Image-guided Computational and Experimental Analyses of Fractured Patient's Bone (GAP)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaura Maria Vergani

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Hip replacement surgery

    Procedure/Surgery

    After hip replacement surgery the sponsor obtains femoral head samples for the study

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Osteoporotic patients1 intervention
Group B: Non osteoporotic patients1 intervention

Trial outcomes

Primary outcomes

1

Number of lacunae interested by damage

We expect to observe difference in osteoporotic and non osteoporotic samples interested or not by the damage

Time frame
six months

Secondary outcomes

Other outcomes

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