The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGPositional differences of the chin between the plan and postoperative results
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.
Time frame: 2 weeks after the operation
Orientation differences of the chin between the plan and postoperative results
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).
Time frame: 2 weeks after the operation
time consuming
time spending for the virtual planning and the design of the PSI
Time frame: 3 days after the operation
economic consuming
economic cost of the fabrication of the patient specific implant
Time frame: 3 days after the operation
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