Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

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.

Study Overview

• Status: Recruiting
• Conditions: Craniosynostosis, Sagittal
• Intervention / Treatment: Procedure: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy; Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David F Bauer, MD, MPH; Phone Number: 832-822-1282; Email: dfbauer@texaschildrens.org
• Study Contact Backup: Name: Betty Tung, MS; Phone Number: 8328223190; Email: btung@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital
      • Sub-Investigator: Andrew M Ferry, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 months (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Endoscopic strip craniectomy (with lateral 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.; Other Names: Endoscopic suturectomy (with barrel-stave osteotomies) with post-operative helmet therapy
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.	Procedure: Endoscopic strip craniectomy (without lateral 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.; Other Names: Endoscopic suturectomy (without barrel-stave osteotomies) with post-operative helmet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	post-operatively (at 1 year of age)
Operative length	Length of operation from incision to closure	during the intervention/procedure/surgery
Estimated Blood loss	Based on estimated volume of blood loss and perioperative changes in hemoglobin mass	during the intervention/procedure/surgery
Instance of transfusion	Whether or not the participant received a blood transfusion intraoperatively or post-operatively	during the intervention/procedure/surgery
Amount of blood transfused	Measured in mL/kg	during the intervention/procedure/surgery
Instance of dural tear	Whether or not the patient experienced a dural tear during surgery	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	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.	1 year after surgery

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: David F Bauer, MD, MPH, Baylor College of Medicine

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Synostosis; Craniosynostoses
• Other Study ID Numbers: H-48130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No