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Clinical Accuracy of Patient-specific Implants in Genioplasty

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ClinicalTrials.gov Identifier: NCT03456869
Recruitment Status : Unknown
Verified February 2018 by Xudong Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Xudong Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2015
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. Positional differences of the chin between the plan and postoperative results [ Time Frame: 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.

  2. Orientation differences of the chin between the plan and postoperative results [ Time Frame: 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 :
  1. time consuming [ Time Frame: 3 days after the operation ]
    time spending for the virtual planning and the design of the PSI

  2. economic consuming [ Time Frame: 3 days after the operation ]
    economic cost of the fabrication of the patient specific implant



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456869


Contacts
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Contact: Biao Li, Master 15900561183 benleex@foxmail.com
Contact: Xudong Wang, Doctor 13818474330

Locations
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China
Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Contact: Biao Li, Master         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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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: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xudong Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
patient specific implant
computer-aided surgery
clinical accuracy