LIPIOJOINT-2 : A randomized sham-controlled, double blind, multicenter trial on the effect of Genicular Arteries Embolization in symptomatic knee osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- The primary endpoint is the change of the Visual Analogue Scale (VAS) pain score between randomization and 3 months (0–100 mm: 0 = No Pain, 100 = Worst Possible Pain).
研究概览
简要总结
Assess GAE efficacy using an ethiodized oil-based emulsion versus a sham procedure, by comparing the 3-months effect on knee pain in patients with symptomatic knee osteoarthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the personal of the Interventional Radiology department of HEGP (only unblinded center) will have the knowledge of the trial arm.
Patient will be blinded from randomization arm using headphones and/or virtual headset.
The research personnel will be trained accordingly and will keep a separate file with patient's images to ensure that they are not transferred on the Pacs system (Carestream).
The research assistant will discard the products after completion of the procedure in specific containers, that will not be accessible to the patient or to nurses and technicians directly involved in the current patient's care.
Patient's blindness will be assessed using a blinding index after GAE and at the 3-month follow-up visit. The proposed blinding index is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 40 – 90 years
- •· Previous intra-articular injection in the target knee
- •Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (4)
- •Radiographic Kellgren and Lawrence score ≥ 2 (5)
- •VAS pain score ≥ 40 mm (scale 0-100 mm)
- •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
排除标准
- •Intra-articular injection of any product in the target joint within 3 months before embolization
- •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)
- •Prior ipsilateral partial or total knee replacement
- •Any inflammatory joint disease other than osteoarthritis
- •Any contra-indication to puncture of the femoral artery
- •Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
- •Regular intake of painkillers (except topical administration) for a pathology other than osteoarthritis
- •Ipsilateral symptomatic hip OA
- •Treated hyperthyroidism
- •Known severe allergy to Lipiodol® and/or iodine contrast medium
- •Known moderate to severe kidney failure (creatinine clearance < 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
结局指标
主要结局
The primary endpoint is the change of the Visual Analogue Scale (VAS) pain score between randomization and 3 months (0–100 mm: 0 = No Pain, 100 = Worst Possible Pain).
The primary endpoint is the change of the Visual Analogue Scale (VAS) pain score between randomization and 3 months (0–100 mm: 0 = No Pain, 100 = Worst Possible Pain).
次要结局
- • Change of the VAS pain score at 1, 6 and 12 months after randomization
- • Change of the patient’s global assessment of her/his health measured by the VAS of EQ-5D questionnaire at 1, 3, 6 and 12 months after randomization
- • Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score and sub-scores (pain, function, stiffness) at 1, 3, 6 and 12 months after randomization
- • Change of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores (knee pain, function, symptoms, sport, quality of life and stiffness) at D0 and 3 months after randomization
- • Change of the Hospital Anxiety and Depression (HAD) scale total score and sub-scores (anxiety and depression) at D0 and 3 months after randomization
- • Change in semi-quantitative MRI scoring (Whole-Organ Magnetic Resonance Imaging Score [WORMS], Knee Osteoarthritis Scoring System [KOSS], Boston-Leeds Osteoarthritis Knee Scoring [BLOKS], MRI Osteoarthritis Knee Score [MOAKS]) (3) of the knee at 6 months after randomization
- • Description of pain medication at 1, 3, 6 and 12 months
- • Description of non-pharmacological treatments at 1, 3, 6 and 12 months
- • Number of responder patients under OMERACT-OARSI definition (1) in both groups at 3, 6 and 12 months.
- • Number of patients reaching an acceptable symptom state at 3, 6 and 12 months.
- • Number and description of AE/SAE at 1, 3, 6 and 12 months
- • Number of events in the target knee including intra-articular injection, GAE, knee surgery at 6 and 12 months
- • Medico-economic study: incremental cost-utility ratio
- • Change of patient’s 3-item priority function McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR) global score at D0 and 3 months after randomization.
研究者
Pr Marc SAPOVAL (Coordinating investigator)
Scientific
Assistance Publique Hopitaux De Paris