An interventional study of Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy and Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy in Craniosynostosis, Sagittal, sponsored by Baylor College of Medicine. Terminated at 1 site in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 6 is below the median of 27 across 22 interventional studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
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Exclusion Criteria:
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
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.
Also known as: Endoscopic suturectomy (with barrel-stave 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.
Also known as: Endoscopic suturectomy (without barrel-stave osteotomies) with post-operative helmet therapy
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.
Time frame: Pre-operatively (at recruitment) & post-operatively (at 1 year of age)
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.
Time frame: post-operatively (at 1 year of age)
Operative length
Length of operation from incision to closure
Time frame: during the intervention/procedure/surgery
Estimated Blood loss
Based on estimated volume of blood loss and perioperative changes in hemoglobin mass
Time frame: during the intervention/procedure/surgery
Instance of transfusion
Whether or not the participant received a blood transfusion intraoperatively or post-operatively
Time frame: during the intervention/procedure/surgery
Amount of blood transfused
Measured in mL/kg
Time frame: during the intervention/procedure/surgery
Instance of dural tear
Whether or not the patient experienced a dural tear during surgery
Time frame: 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
Time frame: 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.
Time frame: 1 year after surgery
Plan to share: No
Ran from Dec 2020 to primary completion in May 2025, 52 months.
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This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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