GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)
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.
Study details:
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05818150
Intervention or treatment
DEVICE: Embosphere Microspheres
DRUG: Corticosteroid injection
Conditions
- Knee Osteoarthritis
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Liverpool Hospital
Select from list below to view details:
Liverpool Hospital
Liverpool, Australia
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Who is running the clinical trial?
Merit Medical Systems, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Genicular artery embolization with Embosphere Microspheres
| Device: Embosphere Microspheres |
ACTIVE_COMPARATOR: Corticosteroid Injection of the knee
| Drug: Corticosteroid injection |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Primary Safety Endpoint | Freedom from treatment-related safety events through 6 months (180 days) following the index procedure. | 6 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Subjects achieving Clinical Success | Number of subjects achieving Clinical Success | 3, 12, and 24 months |
| Numerical rating scale (NRS) | Pain score assessed using numerical rating scale (NRS) | baseline, 3, 6, 12 and 24 months |
References
Clinical Trials Gov: GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)Other trials to consider
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