Prevention of Hip Fracture in Elderly People with Use of a Hip Protector
Pekka Kannus, M.D., Ph.D., Jari Parkkari, M.D., Ph.D., Seppo Niemi, Matti Pasanen, M.Sc., Mika Palvanen, M.D., Markku Järvinen, M.D., Ph.D., and Ilkka Vuori, M.D., Ph.D.
Background Hip fractures are common in frail elderly adultsworldwide. We investigated the effect of an anatomically designedexternal hip protector on the risk of these age-related fractures.
Methods We randomly assigned 1801 ambulatory but frail elderlyadults (1409 women and 392 men; mean age, 82 years), in a 1:2ratio, either to a group that wore a hip protector or to a controlgroup. Fractures of the hip and all other fractures were recordeduntil the end of the first full month after 62 hip fractureshad occurred in the control group. The risk of fracture in thetwo groups was compared, and in the hip-protector group therisk of fracture was also analyzed according to whether theprotector had been in use at the time of a fall.
Results During follow-up, 13 subjects in the hip-protector grouphad a hip fracture, as compared with 67 subjects in the controlgroup. The respective rates of hip fracture were 21.3 and 46.0per 1000 person-years (relative hazard in the hip-protectorgroup, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.008).The risk of pelvic fracture was slightly but not significantlylower in the hip-protector group than in the control group (2subjects and 12 subjects, respectively, had pelvic fracture)(relative hazard, 0.4; 95 percent confidence interval, 0.1 to1.8; P 0.05). The risk of other fractures was similar in thetwo groups. In the hip-protector group, four subjects had ahip fracture (among 1034 falls) while wearing the protector,and nine subjects had a hip fracture (among 370 falls) whilenot wearing the protector (relative hazard, 0.2; 95 percentconfidence interval, 0.05 to 0.5; P=0.002).
Conclusions The risk of hip fracture can be reduced in frailelderly adults by the use of an anatomically designed externalhip protector.
Hip fractures are a major cause of disability, functional impairment,and death in elderly people.1,2,3,4,5,6 Furthermore, the frequencyof hip fractures is likely to increase because the number andmean age of elderly adults are increasing and because, in manycountries, the age-adjusted incidence (that is, the averageindividual risk) of hip fracture is also increasing.4,7,8
The alarming increase in the frequency of hip fracture has resultedin the development of various methods for the prevention offractures, including exercise, calcium and vitamin D supplementation,specific drugs to prevent or treat osteoporosis, and multifacetedinterventions to modify the risk of falling.9,10,11,12,13,14,15However, since in most cases of hip fracture the immediate causeof the fracture is a sideways fall with direct impact on thegreater trochanter of the proximal femur,16,17,18,19,20 a logicaloption, but one that has as yet been poorly studied, is to usea device to protect the hips, so that at the time of a fallthe force and energy of the impact are attenuated and shuntedaway from the greater trochanter, preventing fracture.
We undertook this study to determine whether an external hipprotector would be effective in preventing hip fractures amongelderly adults.
Methods
Study Design
We studied elderly adults from 22 community-based health carecenters in the southern and central parts of Finland. Each centerhad treatment units (geriatric long-stay facilities or outpatientcare units for supported living at home) for the care of elderlypeople at high risk for hip fracture and other fractures inducedby falls.
Between October 1996 and April 1997, the research coordinatorat each health care center, with the help of the other caregivers,selected treatment units for participation in the study and,according to predefined inclusion criteria, identified fromeach unit all ambulatory men and women who were 70 years oldor older and who had at least one easily identifiable risk factorfor hip fracture (a previous fall or fracture, impaired balanceor mobility, use of walking aids, cognitive impairment, impairedvision, poor nutrition, or a disease or medication known topredispose people to falls and fractures).18,21 By definition,persons who were ambulatory were those able to walk, regardlessof whether an assistive device (such as a cane or walker) wasused or whether another person was needed for support.
When the identification of eligible subjects was finished ata given study center, each of its participating treatment unitswas randomly designated, in a 1:2 ratio, either as a hip-protectorunit (in which all the participating subjects would receivea hip protector) or as a control unit (in which none of thesubjects would use a hip protector).22 The randomization wasperformed according to the treatment unit, and not accordingto the subject, because the staff members at all the participatingcenters were convinced that the study could not be conductedsuccessfully if, within a treatment unit, some of the subjectsreceived protectors and others did not, since subjects who didnot receive a protector as part of the study might also startto use one. Randomization was performed at the President UrhoKaleva Kekkonen Institute for Health Promotion Research by anindependent physician with the use of sealed envelopes.
The calculation of sample size indicated that, if the rate ofhip fracture in the hip-protector group was 50 percent lowerthan the expected rate of fracture in the control group (5 percentper year), we would need to enroll a minimum of 410 subjectsin the hip-protector group and 820 subjects in the control groupand follow them for 18 months. However, since the expected rateof hip fracture and the expected reduction in risk were onlyestimates, we decided that, if necessary, the trial would becontinued beyond 18 months, until the end of the first fullmonth after 62 hip fractures had occurred in the control group.
The study protocol was approved by the institutional reviewboard and the ethics committee of the Institute for Health PromotionResearch, and all the subjects or their family members or guardiansgave written informed consent for participation.
Subjects
We identified 1725 subjects who were eligible for the studyaccording to the inclusion criteria described above; 650 ofthem were in units that had been assigned to the hip-protectorgroup and 1075 were in units that had been assigned to the controlgroup. After the study had been explained to them, 204 of thesubjects in units assigned to the hip-protector group (31 percent)and 94 of the subjects in units assigned to the control group(9 percent) declined to participate; thus, at base line therewere 446 subjects in the hip-protector group and 981 subjectsin the control group (Figure 1). The sex and age distributionsof the eligible subjects who chose not to participate and ofthose who did participate were similar.
The dropout rate among these frail elderly adults was expectedto be high because of death, onset of an inability to walk,hip fracture, or withdrawal of consent. Therefore, the studypositions of subjects who dropped out were to be refilled, wheneverpossible, by new eligible subjects from a waiting list. Sinceeach treatment unit had its own waiting list, the chance thata new subject would be in the hip-protector group or in thecontrol group was similar to that of any of the subjects inthe initial group of 1725 subjects.
A subject who discontinued or reduced the amount of time heor she used the hip protector remained in the study, and follow-upwas discontinued only for the reasons given above (death, inabilityto walk, hip fracture, or withdrawal of consent). A subjectwho stopped wearing the hip protector or who reduced the amountof time spent wearing it could, at any time, start wearing itagain or increase the amount of time spent wearing it. All thesubjects who dropped out of the study were included in the analysesfor the period during which they participated.
Hip Protector
The hip protector used (KPH Hip Protector, Respecta, Helsinki,Finland) (Figure 2) was developed and extensively tested beforethe initiation of this trial. The tests to which it was subjectedincluded biomechanical tests of its capacity to attenuate forcein laboratory models23,24 and in young volunteers25 and assessmentof its acceptability among nursing-home residents, and users'compliance, during a six-month period.26
The two padded protectors are worn inside pockets on a stretchy undergarment.
The protector shield (length, 19.0 cm; maximal width, 9.0 cm;maximal height, 4.5 cm) is convex, with its deepest portiondesigned to fit over the greater trochanter, and is shaped tocover the proximal femur. It is anatomically designed to shuntthe energy of an impact away from the greater trochanter tothe soft tissues anterior, posterior, and superior to the proximalfemur and to absorb part of the energy of an impact to the hip.The lowest point of contact of the protector is on the femoralshaft. Two protectors, which are padded, are worn with use ofa specially designed, stretchy undergarment containing a pocketon each side for placement of a protector. The design and paddingof the hip protectors make them relatively easy to wear undera skirt or pants without limiting walking, sitting, or squatting.26
At each center, the local research coordinator and the othercaregivers advised the subjects assigned to the hip-protectorgroup on the use of the device. The subjects in this group wereasked to wear the protector whenever they were on their feetand especially when they were at high risk for falling, as whenwalking on slippery sidewalks in the winter.
Outcome Variables
The primary outcome variable was fracture of the hip or fractureof the proximal femur. All other fractures were also recorded(pelvic fractures, other fractures of the legs or trunk, andfractures of the arms). The fractures were prospectively recordedduring the study so that the principal investigators at theInstitute for Health Promotion Research were informed abouta new fracture as soon as possible after it occurred. In addition,at the end of the study, the research coordinators at each healthcare center retrospectively reviewed the medical records ofthe subjects to verify the completeness of the data on any fractures.Each fracture was documented with radiographs. If a subjecthad more than one fracture other than a hip fracture duringthe study, he or she continued to participate; only if a hipfracture occurred was follow-up discontinued, according to thestopping rules described above.
Secondary outcome variables were the number and rate of fallsin the hip-protector group and the number of days the subjectsin this group wore the protector. At the time of a fall, caregiverscompleted a one-page form with information on the date and placeof the fall, the activity being engaged in at the time of thefall, possible reasons for the fall, the circumstances and mechanismof the fall, the height and direction of the fall, the anatomicalsite of the impact, and injuries, if any. In addition, for subjectsin the hip-protector group, whether or not the subject was usingthe protector at the time of the fall was recorded.
Caregivers used a research diary to mark the days when the subjectsin the hip-protector group wore the protector for a minimumof one hour. The total number of days on which the protectorwas worn was then calculated and expressed as a percentage ofall follow-up days.
Statistical Analysis
In the primary analysis, the occurrence of hip fractures wasanalyzed according to a survival-analysis technique, and theeffect of treatment was expressed as a relative hazard and 95percent confidence interval; the estimate of the relative hazardwas then derived by Cox proportional-hazards analysis with useof the likelihood-ratio method.27 The results were then plottedas the cumulative hazard of fracture according to follow-uptime. For other fractures, which could be recurrent, Poissonanalysis was used.28,29 This analysis took into account thepossibility of multiple events per person during follow-up,and the results were expressed as a relative hazard and corresponding95 percent confidence interval.
In the analysis of the efficacy of the hip protector, our goalwas to determine the risk of hip fracture (and other fractures)in the hip-protector group when the hip protector was actuallyworn at the time of a fall, as compared with the risk when theprotector was not worn. For this analysis the Poisson methodwas used. The rates of hip fracture and other fractures werethen calculated as the number of fractures per 100 falls andexpressed as the relative hazard (and 95 percent confidenceinterval).
The number of patients who would need to be treated with thehip protector to prevent one hip fracture (the number neededto treat) was calculated as the reciprocal of the absolute differencein the incidence of fracture between the control group and thehip-protector group.30,31 The 95 percent confidence limits forthe number needed to treat were calculated as the reciprocalsof the values that defined the confidence interval for the absolutedifference in the incidence of fracture.32
Results
During the study, 219 subjects in the hip-protector group droppedout of the trial but were included in the analysis for the periodduring which they participated, and 207 new subjects from thewaiting list entered the trial; thus, the analysis included653 subjects in the hip-protector group (Figure 1). In the controlgroup, 438 subjects dropped out but were included in the analysisfor the period during which they participated, and 167 new subjectsentered the trial; thus, there were 1148 subjects in this group.The base-line characteristics of the subjects in the two groupswere similar, with a few exceptions (Table 1).
Table 1. Base-Line Characteristics of the Subjects in the Hip-Protector Group and the Control Group.
In the hip-protector group, the mean (±SD) degree ofcompliance with use of the protector (i.e., the number of daysthe protector was worn as a percentage of all available follow-updays) was 48±29 percent (range, <1 to 100). Duringfollow-up, there were 1404 falls in this group, of which 1034(74 percent) occurred while the hip protector was being used.There were few adverse effects resulting from use of the hipprotector; 15 subjects had skin irritation or abrasion, 1 subjectreported that the protector caused swelling of the legs, and1 reported that it caused bowel irritation. None of the subjectshad an allergic skin reaction to the device.
Fractures in the Two Groups
During the study, 13 subjects in the hip-protector group hada hip fracture, as compared with 67 subjects in the controlgroup. The respective rates of hip fracture (per 1000 person-years)were 21.3 and 46.0 (relative hazard of hip fracture in the hip-protectorgroup, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.008)(Table 2 and Figure 3). Two subjects in the hip-protector grouphad pelvic fractures, as compared with 12 subjects in the controlgroup; the respective incidence rates were 3.3 and 8.2 per 1000person-years (relative hazard of pelvic fracture in the hip-protectorgroup, 0.4; 95 percent confidence interval, 0.1 to 1.8; P 0.05).The risk of other fractures was similar in the two groups (Table 2).Adjustment of the results for potentially confounding variablesdid not alter the findings.
Figure 3. Cumulative Hazard of Hip Fracture in the Hip-Protector Group and in the Control Group.
Fractures in the Hip-Protector Group According to Use of the Protector
Four subjects in the hip-protector group had hip fractures (among1034 falls) while wearing the hip protector (0.39 fracture per100 falls), whereas nine subjects in this group had hip fractures(among 370 falls) while not wearing the hip protector (2.43fractures per 100 falls). The relative hazard of hip fracturewhile wearing the device was 0.2 (95 percent confidence interval,0.05 to 0.5; P=0.002) (Table 3).
Table 3. Fractures in the Hip-Protector Group, According to Use of the Protector.
The risk of pelvic fracture or fracture in the legs or trunkalso seemed to be related to the use of the hip protector atthe time of the fall, whereas the risk of fracture of the armswas not (Table 3).
Number Needed to Treat
According to the comparison of the hip-protector group withthe control group, the number needed to treat for one year toprevent one hip fracture was 41 persons (95 percent confidenceinterval, 25 to 115), and the number needed to treat for fiveyears was 8 persons (95 percent confidence interval, 5 to 23).
Discussion
The results of our trial indicate that among ambulatory elderlyadults who are at an increased risk for hip fracture, the riskof fracture can be reduced by 60 percent by the use of an anatomicallydesigned external hip protector. In accordance with this observation,the risk of fracture can be decreased by more than 80 percentif the protector is worn at the time of a fall.
This trial had several strengths. In addition to being randomized,the trial was large enough to fulfill the calculated requirementsfor statistical power. The biomechanical capacity of the hipprotector for force attenuation23,24,25 and the compliance amongpersons offered the protector26 were well documented beforethe trial. These features are probably important reasons whythe protector was efficacious and was used successfully by thesubjects in this study (74 percent of the falls in the hip-protectorgroup occurred while the subjects were wearing the protector).This, in turn, allowed us not only to compare the risk of hipfracture in the hip-protector group with that in the controlgroup but also to assess the biomechanical efficacy of the protectorin actual falls.
The chief weakness of the study was that not all of the subjectswere willing to wear the hip protector as a part of their dailyclothing. In our trial, 31 percent of the eligible subjectsrefused to wear the protector and thus remained without protection.This naturally limits the extent to which the results of ourstudy can be generalized to all elderly persons. On the otherhand, in no study of fracture prevention has the interventionbeen acceptable to all subjects, and in our study 9 percentof the subjects assigned to the control group also refused participation,a sign of the unwillingness of some frail elderly people toparticipate in any type of follow-up.
In this trial, randomization was performed according to treatmentunit at the participating centers rather than according to individualsubject. This technique ordinarily requires allowance in theanalysis for a cluster effect (i.e., correlation among the responseswithin a unit). However, since the events we analyzed (fractures)were rare, the within-unit correlation is likely to have hadlittle effect on the results.
The design of the study resulted in a difference in the ratesat which the subjects in the two groups initially refused toparticipate (31 percent in the hip-protector group and 9 percentin the control group) — an important potential sourceof selection bias. However, we think that the probability ofthis bias is not very high, because the age and sex distributionof the subjects who did participate in the hip-protector groupor the control group was similar to that of the subjects whochose not to participate. Moreover, the other base-line characteristicsof the subjects in the two groups were similar, which suggeststhat their participation was unbiased.
In this study, the risk of pelvic fracture was slightly butnot significantly lower among the subjects in the hip-protectorgroup than among those in the control group. This result isnot surprising, because a pelvic fracture, like a hip fracture,is likely to occur as a result of a fall,25,34 and the protectormay be able to prevent the pelvic fracture by partially absorbingand spreading the energy of impact. The finding that the rateof other fractures was not lower in the hip-protector groupthan in the control group is also not surprising and suggeststhat subjects in the hip-protector group were not more attentivethan their counterparts to the risks of falling and fracturesoverall. Protective devices designed specifically for otherparts of the body will need to be developed if protector-basedprevention against other fractures is desired.
The compliance of the frail elderly adults in our study withuse of the hip protector was in line with that in a preliminarystudy.26 By intention, in both of these studies, the primaryinvestigators never came to the treatment units; the local caregiversindependently took care of the subjects (and the hip protectors).This practical approach should approximate the real-life conditionsof most geriatric health care units.
We conclude that the risk of hip fracture can be reduced infrail elderly adults through the use of an anatomically designedexternal hip protector. Only 41 persons need to use the protectorfor one year (or 8 persons, for five years) in order for onefracture to be prevented.
Supported by grants from the Medical Research Fund of TampereUniversity Hospital, Tampere, Finland, and from the FinnishOffice for Health Care Technology Assessment, Helsinki, Finland.
We are indebted to the local research coordinators and othercaregivers at the health care centers of the study for theirinterest, help, and dedication in conducting the trial.
Source Information
From the Accident and Trauma Research Center (P.K., S.N., M. Pasanen, M. Palvanen, I.V.) and the Research Center of Sports Medicine (J.P.), President Urho Kaleva Kekkonen Institute for Health Promotion Research; and the Department of Surgery, Tampere University Medical School and University Hospital (M.J.) — all in Tampere, Finland.
Address reprint requests to Dr. Kannus at the President Urho Kaleva Kekkonen Institute for Health Promotion Research, Kaupinpuistonkatu 1, FIN-33500 Tampere, Finland, or at klpeka{at}uta.fi.
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0.05). The risk of other fractures was similar in the two groups. In the hip-protector group, four subjects had a hip fracture (among 1034 falls) while wearing the protector, and nine subjects had a hip fracture (among 370 falls) while not wearing the protector (relative hazard, 0.2; 95 percent confidence interval, 0.05 to 0.5; P=0.002). 
