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Prediction Model of Hip Fragility Fracture Realistic Data From a Traumatology Department and Orthogeriatric Ward.

Completed
Conditions
Fragility
Fracture of Femur
Osteoporosis Risk
Interventions
Other: BLOOD SAMPLE
Registration Number
NCT06545487
Lead Sponsor
Universidad de Valparaiso
Brief Summary

The aim of the project is to build a prediction model of hip fragility fracture using hospital data routinely collected in the traumatology department from the last 12 years and up to date Explainable Artificial Intelligence (XAI) tools. This model should be adapted to the "real world" conditions of the region and predict clinical data such as risk of fracture and refracture, mortality risk, fracture type classification and the generation of a specific comorbidity index.

Detailed Description

Osteoporosis and associated fragility fractures remain an increasing worldwide burden for both health systems and families, in the context of ageing populations. Hip fractures are particularly severe due to the hospital stay, operations, arduous recovery and risk of subsequent fractures.

Thus, it is of significant importance to detect patients at high risk of femoral fragility fractures and to anticipate their recovery capacities in order to take appropriate medical decisions. Early detection of bone deterioration would be ideal for better prevention and bone reconstruction.

The current gold standard for osteoporosis remains the Dual-energy X-ray absorptiometry (DXA),however one the one hand, a majority of fractured patients are not classified as osteoporotic using the WMO definition and on the other hand, DXA is not widely available in numerous places.

Different alternative devices, such as 3D X-Rays, MRI or ultrasound, with different costs and availability, have been proposed. Moreover, online forms, such as FRAX, Garvan or Qfracture, propose to calculate the fracture risk from a limited number of clinical factors.

Nowadays, growing accessibility to clinical data, processing methods and computing power, opened the way to novel data driven prediction models using a large number of biomarkers or parameters, opening perspective towards personalised precision medicine. However a few challenges arise:

1. the data availability and quality to build the models,

2. the ability to collect realistic data from new patients in agreement with the cost and possibilities of each country and

3. the determination of the most important parameters in order to help medical decisions in an interpretable way.

The aim of the project is to build a prediction model of hip fragility fracture using available hospital data, routinely collected in the traumatology department and orthogeriatric ward from the last 12 years, data to be acquired of a control group (without fragility fracture) and up to date Explainable Artificial Intelligence (XAI) tools. This model should be adapted to the "real world" conditions of the region and predict clinical data such as risk of fracture and refracture, mortality risk, fracture type classification and the generation of a specific comorbidity index. Special attention will be given to potential early detectors of bone fragility.

Moreover, this model would later include alternative DXA measurements such as ultrasound, using a specific device successfully tested by the same team. It could also be afterwards compared to other countries or regions with similar available data, thanks to international colleagues currently collaborating with the team. In case of success, database format and prediction models could be shared with other hospitals with perspectives of progressive national and international scaling. In the near future this information could be translated into an informatics tool that could help the physician in his clinical following of the older patients.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • minimum 60 years
Exclusion Criteria
  • Hip fractures
  • unable to walk from point of examination

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
FRACTURABLOOD SAMPLE-
CONTROLBLOOD SAMPLE-
Primary Outcome Measures
NameTimeMethod
Comparison between parameters intra-groups2023-2024

Analysis of data extracted from blood samples comparing data in control and fractured group separatedly

Comparison between parameters inter-groups2023-2024

Analysis of data extracted from blood samples comparing data in control and fractured groups

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Universidad de Valparaíso

🇨🇱

Valparaíso, Chile

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