Knee OsteoarthritisMOTIONNCT05818150
GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
A study testing Embosphere Microspheres and Corticosteroid injection in people with Knee Osteoarthritis, run by Merit Medical Systems, Inc. at 27 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Embosphere Microspheres and Corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 16 Jan 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
United States19 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60201
Biotech Clinical Research/ Georgia Vascular Institute
College Park, Georgia, 30337
The Ohio State University
Columbus, Ohio, 43210
Prostate Centers USA
Falls Church, Virginia, 22043
Atlantic Medical Imaging
Galloway, New Jersey, 08205
Prostate Centers USA
Leesburg, Virginia, 20191
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
Northwell Health
Manhasset, New York, 11030
Weill Cornell Medicine
New York, New York, 10022
Rutgers Health
Newark, New Jersey, 07103
Cardiovascular Health Clinic
Oklahoma City, Oklahoma, 73134
Prostate Centers USA
Raleigh, North Carolina, 27617
Sunrise Vascular Center
Sanford, North Carolina, 27330
Saint Louis University
St Louis, Missouri, 63103
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 22010
Atlas Interventional
Williamsville, New York, 14221
Brazil2 sites
Hospital de Clínicas de Passo Fundo
Passo Fundo
University of Sao Paulo
São Paulo
Canada2 sites
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, H2X OC1
Vancouver General Hospital
Vancouver, British Columbia
United Kingdom2 sites
University Hospitals Dorset
Bournemouth
Grange University Hospital
Cwmbran, NP44 8YN
About this study
Official title: 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.
Read the detailed description
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Embosphere Microspheres, Corticosteroid injection
- Keywords
- genicular artery embolization, GAE, knee embolization, knee OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere MicrospheresDevice
Also called Genicular artery embolization
Embolic Agent: Embosphere Microspheres
Corticosteroid injectionDrug
Also called Triamcinolone or methylprednisolone
Corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| Genicular artery embolization with Embosphere Microspheres | Experimental | Device: Embosphere Microspheres
Embolic Agent: Embosphere Microspheres Receives: Device: Embosphere Microspheres |
| Corticosteroid Injection of the knee | Active comparator | Drug: Corticosteroid injection Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Primary Safety Endpoint
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
Measured: 6 months
Secondary outcomes (2)
Subjects achieving Clinical Success
Number of subjects achieving Clinical Success
Measured: 3, 12, and 24 months
Numerical rating scale (NRS)
Pain score assessed using numerical rating scale (NRS)
Measured: baseline, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 Jan 2024
- Primary completionApr 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Bagla, MD, Principal investigator, Prostate Centers, USACraig J McAsey, MD, Principal investigator, Anderson Orthopedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818150
- Sponsor's protocol ID
- GAE-P3-22-01
- Acronym
- MOTION
- Status last verified
- Oct 2025
- First submitted
- 5 Apr 2023
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40050421
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study
- ClinicalTrials.gov ID
- NCT05818150
- Acronym / sponsor ID
- MOTION / GAE-P3-22-01
- Conditions
- Knee Osteoarthritis
- Keywords
- genicular artery embolization, GAE, knee embolization, knee OA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
| Arm | Type | Receives |
|---|---|---|
| Genicular artery embolization with Embosphere Microspheres | Experimental | Device: Embosphere MicrospheresDevice: Embosphere Microspheres Embolic Agent: Embosphere Microspheres |
| Corticosteroid Injection of the knee | Active comparator | Drug: Corticosteroid injectionDrug: Corticosteroid injection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embosphere MicrospheresAlso: Genicular artery embolizationEmbolic Agent: Embosphere Microspheres | Device | Genicular artery embolization with Embosphere Microspheres |
| Corticosteroid injectionAlso: Triamcinolone or methylprednisoloneCorticosteroid injection | Drug | Corticosteroid Injection of the knee |
Primary outcome
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.
Primary Safety Endpoint
Time frame: 6 months
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
2 secondary outcomes
Subjects achieving Clinical Success
Time frame: 3, 12, and 24 months
Numerical rating scale (NRS)
Time frame: baseline, 3, 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Derived from this study: PubMed 40050421Bent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Bagla, MD principal investigator
Prostate Centers, USA
Craig J McAsey, MD principal investigator
Anderson Orthopedic Clinic
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere Microspheres and Corticosteroid injection in people with Knee Osteoarthritis, run by Merit Medical Systems, Inc. at 27 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Brazil, Canada, United Kingdom, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.