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

N/AActive Not RecruitingNCT05818150

Merit Medical Systems, Inc.264 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

264

Conditions

Knee Osteoarthritis

Interventions

Embosphere MicrospheresDEVICE

Embolic Agent: Embosphere Microspheres

Corticosteroid injectionDRUG

Corticosteroid injection

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (27)

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Primary Safety Endpoint

Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.

Time frame: 6 months

Secondary Outcomes

Subjects achieving Clinical Success

Number of subjects achieving Clinical Success

Time frame: 3, 12, and 24 months

Numerical rating scale (NRS)

Pain score assessed using numerical rating scale (NRS)

Time frame: baseline, 3, 6, 12 and 24 months

Data from ClinicalTrials.gov

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