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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Genicular artery embolization with Embosphere Microspheres 		Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres
  • Device: Embosphere Microspheres
    Embolic Agent: Embosphere Microspheres
    Other names:
    • Genicular artery embolization
Active Comparator
Corticosteroid Injection of the knee 		Drug: Corticosteroid injection
  • Drug: Corticosteroid injection
    Corticosteroid injection
    Other names:
    • Triamcinolone or methylprednisolone

Recruiting Locations

Georgetown University Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20007
Contact:
Nairman Nezami, MD
202-444-5478
Nariman.Nezami@medstar.net

MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 22010

More Details

Status
Recruiting
Sponsor
Merit Medical Systems, Inc.

Study Contact

Vanessa Therrien
1 (385) 766-9151
vanessa.therrien@merit.com

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.