Clinical trial NCT03843138: Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthognathic Surgery
Keywords: 3D virtual planning software
Individual Patient Solutions Case Designer (IPSCD)
timing
international
multicenter
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: University of Göttingen
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: University Hospital Heidelberg
name: AZ Monica Campus Antwerpen
name: Academisch Ziekenhuis Maastricht
name: Radboud University Medical Center
First posted: 2019-02-15
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery between May and August 2016

Brief summary: Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD).

Objectives The investigators aim to test pre-release versions of the IPSCD software under real-world working conditions in strictly selected university, general and private hospital settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.

Study design closed beta-phase; international, multi-centric, prospective study Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all the virtual planning steps with the novel software. Timing of the eight major steps will be measured with a digital chronometer.

One hundred and eight patient cases will be planned with the IPSCD software in the participating centers over a period of three months, in the order of respectively one, three and five cases per month per participating center.

Investigators will register anonymized patient demographics (age, gender, clinical diagnosis, type of surgery), and provide feedback regarding the required time to complete the different surgical planning steps, regarding the number of failed alignments, and the occurrence of software bugs. Intergroup comparison of virtual planning time between the different centers will be analyzed. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon and/or orthodontist, or in comparison to the initial beta-testing phase results by GS.


Eligibility criteria: Inclusion Criteria:

* Patients of all ages
* Patients of both genders
* Patients should present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery
* Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
* Preoperative 3D virtual planning should be performed by the same investigator per center with the IPSCD software

Exclusion Criteria:

* All patients that do not fit the abovementioned description
* Patients with posttraumatic deformity
* Patients with congenital deformity
* Patients with pre-prosthetic indication

Primary outcomes:
measure: required time to complete total 3D virtual planning
timeFrame: preoperative
Secondary outcomes:
measure: required time to complete the 8 major virtual planning steps
timeFrame: preoperative
Other outcomes:
Locations:
Study officials:
affiliation: department of maxillofacial surgery, AZ Sint-Jan Brugge-Oostende AV
name: Gwen Swennen
role: PRINCIPAL_INVESTIGATOR
References: