Viscosupplementation is used widely to provide symptomatic relief to patients with knee OA. This study aimed to compare the efficacy and safety of the standard (3×2ml) and single (1×6ml) dosing regimens of hylan G-F 20. Prospective, randomized, blinded (reviewers), comparative independent study. Inclusion criteria was OA knee pain e 60mm on a 100mm VAS; no prior intra articular (IA) injection. Patients were randomised to recieve 1 × 6mL or 3 × 2mL hylan G-F 20. Follow-up at 1, 6, 12, 26 and 52 weeks. Analgesics prohibited for 24 hours prior to follow-up assessments and NSAID's for 26 wks. All adverse events (AE) were recorded. Primary outcome measure: Target knee pain (VAS) at 26 weeks. Secondary outcome measures included WOMAC, Oxford knee score, SF12Introduction
Methods
To compare the clinical effectiveness, functional outcome and patient satisfaction following intra articular injection with Synvisc¯ and Hyalgan¯ in patients with osteoarthritis (OA) of the knee. 348 consecutive patients were randomised into two groups to receive either Hylan G-F 20 -Synvisc (n= 181) or Sodium Hyaluronate -Hyalgan (n=167). All patients were prospectively reviewed by independent assessors blinded for the treatment. Knee pain on a VAS were recorded. The functional outcome was assessed using Tegner, UCLA, Oxford knee score and EuroQol-5D scores. VAS was used to quantify patient satisfaction. Mean follow-up was 12 months.Aim
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