Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2

Официальное название

A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis

Обзор

Knee OsteoArthritis (KOA) is a common disease associated with pain and impaired function. Many patients are not relieved of their symptoms with enough efficacy by conservative treatments. Genicular Arteries Embolization (GAE) is a new minimally invasive endovascular treatment allowing symptoms relief. The investigator previously demonstrated the safety of GAE using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a first-in-man single-arm clinical trial called LipioJoint-1 (clinicaltrials.gov: NCT04733092; EUDRACT: 2020-002206-10). This phase 1 study also provided encouraging evidence of GAE efficacy on knee pain and function. The purpose of LipioJoint-2 study is to assess GAE efficacy using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a multicenter, prospective, randomized sham-controlled clinical trial.

Подробное описание

Patients will be screened during current practice consultation in each recruiting center (Screening Visit). When a patient will meet the eligibility criteria, he will be informed about the protocol.

The Interventional Radiologist will further explain the protocol to the patient and check inclusion/non-inclusion criteria during baseline visit. The date of signature of the informed consent by the patient will be considered as the date of inclusion. GAE (embolization) will be scheduled within the next few days.

Randomization will occur during the embolization visit, before patient is taken to the operating room. Randomization in a 2:1 ratio of GAE using emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score (2-3 versus 4). All target arteries will be injected with an ethiodized oil-based emulsion (GAE group). Patient will be kept blind to the actual treatment using headphones or virtual headset.

Follow-up visits will be scheduled 1, 3, 6 and 12 months after randomization. Patient will be informed about his randomisation group (GAE or sham) after the completion of questionnaires (VAS pain, WOMAC, EQ-5D, HAD) at the 3-month visit and will be allowed to choose further medical \& clinical management of his target KOA.

Вмешательства

• Препарат Ethiodized Oil-based emulsion
  Embolization of genicular arteries
• Процедура Sham-operation
  Mimicked catheterization and embolization of genicular arteries

Первичные конечные точки

• Change of pain assessed by a Visual Analogue Scale (VAS) at 3 months compared to randomization. [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Change of pain assessed by a Visual Analogue Scale (VAS) at 1 month compared to randomization. [Срок оценки: 1 month]
• Change of pain assessed by a Visual Analogue Scale (VAS) at 6 months compared to randomization. [Срок оценки: 6 months]
• Change of pain assessed by a Visual Analogue Scale (VAS) at 12 months compared to randomization. [Срок оценки: 12 months]
• Change of the patient's global assessment of her/his health measured by the Visual Analogue Scale of EQ-5D questionnaire (EQ VAS) at 1, 3, 6, 12 months compared to randomization. [Срок оценки: Up to 12 months]
• Change of the Western Ontario and McMaster Universities Arthritis (WOMAC) total and sub-scores (pain, function,stiffness) at 1, 3, 6, 12 months compared to randomization. [Срок оценки: Up to 12 months]
• Change of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores at 3 months compared to randomization. [Срок оценки: 3 months]
• Change of the Hospital Anxiety and Depression (HAD) score and sub-scores at 3 months compared to randomization. [Срок оценки: 3 months]
• Change of semi-quantitative MRI scoring at 6 months compared to randomization. [Срок оценки: 6 months]
• Description of pain medication at Month 1, 3, 6, 12. [Срок оценки: Up to 12 months]
• Description of non-pharmacological treatments for target knee in both groups at 1, 3, 6, and 12 months. [Срок оценки: Up to 12 months]
• Number of responder patients under OMERACT-OARSI definition in both groups at 3, 6 and 12 months. [Срок оценки: Up to 12 months]
• Number of patients reaching an acceptable symptom state (PASS) in both groups at 3, 6, and 12 months. [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (5)
• Radiographic Kellgren and Lawrence score ≥ 2 (6)
• VAS pain score ≥ 40 mm (scale 0-100 mm)
• Previous intra-articular injection in the target knee
• Patient not eligible to knee surgery
• For woman of childbearing potential: negative bêta-HCG before randomization
• Social security affiliation
• Signed informed consent
• Good understanding of the French language

Критерии исключения

• Intra-articular injection of any product in the target joint within 3 months before embolization
• Prior knee surgery other than ligament repair
• Any inflammatory joint disease other than osteoarthritis
• Any contra-indication to puncture of the ipsilateral femoral artery
• Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
• Ipsilateral symptomatic hip OA
• Treated hyperthyroidism
• Known severe allergy to Lipiodol® and/or iodine contrast medium
• Known moderate to severe kidney failure (creatinine clearance < 30 45 ml/min)
• Known right-to-left cardiac shunt or intra-tumoral vascular shunt
• Asthma attack in the 8 days before randomization
• Exploration or treatment with radioactive iodine scheduled within 1 month after randomization
• Symptomatic atheromatous lesion in the ipsilateral limb
• Patient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)
• Vulnerable populations (such as pregnant or breastfeeding women, patient under guardianship curatorship, deprived of liberty)
• Patient under exclusion period in another trial
• Patient on AME (state medical aid)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• Hôpital Saint Antoine - APHP — Paris
• Hôpital Cochin - APHP — Paris
• Hôpital européen Georges Pomidou - APHP — Paris

Идентификаторы

NCT: NCT06497140 · APHP230828 · PHRC-22-0033 · 2023-508844-24-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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