Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270758
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-14
Brief Title:
Clinical Validation of BBCT-hip
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ValidaBBCT-hip
Brief 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 runin 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None