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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Fibrous Dysplasia/McCune-Albright Syndrome Bone Diseases Bone Diseases, Developmental Fibrous Dysplasia of Bone Fibrous Dysplasia, Polyostotic Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edouard Herriot Hospital - rheumatology

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults with Fibrous Dysplasia (FD) of the bone or McCune-Albright Syndrome (MAS);
who have received care at the center through outpatient consultation, multidisciplinary evaluation, or hospitalization;
whose diagnosis was confirmed by an expert physician from the reference center based on a combination of clinical, biochemical, and radiological criteria, in accordance with the recommendations of the international FD/MAS consortium (Javaid MK et al., Orphanet J Rare Dis. 2019);
for whom a histological confirmation was obtained in cases of diagnostic uncertainty;
no objection to data collection

Exclusion criteria

- CT scan with implanted material on the femur,
Individuals under legal protection measures

Treatment and study plan

Application of MEKANOS tool to CT scans

Other

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.

Primary outcomes

Tool X

Time frame: CT scans of Patients with femoral fibrous dysplasia lesions performed from January 2002 until 9 March 2025.

Obtaining an image suitable for processing with tool X in order to compute failure strength through numerical simulation (i.e., adequate bone segmentation and a correctly implemented numerical model with appropriate boundary conditions).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MEKADYS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Apr 2, 2026
Registry last updated: Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting