SakuraBead Embolization for Osteoarthritis

(SURE Trial)

Recruiting at 7 trial locations

Overseen By Chief Operations Officer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CrannMed

Disqualifiers: Severe knee OA, Autoimmune arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

89 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

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. ^{1 3 4 9 10}

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.

Exclusion Criteria

I have a blood clotting disorder that cannot be corrected.

I have severe knee arthritis.

My affected joint is currently infected.

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

Group I: Genicular Artery Embolization (GAE) Experimental Treatment 1 Intervention

Temporary Embolization of Genicular Arteries using Resorbable Microspheres

Group II: Corticosteroid Injection Active Control 1 Intervention

Corticosteroid injection in the knee

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

Approved in European Union as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in United States as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in Canada as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? Günaydin, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. Douglas, RJ.[2012]

In a study involving 68 patients with knee osteoarthritis, long-term intraarticular steroid injections (triamcinolone acetonide) were found to be safe, showing no negative impact on joint structure over 2 years.

The steroid injections provided significant symptom relief, particularly in knee pain and stiffness, compared to saline injections, especially noted at the 1-year mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial. Raynauld, JP., Buckland-Wright, C., Ward, R., et al.[2023]

In a study of 199 participants with knee osteoarthritis, tenderness around the knee was linked to a better short-term response to intraarticular steroid injections, with 73.4% showing improvement within 2 weeks.

However, factors like chronic widespread pain and higher depression scores were associated with a lower likelihood of achieving long-term benefits from the treatment, indicating that psychological and broader pain conditions can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Clinical Correlates of Knee Osteoarthritis Predict Outcome of Intraarticular Steroid Injections? Maricar, N., Parkes, MJ., Callaghan, MJ., et al.[2023]

Corticosteroid injections, commonly used to reduce inflammation when other treatments fail, can have low incidence but notable sex-related side effects in female patients, including abnormal menstruation and lactation disturbances.

Orthopedic physicians should be aware of these specific side effects and communicate them to female patients during the informed consent process to ensure they are fully informed about potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid Injections: A Review of Sex-Related Side Effects. Brook, EM., Hu, CH., Kingston, KA., et al.[2022]

In a study of 1000 patients receiving intraarticular corticosteroid injections for hip and knee osteoarthritis, only 1% experienced severe complications, indicating a lower complication rate than previously reported in smaller studies.

The study found that women were disproportionately affected, accounting for 90% of the severe complications, which included osteonecrosis and insufficiency fractures, suggesting a need for further investigation into gender differences in response to these injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular Steroid Injection in Hip and Knee with Fluoroscopic Guidance: Reassessing Safety. Graf, DN., Thallinger, A., Zubler, V., et al.[2022]

In a study of 3,822 patients with or at risk of knee osteoarthritis, those who received corticosteroid injections had a significantly higher risk of needing knee arthroplasty, with 31.3% undergoing surgery compared to only 5.0% of those who did not receive injections.

Each corticosteroid injection increased the absolute risk of knee arthroplasty by 9.4% over nine years, suggesting that these injections may harm the joint and accelerate the progression of osteoarthritis, leading to a recommendation for more conservative treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. Wijn, SRW., Rovers, MM., van Tienen, TG., et al.[2020]

Joint aspiration and injection are crucial for diagnosing and treating joint diseases, particularly in the knee, where synovial fluid can be obtained to diagnose conditions like septic and crystal arthritis.

Intra-articular injection of long-acting corticosteroids is effective for rapidly reducing inflammation in joints, is generally safe when performed with sterile techniques, and requires only basic anatomical knowledge, making it a common practice in rheumatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Joint aspiration and injection. Courtney, P., Doherty, M.[2015]

In a study involving 12 patients with persistent buttock pain due to sacroiliitis, MR-guided corticosteroid injections into the sacroiliac joints led to significant clinical improvement, with a mean pain-free period of 9.6 months.

The dolorimetry scale showed a reduction in pain from an average of 7.6 to 2.9 after three months, allowing some patients to discontinue or reduce their use of nonsteroidal anti-inflammatory drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. Pereira, PL., Günaydin, I., Duda, SH., et al.[2013]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? [2018]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. India pubmed.ncbi.nlm.nih.gov

Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Do Clinical Correlates of Knee Osteoarthritis Predict Outcome of Intraarticular Steroid Injections? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid Injections: A Review of Sex-Related Side Effects. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intraarticular Steroid Injection in Hip and Knee with Fluoroscopic Guidance: Reassessing Safety. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Joint aspiration and injection. [2015]

10. France pubmed.ncbi.nlm.nih.gov

[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. [2013]