[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657239":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":36,"studyPopulation":28,"armGroups":37,"interventions":44,"overallOfficials":50,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":28,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":28,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":28,"maxAge":28,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":111,"whyStopped":28,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"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°).","Baseline (preoperative) and 6 months postoperatively",[14,17,20,24],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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\u002Fdrifting of hypotelorism following vault expansion.",{"measure":21,"description":22,"timeFrame":23},"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.","From surgery through 6 months postoperatively",{"measure":25,"description":26,"timeFrame":27},"Postoperative Mortality Rate","Number of participant deaths related or unrelated to the surgical procedure.","Intraoperative through 6 months postoperatively",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"NA","SINGLE_GROUP","A prospective, single-arm interventional clinical cohort study evaluating pre- to postoperative morphometric and clinical outcomes in patients undergoing frontal cranial vault reconstruction without orbital advancement.","TREATMENT",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE","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.\n\nThis 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.\n\nEligible 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.\n\nFollow-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.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Frontal Reconstruction Arm","EXPERIMENTAL","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.",[43],"Procedure: Frontal vault remodelling without orbital advancement",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":28},"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\u002Fadvancement of the supraorbital bandeau.",[39],[51,54],{"name":52,"affiliation":5,"role":53},"Ahmed El Shanawany, M.D., Ph.D.","STUDY_DIRECTOR",{"name":55,"affiliation":5,"role":53},"Farrag Farrag, M.D., Ph.D.",[57],{"name":58,"role":59,"phone":60,"phoneExt":28,"email":61},"mohamed omran, M.B.B.Ch.","CONTACT","+201157223276","Mohamed.18313286@med.aun.edu.eg",[63],{"facility":64,"status":28,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Assiut University Hospital","Asyut","Assiut Governorate","71515","Egypt","EG",{"type":71,"coordinates":72},"Point",[73,74],31.18368,27.18096,{"lat":74,"lon":73},[77],{"name":78,"role":59,"phone":60,"phoneExt":28,"email":61},"Mohamed Omran, M.B.B.Ch.",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Mohamed mahmoud omran abdel-hafez","Neurosurgery Resident","100657239","frontal-reconstruction-without-orbital-advancement-for-moderate-metopic-craniosynostosis-100657239",false,"NCT07837453","Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis","Frontal Reconstruction Without Orbital Advancement for the Management of Moderate Metopic Craniosynostosis: A Clinical and Morphometric Analysis","Inclusion Criteria:\n\n* Diagnosis of isolated, non-syndromic metopic craniosynostosis.\n* Moderate severity, characterized by frontal angle between 90° and 95°.\n\nExclusion Criteria:\n\n* Syndromic metopic craniosynostosis.\n* Mild and severe degrees of metopic craniosynostosis","ALL",{"count":92,"type":93},15,"ESTIMATED","INTERVENTIONAL",[30],"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.\n\nFor 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.",[98,99,100],"Metopic Craniosynostosis","Craniosynostosis","Metopic Synostosis",[102,103,104,105,106,107,108,109,110],"Frontal reconstruction","Cranial vault remodeling","Orbital advancement","Trigonocephaly","Metopic synostosis","Anthropometry","Interfrontal angle","Pediatric neurosurgery","3D CT morphometry","NOT_YET_RECRUITING","2026-09-18",{"date":114,"type":115},"2026-09-23","ACTUAL",{"date":117,"type":93},"2026-10",{"date":119,"type":93},"2029-10",{"name":5,"class":6},1]