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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: Embosphere Microspheres; Drug: 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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Study Start: 2024-01-16
• Status Verified: 2024-08
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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.

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

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