A prospective multi-centre, open study of the safety and efficacy of hylan G-F 20 (Synvisc^®) in patients with symptomatic ankle (talo-crural) osteoarthritis

Abstract 

Background

To evaluate the safety and efficacy of hylan G-F 20 in patients with ankle osteoarthritis.

Methods

A prospective, open study in patients with symptomatic (≥50mm and ≤90mm on a 100mm VAS) ankle osteoarthritis. Patients received 1ml×2ml intra-articular injection of hylan G-F 20, plus an optional, second injection if pain remained at baseline levels after 1, 2 or 3 months. The primary efficacy endpoint was the change from baseline in the pain VAS score at 3 months.

Results

Fifty-five patients received the first injection; 24 patients received a second. There were no serious or severe adverse events (AEs) related to the treatment. Seventeen patients experienced mild or moderate local, treatment-related AEs. The mean pain VAS score decreased from 68.0mm (baseline) to 33.8mm at 3 months (p<0.001), which was maintained to 6 months (34.2mm, p<0.001).

Conclusions

Hylan G-F 20 is well-tolerated and effective for up to 6 months in the treatment of symptomatic ankle osteoarthritis.

Keywords: Osteoarthritis, Ankle, Viscosupplementation, Hylan G-F 20, Hyaluronan