Metopic CraniosynostosisNCT07837453
Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis
A study testing Frontal vault remodelling without orbital advancement in people with Metopic Craniosynostosis and Craniosynostosis, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metopic Craniosynostosis, Craniosynostosis, Metopic Synostosis
- What is being tested?
- Frontal vault remodelling without orbital advancement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of isolated, non-syndromic metopic craniosynostosis.
- Moderate severity, characterized by frontal angle between 90° and 95°.
Who cannot join
- Syndromic metopic craniosynostosis.
- Mild and severe degrees of metopic craniosynostosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital
Asyut, Assiut Governorate, 71515
Mohamed Omran, M.B.B.Ch., +201157223276, Mohamed.18313286@med.aun.edu.eg
About this study
Official title: Frontal Reconstruction Without Orbital Advancement for the Management of Moderate Metopic Craniosynostosis: A Clinical and Morphometric Analysis
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.
Read the detailed description
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.
- Being tested
- Frontal vault remodelling without orbital advancement
- Keywords
- Frontal reconstruction, Cranial vault remodeling, Orbital advancement, Trigonocephaly, Metopic synostosis, Anthropometry, Interfrontal angle, Pediatric neurosurgery, 3D CT morphometry
- Medical subject headings
- Trigonocephaly, Nonsyndromic, Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontal vault remodelling without orbital advancementProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Frontal vault remodelling without orbital advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°).
Measured: Baseline (preoperative) and 6 months postoperatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: From surgery through 6 months postoperatively
Postoperative Mortality Rate
Number of participant deaths related or unrelated to the surgical procedure.
Measured: Intraoperative through 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metopic CraniosynostosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed mahmoud omran abdel-hafez, Assiut University
- Investigators
- Ahmed El Shanawany, M.D., Ph.D., Study director, Assiut UniversityFarrag Farrag, M.D., Ph.D., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837453
- Sponsor's protocol ID
- AUN-NS-METOPIC-01
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Oi S, Matsumoto S. Trigonocephaly (metopic synostosis). Clinical, surgical and anatomical concepts. Childs Nerv Syst. 1987;3(5):259-65. doi: 10.1007/BF00271819.
PubMed 3427566Proctor MR. Endoscopic craniosynostosis repair. Transl Pediatr. 2014 Jul;3(3):247-58. doi: 10.3978/j.issn.2224-4336.2014.07.03.
PubMed 26835342Delashaw JB, Persing JA, Park TS, Jane JA. Surgical approaches for the correction of metopic synostosis. Neurosurgery. 1986 Aug;19(2):228-34. doi: 10.1227/00006123-198608000-00008.
PubMed 3748350Vu HL, Panchal J, Parker EE, Levine NS, Francel P. The timing of physiologic closure of the metopic suture: a review of 159 patients using reconstructed 3D CT scans of the craniofacial region. J Craniofac Surg. 2001 Nov;12(6):527-32. doi: 10.1097/00001665-200111000-00005.
PubMed 11711818
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal Reconstruction Without Orbital Advancement for the Management of Moderate Metopic Craniosynostosis: A Clinical and Morphometric Analysis
- ClinicalTrials.gov ID
- NCT07837453
- Acronym / sponsor ID
- AUN-NS-METOPIC-01
- Keywords
- Frontal reconstruction, Cranial vault remodeling, Orbital advancement, Trigonocephaly, Metopic synostosis, Anthropometry, Interfrontal angle, Pediatric neurosurgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Frontal Reconstruction Arm | Experimental | Procedure: Frontal vault remodelling without orbital advancementPediatric 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of isolated, non-syndromic metopic craniosynostosis.
- Moderate severity, characterized by frontal angle between 90° and 95°.
Key exclusion criteria (2 listed)
- Syndromic metopic craniosynostosis.
- Mild and severe degrees of metopic craniosynostosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frontal vault remodelling without orbital advancementSurgical 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. | Procedure or surgery | Frontal Reconstruction Arm |
Primary outcome
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°).
4 secondary outcomes
Change in Frontal Width
Time frame: Baseline (preoperative) and 6 months postoperatively
Change in Interorbital Distance
Time frame: Baseline (preoperative) and 6 months postoperatively
Postoperative Morbidity Rate
Time frame: From surgery through 6 months postoperatively
Postoperative Mortality Rate
Time frame: Intraoperative through 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 3427566Oi S, Matsumoto S. Trigonocephaly (metopic synostosis). Clinical, surgical and anatomical concepts. Childs Nerv Syst. 1987;3(5):259-65. doi: 10.1007/BF00271819.
- Background: PubMed 26835342Proctor MR. Endoscopic craniosynostosis repair. Transl Pediatr. 2014 Jul;3(3):247-58. doi: 10.3978/j.issn.2224-4336.2014.07.03.
- Background: PubMed 3748350Delashaw JB, Persing JA, Park TS, Jane JA. Surgical approaches for the correction of metopic synostosis. Neurosurgery. 1986 Aug;19(2):228-34. doi: 10.1227/00006123-198608000-00008.
- Background: PubMed 11711818Vu HL, Panchal J, Parker EE, Levine NS, Francel P. The timing of physiologic closure of the metopic suture: a review of 159 patients using reconstructed 3D CT scans of the craniofacial region. J Craniofac Surg. 2001 Nov;12(6):527-32. doi: 10.1097/00001665-200111000-00005.
- Individual participant dataSharing planned: 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.
Related trials for Metopic Craniosynostosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed El Shanawany, M.D., Ph.D. study director
Assiut University
Farrag Farrag, M.D., Ph.D. study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frontal vault remodelling without orbital advancement in people with Metopic Craniosynostosis and Craniosynostosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed omran, M.B.B.Ch. (+201157223276, Mohamed.18313286@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frontal (Interfrontal) Angle (time frame: Baseline (preoperative) and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07837453, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.