Arthritis, Joint Diseases, Musculoskeletal Diseases, Osteoarthritis, Osteo Arthritis Knee, Rheumatic Diseases
Conditions
Keywords
Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis
Brief summary
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Detailed 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.
Interventions
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
DRUGCorticosteroid Injection
Corticosteroid injection in the knee
Sponsors
CrannMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint - Proportion of Responders | 6 Months | Compare the proportion of responders\* (defined as ≥50% reduction in WOMAC Pain\*\* score and ≥2 point reduction in NRS\*\*\*) between the Investigational procedure and Control at 6 months. * Non-responders will include subjects experiencing device-related SAEs. \*\*Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome \*\*\*NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain). |
| Primary Safety Endpoint - Freedom from treatment-related SAEs | 6 Months | Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders at 1 Month and 3 Month | 1 Month and 3 Months | Compare the proportion of responders\* (defined as ≥50% reduction in WOMAC Pain\*\* score and ≥2 point reduction in NRS\*\*\*) between the Investigational procedure and Control at 1 Month and 3 Months. * Non-responders will include subjects experiencing device-related SAEs. \*\*Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome \*\*\*NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain). |
| Change in mean WOMAC Pain | 1 Month, 3 Months and 6 Months | Compare mean change from baseline in the Western Ontario and McMaster University Osteoarthritis Index Pain (WOMAC Pain, Scale: 0-20, where a lower score represents a better outcome) between the Investigational procedure and Control at 1 Month, 3 Months and 6 Months. |
| Change in Numeric Rating Scale (NRS) | 1 Month, 3 Months and 6 Months | Compare mean decrease in pain (measured using the Numeric Rating Scale (NRS)) between the Investigational procedure and Control at 1 month, 3 months and 6 months. Scale: 0-10, where a lower score means a better outcome. |
Countries
Georgia, United Kingdom, United States, Uzbekistan
Outcome results
None listed