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Wiener said that at least two managed care companies have conducted unpublished studies showing that FallGard is associated with a 95% reduction in the rate of hip fractures.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.com
Links within this article:
Hip fractures among older adults, facts (CDC)
http://www.cdc.gov/ncipc/factsheets/adulthipfx.htm
FallGard
http://www.fallgard.com
HipSaver
http://www.hipsaver.com
MJ 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/16034859
JB 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/abstract
K. Weir, "The world's densest bones, The Scientist, October 2006.
'http://www.the-scientist.com/article/display/24837
SL 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=search
P. 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
Advertisement
Rate this article
|
The News |
|||||||
Register for FREE Online Access
- »Current issue
- »Best Places to Work and Salary surveys
- »Daily news and monthly contents emails
Subscribe to the Magazine
- »Monthly print issues
- »Unlimited online access
- »Special offers on books, apparel, and more
[Comment posted 2007-09-04 20:14:27]
FallGard hip protector is the failed hip protector
studied by Douglas Keil, MD of Harvard Medical School as reported in JAMA. As the queen once said:
"what the experts predicted has not come to pass, but what the dam fools said has now happened."
May we all be saved from the experts with their
tax payer grants and publish or perish motivations.
[Comment posted 2007-04-24 13:54:00]
HipSaver, on the other hand, has several independent tests and studies available on its web site.
These tests and studies, by MDs,RNs, PTs, and PhDs, show effectiveness, compliance, and biomechanical mechanical reduction of forces below the fracture threshold of the osteoporotic trochanter. And yes,
HipSaver covers the trochanter in the Minns study.
If Stanley is disturbed by reference to Matthew Lapinski he should direct his efforts to the HHS
Office of Research Integrity which found that as a subcontractor for Stanley's company (Hipco), Lapinski falsified and fabricated data about the effectiveness if Stanley's product. One can google "Matthew Lapinski" to see the HHS report.
[Comment posted 2007-04-23 18:45:51]
not do these studies myself. The large Clinical Grant given to Hipco/FallGard was contracted to Washington University in St Louis. We were not directly involved in this study except to supply hip protectors. Studies by 3 different biomechanical methods have shown FallGard absorbs 70-80% of impact force while Goodwin's Product only 35-40 %. We have confirmed FG pad position by x-ray and palpation on numerous real patients to be over the trochanter. In fact, Goodwin's Hipsaver may be placed too low to cover the trochanter. The Minns Study is only a model and does not match x-ray with radioopaque markers and actual experienced physician palpation of the easily located greater trochanter. of the hip. Mr Goodwin is neither a physician, medical school faculty or a biomedical scientist. He has attacked FallGard for 2 years with allegations that even Dr Minns does not support since it was done on a brand new unvalidated torso model, not real patients. If Mr Goodwin wants to prove his allegations he needs to fund and do a study on real patients or stop this harassment He has not received funds from the NIH because they did not approve his application based on merit and judged with other grants by a committee of 12 or more experts, none of whom do I know, yet alone have influence with. Mr Goodwin also exagerates since he doesn"t need to provide evidence. The greater trochanter of the hip is right under the skin as is the nasal bone, olecranon bone at the elbow,patella at the knee, tibia and are all easily located if you know topographical anatomy (part of physical diagnosis training). which I have taught at the University of Illinois since 1982 and directed the physical exam/diagnosis program for over 14 years. Finally all companies are either profit or nonprofit and FallGard deserves to make some money for salaries, and for research and development to provide an excellent lifesaving product for the elderly. I don't believe Hipsaver is a non profit company. Finally, Mr Goodwin insinuates that FallGard hires engineers to fake results for marketing purposes. We have never and will never falsify data to increase sales. All products have been tested over 20 times each by the same three methods without FallGard input to the final results. The NIH expects integrity in those it funds. I or FallGard have never been accused of lack of integrity or fraud by the NIH Office of Research Integrity. I have been doing biomedical research for over 45 years. We were not employers of Mr Lipski who falsified research data at Washington University and was fired by Washington University. I never hired, fired, or met him.
A brief anatomy lesson, Mr Goodwin. The upper edge of the trochanter begins 3-4 inches below the iliac crest. It is right beneath the skin and fat layer. It is easily palpated except in the very obese. It is located 3-4 inches below the iliac crest and its location confirmed by feeling it move under your fingers as the thigh is flexed.
Try this simple manauver on your hipsaver placement. Your pads are placed 1-2 inches too low by this method. Maybe you should have had an experienced clinician locate the trochanter before you sewed in and placed the upper end of your pads below the trochanter.
[Comment posted 2007-04-21 14:00:55]
None of his studies and testing were conducted by independent researchers, but were all under his direction as the owner of the for profit Hipco.
Worse, yet, his tests "prove" that most hip protectors on the US market are "dangerous" except for his Fall Gard hip protector. This "finding" conflicts with independent university biomechanical testing of those other products.
His Fall Gard product tests are not so glowing when
sujected to independent university evaluations. This fact highlights the need that NIH funds to a commercial enterprise should require the evaluation of external independent researchers
and not the potentially biased internal evaluations of a profit motivated company.
Concerning his commentary on x-ray evaluation of
pad position, he is simply wrong. Professor Minns
pad position study is a confirmation of what those in the trade already knew:the Fall Gard pad is about 4" too high to protect the trochanter.
[Comment posted 2007-04-18 22:56:16]
Generally with hockey, and a few other sports, falls come with the territory. Two pieces of equipment, the compression shorts, and the girdle are designed to minimize the consequences of high-force hits or falls to the hip and tailbone areas for older teen and adult age players.
It would frighten me as a recreational Goalie to think that sports gear design is as random and annecdotal as it seems to be in the article on medical hip protectors, as next to my face mask, my hips seem to take the brunt of my intentional falls to stop low shots, as well as charges on net by other players which go awry.
Professional athletes can command contracts worth more than the gross sales of many small corporations, so the incentive for protecting their bodies from injury is great, and computer modeling and engineering experiments for development of their protective gear common. Of course this research filters down to the much larger recreational sports gear market.
Surely some of the research in sports gear could provide fertile ground for development of more effective hip protectors; but if medical hip protectors are commoditized to the point that they become merely higher-priced Kimbies, then there's not going to be much incentive to improve the product, ehhhhh-
While I understand that important factors are different, such as bone density, and agility, passive protection for hip areas would appear to be mostly an engineering problem. It would be instructive, as well as reassuring to hear some of these companies discuss their products in terms of their engineering prowess; experimental development and trials, instead of annecdotes.