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Clinical Trials in Australia / NCT05818150
Active, not recruiting Not applicable

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

NCT05818150 · tracked via the Priya Life Science Australia tracker
Sponsor
Merit Medical Systems, Inc
Phase
Not applicable
Started
2024-01-16
Last updated
2025-10-24

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Embosphere MicrospheresCorticosteroid injection

Embosphere Microspheres: Embolic Agent: Embosphere Microspheres

Corticosteroid injection: Corticosteroid injection

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Key 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 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.

Primary outcome measure(s)

  • 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.

Trial sites (27)

FacilityCityRegionStatus
Memorial Care Long Beach Medical Center Long Beach California
Georgetown University Medical Center Washington D.C. District of Columbia
MedStar Washington Hospital Center Washington D.C. District of Columbia
Emory University School of Medicine Atlanta Georgia
Biotech Clinical Research/ Georgia Vascular Institute College Park Georgia
Northwestern University Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Saint Louis University St Louis Missouri
Atlantic Medical Imaging Galloway New Jersey
Rutgers Health Newark New Jersey
Northwell Health Manhasset New York
Weill Cornell Medicine New York New York
Atlas Interventional Williamsville New York
Prostate Centers USA Raleigh North Carolina
Sunrise Vascular Center Sanford North Carolina
The Ohio State University Columbus Ohio
Cardiovascular Health Clinic Oklahoma City Oklahoma
Prostate Centers USA Falls Church Virginia
Prostate Centers USA Leesburg Virginia
Liverpool Hospital Liverpool Australia
Hospital de Clínicas de Passo Fundo Passo Fundo Brazil
University of Sao Paulo São Paulo Brazil
Vancouver General Hospital Vancouver British Columbia
CHUM - Centre hospitalier de l'Université de Montréal Montreal Canada
North Shore Hospital/ Te Whatu Ora - Waitemata Takapuna New Zealand
University Hospitals Dorset Bournemouth United Kingdom
Grange University Hospital Cwmbran United Kingdom

More Merit Medical Systems, Inc. trials in Australia

Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP) Active, not recruiting
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE) Recruiting

Other trials for the same condition

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA) Recruiting
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05818150 on ClinicalTrials.gov ↗ ← All trials in Australia