An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Corticosteroid injection in the knee
University of Alabama Medicine
Birmingham, Alabama, United States
Harbor UCLA Medical Center
Torrance, California, United States
Advanced Vascular Institute
Panama City, Florida, United States
IR Centers
Raleigh, North Carolina, United States
Primary Efficacy Endpoint - Proportion of Responders
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).
Time frame: 6 Months
Primary Safety Endpoint - Freedom from treatment-related SAEs
Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control).
Time frame: 6 Months
Proportion of Responders at 1 Month and 3 Month
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).
Time frame: 1 Month and 3 Months
Change in mean WOMAC Pain
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.
Time frame: 1 Month, 3 Months and 6 Months
Change in Numeric Rating Scale (NRS)
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IR Centers
Leesburg, Virginia, United States
Bokhua Memorial Cardiovascular Center
Tbilisi, Georgia
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Nano Medical Clinic
Tashkent, Uzbekistan, Uzbekistan
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.
Time frame: 1 Month, 3 Months and 6 Months