NCT04787679 Image-guided Computational and Experimental Analyses of Fractured Patient's Bone (GAP)
| NCT ID | NCT04787679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laura Maria Vergani |
| Condition | Osteoporosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 52 participants |
| Start Date | 2020-11-09 |
| Primary Completion | 2026-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 52 participants in total. It began in 2020-11-09 with a primary completion date of 2026-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Age: \>=18 years * primary hip replacement * Signature of informed consent * Patients who have a routine preoperative CT scan Exclusion criteria: * 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
Contact & Investigator
Luigi Zagra
PRINCIPAL INVESTIGATOR
IRCCS Istituto Ortopedico Galeazzi
Frequently Asked Questions
Who can join the NCT04787679 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04787679 currently recruiting?
Yes, NCT04787679 is actively recruiting participants. Contact the research team at luigi.zagra@fastwebnet.it for enrollment information.
Where is the NCT04787679 trial being conducted?
This trial is being conducted at Miano, Italy.
Who is sponsoring the NCT04787679 clinical trial?
NCT04787679 is sponsored by Laura Maria Vergani. The principal investigator is Luigi Zagra at IRCCS Istituto Ortopedico Galeazzi. The trial plans to enroll 52 participants.