The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.
Patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study. The primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center. As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed. In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.
Study Type
OBSERVATIONAL
Enrollment
282
Saint Louis University
St Louis, Missouri, United States
Elmhurst Medical Center
New York, New York, United States
Medical University of Innsbruck
Innsbruck, Austria
Major Adverse Events related to treatment / residential status / immobilization
Major AEs related to treatment / residential status / immobilization: * Delirium * Congestive heart failure * Pneumonia * Deep venous thrombosis * Pulmonary embolism * Pressure ulcers * Myocardial infarction
Time frame: From surgery up to 1 year follow-up
Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization
Time frame: From surgery up to 1 year follow-up
Activities of daily living
Modified Barthel index pre-injury, at 12 weeks and 12 months
Time frame: Baseline, 12 weeks and 1 year postoperative
Number of re-admissions to an acute hospital
Time frame: From surgery up to 1 year follow-up
Timed up and go test (TUG)
Time frame: 12 weeks and 1 year follow-up
Parker Mobility Score
Parker Mobility Score pre-injury, at 12 weeks and 12 months
Time frame: Baseline, 12 weeks and 1 year follow-up
Mortality
Time frame: From surgery up to 1 year follow-up
Quality of Life
Quality of life using the EuroQoL questionnaire (EQ-5D)
Time frame: 12 weeks and 1 year postoperative
Pain
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AKH Linz
Linz, Austria
Ziekenhuisgroep Twente
Almelo, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
General Hospital Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Hospital Son LLatzer
Palma de Mallorca, Balearic Island, Spain
Hospital Universitario Costa del Sol
Marbella, Spain
...and 2 more locations
Pain using the numeric rating scale
Time frame: From surgery up to1 year follow-up
Direct and indirect costs
All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc)
Time frame: Baseline up to 1 year follow-up
Time from admission to start of pain medication
Time frame: Baseline (admission to surgery), about 1-2 days
Time from admission to start of fluid management
Time frame: Baseline (admission to surgery), about 1-2 days
Time from admission to surgery
Time frame: Baseline (admission to surgery), about 1-2 days
Time from surgery to discharge 1 and 2
Discharge 1 is defined as discharge from orthopaedic / trauma department Discharge 2 is defined as the timepoint when the patient is discharged to their definite residential status, i.e. residential status where no further change in residential status is planned . Discharge 1 and 2 may occur on the same date.
Time frame: Baseline (admission to discharge), about 1-2 weeks
Residential status
Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months
Time frame: Baseline up to 1 year follow-up
Falls
Numbers of falls
Time frame: From surgery up to 1 year follow-up
Medication
Number of different types of medication at admission, discharge 1, 12 weeks, 12 months and information whether analgesics, osteoporosis and other medications are administered at all study visit time points
Time frame: Baseline up to 1 year follow-up
Number of patients receiving adequate secondary fracture prevention
Time frame: Baseline up to 1 year follow-up
Number of patients for which the nutrition status was evaluated / adapted
Time frame: Baseline (admission to discharge), about 1-2 days
Occurrence of a contralateral hip fracture
Time frame: Retrospective assessment of pre-injury status up to 1 year follow-up