GenioplastyNCT03456869
Clinical Accuracy of Patient-specific Implants in Genioplasty
A study testing Patient Specific Implant in people with Genioplasty and Chin Microgenia, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Genioplasty, Chin Microgenia, Chin Macrogenia
- What is being tested?
- Patient Specific Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- craniofacial syndrome;
- segmental osseous genioplasty;
- previous osseous genioplasty;
- previous mandibular trauma;
- systemic disorders.
Trial locations and contacts
1 site in 1 country.
Xudong Wang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Biao Li, Master
About this study
Official title: 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.
Read the 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.
- Conditions
- Genioplasty, Chin Microgenia, Chin Macrogenia
- Being tested
- Patient Specific Implant
- Keywords
- patient specific implant, computer-aided surgery, clinical accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific ImplantDevice
The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
| Study group | Role | What they receive |
|---|---|---|
| PSI group | Experimental | The patient specific implant (PSI) is used to completed the genioplasty. Receives: Device: Patient Specific Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 2 weeks after the operation
Secondary outcomes (2)
time consuming
time spending for the virtual planning and the design of the PSI
Measured: 3 days after the operation
economic consuming
economic cost of the fabrication of the patient specific implant
Measured: 3 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Nov 2015
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenioplastyStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xudong Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456869
- Sponsor's protocol ID
- PSIcmfs03
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
- ClinicalTrials.gov ID
- NCT03456869
- Acronym / sponsor ID
- PSIcmfs03
- Conditions
- Genioplasty, Chin Microgenia, Chin Macrogenia
- Keywords
- patient specific implant, computer-aided surgery, clinical accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSI group | Experimental | Device: Patient Specific ImplantThe patient specific implant (PSI) is used to completed the genioplasty. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- craniofacial syndrome;
- segmental osseous genioplasty;
- previous osseous genioplasty;
- previous mandibular trauma;
- systemic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Specific ImplantThe patient specific implant is used to simultaneously complete the reposition and fixation of the chin. | Device | PSI group |
Primary outcome
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.
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).
2 secondary outcomes
time consuming
Time frame: 3 days after the operation
economic consuming
Time frame: 3 days after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Accuracy of Patient Specific 3D Printed Titanium Plates Versus Milled Titanium Plates in Genioplasty Orthognathic Surgeries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xudong Wang, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Specific Implant in people with Genioplasty and Chin Microgenia, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biao Li, Master (15900561183, benleex@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positional differences of the chin between the plan and postoperative results (time frame: 2 weeks after the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.