Using SakuraBead for knee pain relief in osteoarthritis
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
This study is testing if a new treatment called SakuraBead can help relieve knee pain better and more safely than regular steroid shots for people with osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 89 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | CrannMed Industry-sponsored |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT06550024 on ClinicalTrials.gov |
What this trial studies
This clinical trial is an open-label, prospective, two-arm, multicenter, randomized controlled trial that compares the safety and efficacy of SakuraBead genicular artery embolization (GAE) with corticosteroid injection for treating pain associated with knee osteoarthritis. Approximately 89 patients with moderate to severe knee pain will be enrolled and followed for two years to assess outcomes. The study aims to determine if SakuraBead can provide a more effective and safer alternative to traditional corticosteroid injections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 80 with moderate to severe knee osteoarthritis pain that has not responded to conservative treatments.
Not a fit: Patients with severe knee osteoarthritis, advanced autoimmune arthritis, or those who have had prior knee replacement surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for patients suffering from knee osteoarthritis pain.
How similar studies have performed: While the approach of using resorbable microspheres for embolization is innovative, similar studies have shown promise in other applications, indicating potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 6 other locations
- University of Alabama Medicine — Birmingham, Alabama, United States (Recruiting)
- Harbor UCLA Medical Center — Torrance, California, United States (Recruiting)
- IR Centers — Raleigh, North Carolina, United States (Recruiting)
- Orthopedic and Fracture Specialists (O&FS) — Beaverton, Oregon, United States (Recruiting)
- IR Centers — Leesburg, Virginia, United States (Recruiting)
- Bokhua Memorial Cardiovascular Center — Tbilisi, Georgia (Recruiting)
- Nano Medical Clinic — Tashkent, Uzbekistan (Recruiting)
Study contacts
- Study coordinator: Chief Operations Officer
- Email: joan.mccabe@crannmed.com
- Phone: +1 800 353 4246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.