Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

This is an interventional treatment trial for Osteoarthritis focused on measuring intra-articular, polyacrylamide hydrogel Read More

Inclusion Criteria:

• 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:

1. 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);
2. Severe degenerative changes in the target knee joint determined as the joint space narrowing less than 2 mm;
3. Varus or valgus deformation of the target knee joint;
4. Instability of the target knee joint;
5. Active inflammation of the target knee joint (edema, hyperemia, present effusion) at the study entry;
6. Microcrystalline arthropathies;
7. Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc.);
8. Seronegative spondyloarthritis and reactive arthritis;
9. Inflammatory diseases of the skin and soft tissues in the proposed injection site for the test MD or placebo in the target joint;
10. History of venous thrombosis and thromboembolia;
11. Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen);
12. Inflammatory changes in the complete blood count (leukocytosis, increase of erythrocyte sedimentation rate [ESR]);
13. Platelet count abnormality (in accordance with the reference ranges of the local laboratory;
14. Increase of rheumatoid factor level;
15. Increase of uric acid level > 360 μmol/l;
16. Diabetes mellitus;
17. Hemophilia and other hemorrhagic diatheses, as well administration of anticoagulants and disaggregants;
18. Positive results of HIV, HBs-Ag, anti-HCV, RW tests;

19. 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.
20. Oral administration of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks prior the study inclusion;
21. Necessity of systemic glucocorticosteroids in any dosage form;
22. Paracetamol administration within 48 hours prior the study inclusion;
23. Pregnancy and lactation;
24. Hypersensitivity to components of the test MD or placebo;
25. 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;
26. 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]);
27. Clinically manifest hip osteoarthritis;
28. History of knee and coxofemoral endoprosthesis;
29. Acute infectious diseases or infectious aggravations of chronic diseases (respiratory infections) within one month prior the study inclusion;
30. 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.