Actively Recruiting
Geniculate Artery Embolization for Osteoarthritis
Led by University of Minnesota · Updated on 2026-02-10
20
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Geniculate Artery Embolization for Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 40 - 70 years of age.
- Unilaterally dominant symptomatic osteoarthritis, with bilateral radiographic OA allowed.
- Symptoms have not improved after at least 3 months of medical and/or rehabilitation treatments.
- Kellgren-Lawrence grade 1, 2, or 3 on knee X-ray.
- Willing to undergo non-contrast MRI during screening and at 12 months.
- Willing to attend regular follow-ups during the 12-month study period.
- Not currently considered for partial or total knee replacement surgery.
- WOMAC score of 6 or higher in at least 2 categories.
You will not qualify if you...
- Body mass index (BMI) greater than 35 kg/m2.
- Advanced peripheral arterial disease with ankle-brachial index (ABI) of 0.9 or less.
- Known significant peripheral arterial disease preventing femoral catheterization.
- Regular tobacco smoking within the last year.
- Diabetes with hemoglobin A1C over 9%.
- Previous lower extremity embolization.
- Uncontrolled emotional disorders.
- Chronic pain syndrome or under a pain management contract.
- Anatomical variations increasing risk of non-target embolization.
- Renal insufficiency with estimated glomerular filtration rate (GFR) below 45 ml/min and not on dialysis.
- Abnormal blood clotting (INR over 1.5).
- Platelet count below 50x10^9/L.
- On anticoagulation medications that cannot be safely stopped for the procedure and 7 days after.
- Severe iodine allergy that cannot be pre-treated.
- Pregnant or planning pregnancy within 6 months.
- Contraindications to sedation drugs used in the procedure.
- Life expectancy less than 60 months.
- Participation in other conflicting clinical investigations.
- Contraindications to medical or physical treatments for OA.
- Advanced atherosclerosis.
- Current or previous lower extremity fistula.
- Rheumatoid arthritis or seronegative arthropathies.
- WOMAC pain score less than 6.
- Steroid injection in the affected joint within 3 months of screening or deemed ineligible by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
R
Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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