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

NCT05818150 | Active Not Recruiting DMC FDA Device

• 1 other identifier: GAE-P3-22-01
• Study Type: interventional
• Target: 264
• Locations: 6 countries
• Sites: 27

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.

Conditions

Knee Osteoarthritis

Keywords

genicular artery embolization; GAE; knee embolization; knee OA

Outcome Measures

Primary Outcomes (2)

• 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 6 months (180 days) following the index procedure.

  6 months

Secondary Outcomes (2)

• Subjects achieving Clinical Success

  3, 12, and 24 months

• Numerical rating scale (NRS)

  baseline, 3, 6, 12 and 24 months

Study Arms (2)

Genicular artery embolization with Embosphere Microspheres

EXPERIMENTAL

Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres

Device: Embosphere Microspheres

Corticosteroid Injection of the knee

ACTIVE COMPARATOR

Drug: Corticosteroid injection

Drug: Corticosteroid injection

Interventions

Embosphere Microspheres DEVICE

Embolic Agent: Embosphere Microspheres

Also known as: Genicular artery embolization

Genicular artery embolization with Embosphere Microspheres

Corticosteroid injection DRUG

Corticosteroid injection

Also known as: Triamcinolone or methylprednisolone

Corticosteroid Injection of the knee

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (27)

Memorial Care Long Beach Medical Center

Long Beach, California, 90806, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 22010, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Biotech Clinical Research/ Georgia Vascular Institute

College Park, Georgia, 30337, United States

Location

Northwestern University

Chicago, Illinois, 60201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Atlantic Medical Imaging

Galloway, New Jersey, 08205, United States

Location

Rutgers Health

Newark, New Jersey, 07103, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Weill Cornell Medicine

New York, New York, 10022, United States

Location

Atlas Interventional

Williamsville, New York, 14221, United States

Location

Prostate Centers USA

Raleigh, North Carolina, 27617, United States

Location

Sunrise Vascular Center

Sanford, North Carolina, 27330, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Cardiovascular Health Clinic

Oklahoma City, Oklahoma, 73134, United States

Location

Prostate Centers USA

Falls Church, Virginia, 22043, United States

Location

Prostate Centers USA

Leesburg, Virginia, 20191, United States

Location

Liverpool Hospital

Liverpool, Australia

Location

Hospital de Clínicas de Passo Fundo

Passo Fundo, Brazil

Location

University of Sao Paulo

São Paulo, Brazil

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, H2X OC1, Canada

Location

North Shore Hospital/ Te Whatu Ora - Waitemata

Takapuna, New Zealand

Location

University Hospitals Dorset

Bournemouth, United Kingdom

Location

Grange University Hospital

Cwmbran, NP44 8YN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40050421 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones; Triamcinolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Pregnadienetriols

Study Officials

• Sandeep Bagla, MD

  Prostate Centers, USA

  PRINCIPAL INVESTIGATOR

• Craig J McAsey, MD

  Anderson Orthopedic Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: January 16, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); CA (2); BR (2); GB (2); AU (1); US (19)