Clinical Accuracy of Patient-specific Implants in Genioplasty
The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 7, 2018
February 1, 2018
4 years
February 5, 2018
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
time consuming
3 days after the operation
economic consuming
3 days after the operation
Study Arms (1)
PSI group
EXPERIMENTALThe patient specific implant (PSI) is used to completed the genioplasty.
Interventions
The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- craniofacial syndrome;
- segmental osseous genioplasty;
- previous osseous genioplasty;
- previous mandibular trauma;
- systemic disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Acting chair of Department of Oral and Craniomaxillofacial Surgery
Study Record Dates
First Submitted
February 5, 2018
First Posted
March 7, 2018
Study Start
November 1, 2015
Primary Completion
October 31, 2019
Study Completion
December 31, 2019
Last Updated
March 7, 2018
Record last verified: 2018-02