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 range30 Years
SexALL
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, Plā¦
What they're measuring
1
Changes in Visual Analog Scale (VAS) as a measure of efficacy