TY - JOUR
T1 - Prevention of heterotopic ossification after spinal cord injury with COX-2 selective inhibitor (rofecoxib)
AU - Banovac, K.
AU - Williams, J. M.
AU - Patrick, L. D.
AU - Levi, A.
PY - 2004/12/1
Y1 - 2004/12/1
N2 - 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.
AB - 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.
KW - COX-2-selective inhibitor
KW - Heterotopic ossification
KW - Prevention
KW - Rofecoxib
KW - Spinal cord injury
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U2 - 10.1038/sj.sc.3101628
DO - 10.1038/sj.sc.3101628
M3 - Article
C2 - 15179440
AN - SCOPUS:11244296166
VL - 42
SP - 707
EP - 710
JO - Spinal Cord
JF - Spinal Cord
SN - 1362-4393
IS - 12
ER -