Table 1 Exclusion criteria
Related to the OA pathology | |
• Bilateral (except asymptomatic and grade I) OA of the knee • Radiological K&L grade I or IV • Chondromatosis or villonodular synovitis of the knee • Recent trauma (< 1 month) of the knee responsible of the symptomatic knee • Acute inflammatory osteoarthritis (Kofus ≥7) • Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget’s disease, hemophilia, hemochromatosis…. • Inflammatory disease i.e. rheumatoid arthritis, gout and infectious arthritis, acute calcium pyrophosphate arthritis • Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..) • Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic) | |
Related to treatments | |
• Corticosteroids injection in the target knee in the last month before first injection • Hyaluronan injection in the target knee in the last 6 months before first injection • Arthroscopy and surgery in the target knee in the last 6 months before first injection • Oral corticotherapy ≥5 mg/day (in Prednisone equivalent) in the last 3 months before first injection • OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection • Change in the dosage of symptomatic slow-acting drugs (SYSAD) i.e. chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months before first injection • Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug). • Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection • An anticipated need for any forbidden OA treatments during the trial • Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site • Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection • Anticoagulant (coumarinic compound) and heparin | |
Related to associated diseases | |
• Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….) • Allergy or contra-indication to hyaluronan and constituents • Severe alteration of mobility unabling functional evaluation • High risk of hemorrhage and risk of infection at the site of injection • Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee | |
Related to patients | |
• Participation to a therapeutic clinical trial in the last 3 months before first injection • Under guardianship or judicial protection • Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy | |
Related to MRI counter-indication | |
• Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump • Patient with a ferromagnetic splinter in the body, or having wire sutures • Serious mobility problem (Parkinson, tremors), • Claustrophobia |