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Hip Protectors 'White Paper'

Questions and Answers about Hip Protectors

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'Hip Protectors - Questions and Answers' White Paper by Edward Goodwin, President, HipSaver, Inc. and Halina Wooldridge, MA, Commercial Director, Win Health Ltd., March 2005.

Q.1: In the past 2 years there have been 4 published randomised clinical studies (JAMA1; Age and Aging2; Osteoporosis International3, Age and Ageing4), all of which reported negatively on hip protectors.

What do these studies tell us?

A.1: The hip protector studied in these four negative reports is Safehip brand, a hard shell hip protector.

General conclusion is that this specific hard shell hip protector is not effective, because of low compliance (average 35%). The conclusion drawn by Van Schoor et al1 is that the 'hip protector studied is not an effective intervention' and that possibly a softer and more comfortable hip protector may increase compliance rates.    

The Age and Aging4 study from Birks et al concluded that it is the specific branded design of hip protectors incorporating the hard shells that the elderly people living in the community will not comply with even after suffering a previous hip fracture.      

Q.2: Why are the compliance rates so low?

A.2: Common sense tells us that most people prefer not to have hard plastic shells in their underwear. Human nature is to reject new interventions that require effort or a degree of hardship or are associated with aging or can be perceived to be an admission of diminishing health status. In fact, the Merck Manual reports that only 50% of patients take their medication as directed, thus indicating similar problems with adherence to pharmacological treatments. In light of this, the 35% compliance with wearing underwear reinforced with hard plastic appears to look much better.

It is also worthwhile noting that one of the negative hip protectors studies (Osteoporosis International3) used a questionable methodology of mailing the hip protectors to its elderly study subjects.         

Q.3: Can the negative results with one specific brand of hip protectors be generalised to all other hip protectors?

A.3: No! These results are product specific!

Each hip protector has a variety of features, which determine its efficacy and acceptability. Hip pads vary in softness, thickness, shape and size. Different designs of garments vary in terms of fabrics, construction, sizing, fit and compatibility with common health problems, such as compromised continence, dementia, poor grip or arthritic hands. The finished hip protector must satisfy the needs of both the wearers and the caregivers. Fulfilment of such different needs and requirements presents a real design challenge to the manufacturers of hip protectors.   

Q.4: Are 'spontaneous' fractures common or are hip fractures caused mainly by a fall related impact?

A.4: Finnish researchers at Tampere University reported in 1999 that 98% of the elderly hip fracture patients sustain their fractures as a result of a fall. Specifically - the vast majority of hip fractures (76%) occur as a result of a sideway fall that exerts a direct impact on the greater trochanter of the proximal femur (Kannus et al5).

Kannus and his team concluded that a 'typical hip fracture is fall related', because it is an outcome of a fall and subsequent impact on the greater trochanter.

Similar findings were also reported by American researchers (Hayes et al6 ).

Kannus and his group suggested that the effective prevention of hip fractures can be achieved by decreasing the numbers as well as the severity of the falls and that further on - the severity of falls could be minimised by the use of external hip protectors.

Hip protectors attenuate the force generated by a fall and shelter the bony vulnerable trochanteric prominences from the full effects of an impact.   

Q.5: Can a soft hip protector pad reduce a fall generated impact force sufficiently enough to prevent a hip fracture? 

A.5: Yes, it can!

Biomechanical studies conducted at Tampere University Affiliated Laboratory show that the soft HipSaver pad reduces a 7300 N fall force to below the fracture threshold.

The 'average fracture force' is defined to be at 3100 N +/- 1200 N.

In a laboratory, surrogate mechanical pelvis devices are used to measure the impact attenuation abilities of hip pads in simulated falls conditions. In such tests, the mechanical pelvis is subjected to a force impact that is similar to that generated in a real fall of an elderly person. Force (= energy) applied as well as force (= energy) transmitted through the tested protective pads are precisely measured.

The equation is as follows: Force applied  -  Force attenuated  =  Force transmitted 

Therefore:  Force attenuated  =  Force applied - Force transmitted

On impact, the pads attenuate a portion of the applied force and proportionally reduce the amount of the force that is transmitted to the hip. 

The outcome is obvious:

More effective pads attenuate more force and reduce the amount of the fall generated force more significantly.

Hence - the graph presented shows that in this instance 'less' is better!

HipSaver pad (purple bar) is more effective than Safehip shell (black bar). The more effective HipSaver pad reduces the fall force from 7300 N to 1790 N, placing it below the fracture threshold, whilst Safehip reduces the force to only 2240 N and therefore remains within the fracture threshold. 

As illustrated above - in the Tampere tests, HipSaver soft pads reduce the force of the impact by 20% more effectively than the hard shells of the Safehip hip protectors.

In summary: In the Tampere University hip protector study published in Bone7, the Safehip hard hip protector shells reduced the applied fall force of 7300 N to 2240 N, thus by 20 % less effectively than the soft HipSaver pads.

The Tampere test confirms a common sense finding that it is better to fall on a soft padding than on a hard surface! 

Q.6: Are there any studies on soft hip protectors?

A.6: Yes! There are 2 studies published on HipSaver.

A two-year study published in Advance for Physical Therapists8 reported zero fractures in 199 falls against a fracture rate of 4.3% in the control group. 

A 13-months study published in the Journal of the American Medical Directors Association (JAMDA9) reported a 93% compliance rate with zero fractures in 126 falls.

HipSaver is the only soft hip protector with published clinical studies. Other studies are currently ongoing or about to commence. There is also a wealth of unpublished evidence presented as 'evaluation or implementation projects' by healthcare professionals aiming to improve their local standards of care and/or public health practices. You can view and read three such projects by clicking here - RHINO Project or here -  South West Kent PCT Hip Protector Trial or here -  Hip Protector Pilot Project Report completed in the Medway and Swale. 

Q.7: How readily is HipSaver accepted?

A.7: HipSaver is fast becoming the hip protector of choice. Generally - HipSaver is preferred over other brands, because of its unique combination of wearer comfort, convenience and ease of use coupled with proven efficacy, high compliance, conformance with institutional high temperature laundry regulations and durability that are all very important to the caregivers.  

HipSaver is already the market leader in some countries. The Irish Medical Journal reported recently that HipSaver is used by 70% of those who use hip protectors10.     

Q.8: Is HipSaver approved by the FDA?

A.8: Yes!

HipSaver is cleared by the FDA and registered as a Class 1 Medical Device. Similarly in Europe, HipSaver carries the CE mark of Class 1 Medical Device and is compliant with the requirements of the Medical Devices Directive 93/24/EEC.

Q.9: Are hip protectors cost effective?

A.9: Yes! They are!

A recent economic analysis published in the Journal of the American Geriatric Society (JAGS11) reported that if hip protectors were used consistently in the US nursing homes, they would save 132 million US Dollars ($) in the first year alone. They would also present the elderly people with significant life expectancy gains.    

Q.10: Are hip protectors covered by Medicare or private insurance? 

A.10: US healthcare provider Medicare currently does not reimburse hip protectors. However, some other healthcare providers already cover hip protector provision.    

Q.11: What is the future of hip protectors?

A.11: More and more healthcare practitioners and caregivers observe and witness the benefits of hip protectors in their practices. Future studies will prove the obvious - hip protectors work, when worn. To be worn - hip protectors must be effective, comfortable and acceptable!

Well designed user friendly effective and comfortable hip protectors will continue to grow in popularity.

Memories of the unfriendly and the unacceptable hip protectors will eventually fade away in light of ever increasing positive experiences with superior hip protectors - the wearer and the carer acceptable user friendly hip protectors.              

References:

1. Prevention of Hip Fractures by External Hip Protectors. A randomised controlled trial. Van Schoor, Smit J. H, Twisk J.W.R, Bouter L. M, Lips P. JAMA. 2003;289: 1957-1962.

2. A cluster randomised controlled trial to evaluate a policy of making hip protectors available to residents of nursing homes. O'Halloran P. D, Cran G. W, Beringer T. R. O, Kernohan G, O'NEill C, Orr J, Dunlop L, Murray L. J. Age and Ageing 2004; 33: 582-588. 

3. Randomised controlled trial of hip protectors among women living in the community. Birks Y.F, Porthouse J, Addie C, Loughney K, Saxon L, Baverstock M, Francis R. M, Reid D. M, Watt I, Torgerson D. J, Primary Care Protector Trial Group. Osteoporosis International. Published online: 3 March 2004.

4. Randomised controlled trial of hip protectors for the prevention of second hip fractures. Birks Y. F, Hildreth R, Campbell P, Sharpe C, Torgerson D.J, Watt I. Age and Ageing:2003;32:442-444.

5. Majority of hip fractures occur as a result of a fall and impact on the greater trochanter of the femur. A prospective controlled hip fracture study with 206 consecutive patients. Parkkari J, Palvanen M, Natri A, Vainio J, Aho H, Jarvinen M. Calcified Tissue International 1999; 65(3): 183-187. 

6. Impact near hip dominates fracture risk in elderly nursing home residents who fall. Hayes W.C, Myers E.R, Morris J.N, Gerhart T.N, Lipsitz L.A. Calcified Tissue International 1993; 52:192-198.

7. Comparison of force attenuation properties of four different hip protectors under simulated fall conditions in the elderly. An in vitro biomechanical study. Kannus P, Parkkari J, Poutala J. Bone 1999. 25(2): 229-235.  

8. Hip Pads: Effective Fracture Prevention. Gross G, Tsan-Hui Chen, Flaherty C. Advance for Physical Therapists 2000. 11(22):45-46.       

9. Hip protector Compliance. A 13 - month study on factors and costs in a long term care facility. Burl J.B, Centola J, Bonner A, Burque C. Journal of the American Medical Directors Association (JAMDA) 2003. 4(5): 245-250.

10. Hip Protectors - A Survey of Practice in Ireland. E. K. Stokes, A. Bourke, F. Monahan, C. Scully. The Irish Medical Journal, January 2005; Volume 98, No 1. 

11. A Cost-Benefit Analysis of External Hip Protectors in the Nursing Home Setting. Honkanen L.A, Schackman B.R, Mushlin A.I,   Lachs M.S.  Journal of American Geriatrics Society (JAGS), 2005; 53:190-197.  

   

Printable HipSaver research:

Hip Pads: Effective fracture prevention. George Gross, Tsan-Hui Chen, Carolyn Flaherty. (2000). Advance for Physical Therapists, 11(22), 45-46.

Hip Protector Compliance: A 13 - Months Study on Factors and Cost in a Long - Term Care Facility. Jeffrey B. Burl, James Centola, Alice Bonner, Colleen Burque. Journal of the American Medical Directors Association, 2003; 4(5):245-250.

In the UK, the RHINO Project - a 12 Months Hip Protector Study carried out in Dudley, West Midlands (project funded by the DTi Modernisation Grant) between July 2003 and June 2004 - also confirmed the superiority of the soft HipSavers over the hard shell Safehips. You can view the Rhino Project Final Report here!

View and print out a summary of another successful Hip Protector Project carried out in South West Kent and Maidstone Weald NHS Primary Care Trusts - South West Kent PCT Care Homes Hip Protector Trial Programme

Read and print a Hip Protector Pilot Project Report completed in the Medway and Swale. 

Prevention of fall-induced hip fractures: Usability evaluation of hip protectors. K.R. Dunn, C.L. Brace, T. Masud, R.A. Haslam, R.O. Morris. Contemporary Ergonomics 2005 (edited by P.D. Bust and P.T. McCabe). Taylor and Francis, London. Ergonomics Society Conference, Hatfield, 6-8 April 2005, pp 464-468, ISBN 0415374480

 

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