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 osteroarthritis.
Eligibility
Key Inclusion Criteria:
Provides written informed consent
Age ≥21 years
Mild to severe knee pain, defined as a numerical rating scale (NRS) score of ≥4 out of 10.
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.