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  • Title: 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.
    Author: Witteveen AG, Giannini S, Guido G, Jerosch J, Lohrer H, Vannini F, Donati L, Schulz A, Scholl J, Sierevelt IN, van Dijk CN.
    Journal: Foot Ankle Surg; 2008; 14(3):145-52. PubMed ID: 19083633.
    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 (>or=50 mm and <or=90 mm on a 100 mm VAS) ankle osteoarthritis. Patients received 1 ml x 2 ml 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 68.0 mm (baseline) to 33.8 mm at 3 months (p<0.001), which was maintained to 6 months (34.2 mm, 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.
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