The main objective is to determine if the application of a patient-specific guidance system improves the accuracy of the genioplasty. The secondary objective is to assess the effect of the application of patient-specific guidance system on the…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are six main study parameters in this study: three describing the
absolute translation (anteroposterior, mediolateral and superoinferior) and
three describing the absolute rotation (pitch, roll and yaw). To compute these
variables, the methodology of the OrthoGnaticAnalyser will be used, since this
method provides reproducible, quantitative outcome measures in three
dimensions. The planned movement of the genial segment can be expressed in
rotation and translation from its preoperative position. The postoperative
(CB)CT scan can be superimposed on the preoperative virtual planning.
Consequently, the preoperative genial segment can be superimposed on the
postoperative position of the genial segment. The actual movement of the genial
segment, in rotation and translation parameters, is automatically obtained from
the superimposition process. The absolute difference between planned and actual
rotations and translations provides an intuitive accuracy measurement of the
genioplasty.
Secondary outcome
The secondary outcome parameter is the surgical time. This will be defined as
the time between the start of incision and the fixation of the last screws. The
surgeon will be asked to report this time after each surgery.
Background summary
The goal of orthognathic surgery is to correct cranio-maxillofacial deformities
in order to improve function and facial appearance. The incorporation of
computed tomography (CT or CBCT) in the surgical planning allows for more
detailed diagnostics and virtual preoperative planning of orthognathic surgery
in all three dimensions. A genioplasty (chin osteotomy) may be necessary to
ensure a harmonious profile or to correct for facial asymmetries. The planning
of rotational and translational movements of the chin segment has become more
detailed and complex with the use of 3D preoperative planning. For this reason,
customized surgical guides have been developed to accurately transfer the
detailed surgical plan to the patient during surgery. We hypothesize that the
application of a patient-specific guidance system can increase surgical
accuracy of the genioplasty.
Study objective
The main objective is to determine if the application of a patient-specific
guidance system improves the accuracy of the genioplasty. The secondary
objective is to assess the effect of the application of patient-specific
guidance system on the duration of the surgical procedure.
Study design
Study design: Prospective randomized intervention study.
Duration of the study: The estimated duration will be 30 months.
Setting of the study: For this study, a multicenter approach is chosen to
ensure sufficient patient inclusion within the indication duration of the
study. Participating centers will be the AUMC location AMC, Spaarne Gasthuis,
and Radboud UMC.
Intervention
In the intervention group, the genioplasty will be executed with the aid of the
patient-specific guidance system. In the control group, the genioplasty will be
executed without the help of guides (conventional method).
Study burden and risks
The extra burden and risks associated with this study are negligible. Both
treatment options can be considered as common practice to their full extend.
They are both used on a regular base in all participating hospitals. No changes
are made to the standard clinical protocol in both control and experimental
group. Risks during surgery might include incompetent fit of the guides or
failure of the guides (i.e. fracturing of the guide). In our experience, these
events have not happened in clinical practice thus far. In any of these
situations, the conventional method will be used as a fallback procedure. No
additional intervention is required in any of the proposed situations.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Orthognathic surgery patients (>18 years) in whom a virtual surgery planning is
made and in whom a genioplasty is indicated.
Exclusion criteria
A potential subject will be excluded from participation in this study when the
surgery is indicated for any of the following conditions:
• Congenital disorders (e.g. craniofacial microsomia)
• Obstructive Sleep Apnea Syndrome (OSAS)
• Transgender surgery
• Previous orthognathic surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL72676.018.20 |
| Other | NL8332 |