Joint Diseases, Muskuloskeletal Diseases, Osteoarthritis, Synovitis
Conditions
Keywords
Chondroitin sulphate, Synovitis, Knee osteoarthritis, Magnetic Resonance Imaging
Brief summary
The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.
Interventions
DRUGChondroitin sulphate (Condrosan)
800 mg (two capsules of 400 mg each) taken once a day for one year
DRUGPlacebo
Two placebo capsules taken once a day for six months followed by an additional six month treatment of 800 mg (two capsules of 400 mg of Chondroitin sulphate each) taken once a day
Sponsors
Bioiberica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary OA of the knee according to ACR with synovitis criteria (warmth, swelling or effusion); * OA of radiological stages 2 and 3 according to Kellgren-Lawrence; * Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray; * VAS of pain while walking ≥40 mm.
Exclusion criteria
* Known allergy to chondroitin sulphate; * Progressive or serious pathologies (cancer, AIDS,...); * Other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis; * Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or chondroitin sulphate during the 12 weeks preceding inclusion; * Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion; * Radioactive synovectomy during the 12 weeks preceding inclusion; * If the patient is receiving NSAID at baseline (D0), it should be maintained at a stable dosage as much as possible from D0 to D180. In the open phase of the study (D180 to D360), NSAID will also be allowed as rescue medication along with acetaminophen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the change in the severity of synovitis measured by MRI according to the modified methods of Loeuille et al. after chondroitin sulphate treatment in patients with knee OA and clinical signs of synovitis | One year |
Secondary
| Measure | Time frame |
|---|---|
| Pain measured by VAS | One year |
| WOMAC index | One year |
| SF-36 Health Questionaire | One year |
| Changes of cartilage volume and subchondral bone lesions | One year |
| Use of rescue medication | One year |
| Tolerability | One year |
| Adverse events | One year |
| Assessment of joint swelling, effusion | One year |
Countries
Canada
Outcome results
None listed