STUDY PARTICIPANTS NEEDED-CONTACT US TODAY! If you are interested in participating in the study, give us a call or send a text to or email [javascript protected email address] to learn more.
Don’t Let Knee Osteoarthritis Stop You From Enjoying Your Life
Knee osteoarthritis is typically the result of progressive wear and tear on the joint as we age and is one of the leading causes of disability. It can be hard when the pain, swelling, stiffness from your knee osteoarthritis impacts you from enjoying your life Patients suffering from knee OA oftentimes have a hard time performing daily activities such as sleeping, walking, using stairs, bending down, taking care of your family, working, and doing your favorite activities.
Have You Tried Conservative Options with Limited Relief and Are Not Ready for Major Surgery?
Surgery is not the first step. Many patients try conservative options first (ex. physical therapy, corticosteroids, other injections, activity modification). Over a period time, these interventions may provide limited relief. There are not many effective treatment options available to patients that have tried conservative options but are ready for major surgery.
What is the purpose of the study? We are searching for new ways to help treat knee osteoarthritis (OA). The ARISE II study will look at how well a naturally, minimally invasive investigational therapy using your own MicroFat helps treat pain and function for patients that have mild to moderate knee osteoarthritis.
Why use your own MicroFat? Your own fat (also known as adipose tissue) is one of the highest quality tissues from your body.
- RESEARCH: Many studies have shown that fat has been used to support the healing process of damaged or injured tissue.1,2,3
- STRUCTURAL TISSUE: Fat is a structural tissue that contains a variety of reparative cells and tissue. It provides cushioning and support to help with the healing environment in response to a tissue injury.4,5,6
- AGE MAY NOT BE A FACTOR: Research has shown that as a person ages, their adipose tissue maintains the reparative properties, unlike other similar tissue, which may lose healing capacity with age.7,8,9
- MINIMALLY INVASIVE: Fat can be easily collected using a minimally invasive procedure using local anesthesia in an outpatient setting.
- VOLUME OF TISSUE: Fat may be collected in a plentiful volume.
- MINIMIZED RISK OF INFECTION: Because the doctor is using your own tissue, there is a minimal risk of rejection or infection.
Study eligibility
You may be eligible to participate in the study if you
- Are aged 18 years or older
- Have mild to moderate knee osteoarthritis
- Have tried other treatment options with little to no improvement, or the improvement did not last
- Did not have an injection in the target knee in the last six months
- Did not have surgery in either knee in the last six months
- Do not have any upcoming planned surgeries
You may not be eligible to participate in the study if you
- X-ray findings of knee osteoarthritis that is K/L grade 1 (doubtful) or 4 (severe)
- BMI greater than 35 kg/m2
- Any local or systemic active infection
- Allergies to anesthetics or corticosteroids
- Current or historical autoimmune disease, inflammatory arthritis, or coagulation disorders
- Current anticoagulation therapy or previous tumor therapy
- Knee pain associated with recent traumatic events
- Active worker's compensation case
- Women with a positive urine pregnancy test
- An injection in the target knee in the last 6 months
- Surgery in either knee in the last 6 months
- Untreated symptomatic injury of the index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, clinically symptomatic meniscus injury characterized by mechanical issue such as locking or catching)
- Impossibility to harvest enough adipose tissue
- Women who are breastfeeding
- History of septic arthritis or sepsis/bacteremia in the affected knee within 6 months prior to screening, or infection requiring antibiotic treatment within the preceding 3 months
- History of uncontrolled diabetes, hypertension, cardiovascular disease and other conditions*
*Other study requirements may apply
FAQ
How many research participants and studies are involved?
The ARISE study will enroll 173 participants across several well-respected orthopaedic institutions across the United States.
Will I need to pay for the procedure?
If you qualify for the study and choose to participate in the study, you will sign an informed consent and you will receive all study related care and investigational device by a trained physician and team at no cost.
Will I receive compensation?
If you choose to participate in the study, compensation may be provided for travel and expenses for each study visit you complete.
Is participation voluntary?
Your participation is voluntary. You may withdraw from the study at any time and for any reason. Please inform your study research team of your decision.
How will the results of this research study be shared, and what measures will the Sponsor take to protect my 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.
The results of this research study may be shared through presentations at meetings or in publications. At most, it will provide a summary of the results. In such instances, the Sponsor will take precautions to ensure that the data is presented in a manner that safeguards your identity.
CONTACT US TODAY! To get started with the study, or if you have any questions, give us a call or send a text to or email [javascript protected email address].
