Could blocking tiny leg arteries relieve knee arthritis pain?
NCT ID NCT04456569
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a procedure called geniculate artery embolization for people with mild to moderate knee osteoarthritis. The treatment blocks abnormal blood vessels in the knee to reduce pain and swelling. Twenty participants will be randomly assigned to either receive the procedure plus standard care (physical therapy and anti-inflammatory drugs) or standard care alone. The goal is to see if the procedure is safe and provides better symptom relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Between 40 - 70 years of age. * Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude). * Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months). * Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee * Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months. * Willing to comply with regular follow up during the 12 month follow-up period. * Not a current candidate for partial or total knee arthroplasty. * WOMAC Score \>=6 in at least 2 categories. Exclusion Criteria: * BMI \>35 kg/m2 * Advanced peripheral arterial disease (resting ABI \<= 0.9). * Known significant peripheral arterial disease precluding common femoral catheterization * Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year * Diabetics with hemoglobin A1C of \>9% * Previous lower extremity embolization * Uncontrolled emotional disorders per patient medical history * Chronic pain syndrome or currently under a pain contract. * Anatomic variants involving the lower extremities which would increase the risk of non-target embolization * Renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis. * Abnormal INR (\>1.5) * Platelet count \<50x109/L. * Currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure. * Known severe allergy to iodine which cannot be adequately pre-medicated * Pregnant or intend to become pregnant within 6 months of the procedure * Contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl * Life expectancy \<60 months * Currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial * Contraindications to medical and physical rehabilitative treatments of OA. * Advanced atherosclerosis. * Current or previous lower extremity fistula. * Rheumatoid arthritis or seronegative arthropathies. * WOMAC Pain Scale \< 6 * Steroid injection in the affected joint within 3 months of screening. I- n investigator assessment, patient is not a candidate for study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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