Maxillofacial InjuryNCT00583856
Computer Modeling With Reconstruction of Maxillofacial Skeleton
An observational study of Maxillofacial Injury, run by University of California, Davis at 1 site in United States.
Trial summary
Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton. Read more about this study
- Who is it for?
- Ages 11 to 50 years
- Conditions the study is for
- Maxillofacial Injury
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2008
- Phase
- Observational
- 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 11 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: UCDMC Patients with specific complex fractures
Who may be able to join
- specific complex maxillofacial trauma
Who cannot join
- must meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: Is Computer Modeling and Intra-Operative Navigation Helpful With Reconstruction of the Maxillofacial Skeleton?
Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.
Read the detailed description
The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.
- Conditions
- Maxillofacial Injury
- Keywords
- computer aided design, maxillofacial fracture, orbital design
- Medical subject headings
- Maxillofacial Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Edward B Strong, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583856
- Sponsor's protocol ID
- 200614968-1
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2007
- Last updated
- 20 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Computer Modeling and Intra-Operative Navigation Helpful With Reconstruction of the Maxillofacial Skeleton?
- ClinicalTrials.gov ID
- NCT00583856
- Acronym / sponsor ID
- 200614968-1
- Conditions
- Maxillofacial Injury
- Keywords
- computer aided design, maxillofacial fracture, orbital design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 2 Jan 2008 (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.
Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.
Detailed description
The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- UCDMC Patients with specific complex fractures
Key inclusion criteria (1 listed)
- specific complex maxillofacial trauma
Key exclusion criteria (1 listed)
- must meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Dec 2010.
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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.
Edward B Strong, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Injury, run by University of California, Davis at 1 site in United States.
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 1 inclusion and 1 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 20 Dec 2010. 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 United States. 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?
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.
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 20 Dec 2010.