No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for adults aged 40 to 80 with mild to moderate knee osteoarthritis. Participants will undergo a procedure to reduce knee pain and will have follow-up visits for about a year.
Are You a Good Fit for This Trial?
Rules you outSevere atherosclerosisLife expectancy less than 6 monthsInfectious arthritisAllergy to iodinated contrast
You may be able to join if
I am between 40 and 80 years old.
I have mild to moderate knee osteoarthritis.
I have pain of at least 5 out of 10.
I have not found relief from pain medications for at least 3 months.
I can understand and sign the consent form.
I can attend follow-up appointments.
I can follow the post-operative care instructions.
You may not be able to join if
I have rheumatoid arthritis.
I have kidney problems that prevent me from having angiography.
I have a bleeding disorder.
I have had knee surgery on the same knee.
I have an infection in my knee joint.
I have mild or severe osteoarthritis (Kellgren-Lawrence grade 1 or 4).
I have poor circulation that causes leg pain.
I am pregnant or planning to become pregnant within three months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching…
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.
Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.
At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.
The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 40-80 years
* Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
* Self-reported pain of at least 5/10 VAS questionnaire
* Failure of conservative therapy, such as pain medications, for at least 3 months
* Patient must understa…
Inclusion Criteria:
* Age 40-80 years
* Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
* Self-reported pain of at least 5/10 VAS questionnaire
* Failure of conservative therapy, such as pain medications, for at least 3 months
* Patient must understand and sign the informed consent
* Patient can comply with the proposed follow-up schedule
* Patient can follow the post-operative management
Exclusion Criteria:
* History of rheumatoid arthritis
* Renal insufficiency precluding angiography (GFR \< 50 mL/min)
* Irreversible coagulopathy
* Previous knee arthroplasty on the intended knee
* Existing knee joint infection
* Kellgren-Lawrence grade 1 or 4
* Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses
* Life expectancy \< 6 months
* Infectious arthritis
* Allergy to iodinated contrast resulting in anaphylaxis
* Pregnant or interested in becoming pregnant three months from the date of the GAE procedure
* Involved in litigation or worker's compensation claims
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