Background: This pilot open noncontrolled study was designed to assess the efficacy of intra-articular injections of\r\na solution combining hyaluronic acid (HA) and chondroitin sulphate (CS) in the treatment of outpatients affected\r\nby knee osteoarthrosis.\r\nFindings: Thirty patients with knee OA have been included. The primary objective was to assess clinical efficacy as\r\nmeasured by pain and Lequesne�s index. Secondary objectives were to assess potential effect of the treatment on\r\nultrasound parameters, safety and biomarkers of cartilage metabolism and joint inflammation. After a selection visit\r\n(V1), the study treatment was administered 3 times on a weekly basis (V2, V3, V4). Follow-up was planned 6 (V5)\r\nand 12 weeks (V6) after the first intra-articular injection. Efficacy results showed a reduction in mean pain at V3 and\r\nV6 and in functional impairment, the most marked changes being measured at the two follow-up visits (V5 and V6).\r\nAlthough statistical significance was not achieved due to small sample size, a clear tendency towards improvement\r\nwas detectable for ultrasound assessments as well as biomarkers. Except for a mild injection site hematoma for\r\nwhich the drug causal relationship could not be excluded, no adverse effect of clinical relevance was recorded\r\nduring the study.\r\nConclusion: Although this pilot study was performed according to an open design only, the ultrasound as well as\r\nbiomarkers changes strongly suggest a non-placebo effect. These preliminary results call now for a randomized\r\ncontrolled study to confirm the clinical relevance of the observed results
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