The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Positional differences of the chin between the plan and postoperative results
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who were scheduled to undergo genioplasty;
- •patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment;
- •patients who agreed to participate in this study
Exclusion Criteria
- •craniofacial syndrome;
- •segmental osseous genioplasty;
- •previous osseous genioplasty;
- •previous mandibular trauma;
- •systemic disorders.
Arms & Interventions
PSI group
The patient specific implant (PSI) is used to completed the genioplasty.
Intervention: Patient Specific Implant (Device)
Outcomes
Primary Outcomes
Positional differences of the chin between the plan and postoperative results
Time Frame: 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
Time Frame: 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 Outcomes
- time consuming(3 days after the operation)
- economic consuming(3 days after the operation)
Investigators
Xudong Wang
Acting chair of Department of Oral and Craniomaxillofacial Surgery
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University