Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

NCT04721769 | Terminated

• 1 other identifier: H-48130
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Craniosynostosis, Sagittal

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-operatively (at recruitment) & post-operatively (at 1 year of age)

Secondary Outcomes (8)

• Aesthetic outcome

  post-operatively (at 1 year of age)

• Operative length

  during the intervention/procedure/surgery

• Estimated Blood loss

  during the intervention/procedure/surgery

• Instance of transfusion

  during the intervention/procedure/surgery

• Amount of blood transfused

  during the intervention/procedure/surgery

Study Arms (2)

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.

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.

Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy

Interventions

Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy PROCEDURE

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.

Also known as: Endoscopic suturectomy (with barrel-stave osteotomies) with post-operative helmet therapy

Endoscopic strip craniectomy with the use of lateral osteotomies

Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy PROCEDURE

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.

Also known as: Endoscopic suturectomy (without barrel-stave osteotomies) with post-operative helmet therapy

Endoscopic strip craniectomy without the use of lateral osteotomies

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.

You may not qualify if:

• Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 28409698 BACKGROUND

• Nguyen 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.

  PMID: 28841109 BACKGROUND

• Fearon 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.

  PMID: 28654600 BACKGROUND

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David F Bauer, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and guardians of participants will not know which arm the participant is randomized to. Regarding care providers, only care providers performing the surgery will be privy to information regarding which arm the patient is randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 25, 2021
• Study Start: December 18, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)