SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

Overview

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

Description

To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.

Eligibility

Inclusion Criteria:

1. Subject is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age ≥ 40 years and < 80 years, and
7. Able to comply with all treatments and follow-up visits.

Exclusion Criteria:

1. Severe knee OA (Kellgren-Lawrence grade 4), or
2. Current infection of target joint, or
3. Life expectancy less than 36 months, or
4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Pain score of >3 NRS on the non-target knee, or
8. An acute internal derangement of the target knee, or
9. History of uncorrectable coagulopathy, or
10. Prior iodinated contrast reaction resulting in anaphylaxis, or
11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
12. Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
13. Contraindication to MRI, or
14. At the discretion of the Principal Investigator