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

Angelique G H Witteveen, Sandro Giannini, Giulio Guido, Joerg Jerosch, Heinz Lohrer, Francesca Vannini, Leonardo Donati, Axel Schulz, Jakob Scholl, Inger N. Sierevelt, C. Niek van Dijk

Research output: Contribution to journalArticle

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 (≥50 mm and ≤90 mm on a 100 mm VAS) ankle osteoarthritis. Patients received 1 ml × 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.

Original languageEnglish
Pages (from-to)145-152
Number of pages8
JournalFoot and Ankle Surgery
Volume14
Issue number3
DOIs
Publication statusPublished - 2008

Keywords

  • Ankle
  • Hyaluronan
  • Hylan G-F 20
  • Osteoarthritis
  • Viscosupplementation

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine

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    Witteveen, A. G. H., Giannini, S., Guido, G., Jerosch, J., Lohrer, H., Vannini, F., Donati, L., Schulz, A., Scholl, J., Sierevelt, I. N., & van Dijk, C. N. (2008). 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. Foot and Ankle Surgery, 14(3), 145-152. https://doi.org/10.1016/j.fas.2008.01.001