Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trialBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38925.471146.4F (Published 07 September 2006) Cite this as: BMJ 2006;333:519
- Marlene Fransen, senior research fellow ()1,
- Craig Anderson, director, neurological and mental health division1,
- Jan Douglas, project manager1,
- Stephen MacMahon, principal director1,
- Bruce Neal, director, cardiac and renal division1,
- Robyn Norton, principal director1,
- Mark Woodward, director, epidemiology and biostatistics division1,
- Ian D Cameron, director and professor of rehabilitation medicine2,
- Ross Crawford, professor of orthopaedic research3,
- Sing Kai Lo, associate professor of biostatistics4,
- Garnet Tregonning, orthopaedic surgeon5,
- Margaret Windolf, research nurse HIPAID Collaborative Group6
- 1 The George Institute for International Health, University of Sydney, Australia
- 2 Faulty of Medicine, University of Sydney, Australia
- 3 Queensland University of Technology, Australia
- 4 Deakin University, Melbourne, Australia
- 5 Middlemore Hospital, Auckland, New Zealand
- 6 Royal Prince Alfred Hospital, NSW, Australia
- Correspondence to: M Fransen
- Accepted 14 July 2006
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.
Members of the HIPAID Collaborative Group are on bmj.com.
We thank Ken Faulder, radiologist, Royal North Shore Hospital, NSW, Australia, who kindly assessed and scored all trial radiographs.
Contributors All members of the writing committee contributed to the study or protocol design, or both, overall study management, interpretation of the data, and writing of the paper. MF and RN directed the project. JD was project manager. MF and RN are guarantors.
Funding National Health and Medical Research Council of Australia and the Medical Benefits Fund of Australia provided funding through competitive peer reviewed processes. Competing interests: None declared.
Ethical approval University of Sydney human research ethics committee and ethics committees at each collaborating hospital approved the study.