Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04721769
Status:
TERMINATED
Last Update Posted:
2025-09-19
First Post:
2021-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: