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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Craniostenosis
• Intervention / Treatment: Other: Biological sample, bones sample and questionaires.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Federico DI ROCCO, Pr; Phone Number: +33 04 72 35 75 72; Email: federico.dirocco@chu-lyon.fr

Study Locations

• France
  • Rhone
    • Bron, Rhone, France, 69500
      • Hopital Femme MèreEnfant / Hospices Civils de Lyon
      • Contact: Federico DI ROCCO, Pr; Phone Number: +33 04 72 35 75 72; Email: federico.dirocco@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Describe , echanical properties, tissue properties, architectural properties, histomorphometry of the parietal bone.	Within 3 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Biomechanics; Skull; Craniostenosis; Pediatric condition
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Synostosis; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniosynostoses
• Other Study ID Numbers: 69HCL26_0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No