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The trial is taking place at:
S

Saint Louis University | SLUCare Academic Pavilion - Endocrinology Division Research

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

M

Merit Medical Systems

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Device: Embosphere Microspheres
Drug: Corticosteroid injection

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 osteroarthritis.

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 numerical rating scale (NRS) score of ≥4 out of 10.

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)

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

Trial contacts and locations

23

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Central trial contact

Vicky Brunk; Vanessa Therrien

Data sourced from clinicaltrials.gov

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