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

Recruiting now · Phase 1/Phase 2

Conditions studied: Osteoarthritis

In brief

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 assess changes in joint vascularisation and damage

Key facts

Study ID

NCT06611007

Run by

University Hospital, Grenoble

People needed

15

Starts

2025-01-30

Expected to finish

2028-07-15

Last updated by the study team

2026-05-05

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• CHU Grenoble Alpes - Sud site — Échirolles, France (enrolling)

Full record on ClinicalTrials.gov

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