Bayer OA Knee Pain Pilot (NCT05349682) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Bayer OA Knee Pain Pilot
United States12 participantsStarted 2022-10-01
Plain-language summary
The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit.
In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.
Who can participate
Age range
25 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 25 to 90
. Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
. One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
. Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
. Patients without contraindication to MRI imaging with gadolinium-based contrast.
Exclusion criteria
. Anaphylaxis to gadolinium or iodinated contrast media
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a procedure called GAE — geniculate artery embolization — for knee osteoarthritis pain, and one of its main goals is tracking adverse events from that procedure. Since it's already active and not enrolling new patients, could you walk me through what the known safety signals for GAE look like so far, and whether it would be appropriate for my situation?
2The trial is measuring whether patients get at least a 50% reduction in pain scores — which is a pretty high bar. Based on what you know about GAE and my current pain levels, is that kind of improvement realistic for someone with my degree of osteoarthritis?
3The study is using specialized MRI scans with contrast dye, called CE-MRI, to track changes in blood flow and joint inflammation in the knee. Does that imaging approach tell us anything meaningful about how well GAE might work compared to what we can already see on my existing scans?
4Since this trial is no longer enrolling, GAE itself is still being studied and isn't a standard treatment — so what are my current standard-of-care options for knee osteoarthritis pain, and how do they compare in terms of evidence and safety to what this trial is exploring?
5The trial tracks synovitis — inflammation of the joint lining — as one of its key measurements. Given that synovitis is part of what this procedure targets, is there any way to tell from my current imaging or symptoms whether synovitis is a significant driver of my knee pain, and would that affect which treatment path makes the most sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in enhancement time intensity curves obtained from CE-MRI
Timeframe: change from baseline at 6 month post procedure
2
Change in Whole-Organ Magnetic Resonance Scoring (WORMS)
Timeframe: change from baseline at 6 month post procedure
3
Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis
Timeframe: change from baseline at 6 month post procedure
4
Number of participants with 50% reduction in pain scores
Timeframe: change from baseline at 1 month post procedure
5
Number of participants with 50% reduction in pain scores
Timeframe: change from baseline at 6 month post procedure
6
Number of participants with 50% reduction in pain scores
Timeframe: change from baseline at 12 month post procedure