Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994679
Recruitment Status : Active, not recruiting
First Posted : June 21, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Krisztian Nagy, AZ Sint-Jan AV

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
Cleft Palate Children

Layout table for study information
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 : November 12, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. duration of total virtual planning time [ Time Frame: preoperative ]
    measurement of total virtual planning time, with a digital chronometer


Secondary Outcome Measures :
  1. duration of segmentation of the cleft defect [ Time Frame: preoperative ]
    measurement of segmentation of the cleft defect, with a digital chronometer

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Belgium
AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium
Sponsors and Collaborators
AZ Sint-Jan AV
Layout table for additonal information
Responsible Party: Krisztian Nagy, principal investigator, maxillofacial surgeon, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03994679    
Other Study ID Numbers: 2368
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krisztian Nagy, AZ Sint-Jan AV:
3D virtual software
bone graft
Additional relevant MeSH terms:
Layout table for MeSH terms
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities