DON’T LET KNEE OSTEOARTHRITIS STOP YOU FROM ENJOYING YOUR LIFE
Knee osteoarthritis (OA) 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 and 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
Working
Taking Care of Your Family
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 of time, these interventions may provide limited relief. There are not many effective treatment options available to patients that have tried conservative options but are not ready for major surgery.
ABOUT THE ARISE II STUDY
This study will look at how well an investigational therapy using MicroFat helps treat pain and function for patients that have mild to moderate knee osteoarthritis.
STUDY PARTICIPANTS
Participation is entirely voluntary. Clinical studies oftentimes have firm inclusion and exclusion criteria. Patients in the study will be screened to determine if they meet the criteria below to see if they are eligible to participate in the study.
You may be able to participate, if you:
- Are aged 18 years or older
- Have mild to moderate Knee OA
- 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 6 months
- Did not have surgery in either knee in the last 6 months
- Do not have any upcoming planned surgeries*
*Other study requirements may apply
LIPOGEMS PROCEDURE
1 FAT COLLECTION PROCEDURE
In a minimally invasive procedure, your physician will make a tiny puncture through your skin and collect a small amount of fat from either your midsection or “love handles”.
2 GENTLE PROCESSING USING THE LIPOGEMS™ DEVICE
The collected fat will then be processed in the patented Lipogems device using only sterile saline to wash away any impurities, including blood and oil residues. During this process, your fat is resized and concentrated into smaller clusters, called MicroFat.
3 MICROFAT
MicroFat is an optimal size for injecting into the knee to potentially help treat pain and function for patients that have mild to moderate knee osteoarthritis.
WHAT ARE THE NEXT STEPS?
If you would like to participate in the study, the physician and research team will screen you to see if you meet the inclusion and exclusion criteria. The study will be thoroughly explained by the team, and you will have the ability to ask any questions.
If you qualify and choose to participate in the study, you will sign an informed consent and be scheduled for treatment. On the day of treatment, we will need to re-confirm your eligibility by checking vitals, urine pregnancy test*, and questionnaires. If you meet the criteria on treatment day, you will have a 2:1 chance of receiving the Lipogems MicroFat (aka MFat) versus a saline injection. You will receive all study related care at no cost. Compensation may be provided for travel and expenses for each study visit you complete.
Screening may include checking:
- Medical History
- Physical Exam
- Vitals
- Blood Test
- Urine Pregnancy Test (if applicable)
- EKG
- X-Rays
- Questionnaires
Are you interested in participating in this study?
To find a site participating in the ARISE 2 trial, please click here and scroll to “Contacts and Locations.”
Learn More About ParticipationFor More Information, Please complete this form:
FREQUENTLY ASKED
QUESTIONS
How many research participants and centers are involved?
The ARISE study will enroll 173 participants across 20 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 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.
Disclaimer:
REFERENCES
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