Study design: A randomized, prospective, double-blind, placebo-controlled clinical trial.
Objectives: To determine the effect of COX-2-selective inhibitor on the prevention of heterotopic ossification (HO) after spinal cord injury (SCI).
Setting: County and University Teaching Hospital, Miami, FL, USA.
Methods: A total of 76 patients were enrolled in the study. Among them, 39 patients received placebo, and 37 received COX-2-selective inhibitor rofecoxib 25 mg daily for a period of 4 weeks. Prevention was started 3 weeks after spinal cord injury (SCI). In both groups of patients there was similar age as well as the level of SCI and ASIA impairment scale. Two methods were used to diagnose early HO, clinical symptoms and bone scintigraphy. Radiography was used for diagnosis of late stages of HO development.
Results: A significantly lower incidence of HO was found in the rofecoxib group (13.4%) than in the placebo group (33.3%: P<0.05). In patients receiving rofecoxib, there was a 2.5 times lower relative risk of developing HO than in the placebo group (95% CI, 2.3-6). There were no patients who discontinued the study due to adverse effects of medication.
Conclusion: Our data suggest that COX-2-selective inhibitor rofecoxib is an effective medication in prevention of HO after SCI.