Arthritis, Joint Diseases, Musculoskeletal Diseases, Osteoarthritis, Osteoarthritis Knee Pain, Osteoarthritis (OA) of the Knee, Rheumatic Diseases
Conditions
Keywords
Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis
Brief summary
A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.
Detailed description
To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.
Interventions
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Sponsors
CrannMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is able and willing to provide written informed consent, and 2. Clinical diagnosis of knee OA, and 3. Moderate to severe knee pain (VAS ≥ 5), and 4. Pain refractory to at least 3 months\* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and 5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and 6. Age 40 years or older. 7. Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).
Exclusion criteria
1. Severe knee OA (Kellgren-Lawrence grade 4) 2. Current infection of target joint, or 3. Life expectancy less than 24 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. Complete meniscal or cruciate tear that requires surgery, or 8. History of uncorrectable coagulopathy, or 9. Prior iodinated contrast reaction resulting in anaphylaxis, or 10. Pregnant and/or lactating female, or 11. At the discretion of the Principal Investigator 12. Subject has evidence of arterial occlusion precluding catheterization. 13. Subject has occlusion of the genicular arteries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up. | 1 month |
| Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up | 1, 3 and 6 months |
| Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up | 3 and 6 months |
| Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months | 3 and 6 months |
| No major device- or procedure-related complication at 3 and 6 months | 3 and 6 months |
Countries
Uzbekistan
Outcome results
None listed