Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

Craniosynostosis, Sagittal Clinical Trial

Official title:

Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721769
• Other study ID #: H-48130
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2023
• Source: Baylor College of Medicine
• Contact: David F Bauer, MD, MPH
• Phone: 832-822-1282
• Email: dfbauer[@]texaschildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Craniosynostoses
• Craniosynostosis, Sagittal

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Operative length	Length of operation from incision to closure	during the intervention/procedure/surgery
Secondary	Estimated Blood loss	Based on estimated volume of blood loss and perioperative changes in hemoglobin mass	during the intervention/procedure/surgery
Secondary	Instance of transfusion	Whether or not the participant received a blood transfusion intraoperatively or post-operatively	during the intervention/procedure/surgery
Secondary	Amount of blood transfused	Measured in mL/kg	during the intervention/procedure/surgery
Secondary	Instance of dural tear	Whether or not the patient experienced a dural tear during surgery	during the intervention/procedure/surgery
Secondary	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
Secondary	Instance of needing further surgical correction	Whether or not the patient requires further surgical intervention to correct their calvarial defect.	1 year after surgery