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Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment

RecruitingPhase 1, Phase 2Ages 40 Years - anyAllUniversity Hospital, Grenoble
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function. The main questions it aims to answer are: * What are the side effects and complications associated with the Lipiodol® arterial embolization procedure? * Does arterial embolization reduce pain intensity and improve hand function? Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will: * Undergo arterial embolization with Lipiodol® * Participate in regular follow-ups to monitor pain relief, hand function, and any side effects * Have imaging studies to

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📋 Eligibility rules (as published)
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.
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What it tests

  • embolization therapy
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Where

1 site
CHU Grenoble Alpes - Sud site
Échirolles, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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