Embosphere Microspheres
DeviceEmbolic Agent: Embosphere Microspheres
Other names: Genicular artery embolization
NCT Number: NCT05818150
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.
This study is active but is not currently recruiting participants.
Notify Me21 year and older
All sexes
Interventional
Not applicable
Liverpool Hospital, Liverpool, Australia
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Embolic Agent: Embosphere Microspheres
Other names: Genicular artery embolization
Corticosteroid injection
Other names: Triamcinolone or methylprednisolone
Time frame: 6 months
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
Freedom from treatment-related safety events through 6 months (180 days) following the index procedure.
Time frame: 3, 12, and 24 months
Number of subjects achieving Clinical Success
Time frame: baseline, 3, 6, 12 and 24 months
Pain score assessed using numerical rating scale (NRS)
Merit Medical Systems, Inc.
Industry
Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study
Acronym: MOTION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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