Purpose Of The Study: To evaluate safety and efficacy of intraarticular (IA) hyaluronic acid (HA; Hyalgan in current medical practice.
Material And Methods: Multicenter, prospective, opened, observational study included 601 patients in 35 centers in Czech Republic. Patients had analgesics and NSAIDs on demand as rescue analgesia, but i. a. corticosteroids were not allowed. Patients received 1 series of 5 IA injectious of HA into one knee. Outcome measures were: pain at rest and on walking, patients global and assessment of therapy, Lequesne's index, consumption of NSAIDs. The patients were followed for 17 weeks (12 weeks after the last injection).
Results: Patients improved in all outcome measures in week 5 (1 week after the last injection) and this improvement remained constant till week 17 (p < 0.001). The patients judged activity level as better or much better for 78% of treated kness in week 5 and 85.7% in week 17. The mean consumption of rescue NSAIDs dropped fom 4 days/1 week before treatment to 1 day/week during and after Hyalgan therapy. There were no severe side effects reported. Injection site pain occurred in 6.8% patients and in 1.45% for injection, and resulted in 1.4% in withdrawal.
Conclusion: Hyalgan provided good clinical benefits and acceptable safety profile in current medical practise. The consumption of NSAIDs dropped considerably and therefore contributed to favourable cost/benefit ratio of Hyalgan therapy.
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