Genioplasty, Chin Microgenia, Chin Macrogenia
Conditions
Keywords
patient specific implant, computer-aided surgery, clinical accuracy
Brief summary
The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.
Detailed description
Chin plays an important role in the lower facial harmony and balance. With the advances in computer-aided surgical simulation (CASS) technology, surgeons are now able to simulate surgical procedures in the computer to achieve the best possible surgical plan. However, CAD/CAM surgical templates do not maximize the potential of CASS technique. Patient specific implants (PSI) has rapidly developed in cranio-maxillofacial surgery in the past few years. However, few studies have introduced PSI technique in osseous genioplasty. The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique in genioplasty for positioning and fixation of the chin segment. Anticipated 30 patients with chin deformities are enrolled. Virtual planning is performed with the computer-aided surgical simulation method. The 3D printing titanium cutting guide and patient specific plate is involved in this PSI method. The cutting guide is designed to guide the osteotomy and screw holes drilling for the following patient specific plate. And the patient specific plate is used to simultaneously complete the reposition and fixation of the chin. The outcome is evaluated by comparing the plan with actual outcomes.
Interventions
DEVICEPatient Specific Implant
The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. patients who were scheduled to undergo genioplasty; 2. patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment; 3. patients who agreed to participate in this study
Exclusion criteria
1. craniofacial syndrome; 2. segmental osseous genioplasty; 3. previous osseous genioplasty; 4. previous mandibular trauma; 5. systemic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positional differences of the chin between the plan and postoperative results | 2 weeks after the operation | The coordinates of the centroid of three land points on the chin segment was used to calculate the position differences between the plan and postoperative results in X, Y and Z axis. |
| Orientation differences of the chin between the plan and postoperative results | 2 weeks after the operation | The coordinates of three independent points were used to define the orientation of the chin in 3D space. The orientation differences were calculated in pitch (the rotation around the X axis), roll (the rotation around the Y axis), and yaw (the rotation around the Z axis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time consuming | 3 days after the operation | time spending for the virtual planning and the design of the PSI |
| economic consuming | 3 days after the operation | economic cost of the fabrication of the patient specific implant |
Countries
China
Contacts
Primary ContactBiao Li, Master
Backup ContactXudong Wang, Doctor
Outcome results
None listed