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Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis. (CRANIOMECA)

10 juin 2026 mis à jour par: Hospices Civils de Lyon
The human skull is a complex structure that protects the underlying tissues, including the brain. Certain rare conditions and diseases, such as craniosynostosis-which affects 1 in 2,000 to 2,500 children-impair these functions and lead to increased intracranial pressure, posing a neurological risk. The most common form of craniosynostosis is scaphocephaly (50%), which manifests as premature closure of the sagittal suture, halting growth at that site and causing an abnormal skull shape and altered local biomechanical properties. The parietal bone is a flat, regular bone that embryologically originates from the neurocranium. Its characteristics vary according to age, sex, and morphotype. Studies on the multimodal characterization of the properties of growing cortical bone focus on the characterization of growing fibulae and femurs. A comparison was made with adult bone, allowing for the establishment of specific pediatric characteristics. The mechanical, morphological, architectural, and tissue properties of the skull vary considerably between adults and children. They are uniquely adapted to the rapid growth and development of the brain. The analysis of the mechanical, architectural, and tissue properties of the parietal bone in infants involves evaluating its ability to resist applied forces and stresses, analyze its shape, composition, and the quality of the bone tissue itself, including aspects such as mineralization, collagen fiber structure, and bone mineral density. A study conducted on samples obtained from parietal resections in infants operated on for scaphocephaly evaluated the microstructural and mechanical characteristics of this region of the skull vault, allowing for the determination of mechanical and morphological characteristics. However, the samples were located near the stenosis, with the sampling site determined macroscopically by the surgeon. The characteristics of the parietal bone in infants with scaphocephaly were also evaluated and show properties correlated with the degree of ossification regardless of age. However, the available data have a significant limitation: existing characterizations are based on pathological samples taken near the stenotic area, or on models of growing long bones that do not reflect the specific characteristics of the cranial vault. To date, there is no certainty regarding the mechanical, architectural, and tissue properties of the parietal bone considered healthy regardless of craniosynostosis in infants, taking into account the developmental constraints specific to the first months of life. These properties are, however, strongly influenced by the compressive forces experienced during birth and then by the gradual changes in gravitational and postural forces associated with motor development (head control, sitting, crawling, and walking on all fours). These data could help improve our understanding of normal cranial physiology and its variations in the presence of pathology. The primary objective is to describe the mechanical, architectural, tissue, and histological properties of the parietal bone in infants with craniosynostosis. To evaluate ex vivo, both near and far from the stenosis, the mechanical, architectural, tissue, and histological properties of the parietal bone and sutures in infants aged 3 to 12 months with craniosynostosis.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

80

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Rhone
      • Bron, Rhone, France, 69500
        • Hopital Femme MèreEnfant / Hospices Civils de Lyon
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

N/A

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

80 Infants aged 3 to 12 months requiring craniostenosis surgery and care at the Women's and Children's Hospital (HFME) in the pediatric neurosurgery department

La description

Inclusion Criteria:

  • Patients diagnosed with craniosynostosis by a pediatric neurosurgeon.
  • Patients treated in the neurosurgery department of Prof. Federico Di Rocco at the Hôpital Femme Mère Enfant.
  • Patients aged 3 to 12 months.

Exclusion Criteria:

  • Positional cranial deformities
  • History of previous cranial surgery in the parietal region (including osteotomies, implant placement, or cranioplasty).
  • Recent significant head trauma (< 6 months) involving the cranial vault.
  • Documented metabolic bone disease (e.g., osteogenesis imperfecta, uncorrected clinical or biochemical rickets).
  • Severe systemic disease likely to alter bone metabolism (e.g., advanced chronic kidney disease, severe liver disease, uncontrolled endocrine disorders).
  • Pharmacological treatment likely to significantly alter bone composition/biomechanics within the last 6 months (e.g., prolonged systemic corticosteroids, bisphosphonates, other antiresorptive agents, chemotherapy).
  • Refusal by parents/guardians to participate

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients with craniostenosis diagnosed

This study focuses on infants aged 3 to 12 months who require craniostenosis surgery and are treated at the Hôpital Femme Mère Enfant (HFME) in the pediatric neurosurgery department.

  • Patients with craniostenosis diagnosed by a pediatric neurosurgeon.
  • Patients followed in the neurosurgery department of Prof. Federico Di Rocco at the Women's, Maternity, and Children's Hospital.
  • Patients aged 3 to 12 months.
In conventional surgery, bone fragments and sutures are removed; the number of these may vary depending on the surgeon's assessment, as well as the location, shape, and surface area, which differ from patient to patient. Some of these fragments, classified as surgical waste and intended for disposal, will be retained for study. A urine sample of approximately 5 mL will be collected directly from the catheter bag; the urine is also considered surgical waste.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Describe , echanical properties, tissue properties, architectural properties, histomorphometry of the parietal bone.
Délai: Within 3 months
Within 3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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