← Back to Search

Embolization Agent

Embolization with Embosphere Microspheres for Knee Osteoarthritis Pain

N/A

Recruiting

Research Sponsored by Shivank Bhatia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

WOMAC score >30

Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of: Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.

Must not have

Local infection of the target knee(s)

Active malignancy other than non-melanomatous skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks (post embolization surgery)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a permanent embolic for treating knee osteoarthritis by blockage of the geniculate artery.

Who is the study for?

This trial is for adults aged 40-80 with moderate to severe knee osteoarthritis who haven't improved after at least 12 weeks of standard treatments like NSAIDs, steroid injections, or physical therapy. Participants must have synovitis, be able to undergo an MRI, and not have advanced arthritis (Kellgren-Lawrence grade >3), prior knee replacement, certain health conditions that affect embolization procedures, allergies to contrast agents without prophylaxis options, active cancers (except skin cancer), local infections in the knee area or a sensitivity to gelatin.

What is being tested?

The study tests Embosphere Microspheres used in geniculate artery embolization as a treatment for pain from moderate to severe knee osteoarthritis. The goal is to see how effective and safe this permanent blockage procedure is compared to other treatments.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions due to materials used during the procedure such as iodinated contrast agents or gelatin products within the microspheres. There might also be risks associated with catheter-based interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My knee or hip pain is severe, based on a score above 30.

Select...

I have tried treatments like painkillers, injections, or physical therapy for my knee arthritis for at least 12 weeks without improvement.

Select...

I have pain in the front area of my knee.

Select...

I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My target knee is infected.

Select...

I have a cancer diagnosis that is not non-melanoma skin cancer.

Select...

I am pregnant, breastfeeding, or planning to become pregnant soon.

Select...

I have had knee replacement surgery.

Select...

I have a condition that prevents me from undergoing procedures involving catheters or embolization.

Select...

I have rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks (post embolization surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks (post embolization surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks (post embolization surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in knee pain as assessed by the WOMAC

Incidence of treatment related adverse events

Secondary study objectives

Change in knee pain

Change in knee pain as assessed by VAS

Incidence of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Embosphere Microspheres groupExperimental Treatment1 Intervention

Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.

0 / 10Eligibility criteria met