- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07650981
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis. (CRANIOMECA)
10. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
80
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Federico DI ROCCO, Pr
- Telefonnummer: +33 04 72 35 75 72
- E-post: federico.dirocco@chu-lyon.fr
Studiesteder
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Rhone
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Bron, Rhone, Frankrike, 69500
- Hopital Femme MèreEnfant / Hospices Civils de Lyon
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Ta kontakt med:
- Federico DI ROCCO, Pr
- Telefonnummer: +33 04 72 35 75 72
- E-post: federico.dirocco@chu-lyon.fr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
N/A
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Describe , echanical properties, tissue properties, architectural properties, histomorphometry of the parietal bone.
Tidsramme: Within 3 months
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Within 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2028
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
10. juni 2026
Først lagt ut (Faktiske)
16. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 69HCL26_0344
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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