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Arterial Embolization

Genicular Artery Embolization for Knee Osteoarthritis

N/A

Recruiting

Led By Andrew C Picel, MD

Research Sponsored by Andrew Picel

Eligibility Criteria Checklist

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

Must have

Ineligibility or refusal of surgical management.

Ineligibility or refusal of surgical management

Must not have

Rheumatoid or infectious arthritis

Chronic renal insufficiency (serum creatinine >2 mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post gae

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a procedure to block abnormal blood vessels caused by knee arthritis is safe and effective in reducing knee pain.

Who is the study for?

This trial is for adults over 40 with moderate to severe knee pain due to osteoarthritis, who haven't found relief from anti-inflammatory meds, physical therapy, or injections. They should have certain MRI features of active synovitis and not be candidates for surgery. People with life-threatening allergies to iodine, recent major knee surgeries (except minor arthroscopic), serious coagulation issues, kidney problems or other types of arthritis are excluded.

What is being tested?

The trial tests the safety of genicular artery embolization (GAE) using HydroPearl® Microspheres in patients with osteoarthritic knee pain. GAE blocks abnormal blood vessels in the knee that contribute to arthritis pain. The study will follow participants for up to 24 months.

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may cause discomfort at the injection site, bruising or bleeding complications due to arterial blockage; allergic reactions including anaphylaxis could occur in those sensitive to materials used.

Eligibility Criteria

Inclusion Criteria

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

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I cannot or will not undergo surgery for my condition.

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I cannot or will not undergo surgery for my condition.

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I have pain in my knee when touched.

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I am 40 years old or older.

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I have received injections directly into a joint.

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I experience moderate to severe knee pain.

Exclusion Criteria

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

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I have rheumatoid or infectious arthritis.

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My kidney function is low (creatinine >2 mg/dL).

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I have an infection in my knee.

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I have had knee surgery, but not for arthroscopy or meniscus issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post gae

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post gae

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post gae for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients with treatment related adverse events

Secondary study objectives

Mean change from baseline knee function scores

Mean change from baseline pain scores

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: Genicular artery embolizationExperimental Treatment1 Intervention

Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

0 / 10Eligibility criteria met