A fight to protect hip protectors

A study of how various devices fit stokes a debate that includes allegations of bias in NIH funding, misconduct, and ineffectiveness

Written byAlison McCook
| 4 min read

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Findings from a study that measured where different brands of hip protectors fall on a user's hip have pitted one competitor against another, with each struggling to earn a greater share of a growing market to prevent one of the most deadly accidents that occur in the elderly.A number of companies -- including Naperville, Illinois-based FallGard and Canton, Massachusetts-based HipSaver -- manufacture hip protectors, which contain protective shells within something akin to an undergarment, worn under regular clothing. Both HipSaver and FallGard cost less than $100 each.To protect the hip during falls, the protective shell of these devices must cover the greater trochanter of the femur. In the February issue of Age and Ageing, researchers used ultrasound to measure where various hip protectors fall on a user's hip, and found that some products -- including FallGard, currently in use by thousands of people -- miss their mark.One of the products the Age and Aging study showed falls on the correct right part of the hip was HipSaver, and HipSaver president Ed Goodwin is now speaking out against FallGard. Although some research has suggested that external hip protectors don't work, studies have also shown that some products do, Goodwin said. A study in a 2003 issue of the Journal of the American Medical Directors Association showed that, over 13 months, 38 people who wore HipSavers experienced no hip fractures, even after a total of 126 falls.Cluttering the industry with products that don't work may turn people off from all hip protectors, he said. "A product like [FallGard] will not push the field forward," Goodwin told The Scientist. "I am trying to protect the image of hip protectors." But FallGard's president Stanley Wiener, former chief of general internal medicine at the University of Illinois in Chicago, argues that X-ray examinations of real patients show his product does fall on the greater trochanter, and X-ray produces a more reliable measurement of placement than the ultrasound technique used in the Age and Ageing study. As a doctor, Wiener said he's an expert at palpating hip bones. "The pad does cover the trochanter completely," he told The Scientist.First author of the paper RJ Minns of Newcastle General Hospital, UK, declined to comment on the implications of his findings for individual products.Wiener said that at least two managed care companies have conducted unpublished studies showing that FallGard is associated with a 95% reduction in the rate of hip fractures. An NIH-sponsored three year study of 560 nursing home residents reported hip fractures in 19 patients who did not wear FallGard, and only 1 fracture among the patients who did. Yet another clinical trial on 14,000 nursing home residents showed FallGard decreased the annual hip fracture rate from 5% to 1.3%. The data are "in preparation" for publication, but have been presented at meetings, Wiener noted. Wiener said he even went so far as to wear FallGard himself and fall, while in his 70s, from a standing position. "I did about 40 falls, never injured my hips," he said. A paper in Clinical Orthopaedics and Related Research showed FallGard protected 10 volunteers from more than 80 falls, and the FallGard homepage includes a short video of a volunteer falling while wearing the protector. "This [product] has been developed very carefully," Wiener said.Pekka Kannus, chief physician at the Injury & Osteoporosis Research Center at the UKK Institute in Finland, who reviewed the Age and Ageing study for The Scientist, said that the Age and Ageing paper used torso models, which are less reliable than in vivo work. And it's not just positioning that makes a good hip protector -- "the biomechanical force attenuation capacity of any hip protector model in a fall situation is crucial for hip fracture prevention," Kannus said.Kannus agreed that there remains "uncertainty" regarding whether hip protectors work at all, "mostly since there are so many poorly-studied protector models on the market." As it is, the consensus is that protectors should only be used in people at especially high risk of fractures.Goodwin also faults FallGard for monopolizing National Institutes of Health (NIH) funding for hip protectors. FallGard has been investigated using NIH funds (Wiener lists a small business grant worth approximately $1 million) but when Goodwin applied for grants, he was denied, a decision he said he believes stemmed from the NIH's unwillingness to sponsor research on more than one hip protector. Sergei Romashkan, chief of the clinical trials branch at the National Institute on Aging, which funds hip protection research, told The Scientist the agency never decides to fund only one product, and all applications are judged based on their own individual merit. He would not say why HipSaver's applications were denied.Goodwin also faxed The Scientist a Department of Health and Human Services report on Matthew Lipski, a researcher working on subcontract for FallGard's company who was found guilty of falsifying and fabricating patient data. However, Wiener said Lipski had "nothing to do with" FallGard, and all of his data were eliminated from any analyses.Alison McCook mail@the-scientist.comLinks within this article:Hip fractures among older adults, facts (CDC) http://www.cdc.gov/ncipc/factsheets/adulthipfx.htmFallGard http://www.fallgard.comHipSaver http://www.hipsaver.comMJ Parker et al, "Hip protectors for preventing hip fractures in older people," Cochrane Database Syst Rev, July 20, 2005. http://www.the-scientist.com/pubmed/16034859JB Burl et al, "Hip Protector Compliance: A 13-Month Study on Factors and Cost in a Long-Term Care Facility," Journal of the American Medical Directors Association, September 2003. http://www.jamda.com/article/PIIS1525861004703679/abstractK. Weir, "The world's densest bones, The Scientist, October 2006. 'http://www.the-scientist.com/article/display/24837SL Wiener et al, "Force reduction by an external hip protector on the human hip after falls," Clinical Orthopaedics and Related Research, May 2002. http://www.corronline.com/pt/re/corr/abstract.00003086-200205000-00023.htm;jsessionid=GbGZJdC1qDybcgx2G3brBcdlGvbJ2y3l3Hgy7rykZJsM0khQ2yJd!-680354521!-949856145!8091!-1?index=1&database=ppvovft&results=1&count=10&searchid=1&nav=searchP. Kannus et al, "Prevention of hip fracture in elderly people with use of a hip protector," New England Journal of Medicine, November 23, 2000. http://www.the-scientist.com/pubmed/11087879
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