Evaluating Lipiodol Embolization for Hand Osteoarthritis Pain Relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of arterial embolization using Lipiodol® in patients suffering from symptomatic hand osteoarthritis that has not responded to conventional treatments. Participants will undergo the embolization procedure and will be monitored over a six-month period for pain relief, hand function improvement, and any potential side effects. The study will also include imaging studies to evaluate changes in joint vascularization and damage. The primary focus is to determine the safety profile of Lipiodol® and its effectiveness in alleviating symptoms of osteoarthritis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged ≥ 40 years.
* Osteoarthritis of the hand according to American College of Rheumatology criteria 1990
* Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with a radiological Kellgren-Lawrence stage ≥ 2.
* Symptomatic osteoarthritis within the last 3 months.
* Visual analogue pain scale of the hand to be treated ≥ 40/100 mm (most painful hand).
* Inadequate response, adverse effects and/or contraindication to NSAIDs and non-opioid analgesics.
* Patient affiliated to french social security or a similar health assurance.

Exclusion Criteria:

* History of allergy to iodinated contrast media, LipiodolⓇ or poppies.
* Vasomotor disorders (Raynaud\'s syndrome, scleroderma, acrocyanosis).
* Stenosis (\>50%) or known atheromatous arterial occlusion of the upper limbs.
* Obliterative arterial disease of the lower limbs at the critical ischaemia stage.
* Severe to end-stage chronic renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m2), dialysis or renal transplant.
* Arteritis such as thromboangiitis obliterans disease or other diseases
* Previous thrombosis/dissection of the radial artery.
* Chronic inflammatory rheumatic disease (rheumatoid arthritis, psoriatic arthritis, microcrystalline arthritis, etc.).
* Known hyperthyroidism or large multinodular goiter.
* Traumatic lesions, haemorrhages or chronic bleeding in the hand (not completely resolved within 3 months of the start of the lesion) requiring embolisation.
* Pregnant or breast-feeding.
* Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code and/or who do not speak French.
* Patients in a period of exclusion or in the course of another interventional clinical trial.

Where it's running

• CHU Grenoble Alpes - Sud site
  Échirolles, France Recruiting

Study contacts

• Principal investigator: Xavier Romand, MD, PhD — CHU Grenoble Alpes, site Sud, France
• Study coordinator: Xavier Romand, MD, PhD
• Email: xromand@chu-grenoble.fr
• Phone: 0476767223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.