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

October 22, 2025 updated by: Merit Medical Systems, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Liverpool, Australia
        • Liverpool Hospital
  • Brazil
      • Passo Fundo, Brazil
        • Hospital de Clinicas de Passo Fundo
      • São Paulo, Brazil
        • University of Sao Paulo
  • Canada
      • Montreal, Canada, H2X OC1
        • CHUM - Centre hospitalier de l'Université de Montréal
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
  • New Zealand
      • Takapuna, New Zealand
        • North Shore Hospital/ Te Whatu Ora - Waitemata
  • United Kingdom
      • Bournemouth, United Kingdom
        • University Hospitals Dorset
      • Cwmbran, United Kingdom, NP44 8YN
        • Grange University Hospital
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Memorial Care Long Beach Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
      • Washington D.C., District of Columbia, United States, 22010
        • Medstar Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • College Park, Georgia, United States, 30337
        • Biotech Clinical Research/ Georgia Vascular Institute
    • Illinois
      • Chicago, Illinois, United States, 60201
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • St Louis, Missouri, United States, 63103
        • Saint Louis University
    • New Jersey
      • Galloway, New Jersey, United States, 08205
        • Atlantic Medical Imaging
      • Newark, New Jersey, United States, 07103
        • Rutgers Health
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • New York, New York, United States, 10022
        • Weill Cornell Medicine
      • Williamsville, New York, United States, 14221
        • Atlas Interventional
    • North Carolina
      • Raleigh, North Carolina, United States, 27617
        • Prostate Centers USA
      • Sanford, North Carolina, United States, 27330
        • Sunrise Vascular Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Cardiovascular Health Clinic
    • Virginia
      • Falls Church, Virginia, United States, 22043
        • Prostate Centers USA
      • Leesburg, Virginia, United States, 20191
        • Prostate Centers USA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genicular artery embolization with Embosphere Microspheres

Device: Embosphere Microspheres

Embolic Agent: Embosphere Microspheres
Device: Embosphere Microspheres
Embolic Agent: Embosphere Microspheres
Other Names:
  • Genicular artery embolization
Active Comparator: Corticosteroid Injection of the knee
Drug: Corticosteroid injection
Drug: Corticosteroid injection
Corticosteroid injection
Other Names:
  • Triamcinolone or methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint
Time Frame: 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.
6 months
Primary Safety Endpoint
Time Frame: 6 months
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit Medical Systems, Inc.

Investigators

  • Principal Investigator: Craig J McAsey, MD, Anderson Orthopedic Clinic
  • Principal Investigator: Sandeep Bagla, MD, Prostate Centers, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAE-P3-22-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Corticosteroid injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe