Effectiveness and acceptability of a newly designed hip protector: a pilot study. Prevention of hip fractures by external hip protectors: a randomized controlled trial. Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial. A randomised trial of hip protector use by frail older women living in their own homes. Randomised controlled trial of hip protectors for the prevention of second hip fractures. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. External hip protectors are effective for the elderly with higher-than-average risk factors for hip fractures. Acceptance of hip protectors for hip fracture prevention in nursing homes. A cluster randomised controlled trial to evaluate a policy of making hip protectors available to residents of nursing homes.
Hip fracture has a significant economic and personal cost, involving hospital admission and functional impairment for elderly people. To assess the benefit of using a newly designed hip protector (new material and new design) to prevent fracture in a realistic setting, a randomised intervention-control design was used to trial the effectiveness of pads worn by high falls risk residents (n=71) in nursing home for 9 months. 40 residents were in the intervention group and 31 were in the control group. A profile of falls, including time of day, and orientation was obtained to demonstrate the potential effectiveness of the protectors for injury prevention. Acceptance of the hip protector was also surveyed amongst nursing home staff and residents. One hundred and one falls and six fractures occurred in the control group. In contrast, one hundred and ninety one falls and three fractures occurred in the hip protector (pads) group. The three fractures in the protector wearing group occurred when pads were not in place. This was extrapolated as 1 in every 16.8 falls and 1 in every 63.7 falls resulting in fracture in the two groups, respectively. The relative risk of fracture was 0.264 (95% CI=0.073-0.959) when the fracture incidence rate in the intervention group (three fractures per 191 falls) was compared to the control group (six fractures per 101 falls). This is a statistically significant result and implies that this newly designed hip protector is effective in preventing hip fracture. The majority of falls occurred during the day, which was when protectors were worn in this study, but the data on orientation was incomplete, with direction unknown in 74% of falls. Compliance was an issue, which was interpreted as only 50.3% of falls recorded with protectors in place. Dementia was identified as the explanation for this as the pads were often removed by these residents who comprised the majority of participants. Perception of low risk was the primary barrier to residents accepting the intervention. Comfort of protectors was not a significant concern for staff or residents, and only staff described appearance as an issue. In conclusion, the newly designed hip protector is protective against fractures in a realistic setting. Compliance and acceptance of the protectors will ultimately determine the viability of this prophylaxis. Several randomized controlled trials have been performed to examine the effectiveness of external hip protectors in reducing the incidence of hip fractures, but the results are controversial.
                To examine the effectiveness of hip protectors in reducing the incidence of hip fractures in an elderly high-risk population.
                Randomized controlled trial of elderly persons aged 70 years or older, who have low bone density, and are at high risk for falls. Participants lived in apartment houses for the elderly, homes for the elderly, and nursing homes in Amsterdam and surrounding areas in the Netherlands. They were enrolled in the study between March 1999 and March 2001; the mean follow-up was 69.6 weeks. Of the 830 persons who were screened, 561 persons were enrolled.
                External hip protector. Both groups received written information on bone health and risk factors for falls.
                Time to first hip fracture. Survival analysis was used to include all participants for the time they participated.
                In the intervention group, 18 hip fractures occurred vs 20 in the control group. Four hip fractures in the intervention group occurred while an individual was wearing a hip protector. At least 4 hip fractures in the intervention group occurred late at night or early in the morning. Both in univariate analysis (log-rank P =.86) and in multivariate analysis (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.55-2.03), no statistically significant difference between the intervention group and control group was found with regard to time to first hip fracture. In addition, the per protocol analysis in compliant participants did not show a statistically significant difference between the groups (HR, 0.77; 95% CI, 0.25-2.38).
                The hip protector studied was not effective in preventing hip fractures. To assess the effects of an intervention programme designed to increase use of hip protectors in elderly people in nursing homes.
                Cluster randomised controlled trial with 18 months of follow up.
                Nursing homes in Hamburg (25 clusters in intervention group; 24 in control group). Participants: Residents with a high risk of falling (459 in intervention group; 483 in control group). Intervention: Single education session for nursing staff, who then educated residents; provision of three hip protectors per resident in intervention group. Usual care optimised by brief information to nursing staff about hip protectors and provision of two hip protectors per cluster for demonstration purposes.
                Incidence of hip fractures.
                Mean follow up was 15 months for the intervention group and 14 months for the control group. In total 167 residents in the intervention group and 207 in the control group died or moved away. There were 21 hip fractures in 21 (4.6%) residents in the intervention group and 42 hip fractures in 39 (8.1%) residents in the control group (relative risk 0.57, absolute risk difference -3.5%, 95% confidence interval -7.3% to 0.3%, P=0.072). After adjustment for the cluster randomisation the proportions of fallers who used a hip protector were 68% and 15% respectively (mean difference 53%, 38% to 67%, P=0.0001). There were 39 other fractures in the intervention group and 38 in the control group.
                The introduction of a structured education programme and the provision of free hip protectors in nursing homes increases the use of protectors and may reduce the number of hip fractures. To investigate the efficacy and effectiveness of hip protectors in frail community living older women.
                Randomised controlled trial.
                Aged care health services in New South Wales, Australia.
                600 women 74 years of age or more (mean age 83 years), who had two or more falls or one fall requiring hospital admission in the previous year, and who lived in their own homes.
                Use of hip protectors.
                Adherence with use of hip protectors, falls, incidence of hip fracture, and adverse effects of use of hip protectors.
                Adherence was approximately 53% over the duration of the study and hip protectors were worn at the time of 51% of falls in the intervention group. The risk of hip fracture when falling while wearing hip protectors, compared with a fall with no hip protectors in place, was significantly reduced (relative risk (RR) 0.23, 95% confidence interval (CI) 0.08 to 0.67). On an intention to treat analysis, 21 and 22 hip fractures occurred in the intervention and control groups respectively (adjusted RR 0.92, 95% CI 0.51 to 1.68). Three users of hip protectors sustained a hip fracture while wearing properly applied protectors, while 16 hip protector users (5%) developed minor local complications.
                Hip protectors prevent hip fractures in community dwelling older women if worn at the time of a fall. The overall effectiveness of hip protectors was not established in this study, because of incomplete adherence with use of the protectors, and limited statistical power. to assess whether the use of Safehip hip protectors would prevent second hip fractures among men and women living in the community.
                pragmatic randomised controlled trial.
                people living in the community.
                men and women aged 70 years and over who had sustained one hip fracture and who were living in the community.
                366 men and women who were either living outside residential care or were about to be discharged back home were randomised to receive three pairs of hip protectors or to act as controls. Approximately 34% of participants allocated to receive hip protectors wore them every day. After a median follow up of 14 months 8 participants had a second hip fracture with 6 in the intervention and 2 in the control group (Odds Ratio for second hip fracture=3.10, 95% confidence interval 0.62-15.58). Hip protectors had no effect on risk of other fractures or on falls.
                this trial does not suggest a benefit of the studied hip protector among people living outside residential accommodation. Past studies of the efficacy of hip protectors to prevent hip fracture in nursing home residents have had conflicting results, possibly due to potential biases from clustered randomization designs and modest adherence to intervention.
                To determine whether an energy-absorbing and energy-dispersing hip protector would reduce the risk of hip fracture when worn by nursing home residents.
                Multicenter, randomized controlled clinical trial in which 37 nursing homes were randomly assigned to having residents wear a 1-sided hip protector on the left or right hip. Participants were 1042 nursing home residents (mean [SD] aged 85 [7] years; 79% women) who consented and adhered to the hip protector use during a 2-week run-in period and were enrolled. Participating facilities were in greater Boston, Massachusetts, St Louis, Missouri, and Baltimore, Maryland from October 2002 to October 2004. Mean duration of participation for nursing home residents was 7.8 months. None were withdrawn because of adverse effects.
                Undergarments with a 1-sided hip protector made of a 0.32-cm outer layer of polyethylene (2.7 kg/m3) backed by a hard high-density polyethylene shield (0.95 cm) that was backed by 0.9 kg/m3 of 1.27-kg ethylene vinyl acetate foam. Each facility was visited 3 times per week to assess adherence and provide staff support.
                Adjudicated hip fracture occurrences on padded vs unpadded hips.
                After a 20-month follow-up (676 person-years of observation), the study was terminated due to a lack of efficacy. The incidence rate of hip fracture on protected vs unprotected hips did not differ (3.1%; 95% confidence interval [CI], 1.8%-4.4% vs 2.5%; 95% CI, 1.3%-3.7%; P = .70). For the 334 nursing home residents with greater than 80% adherence to hip protector use, the incidence rate of hip fracture on protected vs unprotected hips did not differ (5.3%; 95% CI, 2.6%-8.8% vs 3.5%; 95% CI, 1.3%-5.7%; P = .42). Overall adherence was 73.8%.
                In this clinical trial of an energy-absorbing/shunting hip protector conducted in US nursing homes, we were unable to detect a protective effect on the risk of hip fracture, despite good adherence to protocol. These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.
                clinicaltrials.gov Identifier: NCT00058864. In our cluster randomised controlled trial for efficacy of hip protector with 672 ambulatory elderly women, a hip protector was more effective for prevention of hip fractures in residents with fall history (n = 202; hazard ratio (HR), 0.375; 95%CI, 0.14-0.98; p = 0.05) and body-mass index (BMI) < or = 19.0 (n = 206; HR, 0.37; 95%CI, 0.14-0.95; p = 0.04) by a Cox proportional hazards regression model.
                Hip fractures result from both osteoporosis and falling. A potentially cost-effective method of preventing hip fractures involves the use of hip protectors but recent studies have revealed the uncertain effectiveness of hip protectors even in institutional settings.
                This study was a cluster randomised controlled trial with nursing homes. We randomly assigned 76 homes with 672 ambulatory but frail elderly women. Several risk factors were assessed at baseline and incorporated into a Cox proportional hazards regression model. UMIN Clinical Trials Registry number is UMIN000000467. Research period was between January 2004 and March 2006.
                In the intervention group, 19 hip fractures occurred (54.0/1,000 person-years), whereas 39 hip fractures occurred in the control group (78.8/1,000 person-years). Hazard ratio of hip fracture in the intervention group was 0.56 (95%CI, 0.31-1.03; p = 0.06) after adjusting for risk factors. In subgroup analysis, hip protectors were more effective for prevention of hip fractures in residents with fall history (n = 202; HR, 0.375; 95%CI, 0.14-0.98; p = 0.05) and BMI < or = 19.0 (n = 206; HR, 0.37; 95%CI, 0.14-0.95; p = 0.04). Overall compliance with use of hip protectors was 79.7%.
                Risk of hip fracture can be reduced by hip protectors among elderly women with fall history and low BMI. In order to prevent hip fractures 548 fall-prone senior citizens living in 20 nursing homes participated in a randomized controlled trial of hip protectors. One hundred and sixty-four were randomly selected into the control group and 384 into the intervention group. Of the patients in the intervention group 138 (35.9%) wore the protector throughout the whole 10 months of the study's duration, 124 (32.3%) quit wearing the protectors after an initial wearing period and 122 (31.8%) refused to wear them at all. The regular wearers had the protector on during an average of roughly 12 hours a day, so they were protected for 50% of their exposure time (including at night). Fifty-nine percent of the drop-outs stopped wearing the protectors in the first two study months, mostly for non-medical reasons. Calculation by a forecasting model showed that those senior citizens who were initially prepared to wear the protector tended to be those who were physically restricted. to evaluate the effectiveness of a policy of making hip protectors available to residents of nursing homes.
                a cluster randomised controlled trial of the policy in nursing and residential homes, with the home as the unit of randomisation.
                127 nursing and residential homes in the greater Belfast area of Northern Ireland.
                40 homes in the intervention group (representing 1,366 occupied beds) and 87 homes in the control group (representing 2,751 occupied beds).
                a policy of making hip protectors available free of charge to residents of nursing homes and supporting the implementation process by employing a nurse facilitator to encourage staff in the homes to promote their use, over a 72-week period.
                the rate of hip fractures in intervention and control homes, and the level of adherence to use of hip protectors.
                there were 85 hip fractures in the intervention homes and 163 in the control homes. The mean fracture rate per 100 residents was 6.22 in the intervention homes and 5.92 in the control homes, giving an adjusted rate ratio for the intervention group compared to the control group of 1.05 (95% CI 0.77, 1.43, P = 0.76). Initial acceptance of the hip protectors was 37.2% (508/1,366) with adherence falling to 19.9% (272/1,366) at 72 weeks.
                making hip protectors available to residents of nursing and residential homes did not reduce the rate of hip fracture. This research does not support the introduction of a policy of providing hip protectors to residents of nursing homes.
The effectiveness of the provision of hip protectors in reducing the incidence of hip fracture in older people is still not clearly established, although they may reduce the rate of hip fractures if made available to frail older people in nursing care. It remains unknown from studies identified to date if these findings apply to all types of hip protectors. Some cluster-randomised trials have been associated with high risk of bias. Poor acceptance and adherence by older people offered hip protectors have been key factors contributing to the continuing uncertainty.