Frontal Reconstruction Without Orbital Advancement for the Management of Moderate Metopic Craniosynostosis: A Clinical and Morphometric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Frontal (Interfrontal) Angle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of isolated, non-syndromic metopic craniosynostosis.
- •Moderate severity, characterized by frontal angle between 90° and 95°.
排除标准
- •Syndromic metopic craniosynostosis.
- •Mild and severe degrees of metopic craniosynostosis
研究组 & 干预措施
Frontal Reconstruction Arm
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.
干预措施: Frontal vault remodelling without orbital advancement (Procedure)
结局指标
主要结局
Change in Frontal (Interfrontal) Angle
时间窗: 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°).
次要结局
- Postoperative Mortality Rate(Intraoperative through 6 months postoperatively)
- Change in Frontal Width(Baseline (preoperative) and 6 months postoperatively)
- Change in Interorbital Distance(Baseline (preoperative) and 6 months postoperatively)
- Postoperative Morbidity Rate(From surgery through 6 months postoperatively)
研究者
Mohamed mahmoud omran abdel-hafez
Neurosurgery Resident
Assiut University