Craniosynostosis, SagittalNCT04721769
Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
A study testing Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy and Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy in people with Craniosynostosis, Sagittal, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Craniosynostosis, Sagittal
- What is being tested?
- Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy and Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.
Who cannot join
- Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
- Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. ESC is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference.
- Previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes.
- The purpose of this study is to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. In addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.
Read the detailed description
- This prospective, randomized parallel study seeks to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis.
- Both arms of the study will undergo standard care throughout their participation which includes preoperative \& postoperative measurements of cephalic index using the STARscanner© (Orthomerica products Inc.), preoperative \& postoperative photographs, post-operative helmeting, and standard post-operative visits.
- Additional research-related activities include chart review. Primary outcomes include degree of cranial expansion at 1 year post-operatively.
- Secondary outcomes include aesthetic appearance at 1 year post-operatively (using a 5-point Likert scale) and a multitude of intraoperative clinical variables including estimated blood loss, instances of transfusion, instances of dural tear, instances of 30-day readmission, and instances of needing further surgery.
- Conditions
- Craniosynostosis, Sagittal
- Being tested
- Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy, Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapyProcedure or surgery
Also called Endoscopic suturectomy (with barrel-stave osteotomies) with post-operative helmet therapy
Endoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour.
Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapyProcedure or surgery
Also called Endoscopic suturectomy (without barrel-stave osteotomies) with post-operative helmet therapy
Endoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic strip craniectomy with the use of lateral osteotomies | Active comparator | Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. Receives: Procedure: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy |
| Endoscopic strip craniectomy without the use of lateral osteotomies | Experimental | Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. Receives: Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
The cephalic index is the ratio of maximal head width and length. Patients enrolled in the trial will undergo pre-operative and post-operative measurement of their cephalic index using the STARscanner© (Orthomerica products Inc.). Patients will undergo measurement at recruitment and at 1 year of age.
Measured: Pre-operatively (at recruitment) & post-operatively (at 1 year of age)
Secondary outcomes (8)
Aesthetic outcome
The aesthetic appearance of the calvarium will be measured by participating surgeons using a 5-point Likert scale (1-5) with 1 being extremely satisfied with aesthetic outcome and 5 being extremely dissatisfied with aesthetic outcome. Surgeons that are aware of the participant's assignment are excluded from this portion of the study to minimize bias.
Measured: post-operatively (at 1 year of age)
Operative length
Length of operation from incision to closure
Measured: during the intervention/procedure/surgery
Estimated Blood loss
Based on estimated volume of blood loss and perioperative changes in hemoglobin mass
Measured: during the intervention/procedure/surgery
Instance of transfusion
Whether or not the participant received a blood transfusion intraoperatively or post-operatively
Measured: during the intervention/procedure/surgery
Amount of blood transfused
Measured in mL/kg
Measured: during the intervention/procedure/surgery
Instance of dural tear
Whether or not the patient experienced a dural tear during surgery
Measured: during the intervention/procedure/surgery
Instance of 30-day readmission
Whether or not a patient was readmitted to the hospital for complications related to their surgical procedure
Measured: Day of procedure through 30 days post-operatively
Instance of needing further surgical correction
Whether or not the patient requires further surgical intervention to correct their calvarial defect.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start18 Dec 2020
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Craniosynostosis, SagittalStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have two patient groups. Group 1: Endoscopic strip craniectomy with the use of lateral osteotomies. Group 2: Endoscopic strip craniectomy without the use of lateral osteotomies.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bauer, Baylor College of Medicine
- Investigators
- David F Bauer, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721769
- Sponsor's protocol ID
- H-48130
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wood BC, Ahn ES, Wang JY, Oh AK, Keating RF, Rogers GF, Magge SN. Less is more: does the addition of barrel staves improve results in endoscopic strip craniectomy for sagittal craniosynostosis? J Neurosurg Pediatr. 2017 Jul;20(1):86-90. doi: 10.3171/2017.1.PEDS16478. Epub 2017 Apr 14.
PubMed 28409698Nguyen DC, Farber SJ, Skolnick GB, Naidoo SD, Smyth MD, Kane AA, Patel KB, Woo AS. One hundred consecutive endoscopic repairs of sagittal craniosynostosis: an evolution in care. J Neurosurg Pediatr. 2017 Nov;20(5):410-418. doi: 10.3171/2017.5.PEDS16674. Epub 2017 Aug 25.
PubMed 28841109Fearon JA, Ditthakasem K, Herbert M, Kolar J. An Appraisal of the Cephalic Index in Sagittal Craniosynostosis, and the Unseen Third Dimension. Plast Reconstr Surg. 2017 Jul;140(1):138-145. doi: 10.1097/PRS.0000000000003422.
PubMed 28654600
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
- ClinicalTrials.gov ID
- NCT04721769
- Acronym / sponsor ID
- H-48130
- Conditions
- Craniosynostosis, Sagittal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Jan 2021 (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.
- Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. ESC is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference.
- Previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes.
- The purpose of this study is to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. In addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.
Detailed description
- This prospective, randomized parallel study seeks to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis.
- Both arms of the study will undergo standard care throughout their participation which includes preoperative \& postoperative measurements of cephalic index using the STARscanner© (Orthomerica products Inc.), preoperative \& postoperative photographs, post-operative helmeting, and standard post-operative visits.
- Additional research-related activities include chart review. Primary outcomes include degree of cranial expansion at 1 year post-operatively.
- Secondary outcomes include aesthetic appearance at 1 year post-operatively (using a 5-point Likert scale) and a multitude of intraoperative clinical variables including estimated blood loss, instances of transfusion, instances of dural tear, instances of 30-day readmission, and instances of needing further surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- We have two patient groups. Group 1: Endoscopic strip craniectomy with the use of lateral osteotomies. Group 2: Endoscopic strip craniectomy without the use of lateral osteotomies.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic strip craniectomy with the use of lateral osteotomies | Active comparator | Procedure: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapyPatients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. |
| Endoscopic strip craniectomy without the use of lateral osteotomies | Experimental | Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapyPatients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.
Key exclusion criteria (1 listed)
- Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
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 |
|---|---|---|
| Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapyAlso: Endoscopic suturectomy (with barrel-stave osteotomies) with post-operative helmet therapyEndoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour. | Procedure or surgery | Endoscopic strip craniectomy with the use of lateral osteotomies |
| Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapyAlso: Endoscopic suturectomy (without barrel-stave osteotomies) with post-operative helmet therapyEndoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour. | Procedure or surgery | Endoscopic strip craniectomy without the use of lateral osteotomies |
Primary outcome
Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age
Time frame: Pre-operatively (at recruitment) & post-operatively (at 1 year of age)
The cephalic index is the ratio of maximal head width and length. Patients enrolled in the trial will undergo pre-operative and post-operative measurement of their cephalic index using the STARscanner© (Orthomerica products Inc.). Patients will undergo measurement at recruitment and at 1 year of age.
8 secondary outcomes
Aesthetic outcome
Time frame: post-operatively (at 1 year of age)
Operative length
Time frame: during the intervention/procedure/surgery
Estimated Blood loss
Time frame: during the intervention/procedure/surgery
Instance of transfusion
Time frame: during the intervention/procedure/surgery
Amount of blood transfused
Time frame: during the intervention/procedure/surgery
Instance of dural tear
Time frame: during the intervention/procedure/surgery
Instance of 30-day readmission
Time frame: Day of procedure through 30 days post-operatively
Instance of needing further surgical correction
Time frame: 1 year after surgery
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 28409698Wood BC, Ahn ES, Wang JY, Oh AK, Keating RF, Rogers GF, Magge SN. Less is more: does the addition of barrel staves improve results in endoscopic strip craniectomy for sagittal craniosynostosis? J Neurosurg Pediatr. 2017 Jul;20(1):86-90. doi: 10.3171/2017.1.PEDS16478. Epub 2017 Apr 14.
- Background: PubMed 28841109Nguyen DC, Farber SJ, Skolnick GB, Naidoo SD, Smyth MD, Kane AA, Patel KB, Woo AS. One hundred consecutive endoscopic repairs of sagittal craniosynostosis: an evolution in care. J Neurosurg Pediatr. 2017 Nov;20(5):410-418. doi: 10.3171/2017.5.PEDS16674. Epub 2017 Aug 25.
- Background: PubMed 28654600Fearon JA, Ditthakasem K, Herbert M, Kolar J. An Appraisal of the Cephalic Index in Sagittal Craniosynostosis, and the Unseen Third Dimension. Plast Reconstr Surg. 2017 Jul;140(1):138-145. doi: 10.1097/PRS.0000000000003422.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
David F Bauer, MD, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy and Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy in people with Craniosynostosis, Sagittal, run by Baylor College of Medicine at 1 site in United States.
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: stopped early, as of the sponsor's last update on 19 Sep 2025. 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 United States. 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?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cephalic index from preoperative measurement to postoperative measurement at 1 year of age (time frame: Pre-operatively (at recruitment) & post-operatively (at 1 year of age)). 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 NCT04721769, which also lists 3 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 19 Sep 2025.