Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients

Cleft Palate Children Clinical Trial

— VIR-CLEFT  

Official title:

Feasibility and Performance of Brainlab Iplan Software, in Comparison to Freeware for Virtual Bone Graft Planning in Unilateral Cleft Patients: a Retrospective, Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994679
• Other study ID #: 2368
• Status: Completed
• Start date: November 12, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: The investigators aim to compare the licensed Brainlab Iplan® software, considered the gold standard, to the 3D slicers and Blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3D template for development of the bone graft.

Study design Retrospective, pilot study Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). A single surgeon will run all the virtual planning steps with both the licensed software and the freeware. Timing of the four major steps will be measured with a digital chronometer (http://www.online-stopwatch.com/download-stopwatch/).

Ten children, 5 Belgian patients and 5 Hungarian patients, that already had a work-up and surgery for a unilateral cleft requiring a bone graft, will be planned. This based on the preoperative CBCT that is already present, by using both the licensed software and free software. The investigator will register patients' age, gender and cleft size and register the required time to complete the different planning steps, as well as list the number of actions to complete the planning, and the occurrence of software bugs. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon. All patients will be planned twice with an interval of two weeks in order to measure intra-observer reliability. Moreover, a second surgeon will also plan the 10 cases to measure inter-observer reliability.

Main study endpoints The investigators hypothesize that the licensed software is more user-friendly, ensuring a significant shorter overall treatment planning time to create a model for accurate bone transfer from the iliac crest to the jawbone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients with a unilateral cleft

• Patients of all genders

• Patients aged 7-12 years old

• Patients should have presented themselves at the division of maxillofacial surgery, at the participating hospital centers, for bone graft surgery

• Patients should have received standardized cone-beam computed tomography (CBCT) image acquisition as part of routine work-up, and all original DICOM files should be present

• Preoperative 3D virtual planning should be performed by the same investigator per center with both the licensed software and the freeware

Exclusion Criteria:

• All patients that do not fit the abovementioned description

• Patients with previous bone graft surgery

• Patients with posttraumatic deformity

• Patients with preprosthetic indication

Related Conditions & MeSH terms

• Cleft Palate
• Cleft Palate Children

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of total virtual planning time	measurement of total virtual planning time, with a digital chronometer	preoperative
Secondary	duration of segmentation of the cleft defect	measurement of segmentation of the cleft defect, with a digital chronometer	preoperative
Secondary	duration of creation of the individual 3D template	measurement of duration of creation of the individual 3D template, with a digital chronometer	preoperative