Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment

Официальное название

Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients

Обзор

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

Вмешательства

• Препарат embolization therapy
  Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent

Первичные конечные точки

• Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE [Срок оценки: From embolization to 6 months after embolization]

Вторичные конечные точки (12)

• Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1 [Срок оценки: baseline and month 1]
• Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3 [Срок оценки: Baseline and Month 3]
• Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6 [Срок оценки: Baseline and Month 6]
• Change From Baseline in Swollen Joints Counts at Month 1 [Срок оценки: Baseline and Month 1]
• Change From Baseline in Swollen Joints Counts at Month 3 [Срок оценки: Baseline and Month 3]
• Change From Baseline in Swollen Joints Counts at Month 6 [Срок оценки: Baseline and Month 6]
• Change From Baseline in Tender Joints Counts at Month 1 [Срок оценки: Baseline and Month 1]
• Change From Baseline in Tender Joints Counts at Month 3 [Срок оценки: Baseline and Month 3]
• Change From Baseline in Tender Joints Counts at Month 6 [Срок оценки: Baseline and Month 6]
• Change From Baseline in Cochin Hand Function Index score at Month 1 [Срок оценки: From Baseline and Month 1]
• Change From Baseline in Cochin Hand Function Index score at Month 3 [Срок оценки: From Baseline and Month 3]
• Change From Baseline in Cochin Hand Function Index score at Month 6 [Срок оценки: From Baseline and Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU Grenoble Alpes - Sud site — Échirolles

Идентификаторы

NCT: NCT06611007 · 38RC23.0227 · 2024-513361-40-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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