Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis (NCT05360329) | Clinical Trial Compass
CompletedNot Applicable
Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis
Denmark17 participantsStarted 2022-09-20
Plain-language summary
The aim of this study is to investigate the safety and efficacy of geniculate artery embolization (GAE) as pain treatment in patients with mild to moderate knee osteoarthritis.
Who can participate
Age range
30 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:
* Body Mass Index \< 35 kg / m2.
* X-ray verified mild to moderate KOA (Kellgren Lawrence grade 1-3 \[24\]), obtained maximum 6 months prior to inclusion.
* Moderate to severe knee pain during walking (Visual Analog Scale (VAS) \> 50 mm) - resistant to minimum 3 months physiotherapy.
* Willing, able, and mentally competent to provide informed consent.
Exclusion Criteria:
* Local infection in knee or groin areas.
* Moderate to severe pain in ipsilateral lower limb joints; VAS \> 2.
* Intermittent claudication.
* Rheumatoid arthritis or seronegative arthropathies.
* Prior ipsilateral open knee surgery.
* Ipsilateral arthroscopy within 6 months.
* Ipsilateral intra-articular knee injection within 6 months.
* Current/recent (within 4 weeks) use of oral corticosteroids.
* Generalized pain syndrome (e.g. fibromyalgia) or nerve root compression syndromes.
* Pregnant or planned pregnancy during the study period.
* Lactation.
* Active malignancy.
* Known history of allergy to contrast media.
* Contra-indications for MRI (e.g. metallic foreign bodies, etc).
* Manifest hyperthyroidism.
* Diabetes (I+II).
* Liver disease.
* Only one kidney, former kidney surgery, reduced kidney function or failure (chronic or acute).
* Estimated glomerular filtration rate \< 60 ml / min / 1.73 m2 (All participants: blood sample maximum 30 days prior to GAE. Participants \> 60 years: another blood sample maximum 3 months prior to last MRI scan with contrast agents).
* INR \> 1.4, Pl…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Changes in Visual Analog Scale (VAS) as a measure of efficacy