Metopic SynostosisTreat TrigonoNCT06069479
Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
An observational study of Metopic Synostosis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding… Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Metopic Synostosis
- What is being tested?
- craniofacial surgery
- Type of treatment
- Surgery or procedure
- How many people
- 440 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 31 Aug 2031
- Phase
- Observational
- 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 Up to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with mild, moderate or severe trigonocephaly, between 0 and 8 years of age, excluding metopic ridge (i.e. physiologic early closure of metopic suture).
Who may be able to join
- diagnosis of trigonocephaly
Who cannot join
- metopic ridge (physiologic early closure of metopic suture)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, 3012LE
Irene MJ Mathijssen, MD, PhD, MBA-H, +31655758441, i.mathijssen@erasmusmc.nl
About this study
Official title: Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically.
OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs.
Read the detailed description
HYPOTHESIS Conservative treatment is non-inferior to surgery with regard to clinical outcomes, causes less burden of disease, and is cost-effective.
STUDY DESIGN Observational cohort study STUDY POPULATION Children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture) INTERVENTION Conservative policy USUAL CARE/COMPARISON Craniofacial surgery OUTCOME MEASURES Primary: Head growth decline (head circumference in SD), indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs. Repeated measures at 0, 2, 4, 6, 8 years of age SAMPLE SIZE/DATA ANALYSIS Eligible patients <= 3 years of age are included since Sept 2022 Sample size 440 patients <1 year of age: 195 surgery and 245 conservative
Non-inferiority with regard to head growth from 0-4 years (annual measurement) is determined using a linear mixed model adjusted for confounders:
severity of phenotype, sex, syndrome and parental factors (e.g., education). COST-EFFECTIVINESS ANALYSIS/BIA An economic evaluation is performed with the incorporation of medical costs and costs due to loss of productivity for the parents. A detailed costs-study is done for medical specialist care, surgical costs, hospitalization and other costs directly associated with the interventions. Cost prizes of surgery will be determined by the bottom-up micro-costing method. Cost-utility will be measured with QALY (based on EQ-5D utility score) gained, with confidence ellipses and acceptability curves. The impact of conservative policy versus surgery will be investigated on assurance perspective and central level. From the viewpoint of the (health care) government, a societal perspective and perspective of the "budgettair kader zorg" will be highlighted. We will provide a valid framework with budget consequences by a range of predictions. Sensitivity analysis is done.
TIME SCHEDULE Inclusion between Sept 2022 and Sept 2030. Analysis and reporting for each outcome parameter related to age is distributed from January 2025 to September 2031. New recommendation for treatment of trigonocephaly in guideline ready in 2031.
- Conditions
- Metopic Synostosis
- Being tested
- craniofacial surgery
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
craniofacial surgeryProcedure or surgery
Surgical treatment, either stripcraniectomy or fronto-orbital advancement
| Study group | Role | What they receive |
|---|---|---|
| Conservative group | Children with trigonocephaly that are treated conservatively. | |
| Surgical group | Children with trigonocephaly that are treated surgically. Receives: Procedure: craniofacial surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head growth
Annual measurement of head circumference in SD for gender and age. Decline in head growth may indicate raised intracranial pressure
Measured: from 0 to 8 years old
Secondary outcomes (6)
fundoscopy
Annual screening for presence of papilledema as sign of raised intracranial pressure
Measured: from 1 to 4 years old
Cognition and behavior
Validated tests for cognition and behavior of the child
Measured: at 0, 2, 4 and 8 years old
refraction and vision
tests taken by orthoptist
Measured: at 1, 4 and 8 years old
forehead shape
3D photos (objective) and VAS score by parents (subjective) to grade the forehead shape
Measured: at 0, 2, 4, 6 and 8 years old
Quality of life and post-traumatic stress
Validated tests to measure quality of life of the child and parents and presence of PTS in parents
Measured: at 0, 2, 4, 6 and 8 years old
Decisional conflict
questionnaire to determine whether or not parents are still content with their decision on type of treatment
Measured: at 8 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Sep 2022
- Primary completion28 Feb 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metopic SynostosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- LAPOSA, IJsselland Hospital, Sint Franciscus Gasthuis
- Responsible party
- Principal investigator, Irene Mathijssen, Erasmus Medical Center
- Investigators
- Irene MJ Mathijssen, MD, PhD, MBA-H, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069479
- Sponsor's protocol ID
- PaNaMaID 9517
- Acronym
- Treat Trigono
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cornelissen MJ, Loudon SE, van Doorn FEC, Muller RPM, van Veelen MC, Mathijssen IMJ. Very Low Prevalence of Intracranial Hypertension in Trigonocephaly. Plast Reconstr Surg. 2017 Jan;139(1):97e-104e. doi: 10.1097/PRS.0000000000002866.
PubMed 28027242de Planque CA, Petr J, Gaillard L, Mutsaerts HJMM, van Veelen MC, Versnel SL, Dremmen MHG, Mathijssen IMJ. Cerebral Blood Flow of the Frontal Lobe in Untreated Children with Trigonocephaly versus Healthy Controls: An Arterial Spin Labeling Study. Plast Reconstr Surg. 2022 Apr 1;149(4):931-937. doi: 10.1097/PRS.0000000000008931.
PubMed 35171857Mathijssen IMJ; Working Group Guideline Craniosynostosis. Updated Guideline on Treatment and Management of Craniosynostosis. J Craniofac Surg. 2021 Jan-Feb 01;32(1):371-450. doi: 10.1097/SCS.0000000000007035. No abstract available.
PubMed 33156164Abdel-Alim T, Iping R, Wolvius EB, Mathijssen IMJ, Dirven CMF, Niessen WJ, van Veelen MC, Roshchupkin GV. Three-Dimensional Stereophotogrammetry in the Evaluation of Craniosynostosis: Current and Potential Use Cases. J Craniofac Surg. 2021 May 1;32(3):956-963. doi: 10.1097/SCS.0000000000007379.
PubMed 33405445Tio P, van Staalduinen M, Okkerse J, Dulfer K, Erler N, Loudon S, Telleman M, Abdel-Alim T, Roshchupkin G, Heemskerk S, Polinder S, van Veelen ML, Bannink N, van Driel A, Faasse M, Ista E, Joosten K, Spoor J, Weissbach E, Kats J, Versnel SL, Pleumeekers M, Mathijssen I. Comparing effectiveness of conservative policy to craniofacial surgery in children with metopic synostosis: protocol for an observational cohort study on clinical outcomes, psychosocial well-being and costs in a Dutch academic hospital. BMJ Open. 2025 May 6;15(5):e094112. doi: 10.1136/bmjopen-2024-094112.
PubMed 40335143
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
- ClinicalTrials.gov ID
- NCT06069479
- Acronym / sponsor ID
- Treat Trigono / PaNaMaID 9517
- Conditions
- Metopic Synostosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- LAPOSA, IJsselland Hospital, Sint Franciscus Gasthuis
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 5 Oct 2023 (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.
RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically.
OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs.
Detailed description
HYPOTHESIS Conservative treatment is non-inferior to surgery with regard to clinical outcomes, causes less burden of disease, and is cost-effective.
STUDY DESIGN Observational cohort study STUDY POPULATION Children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture) INTERVENTION Conservative policy USUAL CARE/COMPARISON Craniofacial surgery OUTCOME MEASURES Primary: Head growth decline (head circumference in SD), indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs. Repeated measures at 0, 2, 4, 6, 8 years of age SAMPLE SIZE/DATA ANALYSIS Eligible patients <= 3 years of age are included since Sept 2022 Sample size 440 patients <1 year of age: 195 surgery and 245 conservative
Non-inferiority with regard to head growth from 0-4 years (annual measurement) is determined using a linear mixed model adjusted for confounders:
severity of phenotype, sex, syndrome and parental factors (e.g., education). COST-EFFECTIVINESS ANALYSIS/BIA An economic evaluation is performed with the incorporation of medical costs and costs due to loss of productivity for the parents. A detailed costs-study is done for medical specialist care, surgical costs, hospitalization and other costs directly associated with the interventions. Cost prizes of surgery will be determined by the bottom-up micro-costing method. Cost-utility will be measured with QALY (based on EQ-5D utility score) gained, with confidence ellipses and acceptability curves. The impact of conservative policy versus surgery will be investigated on assurance perspective and central level. From the viewpoint of the (health care) government, a societal perspective and perspective of the "budgettair kader zorg" will be highlighted. We will provide a valid framework with budget consequences by a range of predictions. Sensitivity analysis is done.
TIME SCHEDULE Inclusion between Sept 2022 and Sept 2030. Analysis and reporting for each outcome parameter related to age is distributed from January 2025 to September 2031. New recommendation for treatment of trigonocephaly in guideline ready in 2031.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative group | – | –Children with trigonocephaly that are treated conservatively. |
| Surgical group | – | Procedure: craniofacial surgeryChildren with trigonocephaly that are treated surgically. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with mild, moderate or severe trigonocephaly, between 0 and 8 years of age, excluding metopic ridge (i.e. physiologic early closure of metopic suture).
Key inclusion criteria (1 listed)
- diagnosis of trigonocephaly
Key exclusion criteria (1 listed)
- metopic ridge (physiologic early closure of metopic suture)
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 |
|---|---|---|
| craniofacial surgerySurgical treatment, either stripcraniectomy or fronto-orbital advancement | Procedure or surgery | Surgical group |
Primary outcome
Head growth
Time frame: from 0 to 8 years old
Annual measurement of head circumference in SD for gender and age. Decline in head growth may indicate raised intracranial pressure
6 secondary outcomes
fundoscopy
Time frame: from 1 to 4 years old
Cognition and behavior
Time frame: at 0, 2, 4 and 8 years old
refraction and vision
Time frame: at 1, 4 and 8 years old
forehead shape
Time frame: at 0, 2, 4, 6 and 8 years old
Quality of life and post-traumatic stress
Time frame: at 0, 2, 4, 6 and 8 years old
Decisional conflict
Time frame: at 8 years old
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 11 Sep 2026.
- Results publication: PubMed 28027242Cornelissen MJ, Loudon SE, van Doorn FEC, Muller RPM, van Veelen MC, Mathijssen IMJ. Very Low Prevalence of Intracranial Hypertension in Trigonocephaly. Plast Reconstr Surg. 2017 Jan;139(1):97e-104e. doi: 10.1097/PRS.0000000000002866.
- Results publication: PubMed 35171857de Planque CA, Petr J, Gaillard L, Mutsaerts HJMM, van Veelen MC, Versnel SL, Dremmen MHG, Mathijssen IMJ. Cerebral Blood Flow of the Frontal Lobe in Untreated Children with Trigonocephaly versus Healthy Controls: An Arterial Spin Labeling Study. Plast Reconstr Surg. 2022 Apr 1;149(4):931-937. doi: 10.1097/PRS.0000000000008931.
- Results publication: PubMed 33156164Mathijssen IMJ; Working Group Guideline Craniosynostosis. Updated Guideline on Treatment and Management of Craniosynostosis. J Craniofac Surg. 2021 Jan-Feb 01;32(1):371-450. doi: 10.1097/SCS.0000000000007035. No abstract available.
- Results publication: PubMed 33405445Abdel-Alim T, Iping R, Wolvius EB, Mathijssen IMJ, Dirven CMF, Niessen WJ, van Veelen MC, Roshchupkin GV. Three-Dimensional Stereophotogrammetry in the Evaluation of Craniosynostosis: Current and Potential Use Cases. J Craniofac Surg. 2021 May 1;32(3):956-963. doi: 10.1097/SCS.0000000000007379.
- Derived from this study: PubMed 40335143Tio P, van Staalduinen M, Okkerse J, Dulfer K, Erler N, Loudon S, Telleman M, Abdel-Alim T, Roshchupkin G, Heemskerk S, Polinder S, van Veelen ML, Bannink N, van Driel A, Faasse M, Ista E, Joosten K, Spoor J, Weissbach E, Kats J, Versnel SL, Pleumeekers M, Mathijssen I. Comparing effectiveness of conservative policy to craniofacial surgery in children with metopic synostosis: protocol for an observational cohort study on clinical outcomes, psychosocial well-being and costs in a Dutch academic hospital. BMJ Open. 2025 May 6;15(5):e094112. doi: 10.1136/bmjopen-2024-094112.
- Individual participant dataSharing planned: No
Related trials for Metopic Synostosis
Not yet recruiting
Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis
Metopic Craniosynostosis, 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.
Irene MJ Mathijssen, MD, PhD, MBA-H principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metopic Synostosis, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 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 Netherlands. 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 Irene MJ Mathijssen, MD, PhD, MBA-H (+31655758441, i.mathijssen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head growth (time frame: from 0 to 8 years old). 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 NCT06069479, which also lists 5 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 11 Sep 2026.