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.

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.

GIANNINI, SANDRO;
2008

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.
2008
Witteveen A.G.; Giannini S.; Guido G.; Jerosch J.; Lohrer H.; Vannini F.; Donati L.; Schulz A.; Scholl J.; Sierevelt IN.; van Dijk CN.
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/113081
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 11
  • Scopus 57
  • ???jsp.display-item.citation.isi??? ND
social impact