Selective COX-2 inhibitor versus indomethacin for the prevention of heterotopic ossification after hip replacement: a double-blind randomized trial of 100 patients with 1-year follow-up.
BACKGROUND
Recent reports have suggested that selective COX-2 inhibition may be sufficient for the prevention of heterotopic ossification.


METHODS
We performed a randomized controlled study to evaluate the effect of the selective COX-2 inhibitor rofecoxib compared to that of indomethacin on the incidence and extent of heterotopic ossification in patients who had undergone hip replacement surgery. 50 patients received a daily dose of 25 mg rofecoxib and 50 patients received a daily dose of 100 mg indomethacin (25, 25, and 50 mg).


RESULTS
No ossifications were found in 48 patients. Grade-II ossifications were seen in 5/46 patients in the rofecoxib group and in 6/50 patients in the indomethacin group. Grade-III and grade-IV ossifications were seen in 3/46 patients in the rofecoxib group only. The differences were not statistically significant. The study medication had to be discontinued in 2 patients in the indomethacin group, due to dyspepsia.


CONCLUSIONS
After short-term administration, the selective COX-2 inhibitor rofecoxib was effective in preventing heterotopic ossification after total hip arthroplasty.
Grohs
Josef G
JG
Department of Orthopedics, Medical University of Vienna, Austria. Josef.grohs@meduniwien.ac.at
Schmidt
Maximilian
M
Wanivenhaus
Axel
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects*; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage* / Q000009:adverse effects; D007783:Lactones / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009999:Ossification, Heterotopic / Q000209:etiology / Q000517:prevention & control*; D013450:Sulfones / Q000008:administration & dosage* / Q000009:adverse effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D007213:Indomethacin