Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05818150
Registration number
NCT05818150
Ethics application status
Date submitted
5/04/2023
Date registered
18/04/2023
Date last updated
6/04/2025
Titles & IDs
Public title
GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
GAE-P3-22-01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MOTION
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - Embosphere Microspheres
Treatment: Drugs - Corticosteroid injection
Experimental: Genicular artery embolization with Embosphere Microspheres - Device: Embosphere Microspheres
Embolic Agent: Embosphere Microspheres
Active comparator: Corticosteroid Injection of the knee - Drug: Corticosteroid injection
Treatment: Devices: Embosphere Microspheres
Embolic Agent: Embosphere Microspheres
Treatment: Drugs: Corticosteroid injection
Corticosteroid injection
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Primary Efficacy Endpoint
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
6 months
Query!
Primary outcome [2]
0
0
Primary Safety Endpoint
Query!
Assessment method [2]
0
0
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
Query!
Timepoint [2]
0
0
6 months
Query!
Secondary outcome [1]
0
0
Subjects achieving Clinical Success
Query!
Assessment method [1]
0
0
Number of subjects achieving Clinical Success
Query!
Timepoint [1]
0
0
3, 12, and 24 months
Query!
Secondary outcome [2]
0
0
Numerical rating scale (NRS)
Query!
Assessment method [2]
0
0
Pain score assessed using numerical rating scale (NRS)
Query!
Timepoint [2]
0
0
baseline, 3, 6, 12 and 24 months
Query!
Eligibility
Key inclusion criteria
Key
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
Query!
Minimum age
21
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/01/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/10/2027
Query!
Actual
Query!
Sample size
Target
264
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment postcode(s) [1]
0
0
- Liverpool
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
District of Columbia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Georgia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Missouri
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Virginia
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Passo Fundo
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
São Paulo
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
British Columbia
Query!
Country [14]
0
0
New Zealand
Query!
State/province [14]
0
0
Takapuna
Query!
Country [15]
0
0
United Kingdom
Query!
State/province [15]
0
0
Bournemouth
Query!
Country [16]
0
0
United Kingdom
Query!
State/province [16]
0
0
Cwmbran
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merit Medical Systems, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05818150
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Sandeep Bagla, MD
Query!
Address
0
0
Prostate Centers, USA
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Vanessa Therrien
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1 (385) 766-9151
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05818150
Download to PDF