NCT07507942

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

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. MEKADYS Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-03-10
• Completion: 2027-03-10
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: France