title: 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.affiliation: Orthopaedic Research Centre Amsterdam, Academic Medical Center, 1105 AZ Amsterdam, The Netherlands. agh.witteveen@hotmail.com
authors.forename: Angelique G H
authors.initials: AG
authors.lastname: Witteveen
authors.forename: Sandro
authors.initials: S
authors.lastname: Giannini
authors.forename: Giulio
authors.initials: G
authors.lastname: Guido
authors.forename: Joerg
authors.initials: J
authors.lastname: Jerosch
authors.forename: Heinz
authors.initials: H
authors.lastname: Lohrer
authors.forename: Francesca
authors.initials: F
authors.lastname: Vannini
authors.forename: Leonardo
authors.initials: L
authors.lastname: Donati
authors.forename: Axel
authors.initials: A
authors.lastname: Schulz
authors.forename: Jakob
authors.initials: J
authors.lastname: Scholl
authors.forename: Inger N
authors.initials: IN
authors.lastname: Sierevelt
authors.forename: C Niek
authors.initials: CN
authors.lastname: van Dijk
mesh_terms: 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*
chemical_list: D055675:Viscosupplements; C049816:hylan; D006820:Hyaluronic Acid