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VIR-CLEFT: Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients

Sponsor
AZ Sint-Jan AV (Other)
Overall Status
Completed
CT.gov ID
NCT03994679
Collaborator
(none)
10
Enrollment
1
Location
25.6
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Nov 12, 2018
    Actual Primary Completion Date :
    Jul 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    cleft patient requiring bone graft

    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).

    Outcome Measures

    Primary Outcome Measures

    1. duration of total virtual planning time [preoperative]

      measurement of total virtual planning time, with a digital chronometer

    Secondary Outcome Measures

    1. duration of segmentation of the cleft defect [preoperative]

      measurement of segmentation of the cleft defect, with a digital chronometer

    2. duration of creation of the individual 3D template [preoperative]

      measurement of duration of creation of the individual 3D template, with a digital chronometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 12 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AZ Sint-Jan Brugge-Oostende AV Brugge Belgium

    Sponsors and Collaborators

    • AZ Sint-Jan AV

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Krisztian Nagy, principal investigator, maxillofacial surgeon, AZ Sint-Jan AV
    ClinicalTrials.gov Identifier:
    NCT03994679
    Other Study ID Numbers:
    • 2368
    First Posted:
    Jun 21, 2019
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Krisztian Nagy, principal investigator, maxillofacial surgeon, AZ Sint-Jan AV
    3D virtual software
    bone graft
    Additional relevant MeSH terms:
    Cleft Palate

    Study Results

    No Results Posted as of Feb 25, 2022