About this trial
Due to the increase in the average age of the population, the projections on the number of age-dependent bone fractures appear to be constantly increasing.
They are mainly due to bone pathologies, including osteoporosis. The latter leads to a reduction in bone mineral density and deterioration of the micro-architecture, with a consequent increase in bone fragility. However, the mechanisms of damage at the micro-scale have not yet been elucidated and there is no universally recognized damage criterion. Recent research has evaluated the importance of implementing computational models to study the influence of bone gaps, canaliculi and microporosities on the propagation of damage. These models need to be validated through experimental tests, still lacking, in particular on human bones, in the current scientific landscape. Once the experimental validation of computational models has been developed, it will be possible to introduce new fracture indices at the micro-scale, useful for a preventive diagnosis of osteoporosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: >=18 years
primary hip replacement
Signature of informed consent
Patients who have a routine preoperative CT scan
Disqualifiers
Patients unrelated to the inclusion criteria of this study
Bone disease (non-osteoporotic) such as to invalidate sample analysis, including but not limited to genetic disorders and bone tumors
Patients with contralateral hip replacement and/or other synthetic means in the contralateral hip
Patients with synthesis devices in the hip of interest
Trial population
The population consists of 52 subjects, 26 of whom are prosthetic and have osteoporosis detectable by preoperative computed tomography (CT) scan and 26 prosthetic whose CT scan does not indicate the presence of osteoporosis. The classification of the two groups will be made exclusively by analysis of routine preoperative CT scans according to standard radiological classification.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Hip replacement surgery
Procedure/SurgeryAfter hip replacement surgery the sponsor obtains femoral head samples for the study
Treatment groups
Trial outcomes
Primary outcomes
Number of lacunae interested by damage
We expect to observe difference in osteoporotic and non osteoporotic samples interested or not by the damage
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Laura Maria Vergani
Lead sponsor
Politecnico di Milano
Sponsor institution
Ospedale San Donato
Collaborator