TY - JOUR
T1 - 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
AU - Witteveen, Angelique G H
AU - Giannini, Sandro
AU - Guido, Giulio
AU - Jerosch, Joerg
AU - Lohrer, Heinz
AU - Vannini, Francesca
AU - Donati, Leonardo
AU - Schulz, Axel
AU - Scholl, Jakob
AU - Sierevelt, Inger N.
AU - van Dijk, C. Niek
PY - 2008
Y1 - 2008
N2 - 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.
AB - 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.
KW - Ankle
KW - Hyaluronan
KW - Hylan G-F 20
KW - Osteoarthritis
KW - Viscosupplementation
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U2 - 10.1016/j.fas.2008.01.001
DO - 10.1016/j.fas.2008.01.001
M3 - Article
C2 - 19083633
AN - SCOPUS:48849094992
VL - 14
SP - 145
EP - 152
JO - Foot and Ankle Surgery
JF - Foot and Ankle Surgery
SN - 1268-7731
IS - 3
ER -