The HIP Impact Protection Program (HIP PRO)
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|ClinicalTrials.gov Identifier: NCT00058864|
Recruitment Status : Completed
First Posted : April 15, 2003
Last Update Posted : February 27, 2009
|Condition or disease||Intervention/treatment|
|Hip Fractures||Device: Energy absorbing and distributing trochanteric pad|
The HIP PRO Study is a randomized, controlled trial of the efficacy of a trochanteric padding system in the reduction of hip fractures in nursing home residents over the age of 65 in up to 45 nursing homes in three regions: Boston, MA, St. Louis, MO, and Baltimore, MD. Eligible residents of these facilities will be screened and then evaluated during a two week run-in period during which a hip protection compliance rate of at least 67% will be required for enrollment. Recruitment of all eligible residents entering each nursing home will continue throughout the 3.5 year follow-up period.
Each subject will be given a set of 4-6 protective underwear containing a single pocket and protective pad so that each resident becomes his/her own control. The side to be protected will be based on the randomization of nursing home facilities to either right or left-sided hip protection. The hip protection underwear is designed so that it may be worn during the day and while in bed at night. Several types of underwear have been designed for residents with special needs (e.g. incontinence, dementia). Compliance and efficacy are monitored at least three times weekly across all three nursing shifts.
A hip fracture adjudication committee, blinded to the side of the fracture, will review all information (including hospital records and radiologists' reports or hip radiographs) and issue a decision on whether a fracture has occurred. Primary analyses will be performed using an "intention to treat" approach. Secondary analyses will investigate resident and nursing home factors associated with hip protection compliance and effectiveness. An independent Data and Safety Monitoring Board (DSMB) has been convened and will review hip fracture rates and adverse event data at regular intervals.
Institutions participating in HIP PRO are: a Data Coordinating Center at Maryland Medical Research Institute in Baltimore, MD; three Clinical Centers at Washington University School of Medicine in St. Louis, MO, the University of Maryland in Baltimore, MD with the University of North Carolina in Chapel Hill, NC, and the Hebrew Rehabilitation Center for Aged in Boston, MA. The Data Coordinating Center will direct the overall administrative management of the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||546 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trochanteric Padding to Prevent Hip Fractures|
|Study Start Date :||September 2001|
|Primary Completion Date :||August 2006|
|Study Completion Date :||August 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058864
|United States, Maryland|
|University of Maryland, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Maryland Medical Research Institute|
|Baltimore, Maryland, United States, 21210|
|United States, Massachusetts|
|Hebrew Rehabilitation Center for Aged Research and Training Institute|
|Boston, Massachusetts, United States, 02131-1097|
|United States, Missouri|
|Washington University School of Medicine, Division of Geriatrics & Gerontology|
|St. Louis, Missouri, United States, 63108|