title: Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle.
abstract: BACKGROUND
  The potential benefit of hyaluronans in alleviating pain associated with osteoarthritis (OA) in joints other than the knee is of increasing interest. This double-blind, randomized, controlled study examined the safety and efficacy of intraarticular sodium hyaluronate (Hyalgan) in the treatment of pain associated with ankle OA.
  
  
  METHODS
  Thirty consecutive patients with ankle OA documented by X-ray were randomized to treatment with five weekly injections of either sodium hyaluronate 2 mL (HYL) or phosphate-buffered saline 2 mL (control) in the tibiotalar joint. The primary endpoint was pain on movement and weightbearing using the Ankle Osteoarthritis Scale (AOS) 3 months after injection (a 100-mm visual analog scale [VAS]). Additional measures included the Western Ontario and McMaster Universities (WOMAC) OA Index and patient global assessment through 6 months; the Short Form-12 (SF-12) Health Survey at 3 months and 6 months; and all reported adverse events (AEs).
  
  
  RESULTS
  The study groups differed only in age, baseline WOMAC pain, and AOS total scores; 80% of the HYL and 73% of the control patients completed the study. At Month 3, the primary endpoint of the study, the HYL group demonstrated a significantly greater improvement from baseline in AOS total score than did the control group (HYL: -17.4 +/- 5.0 mm;
  
  
  METHODS
  -5.1 +/- 4.0 mm; p = 0.0407). The incidence of AEs was low, with no significant differences between the groups. There were no post-injection flares.
  
  
  CONCLUSIONS
  Our study suggests that sodium hyaluronate may be a safe and effective option for pain associated with ankle OA, although larger studies are needed.
authors.affiliation: Miami Veterans Affairs Medical Center, Surgical Service, 1201 NW 16th St, Miami, FL 33125, USA. michael.cohen@med.va.gov
authors.forename: Michael M
authors.initials: MM
authors.lastname: Cohen
authors.forename: Roy D
authors.initials: RD
authors.lastname: Altman
authors.forename: Richard
authors.initials: R
authors.lastname: Hollstrom
authors.forename: Claire
authors.initials: C
authors.lastname: Hollstrom
authors.forename: Craig
authors.initials: C
authors.lastname: Sun
authors.forename: Brad
authors.initials: B
authors.lastname: Gipson
mesh_terms: D000368:Aged; D000843:Ankle Joint; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D010147:Pain Measurement; D010865:Pilot Projects; D010919:Placebos; D011859:Radiography; D012449:Safety; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D016474:Weight-Bearing
chemical_list: D010919:Placebos; D006820:Hyaluronic Acid