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.

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.

• Authors: 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
• Journal: Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons (Foot Ankle Surg) Vol. 14 Issue 3 Pg. 145-52 ( 2008) ISSN: 1460-9584 [Electronic] France
• PMID: 19083633 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Viscosupplements
• hylan
• Hyaluronic Acid

Topics

• Adult
• Ankle Joint (physiopathology)
• Female
• Humans
• Hyaluronic Acid (analogs & derivatives, therapeutic use)
• Injections, Intra-Articular
• Male
• Middle Aged
• Osteoarthritis (physiopathology, therapy)
• Pain Measurement
• Prospective Studies
• Quality of Life
• Viscosupplements (therapeutic use)