title: A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis.
abstract: BACKGROUND
  Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse.
  
  
  OBJECTIVE
  This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA.
  
  
  METHODS
  This is prospective, and observational study.
  
  
  METHODS
  This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg.
  
  
  METHODS
  The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months).
  
  
  METHODS
  The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497).
  
  
  RESULTS
  Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Coadministration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each).
  
  
  CONCLUSIONS
  The study treatment was safe and well tolerated.
  
  
  CONCLUSIONS
  . The study treatment reduced pain, improved mobility, and increased QoL in participants with OA.
authors.affiliation: Physical and Rehabilitation Medicine Chair, Tor Vergata University, Rome, Italy. foti@med.uniroma2.it
authors.forename: C
authors.initials: C
authors.lastname: Foti
authors.forename: C
authors.initials: C
authors.lastname: Cisari
authors.forename: S
authors.initials: S
authors.lastname: Carda
authors.forename: N
authors.initials: N
authors.lastname: Giordan
authors.forename: A
authors.initials: A
authors.lastname: Rocco
authors.forename: A
authors.initials: A
authors.lastname: Frizziero
authors.forename: G
authors.initials: G
authors.lastname: Della Bella
mesh_terms: D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D019370:Observation; D010003:Osteoarthritis / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013583:Synovial Membrane; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000779:Anesthetics, Local; D055675:Viscosupplements; D006820:Hyaluronic Acid