An interventional study of Frontal vault remodelling without orbital advancement in Metopic Craniosynostosis, Craniosynostosis and Metopic Synostosis, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Metopic craniosynostosis is a condition caused by the early fusion of the metopic suture, leading to restricted frontal bone growth and a triangular head deformity termed trigonocephaly. Conventional surgical treatment typically involves fronto-orbital advancement with a supraorbital bandeau, which can be associated with substantial surgical blood loss and long-term aesthetic deformities such as temporal hollowing.
For children presenting with moderate metopic craniosynostosis (defined by a frontal angle between 90° and 95°), formal advancement of the orbital rim may not be required. This prospective clinical study aims to assess the efficacy and safety of isolated frontal vault remodelling without supraorbital bandeau advancement. By maintaining the intact orbital rim, this technique aims to achieve structural and aesthetic cranial normalisation while reducing surgical invasiveness and associated complications.
Premature fusion of the metopic suture prevents physiological transverse expansion of the anterior cranium, producing the classic keel-shaped forehead, hypotelorism, and pterional constriction characteristic of trigonocephaly. While severe deformities require full fronto-orbital advancement and remodelling (FOAR), moderate presentations often possess orbital bar configurations that do not necessitate extensive supraorbital osteotomies.
This single-center, prospective interventional clinical trial evaluates a tailored cranial vault remodelling procedure that focuses strictly on the superior and lateral frontal bones while preserving the supraorbital bar intact.
Eligible pediatric patients with isolated, non-syndromic, moderate metopic craniosynostosis (interfrontal angle 90°-95°) undergo comprehensive baseline clinical evaluation, neurodevelopmental screening, and thin-slice cranial 3D computed tomography (CT). During surgery, frontal bone osteotomies, reshaping, and reconstruction are performed without manipulating or advancing the supraorbital bandeau.
Follow-up assessments occur postoperatively at routine intervals up to 6 months. Primary efficacy is determined via 3D CT morphometry by calculating the pre- to postoperative change in the frontal (interfrontal) angle, targeting normalisation toward the non-synostotic threshold (>104°). Secondary outcomes evaluate anterior cranial width (distance between the zygomaticofrontal sutures), interorbital distance (dacryon-to-dacryon), operational blood loss, length of stay, and postoperative morbidity or mortality.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's planned enrollment of 15 is below the median of 27 across 22 interventional studies indexed under Craniosynostoses.
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Exclusion Criteria:
Pediatric patients presenting with isolated, moderate metopic craniosynostosis (frontal angle between 90° and 95°) who undergo surgical frontal vault remodelling and reconstruction while preserving the supraorbital bar intact.
Procedure: Frontal vault remodelling without orbital advancement
Surgical cranial vault reconstruction targeting the superior and lateral frontal bones to correct forehead narrowing and trigonocephaly, performed without osteotomies or repositioning/advancement of the supraorbital bandeau.
Change in Frontal (Interfrontal) Angle
Frontal angle measured at the metopic ridge by lines extending to the lateral frontal boundaries on 3D reconstructed CT scans. The primary goal is correction from the moderate baseline range (90°-95°) toward the non-synostotic age-matched norm (\>104°).
Time frame: Baseline (preoperative) and 6 months postoperatively
Change in Frontal Width
Transverse distance measured in millimeters between the bilateral zygomaticofrontal sutures on 3D reconstructed CT scans to assess the correction of anterior cranial narrowing.
Time frame: Baseline (preoperative) and 6 months postoperatively
Change in Interorbital Distance
Distance measured in millimeters between dacryon points (or inner canthi) on 3D reconstructed CT scans to assess correction and natural redraping/drifting of hypotelorism following vault expansion.
Time frame: Baseline (preoperative) and 6 months postoperatively
Postoperative Morbidity Rate
Incidence of surgical and medical complications, including surgical site infections, dural tears, cerebrospinal fluid (CSF) leaks, unplanned reoperation, and substantial intraoperative blood loss requiring blood transfusion.
Time frame: From surgery through 6 months postoperatively
Postoperative Mortality Rate
Number of participant deaths related or unrelated to the surgical procedure.
Time frame: Intraoperative through 6 months postoperatively
Plan to share: Yes — De-identified individual participant morphometric data (interfrontal angles, frontal width, and interorbital distances) and relevant clinical outcome measures will be shared upon reasonable academic request with qualified scientific researchers after publication of the primary study results.
Supporting information: Study protocol
Time frame: Data will be made available beginning 6 months after publication of the main study results and will remain available for up to 3 years.
Access criteria: Data will be shared with academic researchers who provide a methodologically sound proposal approved by an independent institutional review board, following the execution of a formal data sharing agreement. Requests should be directed to the corresponding author via email.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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