Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
Patients are randomly allocated into one of two groups. One group is treated with Hymovis hyaluronic acid (HA) and the other group, Synvisc HA.
All patients will undergo one cycle of i
Sponsors
Fidia Pharmaceuticals S.p.a (Fidia Farmaceutici S.p.a) (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulant patient > 45 years of age in good health conditions 2. Patient of any race, both outpatients or hospitalized, affected by OA diagnosed both clinically and radiologically according to the American College of Rheumatology criteria: 2.1. Pain 2.2. Presence of radiographic osteophytes 2.3. At least one of the following items: 2.3.1. Age > 50 2.3.2. Morning stiffness < 30 minutes of duration 2.3.3. Crepitus on motion 3. Kellgren-Lawrence grade II-IV confirmed by X-ray (performed within 6 months preceding the inclusion in the study) 4. Patient diagnosed with idiopathic OA of the knee since at least one year 5. Patient presenting synovial effusion of the knee joint echographically confirmed 6. Patient who discontinued previous oral/topic NDAIDs therapy since at least one week before the first intra-articular injection 7. Male or fertile, non pregnant or breast feeding female who consents to use a reliable birth control method for the whole treatment duration 8. Patient without conditions or psychological impairment who could interfere with compliance to the protocol and the study conclusion in the investigator's opinion 9. Patient able to understand study obligations and who provided a written informed consent in compliance with the Helsinki declaration (version October 2013)
Exclusion criteria
Exclusion criteria: 1. Concomitant chronic inflammatory diseases (e.g. rheumatoid arthritis or psoriasis) 2. Painful knee condition other than OA 3. Secondary knee OA or relevant knee injuries in the target knee within 6 months before the inclusion 4. Known or suspected allergic reactions to hyaluronic preparations or to other components of the devices under study 5. Presence of infections and/or skin diseases in the area of injection site; e.g. psoriasis 6. Known coagulopathy 7. Therapy with one of the devices under study within 6 months before the inclusion 8. Systemic anti-inflammatory therapy at a fixed dose within 1 month before the inclusion 9. In therapy with i.a. HA or i.a. corticosteroids within 6 months before the inclusion 10. In therapy with biphosphonates, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein within 1 month before inclusion 11. Participation in any other study involving investigational or marketed products simultaneously or within one month prior to study entry 12. Previous surgery in the target knee within 9 months prior to inclusion, or planned surgery throughout the duration of the study 13. Presence of pathologies or conditions that might interfere with subject compliance/cooperation during the study, in the judgment of the investigator 14. History of alcoholism, treatment abuse, psychological or other emotional problems that, in the judgment of the investigator, could invalidate informed consent or limit the subjects compliance with protocol requirements 15. Females who are pregnant, lactating or not in menopause and are not using recognized contraceptive measures as indicated by investigators for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Synovial fluid analysis will be carried out at baseline and at visit 1 2. MMP3 activity will be evaluated via ELISA test | — |
Secondary
| Measure | Time frame |
|---|---|
| The following variables will be evaluated at baseline and visit 1: 1. Macroscopic analysis of SF 2. Microscopic analysis of SF 3. Expression of MMP2 and MMP13 (ELISA test) 4. Expression of inflammatory cytokines (Flowcytomix analysis) At baseline and FU visits the following will be considered: 1. VAS 2. WOMAC 3. Physician?s global assessment For all the duration of the study safety and tolerability will be assessed by recording all AE | — |
Countries
Italy
Outcome results
None listed