An interventional study of Embosphere Microspheres and Corticosteroid injection in Knee Osteoarthritis, sponsored by Merit Medical Systems, Inc.. Active, not recruiting at 27 sites in 6 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-10-24.
Sponsored by Merit Medical Systems, Inc. · Not applicable, Interventional, and Treatment
This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 264 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Merit Medical Systems, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Provides written informed consent
Age ≥21 years
Mild to severe knee pain, defined as a WOMAC Pain score of ≥8 out of 20 (in the target knee)
Pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization.
Kellgren-Lawrence grade 1, 2, 3 or 4
Key Exclusion Criteria:
Planned major surgical or endovascular procedures ≤ 30 days after the index procedure.
Advanced atherosclerosis
Known history of rheumatoid or infectious arthritis.
Prior knee replacement surgery of the target knee.
Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres
Device: Embosphere Microspheres
Drug: Corticosteroid injection
Drug: Corticosteroid injection
Embolic Agent: Embosphere Microspheres
Also known as: Genicular artery embolization
Corticosteroid injection
Also known as: Triamcinolone or methylprednisolone
Primary Efficacy Endpoint
Clinical Success defined as ≥50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale from baseline to 6 months without the need for additional intervention.
Time frame: 6 months
Primary Safety Endpoint
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
Time frame: 6 months
Subjects achieving Clinical Success
Number of subjects achieving Clinical Success
Time frame: 3, 12, and 24 months
Numerical rating scale (NRS)
Pain score assessed using numerical rating scale (NRS)
Time frame: baseline, 3, 6, 12 and 24 months
Plan to share: No
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Merit Medical Systems, Inc.