Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

Overview

– 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.

Full Title of Study: “Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2025

Detailed Description

РThis 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. РBoth 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. РAdditional research-related activities include chart review. Primary outcomes include degree of cranial expansion at 1 year post-operatively. РSecondary 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.

Interventions

  • Procedure: Endoscopic strip craniectomy 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.

Arms, Groups and Cohorts

  • Active Comparator: Endoscopic strip craniectomy with the use of lateral osteotomies
    • Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.
  • Experimental: Endoscopic strip craniectomy without the use of lateral osteotomies
    • Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Aesthetic outcome
    • Time Frame: post-operatively (at 1 year of age)
    • 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.
  • Operative length
    • Time Frame: during the intervention/procedure/surgery
    • Length of operation from incision to closure
  • Estimated Blood loss
    • Time Frame: during the intervention/procedure/surgery
    • Based on estimated volume of blood loss and perioperative changes in hemoglobin mass
  • Instance of transfusion
    • Time Frame: during the intervention/procedure/surgery
    • Whether or not the participant received a blood transfusion intraoperatively or post-operatively
  • Amount of blood transfused
    • Time Frame: during the intervention/procedure/surgery
    • Measured in mL/kg
  • Instance of dural tear
    • Time Frame: during the intervention/procedure/surgery
    • Whether or not the patient experienced a dural tear during surgery
  • Instance of 30-day readmission
    • Time Frame: Day of procedure through 30 days post-operatively
    • Whether or not a patient was readmitted to the hospital for complications related to their surgical procedure
  • Instance of needing further surgical correction
    • Time Frame: 1 year after surgery
    • Whether or not the patient requires further surgical intervention to correct their calvarial defect.

Participating in This Clinical Trial

Inclusion Criteria

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

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Bauer, Principal Investigator – Baylor College of Medicine
  • Overall Official(s)
    • David F Bauer, MD, MPH, Principal Investigator, Baylor College of Medicine
  • Overall Contact(s)
    • David F Bauer, MD, MPH, 832-822-1282, dfbauer@texaschildrens.org

References

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.

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.

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.

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