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
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.
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.
Single group
embolization therapy
DrugHand arterial embolization with Lipiodol in emulsion with iodinated contrast agent
Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
The primary endpoint is the number and frequency of embolisation-related adverse events throughout the study period (6 months). Each adverse event will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to grade 5 (fatal).
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 1. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 3. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 1. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Change From Baseline in Swollen Joints Counts at Month 1
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
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