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Not yet recruitingNCT07650981CRANIOMECAUpdated Oct 26, 2026

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

An observational study in Craniostenosis, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 3 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Hospices Civils de Lyon · Observational

Updated Oct 26, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
3 Months to 12 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Craniostenosis

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Keywords

  • Craniostenosis
  • Pediatric condition
  • Biomechanics
  • Skull
03

In context

Craniosynostoses

51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.

This study's planned enrollment of 80 is above the median of 43 across 26 observational studies indexed under Craniosynostoses.

Browse Craniosynostoses studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 12 Months
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , bisphosphonates, other antiresorptive agents, chemotherapy).
  • Refusal by parents/guardians to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

Interventions

  • OtherBiological 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.

06

What researchers measure

Primary outcomes

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

    Time frame: Within 3 months

07

Study locations

1 site
  • Hopital Femme MèreEnfant / Hospices Civils de Lyon
    Bron, Rhone 69500, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: start Sep 2026 → Nov 2026, primary completion Sep 2028 → Nov 2028 and completion Sep 2028 → Nov 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2026
First posted
Jun 16, 2026
StartEst.
Nov 1, 2026was Sep 2026
Primary completionEst.
Nov 1, 2028was Sep 2028
CompletionEst.
Nov 1, 2028was Sep 2028
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Nov 1, 2026
Oct 26, 2026
Primary completion
Sep 1, 2028→Nov 1, 2028
Oct 26, 2026
Study completion
Sep 1, 2028→Nov 1, 2028
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Start date Sep 1, 2026→Nov 1, 2026
    Primary completion Sep 1, 2028→Nov 1, 2028
    Study completion Sep 1, 2028→Nov 1, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07650981
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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