harmful to you, you will need a treatment not allowed on the study, your disease becomes worse, you are unable to have the procedure as directed, or the study is canceled.
What are the possible risks of the study?
The risks associated with participation in this study include risks associated with conventional meniscectomy. These risks include bleeding, infection, injury to nerves or vessels, stiffness, and persistent (long-term) pain or not obtaining full function of the knee. None of these risks are specifically increased if you participate in the study. The risks associated with the bone marrow aspiration at the site of the iliac crest include bleeding, infection, hematoma formation, damage to adjacent muscle or superficial nerves/blood vessels. You may also experience pain or discomfort at the site the aspiration needle enters the body, and in rare cases, infection.
Are there benefits to taking part in the study?
There may be no direct benefit to you for participating in this study. Subjects who receive bone marrow aspirate injections may experience a decreased progression of osteoarthritis than subjects who do not.
What other options are there?
Instead of participating in this study, you may choose another form of treatment such as: the meniscectomy procedure without the possibility of BMAC injection.
What about confidentiality of your information?
Records of participation in this research study will be maintained and kept confidential as required by law. Only information necessary for the study will be collected. Study files will be kept with access limited to the research staff. All data files will be kept on a password-protected computer. Your identity will not be revealed on any report, publication or at scientific meetings.
If you withdraw from this study, the data already collected from may not be removed from the study records. If you wish the withdraw, you may contact the study coordinator Mukesh Ahuja at 312-563-2214 or firstname.lastname@example.org. The study doctor and/or study team may ask you whether they can continue to collect follow-up data on you. If follow-up information will be requested, you will be asked to sign a separate consent form before this information can be collected.
Your identity will not be revealed on any report, publication, or at scientific meetings. In order to conduct the study, the study doctor, Dr. Cole, Dr. Verma, or Dr. Yanke, will use and share personal health information about you. This includes information already in your medical record, as well as information created or collected during the study. Examples of the information that may be shared include your medical history, physical exam and laboratory test results. The study doctor will use this information about you to complete this research.
Confidentiality and disclosure of your personal information is further described in the attachment to this form. The attachment is titled HIPAA Authorization to Share Personal Health Information in Research (2 pages).
The Rush Institutional Review Board (IRB) will have access to your files as they pertain to this research study. The IRB is a special committee that reviews new and ongoing human research studies to check that the rules and regulations are followed regarding the protection of the rights and welfare of human subjects.
A description of this study will be available on http://www.CLINICALTRIALS.gov, as required by U.S. law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at anytime.
What are the costs of your participation in this study?
All costs that are part of your usual medical care, such as pre-operative X-rays, and physical examinations, as well as follow-up visits will be charged to you or your insurance company. You will be responsible for all costs that are not paid by your insurance company. You should check with your insurance company before you enroll in this research study. The placebo and BMAC injections will be covered by the study. Anything that you otherwise would not receive as a standard of care, including a follow-up visit at two years, post-operative MRI’s and X- rays, and synovial fluid testing will be covered by the study.
Will you be compensated or paid?
No monetary compensation will be given to you if you choose to participate. Your participation in this research study may contribute to the development of commercial products from which the Sponsor company or others may derive economic benefit. You will have no rights to any products, patents or discoveries arising from this research, and you will receive no economic benefit.
What happens if you experience a research related injury?
If you experience any injury or illness as a direct result of your participation in this research study, immediate treatment will be provided. However, the cost of that treatment will be billed to you or your insurance company. Please check with your insurance company regarding coverage. If you have any medical problems during the study, please contact the study doctor. He or she will explain your treatment options to you and/or help you find a place to get treatment. Rush University Medical Center has no program for financial compensation or other forms of compensation for injuries which you may incur as a result of participation in this study.
What happens if you need emergency care?
If you need emergency care while you are participating in this study, it is important that you tell emergency personnel of your participation in this study and notify the study doctor as soon as possible.
Whom do you call if you have questions or problems?
Questions are encouraged. If there are any questions about this research study or if you experience a research related injury, please contact: Mukesh Ahuja 312-563-2214. Questions about the rights of research subjects may be addressed to the Rush Research & Clinical Trials Administration Office at 1-800-876-0772.