Hip Fractures
Conditions
Keywords
Geriatrics [MeSH], Osteoporotic fractures [MeSH], Hip fractures [MeSH], Cost benefit analysis [MeSH], Quality of life [MeSH], Mortality [MeSH], Complications
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
AO Innovation Translation Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Preoperative Inclusion Criteria: * Age ≥ 70 years * Geriatric patients with hip fractures Treated either with oOsteosynthesis or oEndoprosthesis * Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form * Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent Preoperative
Exclusion criteria
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events related to treatment / residential status / immobilization | From surgery up to 1 year follow-up | Major AEs related to treatment / residential status / immobilization: * Delirium * Congestive heart failure * Pneumonia * Deep venous thrombosis * Pulmonary embolism * Pressure ulcers * Myocardial infarction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization | From surgery up to 1 year follow-up | — |
| Activities of daily living | Baseline, 12 weeks and 1 year postoperative | Modified Barthel index pre-injury, at 12 weeks and 12 months |
| Number of re-admissions to an acute hospital | From surgery up to 1 year follow-up | — |
| Timed up and go test (TUG) | 12 weeks and 1 year follow-up | — |
| Parker Mobility Score | Baseline, 12 weeks and 1 year follow-up | Parker Mobility Score pre-injury, at 12 weeks and 12 months |
| Mortality | From surgery up to 1 year follow-up | — |
| Quality of Life | 12 weeks and 1 year postoperative | Quality of life using the EuroQoL questionnaire (EQ-5D) |
| Pain | From surgery up to1 year follow-up | Pain using the numeric rating scale |
| Direct and indirect costs | Baseline up to 1 year follow-up | All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc) |
| Number of patients receiving adequate secondary fracture prevention | Baseline up to 1 year follow-up | — |
| Time from admission to start of fluid management | Baseline (admission to surgery), about 1-2 days | — |
| Time from admission to surgery | Baseline (admission to surgery), about 1-2 days | — |
| Time from surgery to discharge 1 and 2 | Baseline (admission to discharge), about 1-2 weeks | 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. |
| Residential status | Baseline up to 1 year follow-up | Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months |
| Falls | From surgery up to 1 year follow-up | Numbers of falls |
| Medication | Baseline up to 1 year follow-up | 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 |
| Number of patients for which the nutrition status was evaluated / adapted | Baseline (admission to discharge), about 1-2 days | — |
| Occurrence of a contralateral hip fracture | Retrospective assessment of pre-injury status up to 1 year follow-up | — |
| Time from admission to start of pain medication | Baseline (admission to surgery), about 1-2 days | — |
Countries
Austria, Netherlands, Singapore, Spain, Thailand, United States
Outcome results
None listed