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Assessment of Femoral Failure Load and Fracture Risk in Rare Bone Disorders Using MEKANOS Tool. Case Study of Fibrous Dysplasia of Bone/McCune Albright Syndrome

NCT07507942 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-02

No results posted yet for this study

Summary

The issue of rare diseases has become a public health priority. In France, a national plan for rare diseases was published in 2004. It leads to the creation and certification of numerous Rare Disease Reference Centers by the French National Authority for Health (Haute Autorité de Santé).

Our Fibrous Dysplasia Reference Center has been certified since 2006. However, evaluating the mechanical strength and fracture risk of fibrous dysplasia lesions remains a major unresolved challenge for clinicians. Improving the assessment of fracture risk therefore represents a key clinical objective.

Conditions

  • Fibrous Dysplasia/McCune-Albright Syndrome

Interventions

OTHER

Application of MEKANOS tool to CT scans

MEKANOS tool is an algorithm that automatically segments femurs from clinical CT scans, generates a numerical model, and performs a numerical simulation of single leg stance loading on these femurs. The tool is developed within INSERM unit 1033 and is currently available only in the laboratory. Input data consist of CT imaging (DICOM format) and retrospective clinical data. The output is the failure load expressed in Newtons.Interpretation of the results involves determining fracture risk based on the failure load (pathological bone versus healthy bone), and then integrating patient size and weight. CT Scans are issued from the HCL PACS, and clinical data issued from Easily Hybrid DF database.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-03-10
Completion
2027-03-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507942 on ClinicalTrials.gov