Abstract
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 [ClinicalTrials.gov]. Copyright © 2006 BMJ Publishing Group Ltd.
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 [ClinicalTrials.gov]. Copyright © 2006 BMJ Publishing Group Ltd.
| Original language | English |
|---|---|
| Pages (from-to) | 519-521 |
| Journal | British Medical Journal |
| Volume | 333 |
| Issue number | 7567 |
| DOIs | |
| Publication status | Published - 2006 |