Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

Inclusion Criteria

• Men and women above 50 years;
• Verified knee osteoarthritis in accordance with the ACR (knee pain combined with one of the following signs: age above 50 years, knee crepitus or morning joint stiffness lasting for less than 30 minutes combined with radiologic signs of knee osteoarthritis);
• Kellgren Lawrence radiological grade II-III knee osteoarthritis with the predominant involvement of the medial tibiofemoral region of the knee joint;
• Joint space width (JSW) of the target knee joint at least 2.5 mm.

Exclusion Criteria

• History of any injury or surgical intervention on the target knee joint (except for diagnostic arthroscopy made not longer than 60 days at the study entry);
• Severe degenerative changes in the target knee joint determined as the joint space narrowing less than 2 mm;
• Varus or valgus deformation of the target knee joint;
• Instability of the target knee joint;
• Active inflammation of the target knee joint (edema, hyperemia, present effusion) at the study entry;
• Microcrystalline arthropathies;
• Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc.);
• Seronegative spondyloarthritis and reactive arthritis;
• Inflammatory diseases of the skin and soft tissues in the proposed injection site for the test MD or placebo in the target joint;
• History of venous thrombosis and thromboembolia;
• Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen);
• Inflammatory changes in the complete blood count (leukocytosis, increase of erythrocyte sedimentation rate [ESR]);
• Platelet count abnormality (in accordance with the reference ranges of the local laboratory;
• Increase of rheumatoid factor level;
• Increase of uric acid level > 360 μmol/l;
• Diabetes mellitus;
• Hemophilia and other hemorrhagic diatheses, as well administration of anticoagulants and disaggregants;
• Positive results of HIV, HBs-Ag, anti-HCV, RW tests;
• Intra-articular injection to the target knee joint:
• Noltrex - within 24 months prior patient's inclusion to the study;
• hyaluronates - within 6 months prior patient's inclusion to the study;
• glucocorticosteroids - within 1 month prior the study inclusion;
• non-steroidal anti-inflammatory drugs (NSAID) - within 3 weeks prior patient's inclusion to the study.
• Oral administration of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks prior the study inclusion;
• Necessity of systemic glucocorticosteroids in any dosage form;
• Paracetamol administration within 48 hours prior the study inclusion;
• Pregnancy and lactation;
• Hypersensitivity to components of the test MD or placebo;
• Severe liver disorder determined as the increase of one of the values: ALT, AST, ALP, total bilirubin, GGTP more than 3 times the upper limit of normal;
• Renal diseases with the glomerular filtration rate estimated per Cockraft-Gault formula less than 60 ml/min/1.73 m2 (III-V stage chronic renal disease [CRD]);
• Clinically manifest hip osteoarthritis;
• History of knee and coxofemoral endoprosthesis;
• Acute infectious diseases or infectious aggravations of chronic diseases (respiratory infections) within one month prior the study inclusion;
• Severe decompensated chronic or acute diseases and other conditions which, by the opinion of the study physician, may preclude the patient's participation in the study or affect the study results.