Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

Baylor College of Medicine

Status: Enrolling

Conditions: Craniosynostosis, Sagittal

Treatments: Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy; Procedure: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04721769

H-48130

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Endoscopic strip craniectomy with the use of lateral osteotomies

Active Comparator group

Description:

Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.

Treatment:

Procedure: Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy

Endoscopic strip craniectomy without the use of lateral osteotomies

Experimental group

Description:

Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.

Treatment:

Procedure: Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy