An observational study in Hip Fractures, sponsored by AO Innovation Translation Center. Completed at 12 sites in 6 countries. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by AO Innovation Translation Center · Observational
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 282 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →AO Innovation Translation Center is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Primary care clinic (Usual Care clinic) Geriatric center
Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
Patient treatment in a geriatric fracture center A GFC is defined as follows: * General geriatrician or ortho-geriatrician available in trauma/orthopaedic department * Geriatrician sees the patient prior to surgery (except if the patient is admitted over night or during weekends) * Local medical guidelines, consented by orthopedic surgeons and geriatrician * Pre-defined order set for assessing laboratory values * Pre-defined patient pathway to guarantee a fast track in the emergency room * Daily communication among involved specialists * Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): * Daily patient visit by geriatrician * Daily patient visit by orthopedic surgeon in combination with nurse * Daily therapy by physiotherapists, except for weekends * Access to social workers, if required
Patient treatment in an usual care center A UCC is defined as follows: * No geriatrician available in trauma/orthopaedic department * No pre-operative visit by a geriatrician as a standard * No pre-defined medical guidelines for geriatric fracture patients * Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): * No daily patient visits by a geriatrician as a standard
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
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
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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