Prevention of hip fractures by external hip protectors: a randomized controlled trial.

CONTEXT Several randomized controlled trials have been performed to examine the effectiveness of external hip protectors in reducing the incidence of hip fractures, but the results are controversial. OBJECTIVE To examine the effectiveness of hip protectors in reducing the incidence of hip fractures in an elderly high-risk population. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled trial of elderly persons aged 70 years or older, who have low bone density, and are at high risk for falls. Participants lived in apartment houses for the elderly, homes for the elderly, and nursing homes in Amsterdam and surrounding areas in the Netherlands. They were enrolled in the study between March 1999 and March 2001; the mean follow-up was 69.6 weeks. Of the 830 persons who were screened, 561 persons were enrolled. INTERVENTION External hip protector. Both groups received written information on bone health and risk factors for falls. MAIN OUTCOME MEASURE Time to first hip fracture. Survival analysis was used to include all participants for the time they participated. RESULTS In the intervention group, 18 hip fractures occurred vs 20 in the control group. Four hip fractures in the intervention group occurred while an individual was wearing a hip protector. At least 4 hip fractures in the intervention group occurred late at night or early in the morning. Both in univariate analysis (log-rank P =.86) and in multivariate analysis (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.55-2.03), no statistically significant difference between the intervention group and control group was found with regard to time to first hip fracture. In addition, the per protocol analysis in compliant participants did not show a statistically significant difference between the groups (HR, 0.77; 95% CI, 0.25-2.38). CONCLUSION The hip protector studied was not effective in preventing hip fractures.