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

NCT ID: NCT05818150

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2027-10-31

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 osteoarthritis.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genicular artery embolization with Embosphere Microspheres

Device: Embosphere Microspheres

Embolic Agent: Embosphere Microspheres

Group Type EXPERIMENTAL

Embosphere Microspheres

Intervention Type DEVICE

Embolic Agent: Embosphere Microspheres

Corticosteroid Injection of the knee

Drug: Corticosteroid injection

Group Type ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type DRUG

Corticosteroid injection

Interventions

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Embosphere Microspheres

Embolic Agent: Embosphere Microspheres

Intervention Type DEVICE

Corticosteroid injection

Corticosteroid injection

Intervention Type DRUG

Other Intervention Names

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Genicular artery embolization Triamcinolone or methylprednisolone

Eligibility Criteria

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Inclusion Criteria

Provides written informed consent

Age ≥21 years

Mild to severe knee pain, defined as a WOMAC Pain score of ≥8 out of 20 (in the target knee)

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandeep Bagla, MD

Role: PRINCIPAL_INVESTIGATOR

Prostate Centers, USA

Craig J McAsey, MD

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopedic Clinic

Locations

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Memorial Care Long Beach Medical Center

Long Beach, California, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Biotech Clinical Research/ Georgia Vascular Institute

College Park, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Atlantic Medical Imaging

Galloway, New Jersey, United States

Site Status

Rutgers Health

Newark, New Jersey, United States

Site Status

Northwell Health

Manhasset, New York, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Atlas Interventional

Williamsville, New York, United States

Site Status

Prostate Centers USA

Raleigh, North Carolina, United States

Site Status

Sunrise Vascular Center

Sanford, North Carolina, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Cardiovascular Health Clinic

Oklahoma City, Oklahoma, United States

Site Status

Prostate Centers USA

Falls Church, Virginia, United States

Site Status

Prostate Centers USA

Leesburg, Virginia, United States

Site Status

Liverpool Hospital

Liverpool, , Australia

Site Status

Hospital de Clínicas de Passo Fundo

Passo Fundo, , Brazil

Site Status

University of Sao Paulo

São Paulo, , Brazil

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, , Canada

Site Status

North Shore Hospital/ Te Whatu Ora - Waitemata

Takapuna, , New Zealand

Site Status

University Hospitals Dorset

Bournemouth, , United Kingdom

Site Status

Grange University Hospital

Cwmbran, , United Kingdom

Site Status

Countries

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United States Australia Brazil Canada New Zealand United Kingdom

References

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Bent C, McAsey CJ, Bagla S. Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary. Cardiovasc Intervent Radiol. 2025 Apr;48(4):551-558. doi: 10.1007/s00270-025-03994-z. Epub 2025 Mar 6.

Reference Type DERIVED
PMID: 40050421 (View on PubMed)

Other Identifiers

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GAE-P3-22-01

Identifier Type: -

Identifier Source: org_study_id

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