title: Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors.
abstract: BACKGROUND
  Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate.
  
  
  METHODS
  Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine.The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS), Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment) and intake of pain rescue medication (number per week). In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered.
  
  
  CONCLUSIONS
  This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine.
  
  
  BACKGROUND
  NCT01079455.
authors.affiliation: University of Leuven, Department of Orthopaedic Surgery, Weligerveld 1, 3212 Pellenberg, Belgium. sascolen@hotmail.com
authors.forename: Sascha
authors.initials: S
authors.lastname: Colen
authors.forename: Michel P J
authors.initials: MP
authors.lastname: van den Bekerom
authors.forename: Johan
authors.initials: J
authors.lastname: Bellemans
authors.forename: Michiel
authors.initials: M
authors.lastname: Mulier
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D002045:Bupivacaine / Q000008:administration & dosage / Q000627:therapeutic use*; D004185:Disability Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000305:Adrenal Cortex Hormones; D000779:Anesthetics, Local; D055675:Viscosupplements; D006820:Hyaluronic Acid; D002045:Bupivacaine