Clinical Accuracy of Patient-specific Implants in Genioplasty

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03456869

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Genioplasty Chin Microgenia Chin Macrogenia	Device: Patient Specific Implant	N/A

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

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Oct 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PSI group The patient specific implant (PSI) is used to completed the genioplasty.	Device: Patient Specific Implant The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.

Arm

Intervention/Treatment

Experimental: PSI group

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

Device: Patient Specific Implant

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

Outcome Measures

Primary Outcome Measures

Positional differences of the chin between the plan and postoperative results [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 [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 Outcome Measures

time consuming [3 days after the operation]
time spending for the virtual planning and the design of the PSI
economic consuming [3 days after the operation]
economic cost of the fabrication of the patient specific implant

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai		China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xudong Wang, Acting chair of Department of Oral and Craniomaxillofacial Surgery, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

ClinicalTrials.gov Identifier:

NCT03456869

Other Study ID Numbers:

PSIcmfs03

First Posted:

Mar 7, 2018

Last Update Posted:

Mar 7, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xudong Wang, Acting chair of Department of Oral and Craniomaxillofacial Surgery, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

patient specific implant

computer-aided surgery

clinical accuracy

Study Results

No Results Posted as of Mar 7, 2018