Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial

OBJECTIVES: 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. DESIGN: Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision). SETTING: 20 orthopaedic surgery centres in Australia and New Zealand. PARTICIPANTS: 902 patients undergoing elective primary or revision total hip replacement surgery. INTERVENTION: 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery. MAIN OUTCOME MEASURES: 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. TRIAL REGISTRATION: NCT00145730.