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

RECRUITING

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.

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Study details:

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

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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.

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Eligibility

Age eligible for study : 21 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-01-16

Primary completion: 2026-04-01

Study completion finish: 2027-10-01

Study type

TREATMENT

Phase

Trial ID

NCT05818150

Intervention or treatment

DEVICE: Embosphere Microspheres

DRUG: Corticosteroid injection

Conditions

• Knee Osteoarthritis

Condition: Knee Osteoarthritis
DEVICE: Embosphere Microspheres and other drugs
Liverpool, Not Specified, Australia and more
Sponsor: Merit Medical Systems, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Liverpool Hospital

Research sites nearby

Select from list below to view details:

Liverpool Hospital
Liverpool, Not Specified, Australia
Royal Perth Hospital
Perth, Not Specified, Australia

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?

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
ACTIVE_COMPARATOR: Corticosteroid Injection of the knee Drug: Corticosteroid injection	DRUG: Corticosteroid injection Corticosteroid injection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: GAE Using Embosphere Microspheres Vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)