Clinical trial NCT05818150: GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: genicular artery embolization
GAE
knee embolization
knee OA
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 264
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Eligibility 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.

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: 6 months
measure: Primary Safety Endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Subjects achieving Clinical Success
timeFrame: 3, 12, and 24 months
measure: Numerical rating scale (NRS)
timeFrame: baseline, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington, D.C.
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: St Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Galloway
country: United States
facility: Atlantic Medical Imaging
state: New Jersey
city: Newark
country: United States
facility: Rutgers Health
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Williamsville
country: United States
facility: Atlas Interventional
state: New York
city: Raleigh
country: United States
facility: Prostate Centers USA
state: North Carolina
city: Sanford
country: United States
facility: Sunrise Vascular Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Cardiovascular Health Clinic
state: Oklahoma
city: Falls Church
country: United States
facility: Prostate Centers USA
state: Virginia
city: Leesburg
country: United States
facility: Prostate Centers USA
state: Virginia
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Passo Fundo
country: Brazil
facility: Hospital de Clínicas de Passo Fundo
city: São Paulo
country: Brazil
facility: University of Sao Paulo
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Takapuna
country: New Zealand
facility: North Shore Hospital/ Te Whatu Ora - Waitemata
city: Bournemouth
country: United Kingdom
facility: University Hospitals Dorset
city: Cwmbran
country: United Kingdom
facility: Grange University Hospital
Study officials:
affiliation: Prostate Centers, USA
name: Sandeep Bagla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anderson Orthopedic Clinic
name: Craig J McAsey, MD
role: PRINCIPAL_INVESTIGATOR
References: