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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
30/08/2024

Titles & IDs
Public title
GAE Using Embosphere Microspheres Vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
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
Secondary ID [1] 0 0
GAE-P3-22-01
Universal Trial Number (UTN)
Trial acronym
MOTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Endpoint
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Primary Safety Endpoint
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Subjects achieving Clinical Success
Timepoint [1] 0 0
3, 12, and 24 months
Secondary outcome [2] 0 0
Numerical rating scale (NRS)
Timepoint [2] 0 0
baseline, 3, 6, 12 and 24 months

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
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Brazil
State/province [12] 0 0
Passo Fundo
Country [13] 0 0
Brazil
State/province [13] 0 0
São Paulo
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
New Zealand
State/province [15] 0 0
Takapuna
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Poole

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merit Medical Systems, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05818150
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandeep Bagla, MD
Address 0 0
Prostate Centers, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vanessa Therrien
Address 0 0
Country 0 0
Phone 0 0
1 (385) 766-9151
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05818150