What is a research study?
Research studies help us learn more about a problem and how to better address it. In medical research, we aim to learn more about diseases and how to treat them.
What is the purpose of this study?
As leaders in the field of regenerative orthopedics, Regenerative Orthopedics and Sports Medicine (ROSM) physicians are dedicated to advancing our field through their contributions to clinical research. This research study is being conducted to examine the effect of an injection of MFAT versus a saline injection, which is considered the standard-of-care treatment, for addressing the pain and loss of function associated with knee osteoarthritis. Approximately 173 participants will be involved in this research. Adipose tissue, commonly known as fat, possesses numerous natural reparative characteristics that contribute to creating a healing environment within the body.
Do I have to participate in this study?
No, participation in this study is entirely voluntary. The primary goal is to acquire knowledge that can benefit patients in the future. On the other hand, the primary objective of regular medical care is to assist each individual patient. While your participation in the research study is voluntary, it will not result in the loss of any medical benefits. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.
What are the risks of participating in this study?
The Lipogems system carries potential clinical risks, which include but are not limited to the following known complications:
- Damage to joint tissues such as ligaments, meniscus, cartilage, and tendons.
- Delayed healing of the needle entry points, both in the lipoaspirate (fat extraction) and intraarticular (within the joint) injections.
- Hematoma formation (clotted blood) within the knee joint.
- Occurrence of catching, locking, or crepitation (crackling sound) in the knee joint.
- Stiffness of the knee joint.
- Presence of effusion (fluid accumulation around the knee).
- Inflammation.
- Calcification.
- Knee instability.
- Persistent pain, deformity, and/or discomfort.
- Continuation of the osteoarthritic process.
- Fat embolism, where fat particles released into the bloodstream may potentially obstruct circulation and lead to decreased oxygen supply to the heart and/or lungs.
Will I learn the results of this study?
As a participant in the study, you have the option to receive updates on where and when results from our study will be shared with the community. Your pain questionnaire data will be accessible to you and will be stored in your medical record.
Who will have access to the questionnaires I complete?
Your completed questionnaires will be accessible to researchers and medical staff at ROSM. The information we use from your survey will not be tied to your personal information (name, date of birth, etc.).
What is the payment structure for participating in the study, and what happens if I do not complete the study?
You will receive a payment of $50.00 for the screening visit, and for each follow-up study visit, you will be compensated with $100.00. It is important to note that if, for any reason, you do not complete the study, the research staff will only be able to pay you for the follow-up visits that you have already completed up until the point of ending your participation.
How will the results of this research study be shared, and what measures will the Sponsor take to protect my identity?
The results of this research study may be shared through presentations at meetings or in publications. In such instances, the Sponsor will take precautions to ensure that the data is presented in a manner that safeguards your identity. As required by U.S. Law, a description of this clinical trial will be accessible on http://www.ClinicalTrials.gov. However, this website will not contain any information that can personally identify you. At most, it will provide a summary of the results. You have the option to search this website at any time. Rest assured that the Sponsor will ensure that the information provided on the website never includes any details that could reveal your identity.
