Clinical Accuracy of Patient-specific Implants in Genioplasty

NCT ID: NCT03456869

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2019-12-31

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.

Conditions

Genioplasty; Chin Microgenia; Chin Macrogenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PSI group

The patient specific implant (PSI) is used to completed the genioplasty.

Group Type: EXPERIMENTAL

Patient Specific Implant

Intervention Type: DEVICE

The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.

Interventions

Patient Specific Implant

The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Xudong Wang

Acting chair of Department of Oral and Craniomaxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Biao Li, Master

Role: CONTACT

benleex@foxmail.com

15900561183

Xudong Wang, Doctor

Role: CONTACT

13818474330

Facility Contacts

Biao Li, Master

Role: primary

Other Identifiers

PSIcmfs03

Identifier Type: -

Identifier Source: org_study_id