Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
Recruiting · NCT06611007 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Grenoble
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
1 location listed.
- CHU Grenoble Alpes - Sud site - Échirolles, France