Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
1. Group Structum® : 1 capsule (500mg chondroitin sulfate) two times a day (b.i.d) for 12 months.
2. Group Placebo : 1 capsule Placebo two times a day (b.i.d)
Sponsors
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged from 50 to 75 years 2. Symptomatic femorotibial KOA fulfilling American College of Rheumatology (ACR) criteria for KOA 3. A Kellgren-Lawrence radiological grade II or III 4. A global pain score greater than or equal to 30 on a 100mm Visual Analogue Scale (VAS)
Exclusion criteria
Exclusion criteria: 1. Isolated symptomatic femoropatellar osteoarthritis of the knee 2. Inflammatory, infectious or metabolic arthritis 3. Contraindication to MRI examination 4. Intra-articular steroid injection or hyaluronic acid injections in the 3 months preceding inclusion 5. Non steroidal anti-inflammatory drugs (NSAIDs) in the 2 days preceding inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The correlation between the evolution of clinical symptoms (Lequesne Index and VAS pain) and the total volume of cartilage after 12 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean evolution from baseline of the total volume of cartilage and of each knee compartment 2. Evolution of other morphological osteo-articular lesions (sub-chondral oedema, meniscal lesions, synovitis) 3. Mean variation of the pain score (VAS) and of the Lequesne Index 4. Patient?s and investigator?s global assessment scores | — |
Countries
France
Outcome results
None listed