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.
Witteveen A.G., Giannini S., Guido G., Jerosch J., Lohrer H., Vannini F., et al. (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. THE JOURNAL OF FOOT AND ANKLE SURGERY, 14, 145-152 [10.1016/j.fas.2008.01.001].
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
