NCT03456869

Clinical Accuracy of Patient-specific Implants in Genioplasty

The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Genioplasty
• Chin Microgenia
• Chin Macrogenia

Interventions

Type	Name	Description
DEVICE	Patient Specific Implant	The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-10-31
• Completion: 2019-12-31
• First posted: 2018-03-07
• Last updated: 2018-03-07

Locations

1 site across 1 country: China