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Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients (VIR-CLEFT)
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 |
| 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 |
| 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).
|
- 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
| Ages Eligible for Study: | 7 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Sampling Method: | Non-Probability Sample |
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
| Belgium | |
| AZ Sint-Jan Brugge-Oostende AV | |
| Brugge, Belgium | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 19, 2019 | ||||
| First Posted Date | June 21, 2019 | ||||
| Last Update Posted Date | January 7, 2020 | ||||
| Actual Study Start Date | November 12, 2018 | ||||
| Estimated Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
duration of total virtual planning time [ Time Frame: preoperative ] measurement of total virtual planning time, with a digital chronometer
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients | ||||
| 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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). | ||||
| Condition | Cleft Palate Children | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | 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).
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Actual Enrollment |
10 | ||||
| Original Actual Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 7 Years to 12 Years (Child) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03994679 | ||||
| Other Study ID Numbers | 2368 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Krisztian Nagy, AZ Sint-Jan AV | ||||
| Study Sponsor | AZ Sint-Jan AV | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | AZ Sint-Jan AV | ||||
| Verification Date | January 2020 | ||||
