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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFC: Geriatric Fracture Center | Patient treatment in a geriatric fracture center A GFC is defined as follows:
| ||
| UCC: Usual Care Center | Patient treatment in an usual care center A UCC is defined as follows:
|
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| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events related to treatment / residential status / immobilization | Major AEs related to treatment / residential status / immobilization:
| From surgery up to 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Modified Barthel index pre-injury, at 12 weeks and 12 months |
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Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
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Primary care clinic (Usual Care clinic) Geriatric center
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| Name | Affiliation | Role |
|---|---|---|
| Michael Blauth, Professor | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63104 | United States | ||
| Elmhurst Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37918921 | Derived | Joeris A, Sprague S, Blauth M, Gosch M, Wattanapanom P, Jarayabhand R, Poeze M, Wong MK, Kwek EBK, Hegeman JH, Perez-Uribarri C, Guerado E, Revak TJ, Zohner S, Joseph D, Phillips MR. Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study. BMJ Open. 2023 Nov 2;13(11):e072744. doi: 10.1136/bmjopen-2023-072744. | |
| 33972329 |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Baseline, 12 weeks and 1 year postoperative |
| 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 | Parker Mobility Score pre-injury, at 12 weeks and 12 months | Baseline, 12 weeks and 1 year follow-up |
| Mortality | From surgery up to 1 year follow-up |
| Quality of Life | Quality of life using the EuroQoL questionnaire (EQ-5D) | 12 weeks and 1 year postoperative |
| Pain | Pain using the numeric rating scale | 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) | Baseline up to 1 year follow-up |
| Time from admission to start of pain medication | Baseline (admission to surgery), about 1-2 days |
| 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 | 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. | Baseline (admission to discharge), about 1-2 weeks |
| Residential status | Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months | Baseline up to 1 year follow-up |
| Falls | Numbers of falls | 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 | Baseline up to 1 year follow-up |
| Number of patients receiving adequate secondary fracture prevention | Baseline up to 1 year follow-up |
| 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 |
| New York |
| New York |
| 11373 |
| United States |
| Medical University of Innsbruck | Innsbruck | 6020 | Austria |
| AKH Linz | Linz | 4020 | Austria |
| Ziekenhuisgroep Twente | Almelo | 7609 SZ | Netherlands |
| Maastricht University Medical Center | Maastricht | 6202 AZ | Netherlands |
| General Hospital Singapore | Singapore | 169608 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Hospital Son LLatzer | Palma de Mallorca | Balearic Island | 07198 | Spain |
| Hospital Universitario Costa del Sol | Marbella | 29603 | Spain |
| Bhumibol Adulyadej Hospital | Bangkok | 10220 | Thailand |
| Hospital Medical Center Bangkok | Bangkok | 10310 | Thailand |
| Blauth M, Joeris A, Rometsch E, Espinoza-Rebmann K, Wattanapanom P, Jarayabhand R, Poeze M, Wong MK, Kwek EBK, Hegeman JH, Perez-Uribarri C, Guerado E, Revak TJ, Zohner S, Joseph D, Gosch M. Geriatric fracture centre vs usual care after proximal femur fracture in older patients: what are the benefits? Results of a large international prospective multicentre study. BMJ Open. 2021 May 10;11(5):e039960. doi: 10.1136/bmjopen-2020-039960. |
| 28706090 | Derived | Hurtado-Chong A, Joeris A, Hess D, Blauth M. Improving site selection in clinical studies: a standardised, objective, multistep method and first experience results. BMJ Open. 2017 Jul 12;7(7):e014796. doi: 10.1136/bmjopen-2016-014796. |
| 28706089 | Derived | Joeris A, Hurtado-Chong A, Hess D, Kalampoki V, Blauth M. Evaluation of the geriatric co-management for patients with fragility fractures of the proximal femur (Geriatric Fracture Centre (GFC) concept): protocol for a prospective multicentre cohort study. BMJ Open. 2017 Jul 12;7(7):e014795. doi: 10.1136/bmjopen-2016-014795. |
| D007869 |
| Leg Injuries |