Abstract
BackgroundThe economic and public health burden of fragility fractures of the hip in Germany is high. The likelihood of requiring long-term care and the risk of suffering from a secondary fracture increases substantially after sustaining an initial fracture. Neither appropriate confirmatory diagnostics of the suspected underlying osteoporosis nor therapy, which are well-recognised approaches to reduce the burden of fragility fractures, are routinely initiated in the German healthcare system. Therefore, the aim of the study FLS-CARE is to evaluate whether a coordinated care programme can close the prevention gap for patients suffering from a fragility hip fracture through the implementation of systematic diagnostics, a falls prevention programme and guideline-adherent interventions based on the Fracture Liaison Services model.MethodsThe study is set up as a non-blinded, cluster-randomised, controlled trial with unequal cluster sizes. Allocation to intervention group (FLS-CARE) and control group (usual care) follows an allocation ratio of 1:1 using trauma centres as the unit of allocation. Sample size calculations resulted in a total of 1216 patients (608 patients per group distributed over 9 clusters) needed for the analysis. After informed consent, all participants are assessed directly at discharge, after 3 months, 12 months and 24 months. The primary outcome measure of the study is the secondary fracture rate 24 months after initial hip fracture. Secondary outcomes include differences in the number of falls, mortality, quality-adjusted life years, activities of daily living and mobility.DiscussionThis study is the first to assess the effectiveness and cost-effectiveness/utility of FLS implementation in Germany. Findings of the process evaluation will also shed light on potential barriers to the implementation of FLS in the context of the German healthcare system. Challenges for the study include the successful integration of the outpatient sector as well as the future course of the coronavirus pandemic in 2020 and its influence on the intervention.Trial registrationGerman Clinical Trial Register (DRKS) 00022237, prospectively registered 2020-07-09
Highlights
The economic and public health burden of fragility fractures of the hip in Germany is high
Challenges for the study include the successful integration of the outpatient sector as well as the future course of the coronavirus pandemic in 2020 and its influence on the intervention
Even though hip fractures represent a fifth of all fragility fractures, they make up half of the total fracture-related healthcare costs [2]
Summary
The economic and public health burden of fragility fractures of the hip in Germany is high. Neither appropriate confirmatory diagnostics of the suspected underlying osteoporosis nor therapy, which are wellrecognised approaches to reduce the burden of fragility fractures, are routinely initiated in the German healthcare system. With increasing life expectancy in Germany, the number of people with age-associated progressive metabolic bone disease, so-called osteoporosis, rises steadily as well. Women aged 50 years or above are prone to develop osteoporosis and, have a significantly higher lifetime risk of sustaining a major osteoporotic fracture (i.e. arm, hip and spine) compared with men [2]. In Germany, osteoporosis-related healthcare costs amounted to 4.5 billion Euros in 2009 [3]. Between 2017 and 2030, osteoporosis-induced healthcare costs are expected to increase further up to 14 billion Euros per year. Even though hip fractures represent a fifth of all fragility fractures, they make up half of the total fracture-related healthcare costs [2]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
