GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Embosphere MicrospheresDrug: Corticosteroid injection
- Registration Number
- NCT05818150
- Lead Sponsor
- Merit Medical Systems, Inc.
- Brief Summary
This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.
- Detailed Description
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
Provides written informed consent
Age ≥21 years
Mild to severe knee pain, defined as a numerical rating scale (NRS) score of ≥4 out of 10.
Pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization.
Kellgren-Lawrence grade 1, 2, 3 or 4
Key
Planned major surgical or endovascular procedures ≤ 30 days after the index procedure.
Advanced atherosclerosis
Known history of rheumatoid or infectious arthritis.
Prior knee replacement surgery of the target knee.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genicular artery embolization with Embosphere Microspheres Embosphere Microspheres Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres Corticosteroid Injection of the knee Corticosteroid injection Drug: Corticosteroid injection
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint 6 months Clinical Success defined as ≥50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale from baseline to 6 months without the need for additional intervention.
Primary Safety Endpoint 6 months Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
- Secondary Outcome Measures
Name Time Method Subjects achieving Clinical Success 3, 12, and 24 months Number of subjects achieving Clinical Success
Numerical rating scale (NRS) baseline, 3, 6, 12 and 24 months Pain score assessed using numerical rating scale (NRS)
Trial Locations
- Locations (21)
Georgetown University Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
MedStar Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Saint Louis University
🇺🇸St Louis, Missouri, United States
Atlantic Medical Imaging
🇺🇸Galloway, New Jersey, United States
Rutgers Health
🇺🇸Newark, New Jersey, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Atlas Interventional
🇺🇸Williamsville, New York, United States
Prostate Centers USA
🇺🇸Leesburg, Virginia, United States
Sunrise Vascular Center
🇺🇸Sanford, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Cardiovascular Health Clinic
🇺🇸Oklahoma City, Oklahoma, United States
Liverpool Hospital
🇦🇺Liverpool, Australia
Hospital de Clínicas de Passo Fundo
🇧🇷Passo Fundo, Brazil
University of Sao Paulo
🇧🇷São Paulo, Brazil
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
North Shore Hospital/ Te Whatu Ora - Waitemata
🇳🇿Takapuna, New Zealand
University Hospitals Dorset
🇬🇧Bournemouth, United Kingdom
Grange University Hospital
🇬🇧Cwmbran, United Kingdom