Clinical Validation of BBCT-hip
NCT06270758 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2026-05-22
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.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
CT scan at the femur
Additional CT scan which is not part of the standard clinical path
Sponsors & Collaborators
-
Istituto Ortopedico Rizzoli
lead OTHER
Eligibility
- Min Age
- 65 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-07
- Primary Completion
- 2030-11-06
- Completion
- 2030-11-06
Countries
- Italy
Study Locations
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