title: Clinical response to intra-articular injections of hylan G-F 20 in symptomatic hip osteoarthritis: the OMERACT-OARSI criteria applied to the results of a pilot study.
abstract: OBJECTIVE
  To assess, using the OMERACT-OARSI criteria, the clinical response of patients presenting with symptomatic hip osteoarthritis (OA) to one intra-articular injection of hylan G-F 20.
  
  
  METHODS
  Open-label, multi-centre, prospective, pilot study. Fifty-six patients presenting with primary hip OA, Kellgren-Lawrence grade II-III, age > or =40, with walking pain measuring 50-90 mm on a 100 mm visual analogue scale (VAS). Intra-articular injection of a single 2 ml dose of hylan G-F 20 into the hip joint under fluoroscopic guidance. A second injection could be administered at day (D) 30, 60 or 90 if pain was unchanged or returned to baseline levels. EFFICACY CRITERIA: The outcome of the first injection in the intent-to-treat (ITT) population was analysed 90 days after the injection in those patients that received a single injection, and on the day of the second injection in those patients that required two injections, using OMERACT-OARSI responder criteria (obtained from WOMAC A and C indices and the patient's global evaluation) and variation in walking pain on VAS.
  
  
  RESULTS
  The percentage of responders according to the OMERACT-OARSI response criteria was 53.6%. An inverse correlation was observed between reduction in pain and joint space narrowing score (P=0.03).
  
  
  CONCLUSIONS
  In the absence of a control group, the efficacy of the treatment cannot be determined conclusively. Nevertheless these data suggest that hylan G-F 20 is a symptomatic treatment of hip OA, particularly in less severe radiological cases. A double-blind, controlled study is required to confirm these data.
authors.affiliation: Department of Rheumatology, Centre Hospitalier Lyon-Sud, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France. thierry.conrozier@chu-lyon.fr
authors.forename: Thierry
authors.initials: T
authors.lastname: Conrozier
authors.forename: Philippe
authors.initials: P
authors.lastname: Bertin
authors.forename: François
authors.initials: F
authors.lastname: Bailleul
authors.forename: Pierre
authors.initials: P
authors.lastname: Mathieu
authors.forename: Jacques
authors.initials: J
authors.lastname: Charlot
authors.forename: Eric
authors.initials: E
authors.lastname: Vignon
authors.forename: Richard
authors.initials: R
authors.lastname: Treves
authors.forename: Xavier
authors.initials: X
authors.lastname: Chevalier
mesh_terms: D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; C049816:hylan; D006820:Hyaluronic Acid