Abstract
Introduction
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.
Methods
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, SF12
Results
412 patients were randomized (1 × 6mL N=194, 3 × 2 mL N=218). There were no significant differences in age, gender or grade of OA. Injection and/or treatment-related AE (all mild/moderate) were reported in 10.5% (3 × 2 mL) and 9.1% (1 × 6 mL) of patients Significant pain reduction was observed in both groups at 26 weeks (3 × 2 mL: 50% (mean) decrease, 1 × 6mL: 45%). There were no significant differences between groups for any of the primary or secondary outcome measures at 26 weeks.
Discussion and Conclusion
Single dose of 6 mL hylan G-F 20 offer comparable safety and efficacy to 3 × 2 mL at 26 weeks. It provides both the patients and physicians a choice with the potential additional benefits of reduced operational costs.
