Study design: A randomized, prospective, double-blind, placebo-controlled clinical trial. Objectives: To determine the e ect of indomethacin on the prevention of heterotopic ossi®cation (HO) following spinal cord injury (SCI). Setting: County Hospital, Miami, Florida, USA. Methods: Sixteen patients were treated with slow-release indomethacin 75 mg daily and 17 patients received placebo for a period of 3 weeks. Prevention was started 21+14 days after SCI. In both groups of patients there was similar age of the patients as well as the level of SCI and ASIA impairment scale. Two methods were used to diagnose HO, bone scintigraphy and radiographic examination. Bone scintigraphy with technetium labeled methylenediphosphonate was used for diagnosis of early stage, while radiography was used for diagnosis of late stage of HO development. Results: A signi®cantly lower incidence of early HO was found in the indomethacin group (25%) than in the placebo group (65%; P50.001). Similarly there was a signi®cant reduction of late HO in the indomethacin group (12.5%) as compared to the placebo group (41%; P50.001). Conclusion: Our data suggest that indomethacin used during the ®rst 2 months after SCI is e ective in prevention of HO in a signi®cant number of patients.

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%: Po0.05). 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.

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