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

Knee Osteoarthritis Clinical Trial

— MOTION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818150
• Other study ID #: GAE-P3-22-01
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: October 2027

Study information

• Verified date: March 2024
• Source: Merit Medical Systems, Inc.
• Contact: Vanessa Therrien
• Phone: 1 (385) 766-9151
• Email: vanessa.therrien[@]merit.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: October 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Embosphere Microspheres
Embolic Agent: Embosphere Microspheres

Drug:
• Corticosteroid injection
Corticosteroid injection

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Passo Fundo	Passo Fundo
Brazil	University of Sao Paulo	São Paulo
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	McGill University	Montréal	Quebec
Canada	Chu De Quebec-Universite Laval	Quebec City	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
United Kingdom	Grange University Hospital	Cwmbran
United Kingdom	University Hospitals Dorset	Poole
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Prostate Centers USA	Falls Church	Virginia
United States	Prostate Centers USA	Leesburg	Virginia
United States	ECCO Medical	Lone Tree	Colorado
United States	University of Miami	Miami	Florida
United States	El Camino Hospital	Mountain View	California
United States	Cornell University, New York Presbyterian	New York	New York
United States	Cardiovascular Health Clinic	Oklahoma City	Oklahoma
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Prostate Centers USA	Raleigh	North Carolina
United States	Prostate Centers USA	Reston	Virginia
United States	Saint Louis University	Saint Louis	Missouri
United States	Sunrise Vascular Center	Sanford	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	Primary Safety Endpoint	Freedom from treatment-related safety events through 30 days following the index procedure.	30 days post index procedure
Secondary	Subjects achieving Clinical Success	Number of subjects achieving Clinical Success	3, 12, and 24 months
Secondary	Numerical rating scale (NRS)	Pain score assessed using numerical rating scale (NRS)	baseline, 3, 6, 12 and 24 months