RecruitingNot ApplicableNCT04456569

Geniculate Artery Embolization for Osteoarthritis

Geniculate Artery Embolization for Osteoarthritis: Pilot Study

Sponsor

University of Minnesota

Enrollment

20 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Arthritis Osteo Arthritis Knee Osteoarthritis Osteoarthritis, Knee

Summary

The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care. This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called geniculate artery embolization (GAE) — where small particles are injected into blood vessels feeding the knee to reduce inflammation — as a treatment for knee osteoarthritis (joint wear-and-tear) in patients who haven't responded to other treatments and aren't yet ready for knee replacement. **You may be eligible if:** - You are between 40 and 70 years old - You have knee osteoarthritis that causes significant pain in one knee - Standard treatments (anti-inflammatories, physical therapy, injections) haven't worked after at least 3 months - Your osteoarthritis is mild to moderate (grades 1-3 on X-ray) - You are not currently a candidate for knee replacement surgery **You may NOT be eligible if:** - Your BMI is above 35 - You have significant peripheral artery disease (poor circulation in the legs) - You have smoked in the last year - You have diabetes with poorly controlled blood sugar (HbA1c above 9%) - You have kidney insufficiency - You have chronic pain syndrome or are on a pain contract - You have had previous embolization procedures in the lower limbs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGeniculate Artery Embolization

All patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries. For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee.