Osteoarthritis of the knee Musculoskeletal Diseases Gonarthrosis
Conditions
Interventions
Three weekly intra-articular injections of HA/CS in knees affected by femoro-tibial osteoarthritis
over a 3 week period
Sponsors
Pierre Fabre Research Institute [Institut de Recherche Pierre Fabre] (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 45 and and 80 years 2. Suffering from internal and/or external femoro tibial OA: 2.1. Meeting the criteria of the American College of Rheumatology (ACR) 2.2. Lasting for at least 6 months 2.3. Pain > = 40mm as measured on a visual analogue scale (VAS) 2.4. Stage Kellgren and Lawrence II or III 3. OA deemed to justify a treatment with intra articular HA according to the investigator 4. Patient?s written informed consent
Exclusion criteria
Exclusion criteria: 1. Symptomatic femoro-patellar arthrosis or hip arthrosis on the same side, concomitant skeletal disease (Paget disease, rheumatoid arthritis, ankylosing spondylitis) 2. Former or concomitant treatment (intra-articular corticosteroids, topical or oral NSAIDs, anti-arthritis slow acting treatment, recent surgery) 3. Individual characteristics incompatible with a drug trial (pregnancy or lack of contraception, serious concomitant disease, participation in a clinical trial within the preceding 30 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain (VAS) and function (Lequesne?s Algo-Functional Knee Index) over a period of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ultrasound parameters (joint effusion, synovial and popliteal cysts) 2. OA biomarkers of inflammation [IL-6], degradation [Coll2-1] and synthesis [CPII] of collagen type II, degradation of aggrecan [CS846], and markers of oxidative stress [Coll2-1NO2] | — |
Countries
Belgium
Outcome results
None listed