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

Merit Medical Systems

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Drug: Corticosteroid injection; Device: Embosphere Microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT05818150

GAE-P3-22-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 264 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Genicular artery embolization with Embosphere Microspheres

Experimental group

Description:

Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres

Treatment:

Device: Embosphere Microspheres

Corticosteroid Injection of the knee

Active Comparator group

Description:

Drug: Corticosteroid injection

Treatment:

Drug: Corticosteroid injection