Zygomatic FracturesPhase 3NCT01487018
Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity
A Phase 3 study testing Navigation Surgery and Traditional Surgery in people with Zygomatic Fractures, run by Peking University at 1 site in China.
Trial summary
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Zygomatic Fractures
- What is being tested?
- Navigation Surgery and Traditional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jul 2015
- Phase
- Phase 3
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- post-traumatic unilateral deformities of the zygomaticomaxillary complex
- The interval after the primary injury should be more than 21 days
- Meet the operation indication
- Voluntarily join this study with informed consents
Who cannot join
- Obviously asymmetric of craniofacial structure
- Poor compliance of patient
- Any other condition that do not fit to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
Beijing, 100081
About this study
Official title: Evaluation of the Application of Point-to-Point Computer-Assisted Navigation for Mirroring-Reconstructing of Unilateral Posttraumatic Zygomatic Deformity: A Randomized Controlled Trial
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Read the detailed description
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. Even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.However,The development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
- Conditions
- Zygomatic Fractures
- Being tested
- Navigation Surgery, Traditional Surgery
- Keywords
- Zygomatic Fractures, Surgery, Computer-Assisted, Facial Asymmetry
- Medical subject headings
- Zygomatic Fractures, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation SurgeryProcedure or surgery
Also called Computer-Aided Surgery, Surgical Navigation
To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Traditional SurgeryProcedure or surgery
Also called Control Group
To compare with the experamental group.
| Study group | Role | What they receive |
|---|---|---|
| Navigation Surgery | Experimental | To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation. Receives: Procedure: Navigation Surgery |
| Traditional Surgery | Active comparator | To compare with the experimental arm. Receives: Procedure: Traditional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zygomatic Symmetry
Measurement the zygomatic symmetry of postoperative CT scan
Measured: 1 month
Secondary outcomes (2)
Accuracy evaluation of CT image
Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated.
Measured: 1 month
Facial Symmetry
Facial symmetry on the Visual Analog Scale and three-dimensional camera
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic FracturesStudies of the same condition, open and under way.
- More trials run by Peking 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Xi, Peking University
- Investigators
- Yi Zhang, Professor, Principal investigator, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487018
- Sponsor's protocol ID
- gongx31480528
- Status last verified
- Oct 2015
- First submitted
- 29 Nov 2011
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Application of Point-to-Point Computer-Assisted Navigation for Mirroring-Reconstructing of Unilateral Posttraumatic Zygomatic Deformity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01487018
- Acronym / sponsor ID
- gongx31480528
- Conditions
- Zygomatic Fractures
- Keywords
- Zygomatic Fractures, Surgery, Computer-Assisted, Facial Asymmetry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Dec 2011 (estimated)
- 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.
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Detailed description
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. Even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.However,The development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation Surgery | Experimental | Procedure: Navigation SurgeryTo evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation. |
| Traditional Surgery | Active comparator | Procedure: Traditional SurgeryTo compare with the experimental arm. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- post-traumatic unilateral deformities of the zygomaticomaxillary complex
- The interval after the primary injury should be more than 21 days
- Meet the operation indication
- Voluntarily join this study with informed consents
Key exclusion criteria (3 listed)
- Obviously asymmetric of craniofacial structure
- Poor compliance of patient
- Any other condition that do not fit to participate in the study
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 |
|---|---|---|
| Navigation SurgeryAlso: Computer-Aided Surgery, Surgical NavigationTo evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation. | Procedure or surgery | Navigation Surgery |
| Traditional SurgeryAlso: Control GroupTo compare with the experamental group. | Procedure or surgery | Traditional Surgery |
Primary outcome
Zygomatic Symmetry
Time frame: 1 month
Measurement the zygomatic symmetry of postoperative CT scan
2 secondary outcomes
Accuracy evaluation of CT image
Time frame: 1 month
Facial Symmetry
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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.
Yi Zhang, Professor principal investigator
Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Navigation Surgery and Traditional Surgery in people with Zygomatic Fractures, run by Peking 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 21 Oct 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zygomatic Symmetry (time frame: 1 month). 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 21 Oct 2015.