Intra-articular hyaluronic acid and chondroitin sulfate in osteoarthritis of the knee

Phase 4

Completed

Conditions: Osteoarthritis of the knee
Musculoskeletal Diseases
Gonarthrosis

Registration Number: ISRCTN91883031

Lead Sponsor: Pierre Fabre Research Institute [Institut de Recherche Pierre Fabre] (France)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain (VAS) and function (Lequesne?s Algo-Functional Knee Index) over a period of 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. Ultrasound parameters (joint effusion, synovial and popliteal cysts)<br>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]