Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: embolization therapy.
- Who it may be relevant to
- Registry conditions: Osteoarthritis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
Overview
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
Interventions
- Drug embolization therapy
Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent
Primary outcome measures
- Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE [Time frame: From embolization to 6 months after embolization]
Secondary outcome measures (12)
- Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1 [Time frame: baseline and month 1]
- Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3 [Time frame: Baseline and Month 3]
- Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6 [Time frame: Baseline and Month 6]
- Change From Baseline in Swollen Joints Counts at Month 1 [Time frame: Baseline and Month 1]
- Change From Baseline in Swollen Joints Counts at Month 3 [Time frame: Baseline and Month 3]
- Change From Baseline in Swollen Joints Counts at Month 6 [Time frame: Baseline and Month 6]
- Change From Baseline in Tender Joints Counts at Month 1 [Time frame: Baseline and Month 1]
- Change From Baseline in Tender Joints Counts at Month 3 [Time frame: Baseline and Month 3]
- Change From Baseline in Tender Joints Counts at Month 6 [Time frame: Baseline and Month 6]
- Change From Baseline in Cochin Hand Function Index score at Month 1 [Time frame: From Baseline and Month 1]
- Change From Baseline in Cochin Hand Function Index score at Month 3 [Time frame: From Baseline and Month 3]
- Change From Baseline in Cochin Hand Function Index score at Month 6 [Time frame: From Baseline and Month 6]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Grenoble Alpes - Sud site — Échirolles
Identifiers
NCT: NCT06611007 · 38RC23.0227 · 2024-513361-40-00