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

Обзор

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.

Вмешательства

• Другое Biological sample, bones sample and questionaires.
  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.

Первичные конечные точки

• Describe , echanical properties, tissue properties, architectural properties, histomorphometry of the parietal bone. [Срок оценки: Within 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hopital Femme MèreEnfant / Hospices Civils de Lyon — Bron

Идентификаторы

NCT: NCT07650981 · 69HCL26_0344

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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