Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Missouri
Saint Louis University
RECRUITING
St Louis
North Carolina
Prostate Centers USA
RECRUITING
Raleigh
Sunrise Vascular Center
RECRUITING
Sanford
New Jersey
Atlantic Medical Imaging
RECRUITING
Galloway
Rutgers Health
RECRUITING
Newark
New York
Northwell Health
RECRUITING
Manhasset
Weill Cornell Medicine
NOT_YET_RECRUITING
New York
Atlas Interventional
RECRUITING
Williamsville
Ohio
The Ohio State University
RECRUITING
Columbus
Oklahoma
Cardiovascular Health Clinic
RECRUITING
Oklahoma City
Virginia
Prostate Centers USA
RECRUITING
Falls Church
Prostate Centers USA
RECRUITING
Leesburg
Other Locations
Australia
Liverpool Hospital
NOT_YET_RECRUITING
Liverpool
Brazil
Hospital de Clínicas de Passo Fundo
NOT_YET_RECRUITING
Passo Fundo
University of Sao Paulo
NOT_YET_RECRUITING
São Paulo
Canada
Vancouver General Hospital
RECRUITING
Vancouver
New Zealand
North Shore Hospital/ Te Whatu Ora - Waitemata
RECRUITING
Takapuna
United Kingdom
University Hospitals Dorset
NOT_YET_RECRUITING
Bournemouth
Grange University Hospital
NOT_YET_RECRUITING
Cwmbran
Contact Information
Primary
Vanessa Therrien
vanessa.therrien@merit.com
1 (385) 766-9151
Backup
Vicky Brunk
vicky.brunk@merit.com
(385) 766-9152
Time Frame
Start Date: 2024-01-16
Estimated Completion Date: 2027-10
Participants
Target number of participants: 264
Treatments
Experimental: Genicular artery embolization with Embosphere Microspheres
Device: Embosphere Microspheres~Embolic Agent: Embosphere Microspheres
Active_comparator: Corticosteroid Injection of the knee
Drug: Corticosteroid injection
Related Therapeutic Areas
Sponsors
Leads: Merit Medical Systems, Inc.