Active (not recruiting)
Not applicable
NCT05818150
GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
No applicable phase (e.g. observational)
Conditions:
Knee Osteoarthritis
Sponsor: Merit Medical Systems, Inc.
trial.available_in:
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Overview
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.
Description
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
Who can participate
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.