Prevention of heterotopic ossification after spinal cord injury with COX-2 selective inhibitor (rofecoxib).

Abstract:

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.

journal_name

Spinal Cord

journal_title

Spinal cord

authors

Banovac K,Williams JM,Patrick LD,Levi A

doi

10.1038/sj.sc.3101628

subject

Has Abstract

pub_date

2004-12-01 00:00:00

pages

707-10

issue

12

eissn

1362-4393

issn

1476-5624

pii

3101628

journal_volume

42

pub_type

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