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Corticosteroid

SakuraBead Embolization for Osteoarthritis (SURE Trial)

N/A
Recruiting
Research Sponsored by CrannMed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 40 years and < 80 years
Moderate to severe knee pain (WOMAC Pain ≥ 10)
Must not have
History of uncorrectable coagulopathy
Severe knee OA (Kellgren-Lawrence grade 4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 3 months and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing the effectiveness of SakuraBead genicular artery embolization (GAE) to corticosteroid injection in treating a specific condition.

Who is the study for?
This trial is for adults aged 40-80 with knee osteoarthritis (OA) who haven't found relief from pain after at least 3 months of anti-inflammatory drugs, physical therapy, or injections. Participants must be able to give consent and attend all treatments and follow-ups. They need confirmed OA evidence via specific angiographic patterns in the knee.
What is being tested?
The study compares SakuraBead genicular artery embolization (GAE), a procedure that blocks certain blood vessels in the knee to reduce pain and inflammation, against corticosteroid injections which are commonly used for OA pain relief.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, allergic reactions to materials used during GAE or corticosteroids, temporary increase in joint pain following treatment, and rare complications related to embolization such as non-target embolization.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 79 years old.
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I experience moderate to severe knee pain.
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I have been diagnosed with knee osteoarthritis.
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My knee X-ray shows mild to moderate arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a blood clotting disorder that cannot be corrected.
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I have severe knee arthritis.
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My affected joint is currently infected.
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My other knee's pain level is more than 3 on a scale.
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I have a recent injury or issue with my knee.
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I have had a knee replacement surgery on the knee in question.
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I have been diagnosed with advanced hardening of the arteries.
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I have been diagnosed with rheumatoid or autoimmune arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint - Proportion of Responders
Primary Safety Endpoint - Freedom from treatment-related SAEs
Secondary study objectives
Change in Numeric Rating Scale (NRS)
Change in mean WOMAC Pain
Proportion of Responders at 1 Month and 3 Month

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Genicular Artery Embolization (GAE)Experimental Treatment1 Intervention
Temporary Embolization of Genicular Arteries using Resorbable Microspheres
Group II: Corticosteroid InjectionActive Control1 Intervention
Corticosteroid injection in the knee

Find a Location

Who is running the clinical trial?

CrannMedLead Sponsor
~59 spots leftby Oct 2025
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