Viewing Study NCT06545487



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06545487
Status: COMPLETED
Last Update Posted: None
First Post: 2024-08-05

Brief Title: Prediction Model of Hip Fragility Fracture Realistic Data From a Traumatology Department and Orthogeriatric Ward
Sponsor: None
Organization: None

Study Overview

Official Title: Prediction Model of Hip Fragility Fracture Using Explainable Artificial Intelligence and Realistic Data From a Traumatology Department and Orthogeriatric Ward
Status: COMPLETED
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 DXAhowever 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None