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

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Embosphere Microspheres
Corticosteroid injection
Sponsored by
Merit Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring genicular artery embolization, GAE, knee embolization, knee OA

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • El Camino Hospital
  • ECCO Medical
  • University of Miami
  • Emory University School of Medicine
  • Northwestern University
  • Johns Hopkins Medicine
  • Saint Louis University
  • Cornell University, New York Presbyterian
  • Prostate Centers USA
  • Sunrise Vascular Center
  • Cardiovascular Health Clinic
  • University of Pittsburgh Medical Center
  • Prostate Centers USA
  • Prostate Centers USA
  • Prostate Centers USA
  • Hospital de Clínicas de Passo Fundo
  • University of Sao Paulo
  • Foothills Medical Centre
  • Vancouver General Hospital
  • McGill University
  • Chu De Quebec-Universite Laval
  • Grange University Hospital
  • University Hospitals Dorset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genicular artery embolization with Embosphere Microspheres

Corticosteroid Injection of the knee

Arm Description

Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres

Drug: Corticosteroid injection

Outcomes

Primary Outcome Measures

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.
Primary Safety Endpoint
Freedom from treatment-related safety events through 30 days following the index procedure.

Secondary Outcome Measures

Subjects achieving Clinical Success
Number of subjects achieving Clinical Success
Numerical rating scale (NRS)
Pain score assessed using numerical rating scale (NRS)

Full Information

First Posted
April 5, 2023
Last Updated
October 12, 2023
Sponsor
Merit Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05818150
Brief Title
GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA
Acronym
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merit Medical Systems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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 osteroarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
genicular artery embolization, GAE, knee embolization, knee OA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genicular artery embolization with Embosphere Microspheres
Arm Type
Experimental
Arm Description
Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres
Arm Title
Corticosteroid Injection of the knee
Arm Type
Active Comparator
Arm Description
Drug: Corticosteroid injection
Intervention Type
Device
Intervention Name(s)
Embosphere Microspheres
Other Intervention Name(s)
Genicular artery embolization
Intervention Description
Embolic Agent: Embosphere Microspheres
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Other Intervention Name(s)
Triamcinolone or methylprednisolone
Intervention Description
Corticosteroid injection
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint
Description
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.
Time Frame
6 months
Title
Primary Safety Endpoint
Description
Freedom from treatment-related safety events through 30 days following the index procedure.
Time Frame
30 days post index procedure
Secondary Outcome Measure Information:
Title
Subjects achieving Clinical Success
Description
Number of subjects achieving Clinical Success
Time Frame
3, 12, and 24 months
Title
Numerical rating scale (NRS)
Description
Pain score assessed using numerical rating scale (NRS)
Time Frame
baseline, 3, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Therrien
Phone
1 (385) 766-9151
Email
vanessa.therrien@merit.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Alwyn
Phone
1 (385) 766-9136
Email
rachel.alwyn@merit.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Bagla, MD
Organizational Affiliation
Prostate Centers, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig J McAsey, MD
Organizational Affiliation
Anderson Orthopedic Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Dolmatch, MD
Facility Name
ECCO Medical
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Nutting, DO
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivank Bhatia, MD
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John David Prologo, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahsun Riaz, MD
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gray Lyons, MD
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Pereira, MD
Facility Name
Cornell University, New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Holzwanger, MD
Facility Name
Prostate Centers USA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari Isaacson, MD
Facility Name
Sunrise Vascular Center
City
Sanford
State/Province
North Carolina
ZIP/Postal Code
27330
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sreejit Nair, MD
Facility Name
Cardiovascular Health Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blake Parsons, DO
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anish Ghodadra, MD
Facility Name
Prostate Centers USA
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22043
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Pavidapha, MD
Facility Name
Prostate Centers USA
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20191
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Bagla, MD
Facility Name
Prostate Centers USA
City
Reston
State/Province
Virginia
ZIP/Postal Code
20191
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Piechowiak, DO
Facility Name
Hospital de Clínicas de Passo Fundo
City
Passo Fundo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mateus Correa, MD
Facility Name
University of Sao Paulo
City
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Assis, MD
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wong, MD
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maziar Badii, MD
Facility Name
McGill University
City
Montréal
State/Province
Quebec
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Pelage, MD
First Name & Middle Initial & Last Name & Degree
Louis-Martin Boucher, MD
Facility Name
Chu De Quebec-Universite Laval
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Lamarre, MD
Facility Name
Grange University Hospital
City
Cwmbran
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimit Goyal, MD
Facility Name
University Hospitals Dorset
City
Poole
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Bent, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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