Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Conditions
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Synovitis, Osteoarthritis, Joint Diseases, Muskuloskeletal Diseases

Intervention / Treatment
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* Drug: Chondroitin sulphate (Condrosan)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chondroitin sulphate | Drug: Chondroitin sulphate (Condrosan)<br>* 800 mg (two capsules of 400 mg each) taken once a day for one year<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cartilage volume and subchondral bone lesions |  | One year | 
| Pain measured by VAS |  | One year | 
| WOMAC index |  | One year | 
| SF-36 Health Questionaire |  | One year | 
| Assessment of joint swelling, effusion |  | One year | 
| Use of rescue medication |  | One year | 
| Tolerability |  | One year | 
| Adverse events |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chondroitin sulphate, Synovitis, Knee osteoarthritis, Magnetic Resonance Imaging