Actively Recruiting

Age: 18Years +
All Genders
ID04787679

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

Led by Laura Maria Vergani · Updated on 2026-01-29

52

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

L

Laura Maria Vergani

Lead Sponsor

O

Ospedale San Donato

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the mechanisms of bone damage at the microscopic level, focusing on fractures related to aging and conditions like osteoporosis. The study aims to better understand how features such as bone gaps, canaliculi, and microporosities influence damage and fracture risk. Current tools for predicting fractures mainly use bone mineral density, but this research seeks to develop new micro-scale fracture indices to improve early diagnosis of osteoporosis. The study involves collecting femoral head bone samples from patients undergoing hip replacement surgery. These samples are examined using advanced imaging techniques such as micro-tomography and tested with micro-compression machines inside a synchrotron. Two groups are compared: osteoporotic patients and non-osteoporotic patients, to evaluate differences in bone damage patterns, especially the number of bone gaps affected by micro-damage. Participants provide routine preoperative CT scans and consent for use of their bone samples. Researchers analyze the bone microstructure, perform numerical modeling, and validate computational damage models through experimental testing. The main outcome measured is the number of lacunae (small cavities in bone) involved in damage over six months. This research could lead to better tools for fracture risk prediction and osteoporosis diagnosis, with the study extending through August 2028.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Undergoing primary hip replacement surgery
  • Signed informed consent to participate
  • Have a routine preoperative CT scan
Not Eligible

You will not qualify if you...

  • Patients who do not meet the inclusion criteria
  • Presence of bone diseases other than osteoporosis that affect sample analysis, including genetic disorders and bone tumors
  • Having a hip replacement or synthetic implant in the opposite hip
  • Having synthetic devices in the hip being studied

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo hip replacement surgery during which femoral head samples are obtained for the study.

1 visit (in-person)

Diagnostic Evaluation

Duration - Short-term, within days after surgery

Participants' femoral head bone samples are scanned by micro-tomograph to define microstructural morphological parameters and create numerical models.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are observed as computational models of bone damage are validated by micro-compression tests on their samples in a synchrotron, including quantification of bone damage.

Follow-up visits as needed for assessments

Trial Site Locations

Total: 1 location

1

IRCCS Istituto Ortopedico Galeazzi

Miano, Milano, Italy, 20161

Actively Recruiting

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Research Team

L

Laura M Vergani

F

Federica Buccino

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

A quantitative approach for high-throughput mapping of collagen fibril orientation using polarization-dependent Second Harmonic Generation.

Valeria Zanrè, David Nguyen, Tatiana Kochetkova...

https://pubmed.ncbi.nlm.nih.gov/42034302