Analyzing bone damage in patients with osteoporosis and fragility fractures
Image-guided Computational and Experimental Analyses of Fractured Patient's Bone (GAP)
Politecnico di Milano · NCT04787679
This study is testing how tiny changes in bones affect fracture risk in people with osteoporosis and fragility fractures who are having hip replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Politecnico di Milano (other) |
| Locations | 1 site (Miano, Milano) |
| Trial ID | NCT04787679 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms of bone damage at the microscale in patients suffering from osteoporosis and fragility fractures. By utilizing advanced imaging techniques and computational models, the study seeks to understand how microstructural features of bone contribute to fracture risk. The research will involve patients undergoing primary hip replacement surgery, with a focus on validating computational models through experimental tests on human bones. The ultimate goal is to develop new fracture indices that can aid in early diagnosis and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for primary hip replacement surgery and have undergone a routine preoperative CT scan.
Not a fit: Patients with non-osteoporotic bone diseases or those who have had previous hip replacements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients with osteoporosis, potentially reducing fracture risk.
How similar studies have performed: While there have been studies exploring bone damage mechanisms, this approach combining microscale imaging with computational modeling is relatively novel and has not been extensively tested in human bones.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miano, Milano
- IRCCS Istituto Ortopedico Galeazzi — Miano, Milano, Italy (RECRUITING)
Study contacts
- Principal investigator: Luigi Zagra — IRCCS Istituto Ortopedico Galeazzi
- Study coordinator: Laura M Vergani
- Email: luigi.zagra@fastwebnet.it
- Phone: +393393758630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporosis, Fragility Fracture, lacunae, damage models, micro-cracks, synchrotron, numerical models