title: Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial.
abstract: OBJECTIVE
  To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.
  
  
  METHODS
  Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
  
  
  METHODS
  20 orthopaedic surgery centres in Australia and New Zealand.
  
  
  METHODS
  902 patients undergoing elective primary or revision total hip replacement surgery.
  
  
  METHODS
  14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
  
  
  METHODS
  Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).
  
  
  RESULTS
  There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
  
  
  CONCLUSIONS
  These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
  
  
  BACKGROUND
  NCT00145730.
authors.affiliation: The George Institute for International Health, University of Sydney, Australia. mfransen@george.org.au
authors.forename: Marlene
authors.initials: M
authors.lastname: Fransen
authors.forename: Craig
authors.initials: C
authors.lastname: Anderson
authors.forename: Jan
authors.initials: J
authors.lastname: Douglas
authors.forename: Stephen
authors.initials: S
authors.lastname: MacMahon
authors.forename: Bruce
authors.initials: B
authors.lastname: Neal
authors.forename: Robyn
authors.initials: R
authors.lastname: Norton
authors.forename: Mark
authors.initials: M
authors.lastname: Woodward
authors.forename: Ian D
authors.initials: ID
authors.lastname: Cameron
authors.forename: Ross
authors.initials: R
authors.lastname: Crawford
authors.forename: Sing Kai
authors.initials: SK
authors.lastname: Lo
authors.forename: Garnet
authors.initials: G
authors.lastname: Tregonning
authors.forename: Margaret
authors.initials: M
authors.lastname: Windolf
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D019644:Arthroplasty, Replacement, Hip / Q000379:methods*; D001315:Australia; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D009999:Ossification, Heterotopic / Q000517:prevention & control*; D010149:Postoperative Pain / Q000517:prevention & control*; D010349:Patient Compliance; D011182:Postoperative Care / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen