GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA

Study Overview
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Brief Summary
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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
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This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteroarthritis.

Official Title
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Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Embosphere Microspheres
* Drug: Corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Key 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 10. Pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization. Kellgren-Lawrence grade 1, 2, 3 or 4 Key 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genicular artery embolization with Embosphere Microspheres<br>Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres | Device: Embosphere Microspheres<br>* Embolic Agent: Embosphere Microspheres<br>* Other names: Genicular artery embolization;|
| Active Comparator: Corticosteroid Injection of the knee<br>Drug: Corticosteroid injection | Drug: Corticosteroid injection<br>* Corticosteroid injection<br>* Other names: Triamcinolone or methylprednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint | 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. | 6 months | 
| Primary Safety Endpoint | Freedom from treatment-related safety events through 30 days following the index procedure. | 30 days post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects achieving Clinical Success | Number of subjects achieving Clinical Success | 3, 12, and 24 months | 
| Numerical rating scale (NRS) | Pain score assessed using numerical rating scale (NRS) | baseline, 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genicular artery embolization, GAE, knee embolization, knee OA