89 Participants Needed

SakuraBead Embolization for Osteoarthritis

(SURE Trial)

Recruiting at 7 trial locations
CO
Overseen ByChief Operations Officer
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CrannMed
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that corticosteroid injections can reduce pain and inflammation in knee osteoarthritis, providing relief for some patients. This suggests that the corticosteroid component of the SakuraBead treatment may help alleviate symptoms in osteoarthritis.12345

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

I am between 40 and 79 years old.
Able to comply with all treatments and follow-up visits
I experience moderate to severe knee pain.
See 4 more

Exclusion Criteria

I have a blood clotting disorder that cannot be corrected.
I have severe knee arthritis.
My affected joint is currently infected.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SakuraBead genicular artery embolization or corticosteroid injection for knee osteoarthritis

6 months
Multiple visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months
Regular follow-up visits

Treatment Details

Interventions

  • Corticosteroid Injection
  • SakuraBead Resorbable Microspheres
Trial Overview 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.
Participant Groups
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

Corticosteroid Injection is already approved in European Union, United States, Canada for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Corticosteroid injection for:
  • Acromioclavicular joint pain
  • Shoulder impingement syndrome
  • Rotator cuff disease
  • Adhesive capsulitis
  • Glenohumeral osteoarthritis
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Corticosteroid injection for:
  • Acromioclavicular joint pain
  • Shoulder impingement syndrome
  • Rotator cuff disease
  • Adhesive capsulitis
  • Glenohumeral osteoarthritis
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Corticosteroid injection for:
  • 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

Trials
2
Recruited
100+

Findings from Research

In a study involving 31 patients with spondylarthropathy, MR-guided corticosteroid injections into inflamed sacroiliac joints were found to be effective and safe, with no complications reported.
A second injection was beneficial for patients who did not respond to the first treatment, with 9 out of 15 showing improvement lasting an average of 16.1 months, indicating that repeated injections can provide additional relief.
Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial?Gรผnaydin, I., Pereira, PL., Fritz, J., et al.[2018]
Intra-articular corticosteroid injections for knee osteoarthritis showed a mild to moderate effect on pain severity lasting up to 3 months, which is longer than previously reported, based on a review of eight randomized controlled studies with follow-ups ranging from 1 to 26 weeks.
The risk of adverse effects from these injections was low, indicating that they are a relatively safe option for managing knee osteoarthritis pain.
The Magnitude and Duration of the Effect of Intra-articular Corticosteroid Injections on Pain Severity in Knee Osteoarthritis: A Systematic Review and Meta-Analysis.Saltychev, M., Mattie, R., McCormick, Z., et al.[2021]
Corticosteroid injections are the most common treatment for osteoarthritis in the knee, but there is still debate among practitioners about their effectiveness and the best corticosteroid to use.
No consensus has been reached on the optimal corticosteroid type, dosage, or injection frequency, suggesting that treatment should be personalized based on individual patient needs and responses.
Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency.Douglas, RJ.[2012]

References

Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? [2018]
The Magnitude and Duration of the Effect of Intra-articular Corticosteroid Injections on Pain Severity in Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2021]
Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. [2012]
Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial. [2023]
Do Clinical Correlates of Knee Osteoarthritis Predict Outcome of Intraarticular Steroid Injections? [2023]
Corticosteroid Injections: A Review of Sex-Related Side Effects. [2022]
Intraarticular Steroid Injection in Hip and Knee with Fluoroscopic Guidance: Reassessing Safety. [2022]
Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. [2020]
Joint aspiration and injection. [2015]
[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. [2013]
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