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Efficacy of embolization using ethyl esters of iodised fatty acids and ioversol in patients with painful joints (knee osteoarthritis, frozen shoulder, elbow tendinopathy)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people with painful joints that are part of musculoskeletal and connective tissue disorders, specifically those with knee osteoarthritis, adhesive capsulitis (frozen shoulder) or epicondylitis (elbow tendinopathy) that have not improved with usual medicines or injections and are not candidates for surgery. The treatment being tested is a minimally invasive procedure that blocks abnormal blood vessels in the joint using an ethiodized oil-based emulsion made from two injectable solutions, LIPIODOL ULTRA FLUIDE 480 mg/ml and OPTIRAY 300, which are delivered through a small catheter placed in the artery that supplies the affected joint.

The purpose of the study is to assess how well this embolization technique works to reduce pain and improve joint function over a three‑month period. Participants will have the procedure and then attend follow‑up visits at one, three, six and twelve months, during which they will complete simple questionnaires about pain and daily activities, such as the WOMAC for the knee, the QUICK-DASH for the shoulder and elbow, and a visual rating of pain called the VAS. Imaging of the joint with a scan called MRI will also be performed to look at any changes inside the joint.

The study schedule includes an initial screening, the embolization treatment, and a series of clinic visits where researchers will record pain levels, functional scores, any additional therapies used, and any side effects or complications that may occur. Data collected at each visit will be used to determine the overall success of the procedure and to monitor safety throughout the year following treatment.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After joining the study, you will undergo a baseline assessment that includes a review of your medical history, a physical examination of the painful joint, and completion of pain and disability questionnaires such as the WOMAC for the knee or the QUICK‑DASH for the shoulder or elbow.

    An MRI scan of the affected joint will be performed to document the condition before any treatment.

  2. Step 2

    Scheduling and preparation for the embolization procedure

    The study team will arrange a date for the embolization (TAME) procedure. You will receive instructions on any required preparations, such as arriving on time and informing the staff of any new medications or health changes.

  3. Step 3

    Arrival on procedure day and pre‑procedure checks

    On the day of the procedure, you will check in at the clinical facility. A nurse will verify your identity, confirm that you have fasted if required, and check vital signs.

    A physician will review the planned treatment, answer any remaining questions, and obtain your consent for the procedure.

  4. Step 4

    Embolization procedure – administration of medications

    A catheter will be inserted into an artery that supplies blood to the inflamed joint. Through this catheter, an ethiodized oil‑based emulsion will be injected.

    The emulsion consists of two injectable solutions:

    LIPIODOL ULTRA FLUIDE (ethyl esters of iodised fatty acids) – 6 ml injected intra‑arterially.

    OPTIRAY 300 (ioversol) – 2 ml injected intra‑arterially.

    Both solutions are given only once during the procedure. The injection is performed under imaging guidance to ensure the target vessels are correctly treated.

  5. Step 5

    Immediate technical success evaluation

    Immediately after the injection, the interventional radiologist will assess whether all target arteries have been successfully catheterized and embolized. This assessment determines the immediate technical success of the procedure.

  6. Step 6

    Post‑procedure monitoring and discharge

    You will be observed in a recovery area for a short period to monitor vital signs and watch for any immediate adverse events such as pain, bleeding, or allergic reactions.

    If the monitoring period is uneventful, you will be discharged home with written instructions for post‑procedure care and a schedule for follow‑up visits.

  7. Step 7

    First follow‑up visit at 1 month

    One month after the embolization, you will return for a clinical visit. The physician will evaluate joint pain, function, and any adverse events that may have occurred since the procedure.

    Questionnaires and a physical examination will be repeated, and any additional imaging will be ordered only if clinically indicated.

  8. Step 8

    Second follow‑up visit at 3 months (primary efficacy assessment)

    At three months, the primary effectiveness of the treatment is measured. You will complete the same pain and disability questionnaires as at baseline, and the physician will assess clinical success of the embolization.

    An MRI of the joint may be performed again to compare the synovitis and structural scores with the baseline scan.

    Your overall satisfaction with the procedure will be recorded.

  9. Step 9

    Third follow‑up visit at 6 months

    The six‑month visit repeats the clinical and imaging assessments performed at three months to track the durability of the treatment effect.

    Any new or ongoing adverse events, as well as changes in pain medication use, will be documented.

  10. Step 10

    Final follow‑up visit at 12 months

    The twelve‑month visit is the final assessment of the study. You will again complete the pain and function questionnaires, undergo a clinical examination, and have imaging if required.

    The physician will summarize the long‑term outcomes, including the overall rate of clinical success and any late adverse events.

Who can join the trial?

7 criteria

  • Be between 18 and 90 years old.
  • Have painful joints caused by knee osteoarthritis (wear‑and‑tear of the knee joint), adhesive capsulitis (frozen shoulder) (stiff, painful shoulder), or epicondylitis (elbow tendinopathy) that have not improved after at least three months of usual medicines or injections and are not suitable for surgery.
  • Agree to join the study by signing an informed consent form, which shows you understand what will happen.
  • If you are a woman who could become pregnant, you must have a negative beta‑hCG pregnancy test before the treatment.
  • Be covered by French social security (the national health insurance system).
  • Be able to understand spoken and written French language well enough to follow study instructions.
  • If you are a woman who could become pregnant, you must use a very effective method of contraception (birth control) from the screening visit until three months after the treatment.

Who cannot join the trial?

9 criteria

  • Currently taking medicines such as cyclosporine (a drug that lowers the activity of the immune system), tacrolimus (another immune‑suppressing medicine), cisplatin (a chemotherapy drug), vancomycin (an antibiotic used for serious infections), amphotericin B (an antifungal medication), or any aminoglycoside antibiotics (a group of strong antibiotics).
  • Having a treated case of hyperthyroidism (an overactive thyroid gland) or clear signs of thyrotoxicosis (too much thyroid hormone in the body).
  • Having a recent (within the last 7 days) injury, serious bleeding, or hemorrhage (bleeding inside the body) that could cause fluid to leak out of blood vessels (extravasation) or create a blockage in a vessel (embolism).
  • Having ever had a severe, immediate allergic reaction to an injection of Optiray®, Lipiodol®, any iodine‑based contrast dye, or the substances used to make those dyes (their excipient).
  • Having moderate to severe kidney failure, shown by a test called creatinine clearance that is less than 45 ml per minute (meaning the kidneys are not filtering waste well).
  • Being unable or unwilling to keep the required doctor visits and check‑ups after treatment (the follow‑up schedule).
  • Being part of a vulnerable group, such as a woman who is pregnant or breastfeeding, a person under legal guardianship or curatorship, or someone who is deprived of liberty.
  • Being currently enrolled in another clinical study and still in the waiting (exclusion) period required by that study.
  • Receiving AME (state medical aid or government‑provided health assistance).
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Investigated drugs

  • LIPIODOL ULTRA FLUIDE

    is a special oil that contains iodine and is made from poppyseed oil. In this study it is used as the oily part of a mixture that is injected into the artery that supplies a painful joint. The oil helps to block tiny blood vessels that are feeding the inflamed joint, which can reduce pain and swelling.

  • OPTIRAY 300

    is a clear liquid that contains iodine and is used as a contrast agent. It is mixed with the oil to create an emulsion that can be seen on X‑ray images. This lets the doctors watch the injection in real time and make sure the treatment is delivered to the right spot in the joint.

What is already known about the treatment

  • LIPIODOL ULTRA FLUIDE 480 mg/ml, solution injectable

    This medication is given by injection directly into an artery as a clear liquid. It is already approved and used as a contrast and embolic agent in medical imaging and procedures. In this trial it is used to block tiny blood vessels in painful joints, helping to lower inflammation and pain. It belongs to the class of ethiodized oil contrast agents that contain iodine‑rich fatty acids.

  • OPTIRAY 300 (300 mg I/mL), solution injectable en flacon

    This drug is also injected into an artery as a sterile solution. It is a widely accepted iodine‑based contrast medium used for X‑ray imaging of blood vessels. In the study it helps doctors see the joint’s blood supply while the ethiodized oil works, but its main role is to improve picture quality. It is classified as a non‑ionic iodinated contrast agent.

Investigated diseases

  • Knee osteoarthritis

    A chronic condition where the cartilage that cushions the ends of the thigh bone and shin bone wears away, leading to bone rubbing on bone. The joint may become stiff and swollen, and pain often worsens with activity. Over time the cartilage loss can enlarge bone spurs and further limit movement. The disease usually progresses slowly, with symptoms gradually increasing over years.

  • Adhesive capsulitis of the shoulder

    Also called frozen shoulder, this disorder involves thickening and tightening of the capsule surrounding the shoulder joint. It begins with shoulder pain that is most noticeable at night and with certain movements. As the capsule tightens, the range of motion becomes increasingly restricted. The condition typically follows a pattern of pain, stiffness, and then gradual loss of mobility over several months.

  • Lateral epicondylitis

    Commonly known as tennis elbow, it is an inflammation of the tendons that attach to the outer part of the elbow. Repetitive wrist and forearm motions cause microscopic tears and pain at the tendon origin. The pain may spread down the forearm and worsen with gripping or lifting. If the activity continues, the tendon can become increasingly weak and the discomfort may persist for many months.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526069-92-00Estimated enrolment120 patientsSponsorAssistance Publique Hopitaux De Paris

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