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

RECRUITINGPhase 1/2Sponsored by University Hospital, Grenoble
Actively Recruiting
PhasePhase 1/2
SponsorUniversity Hospital, Grenoble
Started2025-01-30
Est. completion2028-07-15
Eligibility
Age40 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 40 Years+Healthy volunteers accepted
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.

Conditions2

ArthritisOsteoarthritis

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