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NCT Number: NCT07837453

Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of isolated, non-syndromic metopic craniosynostosis.
  • Moderate severity, characterized by frontal angle between 90° and 95°.

Exclusion criteria

  • Syndromic metopic craniosynostosis.
  • Mild and severe degrees of metopic craniosynostosis

Treatment and study plan

Frontal vault remodelling without orbital advancement

Procedure

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.

Primary outcomes

  1. Change in Frontal (Interfrontal) Angle

    Time frame: Baseline (preoperative) and 6 months postoperatively

    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°).

Secondary outcomes

  1. Change in Frontal Width

    Time frame: Baseline (preoperative) and 6 months postoperatively

    Transverse distance measured in millimeters between the bilateral zygomaticofrontal sutures on 3D reconstructed CT scans to assess the correction of anterior cranial narrowing.

  2. Change in Interorbital Distance

    Time frame: Baseline (preoperative) and 6 months postoperatively

    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.

  3. Postoperative Morbidity Rate

    Time frame: From surgery through 6 months postoperatively

    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.

  4. Postoperative Mortality Rate

    Time frame: Intraoperative through 6 months postoperatively

    Number of participant deaths related or unrelated to the surgical procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed omran, M.B.B.Ch.

CONTACT

[email protected]

+201157223276

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Frontal Reconstruction Without Orbital Advancement for the Management of Moderate Metopic Craniosynostosis: A Clinical and Morphometric Analysis

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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