Children's National

Clinical Feasibility Study of Preoperative Surgical Planning

Purpose

Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main goal of this procedure is to reduce the risk of elevated intracranial pressure and to provide a more normal cranial shape and volume. Personalized surgical planning systems to optimize intervention and leverage surgical expertise in the reconstruction of the cranial vault do not exist. Thus, the expertise of the surgeon is paramount for the success of the surgical correction of craniosynostosis. The goal of our project is to evaluate the feasibility and utility of a surgical plan derived from software developed at Children's National, iCSPlan.

Condition

Craniosynostoses

Eligibility

Eligible Ages: Under 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Patients under 18 years of age. 2. Diagnosis of craniosynostosis. 3. Scheduled for open crania vault reconstruction. 4. Patients seen in Children's National Medical Center.

Exclusion Criteria

Lack of interest in participating and refusal to consent. 2. Plan for endoscopic craniectomy of synostosis.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Presurgical planning	Undergo crania-vault reconstruction following the presurgical planning (iCSPlan)	Device: iCSPlan The Investigator will acquire a routine pre-operative CT-scan to help assess the synostosis severity. A week before the surgery a routine preoperative visit will be done. If the potential subject agrees to participate in the study, a presurgical plan will be built, and based on the CT scan, it will (1) quantify shape differences between pathological and healthy cranial shapes; (2) compensates for brain and cranial growth during the months between diagnosis, treatment and recovery; and (3) guides bone-cuts and bone-placement for the simplest and optimal surgical procedure. Finally this plan will be recorded in a software, iCSPlan, which will be reviewed by the surgeon. If it is accepted, it will be available during the surgery as a rely-on tool which may or may not be followed.

Recruiting Locations

More Details

NCT ID: NCT03812159
Status: Withdrawn
Sponsor: Gary F. Rogers, MD

Detailed Description

Presurgical planning will be performed in patients that require an open crania-vault reconstruction for craniosynostosis. The participants will come from the outpatient clinics of neurosurgery and plastic surgery. The treating physician/study team member will explain and give a copy of Institutional review board (IRB) approved study information letter to the participant's legally authorized representative (LAR). The investigators will acquire a pre-operative CT-scan, per standard of care, to help assess the synostosis severity, within 4 weeks before the procedure. A week before the surgery, a routine preoperative visit will be done where the participant and/or LAR, if agree to participate in the study, will sign the informed consent document(s). A presurgical plan will be built and will be recorded in a software, iCSPlan. Although this plan will not be integrated in the OR workflow, if needed, it would be visualized on a desktop monitor, which will be available to the surgical team. This tool will not influence any clinical decision making in the study. Instead, it will work as a rely-on tool in the preparation of the surgery, which may or may not be followed by the surgeon. Demographic information (sex, age), as well as intraoperative information (Anesthesia length, anesthesia medications, length of surgery, blood loss, # of blood units transfused, complications), will be recorded for analysis. These variables are generally recorded during surgery and add no additional operative time. Following the surgery, the specialists will evaluate the feasibility of the use of the presurgical plan by completing a questionnaire to report their options on (1): Quality of the surgical outcome; (2) the quality of the surgical strategy, and (3) the utility of the surgical planning in the treatment. The questions will be answered on a 5-point Likert scale, ranging from "not useful/strongly dislike" to "very useful/strongly like". All study team pre-screening materials that contain participants information will be maintained on password protected computers. Only authorized study team members will have access to the pre-screening materials. Any pre-screening protected health information (PHI) that is collected will be destroyed once study enrollment is completed.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.