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.
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.
Witteveen
Angelique G H
AG
Orthopaedic Research Centre Amsterdam, Academic Medical Center, 1105 AZ Amsterdam, The Netherlands. agh.witteveen@hotmail.com
Giannini
Sandro
S
Guido
Giulio
G
Jerosch
Joerg
J
Lohrer
Heinz
H
Vannini
Francesca
F
Donati
Leonardo
L
Schulz
Axel
A
Scholl
Jakob
J
Sierevelt
Inger N
IN
van Dijk
C Niek
CN
D000328:Adult; D000843:Ankle Joint / Q000503:physiopathology*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D055675:Viscosupplements / Q000627:therapeutic use*
D055675:Viscosupplements; C049816:hylan; D006820:Hyaluronic Acid