SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

Launched by CRANNMED · Aug 9, 2024

Keywords

ClinConnect Summary

The clinical trial, titled "SakuraBead Used As Resorbable Embolic for Genicular Artery Embolization," is looking into a new treatment method for people suffering from moderate to severe knee osteoarthritis (OA). This study compares a procedure using SakuraBead, which is designed to reduce pain by blocking certain blood vessels in the knee, to a standard treatment of corticosteroid injections. The trial is currently recruiting participants aged 40 to 80 who have been experiencing significant knee pain that hasn’t improved with other treatments like medication or physical therapy for at least three months.

To be eligible for this trial, individuals must have a confirmed diagnosis of knee OA and a specific level of pain, among other criteria. Participants will receive either the SakuraBead treatment or the corticosteroid injection and will be monitored over time to see how well each method helps alleviate pain. This trial is important because it aims to find more effective options for managing knee pain due to osteoarthritis, offering hope for those who have not found relief through traditional therapies.

Gender

ALL

Eligibility criteria

• 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