Prevention of heterotopic ossification after spinal cord injury with indomethacin

Study design: A randomized, prospective. double-blind. placebo-controlled c linical trial. Objectives: To determine the effect of indomethacin on the prevention of he terotopic ossification (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 impairmen t scale. Two methods were used to diagnose HO, bone scintigraphy and radiog raphic examination. Bone scintigraphy with technetium labeled methylene-dip hosphonate was used for diagnosis of early stage, while radiography was use d for diagnosis of late stage of HO development. Results: A significantly lower incidence of early HO was found in the indom ethacin group (25%) than in the placebo group (65%; P<0.001). Similarly the re was a significant reduction of late HO in the indomethacin group (12.5%) as compared to the placebo group (41%; P<0.001). Conclusion: Our data suggest that indomethacin used during the first 2 mont hs after SCI is effective in prevention of HO in a significant number of pa tients.