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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04721769
Other study ID # H-48130
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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