Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Merit Medical Systems, Inc.
- Enrollment
- 264
- Locations
- 25
- Primary Endpoint
- Primary Efficacy Endpoint
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provides written informed consent
- •Age ≥21 years
- •Mild to severe knee pain, defined as a numerical rating scale (NRS) score of ≥4 out of
- •Pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization.
- •Kellgren-Lawrence grade 1, 2, 3 or 4
Exclusion Criteria
- •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.
Arms & Interventions
Genicular artery embolization with Embosphere Microspheres
Device: Embosphere Microspheres
Embolic Agent: Embosphere Microspheres
Intervention: Embosphere Microspheres (Device)
Corticosteroid Injection of the knee
Drug: Corticosteroid injection
Intervention: Corticosteroid injection (Drug)
Outcomes
Primary Outcomes
Primary Efficacy Endpoint
Time Frame: 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
Time Frame: 6 months
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
Secondary Outcomes
- Subjects achieving Clinical Success(3, 12, and 24 months)
- Numerical rating scale (NRS)(baseline, 3, 6, 12 and 24 months)