SakuraBead Embolization for Osteoarthritis
(SURE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves treatments for knee osteoarthritis, it's best to discuss your current medications with the trial team to ensure there are no conflicts.
What data supports the effectiveness of the treatment SakuraBead Embolization for Osteoarthritis?
Is SakuraBead Embolization for Osteoarthritis safe for humans?
Corticosteroid injections, which are similar to SakuraBead treatments, have been shown to have some side effects, especially in women, such as abnormal menstruation and facial flushing. In a study of 1000 patients, 1% experienced severe complications like bone damage, with women being more affected. Overall, these treatments are generally considered safe, but there are risks to be aware of.34678
How does the corticosteroid injection treatment for osteoarthritis differ from other treatments?
Corticosteroid injections for osteoarthritis are unique because they are administered directly into the joint, providing rapid relief from inflammation and pain. This method is well-established and can be repeated safely, unlike some other treatments that may not offer the same direct and immediate effect.134910
What is the purpose of this trial?
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either SakuraBead genicular artery embolization or corticosteroid injection for knee osteoarthritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Corticosteroid Injection
- SakuraBead Resorbable Microspheres
Corticosteroid Injection is already approved in European Union, United States, Canada for the following indications:
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
CrannMed
Lead Sponsor