Evaluating Lipiodol Embolization for Hand Osteoarthritis Pain Relief
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
This study is testing whether a procedure using Lipiodol can help relieve pain and improve hand function in people with osteoarthritis who haven't found relief from standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Échirolles) |
| Trial ID | NCT06611007 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of arterial embolization using Lipiodol® in patients suffering from symptomatic hand osteoarthritis that has not responded to conventional treatments. Participants will undergo the embolization procedure and will be monitored over a six-month period for pain relief, hand function improvement, and any potential side effects. The study will also include imaging studies to evaluate changes in joint vascularization and damage. The primary focus is to determine the safety profile of Lipiodol® and its effectiveness in alleviating symptoms of osteoarthritis.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older with symptomatic hand osteoarthritis that has not adequately responded to standard treatments.
Not a fit: Patients with a history of allergy to iodinated contrast media or those with severe vascular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved hand function for patients with refractory hand osteoarthritis.
How similar studies have performed: While the approach of using embolization for osteoarthritis is relatively novel, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Échirolles
- CHU Grenoble Alpes - Sud site — Échirolles, France (Recruiting)
Study contacts
- Principal investigator: Xavier Romand, MD, PhD — CHU Grenoble Alpes, site Sud, France
- Study coordinator: Xavier Romand, MD, PhD
- Email: xromand@chu-grenoble.fr
- Phone: 0476767223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.