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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05818150

Acronym

MOTION

Enrollment

264

Registered

2023-04-18

Start date

2024-01-16

Completion date

2027-10-31

Last updated

2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

genicular artery embolization, GAE, knee embolization, knee OA

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.

Detailed description

This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.

Interventions

DEVICEEmbosphere Microspheres

Embolic Agent: Embosphere Microspheres

DRUGCorticosteroid injection

Corticosteroid injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

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

Countries

Australia, Brazil, Canada, New Zealand, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026