LIPIOJOINT-2 : A randomized sham-controlled, double blind, multicenter trial on the effect of Genicular Arteries Embolization in symptomatic knee osteoarthritis

Knee OsteoArthritis

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).

• 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.

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