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NCT05818150 | RECRUITING | Knee Osteoarthritis


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

Merit Medical Systems, Inc.

Brief Summary:

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 or disease

Knee Osteoarthritis

Intervention/treatment

Embosphere Microspheres

Corticosteroid injection

Phase

NA

Detailed Description:

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
Estimated Enrollment : 264 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid INjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study
Actual Study Start Date : 2024-01-16
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT05818150


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


NOT YET RECRUITING

United States, District of Columbia

Georgetown University Medical Center

Washington, D.C., District of Columbia, United States, 20007

NOT YET RECRUITING

United States, Florida

Tampa General Hospital

Tampa, Florida, United States, 33606

NOT YET RECRUITING

United States, Georgia

Emory University School of Medicine

Atlanta, Georgia, United States, 30322

NOT YET RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60201

RECRUITING

United States, Missouri

Saint Louis University

St Louis, Missouri, United States, 63103

RECRUITING

United States, New Jersey

Atlantic Medical Imaging

Galloway, New Jersey, United States, 08205

NOT YET RECRUITING

United States, New Jersey

Rutgers Health

Newark, New Jersey, United States, 07103

NOT YET RECRUITING

United States, New York

Northwell Health

Manhasset, New York, United States, 11030

RECRUITING

United States, North Carolina

Prostate Centers USA

Raleigh, North Carolina, United States, 27617

RECRUITING

United States, North Carolina

Sunrise Vascular Center

Sanford, North Carolina, United States, 27330

NOT YET RECRUITING

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

RECRUITING

United States, Oklahoma

Cardiovascular Health Clinic

Oklahoma City, Oklahoma, United States, 73134

RECRUITING

United States, Virginia

Prostate Centers USA

Falls Church, Virginia, United States, 22043

RECRUITING

United States, Virginia

Prostate Centers USA

Leesburg, Virginia, United States, 20191

RECRUITING

United States, Virginia

Prostate Centers USA

Reston, Virginia, United States, 20191

NOT YET RECRUITING

Australia,

Liverpool Hospital

Liverpool, Australia,

NOT YET RECRUITING

Australia,

Royal Perth Hospital

Perth, Australia,

NOT YET RECRUITING

Brazil,

Passo Fundo Clinical Hospital

Passo Fundo, Brazil,

NOT YET RECRUITING

Brazil,

University of Sao Paulo

São Paulo, Brazil,

NOT YET RECRUITING

Canada, British Columbia

Vancouver General Hospital

Vancouver, British Columbia, Canada,

NOT YET RECRUITING

New Zealand,

North Shore Hospital/ Te Watu Ora - Waitemata

Takapuna, New Zealand,

NOT YET RECRUITING

United Kingdom,

University Hospitals Dorset

Poole, United Kingdom,

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