Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

Study Overview
=================
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.

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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We have two patient groups. Group 1: Endoscopic strip craniectomy with the use of lateral osteotomies. Group 2: Endoscopic strip craniectomy without the use of lateral osteotomies.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic strip craniectomy with the use of lateral osteotomies<br>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<br>* 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.<br>* Other names: Endoscopic suturectomy (with barrel-stave osteotomies) with post-operative helmet therapy;|
| Experimental: Endoscopic strip craniectomy without the use of lateral osteotomies<br>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<br>* 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.<br>* 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 |