The HIP Impact Protection Program (HIP PRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058864
Recruitment Status : Completed
First Posted : April 15, 2003
Last Update Posted : February 27, 2009
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
HIP PRO is a multicenter randomized, controlled trial of an energy absorbing and distributing padding system designed to reduce the incidence of hip fractures in 546 nursing home (NH) residents. The trial is being conducted in three geographic regions of the US: Boston, St. Louis, and Baltimore. Non bed- or chair-bound residents over the age of 65 are given protective underwear containing a single pocket and hip pad so that each resident becomes his/her own control. During the trial, hip fracture incidence will be compared in padded and unpadded hips using an intent to treat analysis. A secondary aim is to identify resident and facility factors contributing to non-adherence with the use of the hip protector.

Condition or disease Intervention/treatment Phase
Hip Fractures Device: Energy absorbing and distributing trochanteric pad Not Applicable

Detailed Description:

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)
Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Trochanteric Padding to Prevent Hip Fractures
Study Start Date : September 2001
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • Resident of eligible nursing home for at least two weeks
  • Occupying a non-Medicare, non-acute, non-rehabilitation bed in the nursing home
  • Over age 65
  • Capable of independent transfer, not chair- or bed-bound
  • Must give informed consent

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
National Institute on Aging (NIA)

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00058864     History of Changes
Other Study ID Numbers: AG0001
5R01AG018461-02 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2003    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries