GAE with Embosphere Microspheres for Knee Osteoarthritis

(MOTION Trial)

Not currently recruiting at 42 trial locations

Overseen By Ahsun Riaz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Merit Medical Systems, Inc.

Disqualifiers: Advanced atherosclerosis, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine which better eases knee pain from osteoarthritis, a condition causing pain and stiffness. One group receives a corticosteroid injection, commonly used to reduce inflammation and pain. The other group receives a newer treatment called genicular artery embolization (GAE) with Embosphere Microspheres, which aims to reduce pain by blocking blood flow to specific areas of the knee. Participants should have experienced knee pain that hasn't improved with other treatments for at least three months. The trial will evaluate which treatment works better over two years. As an unphased trial, it offers patients the opportunity to explore innovative treatments that may provide relief when other options have failed.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Embosphere Microspheres are safe for treating knee osteoarthritis. Studies indicate that patients tolerate them well during genicular artery embolization, a procedure that blocks certain blood vessels. Over two years, patients have reported only minor side effects, suggesting this is a reliable option for managing knee pain.

Corticosteroid injections are already a common treatment for knee pain relief. They are generally safe, though some people might experience temporary side effects like swelling or discomfort at the injection site. Both treatments in this trial have demonstrated good safety records in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about genicular artery embolization with Embosphere Microspheres for knee osteoarthritis because this approach offers a novel way to manage pain and inflammation. Unlike traditional treatments such as oral pain relievers or corticosteroid injections that typically focus on reducing inflammation throughout the body, this method targets the blood vessels supplying the knee. By blocking these vessels, the treatment can potentially decrease inflammation and pain directly at the source, leading to more effective relief. This targeted approach could mean fewer side effects and longer-lasting results compared to current options.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that Embosphere Microspheres, a treatment in this trial, could be a promising option for knee osteoarthritis. Studies have found that patients who underwent genicular artery embolization (GAE) with these microspheres experienced significant and lasting relief from knee pain, with positive results lasting up to two years. This treatment works by blocking small blood vessels in the knee, reducing inflammation and pain. Another treatment arm in this trial involves corticosteroid injections, which can also provide temporary relief by reducing inflammation. ^{1 2 3 5 6}

Who Is on the Research Team?

Sandeep Bagla, MD

Principal Investigator

Prostate Centers, USA

Craig J McAsey, MD

Principal Investigator

Anderson Orthopedic Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 21 with knee osteoarthritis who still have pain (score of ≥4 out of 10) despite trying other treatments for at least 3 months. It's not suitable for those planning major surgeries within a month, with advanced artery disease, previous knee replacement on the affected knee, or arthritis due to rheumatoid or infection.

Inclusion Criteria

I am 21 years old or older.

My pain hasn't improved with treatment for over 3 months.

Provides written informed consent

Exclusion Criteria

I have a history of rheumatoid or infectious arthritis.

I have advanced hardening of the arteries.

I have had a knee replacement surgery on the knee in question.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either genicular artery embolization using Embosphere Microspheres 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

Follow-up assessments at 3, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid injection
• EmboSphere Microspheres

Trial Overview The study compares two treatments for knee osteoarthritis: genicular artery embolization (GAE) using Embosphere Microspheres and steroid injections. Participants will be randomly assigned to one treatment and followed up for two years to see which is more effective.

How Is the Trial Designed?

Group I: Genicular artery embolization with Embosphere Microspheres Experimental Treatment 1 Intervention

Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres

Group II: Corticosteroid Injection of the knee Active Control 1 Intervention

Drug: Corticosteroid injection

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

Approved in United States as Corticosteroids for:

• Allergic reactions
• Asthma
• COPD
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendonitis
• Skin conditions
• Eye conditions
• Gastrointestinal disorders

Approved in European Union as Corticosteroids for:

• Allergic reactions
• Asthma
• COPD
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendonitis
• Skin conditions
• Eye conditions
• Gastrointestinal disorders

Approved in Canada as Corticosteroids for:

• Allergic reactions
• Asthma
• COPD
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendonitis
• Skin conditions
• Eye conditions
• Gastrointestinal disorders

Who Is Running the Clinical Trial?

Merit Medical Systems, Inc.

Lead Sponsor

Trials

35

Recruited

3,500+

Published Research Related to This Trial

Intra-articular injections of triamcinalone acetonide, a common glucocorticoid, can lead to cutaneous hypopigmentation, which is a rare but notable side effect.

This case highlights a unique pattern of hypopigmentation with a linear ray distribution, suggesting that the glucocorticoid may spread through lymphatic channels after injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear rays of hypopigmentation following intra-articular corticosteroid injection for post-traumatic degenerative joint disease. Schwartz, C., Javvaji, S., Feinberg, JS.[2013]

In a study of 20 patients with rheumatoid arthritis, post-injection rest did not significantly affect the resorption of the glucocorticoid triamcinolone hexacetonide (THA) after intra-articular administration, as serum levels peaked similarly in both resting and active groups.

Both resting and mobile patients experienced short-term decreases in serum cortisol and ACTH levels, indicating a temporary suppression of the hypothalamic-pituitary-adrenal axis, but this effect was not influenced by the level of activity after the injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucocorticoid resorption and influence on the hypothalamic-pituitary-adrenal axis after intra-articular treatment of the knee in resting and mobile patients. Weitoft, T., Rönnblom, L.[2018]

In a double-blind study involving 30 patients with rheumatoid arthritis, all three intra-articular steroid preparations (prednisolone t-butyl acetate, methyl prednisolone acetate, and triamcinolone hexacetonide) showed thermographic improvement in knee synovitis, with triamcinolone demonstrating the greatest and longest-lasting effect.

Despite the local improvements in knee symptoms, no significant overall systemic improvement was observed after a single injection of any steroid, although all three preparations suppressed the body's natural cortisol production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Bird, HA., Ring, EF., Bacon, PA.[2022]

A single intra-articular injection of triamcinolone acetonide extended-release (TA-ER) showed prolonged presence in the joint compared to the standard crystalline suspension, indicating its potential for sustained therapeutic effects in knee osteoarthritis.

The study found that while TA-ER and the crystalline form had similar mild effects on cartilage, the transient nature of these effects suggests that TA-ER's benefits may be more pronounced in diseased joints rather than in healthy ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Effects Following Single and Repeat Intra-Articular Injections of Triamcinolone Acetonide Extended-Release: Results from Three Nonclinical Toxicity Studies in Dogs. Bodick, N., Williamson, T., Strand, V., et al.[2020]

Intra-articular glucocorticosteroid injections, particularly with triamcinolone hexacetonide, can effectively reduce joint inflammation in conditions like rheumatoid arthritis and osteoarthritis, providing rapid relief with minimal systemic side effects.

However, these injections should be administered cautiously by experienced clinicians due to risks such as local tissue necrosis and potential cartilage damage, with recommendations to limit injections to no more than three or four per year in the same joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intra-articular glucocorticoid injections in joint diseases]. Ostergaard, M., Halberg, P.[2017]

In a study involving 7 patients with osteoarthritis, both prednisolone tebuate and triamcinolone hexacetonide were injected into knee joints, revealing that most patients experienced an increase in synovial fluid leukocyte counts, indicating some inflammatory response.

Electron microscopy (EM) successfully identified corticosteroid crystals in the joint fluid 24 hours and 1 week post-injection, providing a valuable method for distinguishing these crystals from others, which could enhance the understanding of corticosteroid behavior in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electron microscopic study of depot corticosteroid crystals with clinical studies after intra-articular injection. Gordon, GV., Schumacher, HR.[2013]

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]

The extended-release formulation of triamcinolone acetonide (FX006) provided prolonged synovial fluid residency in knee osteoarthritis patients, maintaining therapeutic levels for up to 12 weeks, compared to the crystalline suspension (TAcs) which had minimal presence by Week 6.

FX006 resulted in lower peak plasma levels of the drug, reducing systemic exposure and potential side effects, while both formulations had similar safety profiles in terms of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synovial and systemic pharmacokinetics (PK) of triamcinolone acetonide (TA) following intra-articular (IA) injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis (OA). Kraus, VB., Conaghan, PG., Aazami, HA., et al.[2018]

In a study of 289 rheumatoid arthritis patients, intra-articular injection of triamcinolone hexacetonide showed significant improvement in pain, particularly in patients receiving injections in the elbow and metacarpophalangeal joints, as well as those with a functional class II status.

Long-term response predictors included being male, non-white, receiving polyarticular injections, and using a higher total dose of triamcinolone, indicating that specific demographic and treatment factors can influence the effectiveness of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intra-articular injections of triamcinolone hexacetonide in rheumatoid arthritis: short and long-term improvement predictors]. Furtado, RN., Machado, FS., Luz, KR., et al.[2017]

In a study of 79 children with juvenile chronic arthritis, triamcinolone injections were found to significantly improve the likelihood of remission compared to methylprednisolone, with results showing a strong statistical significance (p < 0.0005).

The length of remission was associated with the proportion of polymorphonuclear leucocytes in the synovial fluid, indicating that patients with lower levels of these cells experienced longer remissions, suggesting a potential biomarker for treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular glucocorticoids in early juvenile chronic arthritis. Honkanen, VE., Rautonen, JK., Pelkonen, PM.[2019]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0968016022002186

Two-year outcomes comparing Embosphere ... Embosphere Microspheres can be considered a safe and effective embolic agent for GAE for treating moderate to severe knee osteoarthritis with sustained outcomes ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36608360/

Two-year outcomes comparing Embosphere® ... This study compares the efficacy and safety of trisacryl gelatin microspheres to Imipenem/Cilastatin particles for GAE with 2 years of clinical follow-up.

3. thekneejournal.com thekneejournal.com/article/S0968-0160(22)00218-6/abstract

Two-year outcomes comparing Embosphere ... In this retrospective study, eight patients with knee osteoarthritis (11 knees) who underwent GAE with 100–300 μm trisacryl gelatin microspheres ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12428030/

Single-Session Bilateral Genicular Artery Embolization for ... Two-year outcomes comparing Embosphere® microspheres versus imipenem-cilastatin for genicular artery embolization in knee osteoarthritis. Knee.

5. trials.arthritis.org trials.arthritis.org/trials/NCT05112926

Effectiveness and Safety of Embosphere Microspheres for ... The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05112926?locStr=Miami,%20FL&country=United%20States&state=Florida&city=Miami&intr=Geniculate%20Artery%20Embolization&rank=1

Effectiveness and Safety of Embosphere Microspheres for ... The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the ...