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

NCT04787679 | Recruiting

• 1 other identifier: Polimi_Galeazzi_GAP
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Fragility Fracture

Keywords

lacunae; damage models; micro-cracks; synchrotron; numerical models

Outcome Measures

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

  six months

Study Arms (2)

Osteoporotic patients

Osteoporotic patients, age \> 18 years old

Procedure: Hip replacement surgery

Non osteoporotic patients

Non osteoporotic patients, age \> 18 years old

Procedure: Hip replacement surgery

Interventions

Hip replacement surgery PROCEDURE

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

Non osteoporotic patients; Osteoporotic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Age: \>=18 years
• primary hip replacement
• Signature of informed consent
• Patients who have a routine preoperative CT scan

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Maria Vergani: lead
• Ospedale San Donato: collaborator

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Miano, Milano, 20161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Waste materials from human femoral heads collected after hip replacement surgery

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Luigi Zagra

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura M Vergani

CONTACT

+393393758630; luigi.zagra@fastwebnet.it

Federica Buccino

CONTACT

federica.buccino@polimi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 9, 2021
• Study Start: November 9, 2020
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): August 9, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

IT (1)