Clinical trial: Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis (NCT03897686)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment