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RECRUITING
NCT06270758

Clinical Validation of BBCT-hip

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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