Clinical Accuracy of Patient-specific Implants in Genioplasty

Chin Microgenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03456869
• Other study ID #: PSIcmfs03
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 28, 2018
• Start date: November 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Shanghai 9th People's Hospital
• Contact: Biao Li, Master
• Phone: 15900561183
• Email: benleex[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chin Macrogenia
• Chin Microgenia
• Genioplasty

Intervention

Device:
• Patient Specific Implant
The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.

Locations

Country	Name	City	State
China	Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positional 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.	2 weeks after the operation
Primary	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).	2 weeks after the operation
Secondary	time consuming	time spending for the virtual planning and the design of the PSI	3 days after the operation
Secondary	economic consuming	economic cost of the fabrication of the patient specific implant	3 days after the operation