Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial.
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.
Fransen
Marlene
M
The George Institute for International Health, University of Sydney, Australia. mfransen@george.org.au
Anderson
Craig
C
Douglas
Jan
J
MacMahon
Stephen
S
Neal
Bruce
B
Norton
Robyn
R
Woodward
Mark
M
Cameron
Ian D
ID
Crawford
Ross
R
Lo
Sing Kai
SK
Tregonning
Garnet
G
Windolf
Margaret
M
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
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen