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.