Tiny beads aim to quiet arthritic knees without surgery
NCT ID NCT06550024
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new procedure called genicular artery embolization using SakuraBead, a dissolvable bead that blocks small blood vessels in the knee to reduce pain. It involves 89 adults aged 40-79 with moderate to severe knee osteoarthritis that hasn't improved with standard treatments. The bead procedure is compared to a steroid injection to see which provides better pain relief at 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 89 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advanced Vascular Institute
Panama City, Florida, 32405, United States
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Bokhua Memorial Cardiovascular Center
Tbilisi, Georgia
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Harbor UCLA Medical Center
Torrance, California, 90502, United States
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IR Centers
Raleigh, North Carolina, 27617, United States
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IR Centers
Leesburg, Virginia, 20176, United States
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Nano Medical Clinic
Tashkent, Uzbekistan, 100095, Uzbekistan
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Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN, United Kingdom
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University of Alabama Medicine
Birmingham, Alabama, 35233, United States
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Other studies related to the condition(s) this trial covers.
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