Study finds no clinical benefit from routine ibuprofen use following THA

Hip replacement patients treated with ibuprofen had a reduced risk of ectopic bone formation, but a significantly greater risk of major bleeding complications.

Routinely administering ibuprofen following total hip arthroplasty can significantly decrease the risk of developing ectopic bone, a randomized study confirms. However, the drug significantly increases the risk of major bleeding events and does not improve long-term clinical outcomes, the study authors noted.

Marlene Fransen, senior research fellow at the George Institute for International Health in Sydney, and colleagues at centers in Australia and New Zealand, conducted the double-blind and placebo-controlled trial. The researchers randomly assigned 452 patients to treatment with 400 mg of ibuprofen three times daily for 2 weeks and 450 patients to a control group that received placebo pills identical in appearance. Of these, 875 patients (96%) started their assigned treatment, but 188 patients (26%) prematurely stopped, including 106 ibuprofen patients (24%) and 82 placebo patients (19%), according to the study.

The researchers found both groups had similar improvements in both pain and physical function at 12 months postop. Additionally, both groups showed similar results for secondary outcomes of general health status, global assessments, participation in physical activities and objective measures of physical performance.

Treatment with ibuprofen also significantly lowered the risk for developing any grade of ectopic bone, particularly severe ectopic bone. However, ibuprofen-treated patients had a significantly higher risk of major bleeding complications (P=.046), although both groups had similar rates of red cell transfusion, similar suction drainage volumes and similar hemoglobin concentrations at 48 hours postop, according to the study.

"Ibuprofen routinely administered after total hip replacement surgery does not result in better long-term clinical outcomes, despite significantly decreasing the risk of ectopic bone formation.

"We observed the anticipated beneficial effect of ibuprofen on radiographic outcomes but found no corresponding improvement in clinical outcomes," the study authors said.

"There is no particular reason to believe that other conventional NSAIDs would have produced materially different results," they added.

"These findings, therefore, suggest that recommendations promoting routine prophylaxis with a short course of postoperative NSAIDs for all patients undergoing total hip arthroplasty are not justified," they said.

For more information:
Fransen M, Anderson C, Douglas J, et al. Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial. BMJ. 2006;333:519-521.