Clinical Feasibility Study of Preoperative Surgical Planning

NCT03812159 | Withdrawn FDA Device

• 2 other identifiers: Pro00011015R42HD081712
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniosynostoses

Keywords

Shape analysis; Computer-assisted surgical plan; Surgical planning; Computational anatomy

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility of a surgical planning software (iCSPlan) for open cranial vault reconstructions assessed by how often will the surgeon use or discard the surgical plan

  Preoperative planning for cranial vault reconstruction will be built in patients under 18 years old with craniosynostosis. We will document the number of times the surgical plan is followed by the surgeon.

  a week before surgery

Secondary Outcomes (6)

• To evaluate the utility of the surgical planning software (iCSPlan) assessed by a 5-point Likert scale questionnaire.

  A week before surgery

• To evaluate the quality of the surgical strategy and the surgical outcome built by the surgical planning software (iCSPlan) surgeons will complete a 5-point Likert scale questionnaire.

  a week before surgery

• To evaluate the impact of the surgical planning software (iCSplan) assessed by the difference in the length of surgery if the plan is used.

  The day of surgery (One day)

• To evaluate the intra-operative impact of using a surgical planning software (iCSPlan) assessed by the amount of blood loss, and thus, the amount of transfusion needed.

  The day of surgery (One day)

• To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the complications encountered 30-days after the surgery.

  30 days after surgery.

Study Arms (1)

Presurgical planning

EXPERIMENTAL

Undergo crania-vault reconstruction following the presurgical planning (iCSPlan)

Device: iCSPlan

Interventions

iCSPlan DEVICE

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.

Presurgical planning

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gary F. Rogers, MD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Childrens National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (3)

• Porras AR, Paniagua B, Ensel S, Keating R, Rogers GF, Enquobahrie A, Linguraru MG. Locally Affine Diffeomorphic Surface Registration and Its Application to Surgical Planning of Fronto-Orbital Advancement. IEEE Trans Med Imaging. 2018 Jul;37(7):1690-1700. doi: 10.1109/TMI.2018.2816402.

  PMID: 29969419 BACKGROUND

• Porras AR, Zukic D, Equobahrie A, Rogers GF, Linguraru MG. Personalized Optimal Planning for the Surgical Correction of Metopic Craniosynostosis. Clin Image Based Proced. 2016;2016:60-67. doi: 10.1007/978-3-319-46472-5_8. Epub 2016 Sep 21.

  PMID: 28149960 BACKGROUND

• Porras AR, Paniagua B, Enquobahrie A, Ensel S, Shah H, Keating R, Rogers GF, Linguraru MG. Locally affine diffeomorphic surface registration for planning of metopic craniosynostosis surgery. Med Image Comput Comput Assist Interv. 2017 Sep;10434:479-487. doi: 10.1007/978-3-319-66185-8_54. Epub 2017 Sep 4.

  PMID: 29527598 BACKGROUND

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gary Rogers, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 23, 2019
• Study Start: January 1, 2020
• Primary Completion: March 20, 2024
• Study Completion: April 20, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)