title: [Efficacy and safety of a single intra-articular injection of 2% hyaluronic acid plus mannitol in knee osteoarthritis over a 6-month period].
abstract: OBJECTIVE
  To evaluate the safety and efficacy of a single intra-articular injection of 2% hyaluronic acid (HA)+mannitol in symptomatic knee osteoarthritis (KOA).
  
  
  METHODS
  Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2ml of 2% HA+0.5% mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded.
  
  
  RESULTS
  A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (P<.001). Joint function improved by 38.7% on Day 30, reaching 47.5% on Day 180. Rescue medication use decreased from 58.2% at baseline to 2.5% on Day 90, increasing in the last visits. Efficacy and safety were positively evaluated by investigators and patients. No serious adverse events were observed. Mild side effects were reported in 4 patients (local pain and swelling in the infiltration area).
  
  
  CONCLUSIONS
  There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months.
authors.affiliation: Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Virgen Macarena, Sevilla, España. aurelioborras@telefonica.net
authors.forename: A
authors.initials: A
authors.lastname: Borrás-Verdera
authors.forename: V
authors.initials: V
authors.lastname: Calcedo-Bernal
authors.forename: J
authors.initials: J
authors.lastname: Ojeda-Levenfeld
authors.forename: C
authors.initials: C
authors.lastname: Clavel-Sainz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000627:therapeutic use; D008353:Mannitol / Q000008:administration & dosage* / Q000627:therapeutic use; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome; D055676:Viscosupplementation / Q000379:methods*; D055675:Viscosupplements / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D055675:Viscosupplements; D008353:Mannitol; D006820:Hyaluronic Acid