As measured by their frequency, influence on quality of life and economic cost, hip fractures are a public health problem of crisis proportions. Studies suggest that hip fractures may be prevented by the use of protective trochanteric padding, although some of those studies were small, had potential biases introduced by randomizing nursing homes or nursing home units, and used energy shunting pads. Fractures may still occur beneath such pads, and compliance has been variable because these pads were not particularly easy to wear or comfortable. We plan to conduct a randomized controlled trial of an energy absorbing and distributing, trochanteric padding system to reduce the incidence of hip fractures in 546 NH residents followed for an average of three years. To carry out this trial, a Coordinating Center (Maryland Medical Research Institute in Baltimore) will work with three clinical centers in Boston, Baltimore, and St. Louis that will each recruit 10-14 NHs and 182 NH residents to participate; residents will be replaced as they drop out during the follow up period. This sample size accounts for an effect size of 50 percent, and compliance rate of 50 percent. Each subject will be given a set of protective underwear containing a single pocket and hip pad so that each resident becomes his/her own control. The side to be protected is based on the randomization of facilities to be either """"""""right"""""""" or """"""""left-sided"""""""" such that the final sample will consist of an approximately equal number of residents with protection on the right as on the left hip. Using an intent to treat analysis, we will compare hip fracture incidence in padded and unpadded hips. The secondary aim will be to identify patient and facility factors contributing to non-adherence with the use of hip protectors. This will be the largest clinical trial of this biomechanically tested, energy absorbing and distributing hip protector ever conducted in the United States.
| Cameron, I D; Robinovitch, S; Birge, S et al. (2010) Hip protectors: recommendations for conducting clinical trials--an international consensus statement (part II). Osteoporos Int 21:1-10 |
| Zimmerman, Sheryl; Magaziner, Jay; Birge, Stanley J et al. (2010) Adherence to hip protectors and implications for U.S. long-term care settings. J Am Med Dir Assoc 11:106-15 |
| Robinovitch, S N; Evans, S L; Minns, J et al. (2009) Hip protectors: recommendations for biomechanical testing--an international consensus statement (part I). Osteoporos Int 20:1977-88 |
| Barton, Bruce A; Birge, Stanley J; Magaziner, Jay et al. (2008) The Hip Impact Protection Project: design and methods. Clin Trials 5:347-55 |
| Kiel, Douglas P; Magaziner, Jay; Zimmerman, Sheryl et al. (2007) Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA 298:413-22 |
