Clinical Accuracy of Patient-specific Implants in Genioplasty

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

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

Study Overview

• Status: Unknown
• Conditions: Chin Microgenia; Genioplasty; Chin Macrogenia
• Intervention / Treatment: Device: Patient Specific Implant

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
    • Contact: Biao Li, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time consuming	time spending for the virtual planning and the design of the PSI	3 days after the operation
economic consuming	economic cost of the fabrication of the patient specific implant	3 days after the operation

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: patient specific implant; computer-aided surgery; clinical accuracy
• Other Study ID Numbers: PSIcmfs03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No