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CraniostenosisCRANIOMECANCT07650981

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

An observational study of Craniostenosis, run by Hospices Civils de Lyon at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 12 months
Conditions the study is for
Craniostenosis
What is being tested?
Biological sample, bones sample and questionaires.
How many people
80 participants
Where
1 siteFrance
Study dates
1 Nov 2026to 1 Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 months
  • All sexes
  • Child

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Hopital Femme MèreEnfant / Hospices Civils de Lyon

    Bron, Rhone, 69500

    Federico DI ROCCO, Pr, 04 72 35 75 72 ext. +33, federico.dirocco@chu-lyon.fr

Other trials in France

About this study

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.

Conditions
Craniostenosis
Being tested
Biological sample, bones sample and questionaires.
Keywords
Craniostenosis, Pediatric condition, Biomechanics, Skull
Medical subject headings
Craniosynostoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological sample, bones sample and questionaires.Other

    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.

Study groups in NCT07650981
Study groupRoleWhat they receive
Patients with craniostenosis diagnosedThis 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.
Receives: Other: Biological sample, bones sample and questionaires.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe , echanical properties, tissue properties, architectural properties, histomorphometry of the parietal bone.

    Measured: Within 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07650981
Sponsor's protocol ID
69HCL26_0344
Acronym
CRANIOMECA
Status last verified
Oct 2026
First submitted
4 Jun 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Craniostenosis, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Federico DI ROCCO, Pr (04 72 35 75 72 ext. +33, federico.dirocco@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe , echanical properties, tissue properties, architectural properties, histomorphometry of the parietal bone. (time frame: Within 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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