Health TrialsbyHealthPanel

Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis

ConditionsMetopic CraniosynostosisCraniosynostosisMetopic Synostosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of isolated, non-syndromic metopic craniosynostosis.

Moderate severity, characterized by frontal angle between 90° and 95°.

Disqualifiers

Syndromic metopic craniosynostosis.

Mild and severe degrees of metopic craniosynostosis

Trial design

Design model

Single group

Treatments tested in this trial

  • Frontal vault remodelling without orbital advancement

    Procedure/Surgery

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Frontal Reconstruction ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Postoperative Mortality Rate

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

Time frame
Intraoperative through 6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: