Evaluation of the biological and imaging markers of bone and cartilage degradation in patients with knee osteoarthritis receiving intra-articular injections of a hyaluronan derivative Hymovis®: a pilot study

Fidia Farmaceutici Spa0 个研究点目标入组 46 人开始时间: 2015年2月11日最近更新: 2019年7月15日

适应症

试验速览

•1. Age 40–75 years old
•2. Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee osteoarthritis associated or not with femoropatellar knee osteoarthritis
•3. Clinical and radiological criteria of the American College of Rheumatology
•4. Symptomatic for more than 6 months in the most painful knee
•5. Radiological Kellgren and Lawrence grade II or III in radiographs from less than 12 months ago
•6. Mean knee pain score of the most painful knee at rest over the past 24 hours on the Visual Analogue Scale (0–100) of at least 40 with a washout period for Paracetamol and oral non-steroidal anti-inflammatory drugs depending on the half-life of the drug
•7. Able to follow the instructions of the study
•8. Signed an informed consent form

•1. Bilateral (except asymptomatic and grade I) osteoarthritis of the knee
•2. Radiological Kellgren and Lawrence grade I or IV
•3. Chondromatosis or villonodular synovitis of the knee
•4. Recent trauma (<1 month) of the symptomatic knee
•5. Acute inflammatory osteoarthritis
•6. Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget’s disease, haemophilia or haemochromatosis
•7. Inflammatory disease
•8. Pathologies interfering with the evaluation of osteoarthritis
•9. Contraindications to Hymovis®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site
•10. Anticoagulants (coumarinic compounds) and heparin

发起方