Status:
RECRUITING
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief 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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06611007
Start Date
January 30 2025
End Date
July 15 2028
Last Update
February 3 2025
Active Locations (1)
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1
CHU Grenoble Alpes - Sud site
Échirolles, France, 38130