Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients (VIR-CLEFT)
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|ClinicalTrials.gov Identifier: NCT03994679|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2019
Last Update Posted : January 7, 2020
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|
|Cleft Palate Children|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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 :||November 12, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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).
- duration of total virtual planning time [ Time Frame: preoperative ]measurement of total virtual planning time, with a digital chronometer
- duration of segmentation of the cleft defect [ Time Frame: preoperative ]measurement of segmentation of the cleft defect, with a digital chronometer
- duration of creation of the individual 3D template [ Time Frame: preoperative ]measurement of duration of creation of the individual 3D template, with a digital chronometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994679
|AZ Sint-Jan Brugge-Oostende AV|