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Clinical Validation of BBCT-hip
Sponsor: Istituto Ortopedico Rizzoli
Summary
The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.
Official title: Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
Key Details
Gender
FEMALE
Age Range
65 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2023-11-07
Completion Date
2030-11-06
Last Updated
2025-02-17
Healthy Volunteers
Yes
Conditions
Interventions
CT scan at the femur
Additional CT scan which is not part of the standard clinical path
Locations (2)
Rizzoli Orthopaedic Institute
Bologna, Italy
Rizzoli Orthopaedic Institute
Bologna, Italy