Clinical trial: Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1) (NCT04733092)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a
             knee osteoarthritis according to the American College of Rheumatology (ACR)
             classification and a score ≥ 2 according to the classification of Kellgren and
             Lawrence

          -  Patient not eligible for surgery (or refusing surgery)

          -  Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3
             months

          -  Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen,
             and/or failure or intolerance or patient refusing strong opioids medication (morphine,
             codeine)

          -  Failure or patient refusal of corticosteroid infiltration

          -  Patient who has signed an informed consent

        Exclusion Criteria:

          -  Patient who is unable or unable to comply with the follow-up schedule

          -  Infiltration of target joint less than three months old

          -  Treated hyperthyroidism

          -  Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint

          -  Known arterial disease of the lower limbs stage ≥ 2 according to the classification of
             Leriche and Fontaine

          -  Known severe allergy to Lipiodol® and/or iodized contrast product

          -  Known severe kidney failure (creatinine clearance < 30 ml/min)

          -  Pregnant or breastfeeding woman

          -  Patient not affiliated with a French Medicare

          -  Patient benefiting from legal protection

          -  Participation in another interventional research
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment