Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program
- Conditions
- Hip Fractures
- Registration Number
- NCT02297581
- Lead Sponsor
- AO Innovation Translation Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Quality of Life 12 weeks and 1 year postoperative Quality of life using the EuroQoL questionnaire (EQ-5D)
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
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 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 Mortality From surgery up to 1 year follow-up 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)
Time from admission to start of pain medication Baseline (admission to surgery), about 1-2 days Time from admission to surgery Baseline (admission to surgery), 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 fluid management 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.
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
Trial Locations
- Locations (12)
Elmhurst Medical Center
🇺🇸New York, New York, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
Hospital Son LLatzer
🇪🇸Palma de Mallorca, Balearic Island, Spain
General Hospital Singapore
🇸🇬Singapore, Singapore
Hospital Universitario Costa del Sol
🇪🇸Marbella, Spain
Bhumibol Adulyadej Hospital
🇹🇭Bangkok, Thailand
Hospital Medical Center Bangkok
🇹🇭Bangkok, Thailand
Ziekenhuisgroep Twente
🇳🇱Almelo, Netherlands
AKH Linz
🇦🇹Linz, Austria
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore