FracturesNCT01136616
CT Analysis of Structural Buttresses in the Traumatised Nose
An observational study of Fractures, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Hypothesis: There are 5 support buttresses in the complex osteocartilaginous architecture of the nose. 1. The membranous septum; 2. The Right nasal bone; 3. The Left nasal bone; 4. The perpendicular plate of the ethmoid; 5. The vomer, vomerine groove and anterior nasal spine. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Fractures
- How many people
- 67 participants
- Where
- 1 siteSingapore
- Study dates
- May 2009to May 2013
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 67 consecutive patients admitted for facial fractures and who undergo routine CT scans of the face with our protocol of axial and coronal sections taken at 0.6mm and gantry 0 are to be studied. The CT scans are evaluated to assess the position, comminution and displacement of the 5 said buttresses.
Who may be able to join
- Age 21 - 80 years old
- Both Male, Female
- All patients with nasal fracture and are able to give informed consent
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Hospital, Singapore
Singapore, Singapore, 119074
About this study
Official title: CT Analysis of Structural Buttresses in the Traumatised Nose - A Basis for Decision Making for Early Open Rhinoplasty and Biomechanical Study of Nasal Structural Support
Hypothesis: There are 5 support buttresses in the complex osteocartilaginous architecture of the nose.
- The membranous septum;
- The Right nasal bone;
- The Left nasal bone;
- The perpendicular plate of the ethmoid;
- The vomer, vomerine groove and anterior nasal spine.
Read the detailed description
Aim:
- Study the 3-dimensional anatomy of the nasal buttresses.
- Diagnose fracture patterns in the nasal buttresses.
- Identify the buttress fractures associated with deviation of the external nasal morphology.
- Identify the buttress fractures associated with septal deviation.
- Assess the airflow patterns and its associated distribution of flow velocity, pressure, and wall shear stress in the nasal cavity for patient specific models with nose fracture.
- Assess the stress distribution in the nasal bone structures subject to various scenarios of loading conditions.
Methodology:
67 consecutive patients admitted for facial fractures and who undergo routine CT scans of the face with our protocol of axial and coronal sections taken at 0.6mm and gantry 0 are to be studied. The CT scans are evaluated to assess the position, comminution and displacement of the 5 said buttresses.
The buttresses are graded Grade 1 Simple fracture without displacement Grade 2 Simple fracture with displacement Grade 3 Comminuted fracture without displacement Grade 4 Comminuted fracture with minimal displacement Grade 5 Comminuted fractured with displacement
The septum is graded from Grade 0 Septum is straight Grade 1 Septum is deviated by less than 1 half the distance from the midline to the nasal turbinate Grade 2 Septum is deviated by more than 1 half the distance from the midline to the nasal turbinate Grade 3 Septum is almost touching the nasal turbinate
Variables to be assessed included
- Grade of Severity of Nasal and Septal fracture
- Which is the weakest buttress that is most commonly broken?
- Which is the least often fractured and strongest buttress?
- Which buttress or buttresses are involved in a undisplaced septal fracture?
- Which buttress or buttresses are involved in a displaced septal fracture?
- Which buttresses or buttresses are involved in a undisplaced nasal fracture?
- Which buttress or buttresses are involved in a displaced nasal fracture?
- For a buttress to be displaced, the number of fractures in a single buttress?
- Assessment of biomechanical stability
- Assessment of stress distribution in the nasal buttresses for various scenarios of external loadings
- Assessment of nasal fracture patterns in different traumatic forces
- Assessment of stress wave propagation in the nasal bones during impact.
- Assessment of nasal air-flow via the nasal airways
Methods for data management and analysis (incl. Biostatistical check)
- Segmentation and Reconstruction of 3D Nasal Model Given the CT images of a patient, the nasal bones and surrounding facial bones are segmented and a 3D model of the bones is reconstructed. This can be accomplished using a segmentation and 3D reconstruction software. We have developed a preliminary version of the software for segmenting and reconstructing 3D model of craniofacial bones based on fast marching method. The software can be adapted to focus on reconstructing 3D model of the nasal buttresses.
- Nonlinear Registration with Reference Model The 3D fractured model is registered with a normal reference model for fracture analysis. A novel nonlinear registration technique is required to decouple normal variations among normal people and variations due to fractures. In this way, the normal reference model can be deformed in a manner consistent with normal variations to register to the fractured model. After registration, the registered reference could serve as a model of the patient prior to the injury. Moreover, differences between the fractured model and the registered reference would indicate variations due to fractures. The extent of the fractures and displacements of bones can also be measured. To accomplish the novel nonlinear registration, a generalized form of source separation method is needed. In particular, the idea of discriminates subspace analysis (Zhang and Sim) developed by our colleagues for analyzing variations of facial images for face recognition may be applicable. The method can decouple variations due to different people and variations due to illumination and view point. To enhance the accuracy of analysis, multiple normal reference models may be required for the patients in different ethnic groups.
- Visualization of 3D Models Generic visualization tools do not discriminate between the nasal bones and other craniofacial bones. It is difficult and inconvenient to use them to visualize only the nasal structure. So, a software tool will be developed to visualize the nasal structure of the fractured models. It can also be used to visualize the registration of the fractured models with the normal reference and other fracture analysis results.
- Classification of Fracture Patterns
After detecting and measuring the fractured bones, the fractured models can be classified according to their fracture patterns. This can be accomplished manually with the assistance of classification software.
Subsequently,
- Refinement of Nonlinear Registration Method Refinement of the nonlinear registration method will be performed to improve its accuracy.
- Biomechanical studies
Three dimensional finite element models of the nose, in particular the septum will be constructed from the CT scans. Finite element analysis will be carried out to assess the deformation, stress wave propagation and stress distribution in the nasal structures. Flow simulation using computational fluid dynamics will also be carried out to assess the flow pattern in the nasal cavity due to the nasal fracture.
Finally,
- Biomechanical studies
Three dimensional finite element models of the nose with various proposed techniques for the correction of nasal fracture will be carried out to assess the strength and weakness of the resulting nasal structures due to the corrective surgical procedure. Computation fluid dynamics will also be carried out to assess the flow pattern or nasal patency of the airway after the proposed surgical corrections.
- Conditions
- Fractures
- Keywords
- Nasal fracture, Nasal buttresses, Septal deviation, Nasal morphology, CT Scan
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Fracture | 67 patients admitted for facial fractures and who undergo routine CT scans of the face are to be studied. CT scans are evaluated to assess the position, comminution and displacement of the 5 said buttresses. The buttresses are graded Grade 1 Simple fracture without displacement Grade 2 Simple fracture with displacement Grade 3 Comminuted fracture without displacement Grade 4 Comminuted fracture with minimal displacement Grade 5 Comminuted fractured with displacement The septum is graded from Grade 0 Septum is straight Grade 1 Septum is deviated by less than 1 half the distance from the midline to the nasal turbinate Grade 2 Septum is deviated by more than 1 half the distance from the midline to the nasal turbinate Grade 3 Septum is almost touching the nasal turbinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal architecture of the nasal buttresses
To impact current clinical practice and improve the treatment outcomes by utilizing CT scans to analyze
- Normal architecture of the nasal buttresses;
- Fracture patterns of the buttresses associated with septal deviation and changes to the external nasal morphology;
- Weakest buttress as seen by the highest frequency of fracture;
- Strongest buttress as seen by the lowest frequent of fracture;
- Assessment of nasal patency due to the changes in nasal morphology before and after the surgical correction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu Jin Lee, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136616
- Sponsor's protocol ID
- NUHS/SUR-PRAS/2010/3
- Other IDs
- D / 09 / 383
- Status last verified
- Apr 2014
- First submitted
- 2 Jun 2010
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Analysis of Structural Buttresses in the Traumatised Nose - A Basis for Decision Making for Early Open Rhinoplasty and Biomechanical Study of Nasal Structural Support
- ClinicalTrials.gov ID
- NCT01136616
- Acronym / sponsor ID
- NUHS/SUR-PRAS/2010/3
- Conditions
- Fractures
- Keywords
- Nasal fracture, Nasal buttresses, Septal deviation, Nasal morphology, CT Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Jun 2010 (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.
Hypothesis: There are 5 support buttresses in the complex osteocartilaginous architecture of the nose.
- The membranous septum;
- The Right nasal bone;
- The Left nasal bone;
- The perpendicular plate of the ethmoid;
- The vomer, vomerine groove and anterior nasal spine.
Detailed description
Aim:
- Study the 3-dimensional anatomy of the nasal buttresses.
- Diagnose fracture patterns in the nasal buttresses.
- Identify the buttress fractures associated with deviation of the external nasal morphology.
- Identify the buttress fractures associated with septal deviation.
- Assess the airflow patterns and its associated distribution of flow velocity, pressure, and wall shear stress in the nasal cavity for patient specific models with nose fracture.
- Assess the stress distribution in the nasal bone structures subject to various scenarios of loading conditions.
Methodology:
67 consecutive patients admitted for facial fractures and who undergo routine CT scans of the face with our protocol of axial and coronal sections taken at 0.6mm and gantry 0 are to be studied. The CT scans are evaluated to assess the position, comminution and displacement of the 5 said buttresses.
The buttresses are graded Grade 1 Simple fracture without displacement Grade 2 Simple fracture with displacement Grade 3 Comminuted fracture without displacement Grade 4 Comminuted fracture with minimal displacement Grade 5 Comminuted fractured with displacement
The septum is graded from Grade 0 Septum is straight Grade 1 Septum is deviated by less than 1 half the distance from the midline to the nasal turbinate Grade 2 Septum is deviated by more than 1 half the distance from the midline to the nasal turbinate Grade 3 Septum is almost touching the nasal turbinate
Variables to be assessed included
- Grade of Severity of Nasal and Septal fracture
- Which is the weakest buttress that is most commonly broken?
- Which is the least often fractured and strongest buttress?
- Which buttress or buttresses are involved in a undisplaced septal fracture?
- Which buttress or buttresses are involved in a displaced septal fracture?
- Which buttresses or buttresses are involved in a undisplaced nasal fracture?
- Which buttress or buttresses are involved in a displaced nasal fracture?
- For a buttress to be displaced, the number of fractures in a single buttress?
- Assessment of biomechanical stability
- Assessment of stress distribution in the nasal buttresses for various scenarios of external loadings
- Assessment of nasal fracture patterns in different traumatic forces
- Assessment of stress wave propagation in the nasal bones during impact.
- Assessment of nasal air-flow via the nasal airways
Methods for data management and analysis (incl. Biostatistical check)
- Segmentation and Reconstruction of 3D Nasal Model Given the CT images of a patient, the nasal bones and surrounding facial bones are segmented and a 3D model of the bones is reconstructed. This can be accomplished using a segmentation and 3D reconstruction software. We have developed a preliminary version of the software for segmenting and reconstructing 3D model of craniofacial bones based on fast marching method. The software can be adapted to focus on reconstructing 3D model of the nasal buttresses.
- Nonlinear Registration with Reference Model The 3D fractured model is registered with a normal reference model for fracture analysis. A novel nonlinear registration technique is required to decouple normal variations among normal people and variations due to fractures. In this way, the normal reference model can be deformed in a manner consistent with normal variations to register to the fractured model. After registration, the registered reference could serve as a model of the patient prior to the injury. Moreover, differences between the fractured model and the registered reference would indicate variations due to fractures. The extent of the fractures and displacements of bones can also be measured. To accomplish the novel nonlinear registration, a generalized form of source separation method is needed. In particular, the idea of discriminates subspace analysis (Zhang and Sim) developed by our colleagues for analyzing variations of facial images for face recognition may be applicable. The method can decouple variations due to different people and variations due to illumination and view point. To enhance the accuracy of analysis, multiple normal reference models may be required for the patients in different ethnic groups.
- Visualization of 3D Models Generic visualization tools do not discriminate between the nasal bones and other craniofacial bones. It is difficult and inconvenient to use them to visualize only the nasal structure. So, a software tool will be developed to visualize the nasal structure of the fractured models. It can also be used to visualize the registration of the fractured models with the normal reference and other fracture analysis results.
- Classification of Fracture Patterns
After detecting and measuring the fractured bones, the fractured models can be classified according to their fracture patterns. This can be accomplished manually with the assistance of classification software.
Subsequently,
- Refinement of Nonlinear Registration Method Refinement of the nonlinear registration method will be performed to improve its accuracy.
- Biomechanical studies
Three dimensional finite element models of the nose, in particular the septum will be constructed from the CT scans. Finite element analysis will be carried out to assess the deformation, stress wave propagation and stress distribution in the nasal structures. Flow simulation using computational fluid dynamics will also be carried out to assess the flow pattern in the nasal cavity due to the nasal fracture.
Finally,
- Biomechanical studies
Three dimensional finite element models of the nose with various proposed techniques for the correction of nasal fracture will be carried out to assess the strength and weakness of the resulting nasal structures due to the corrective surgical procedure. Computation fluid dynamics will also be carried out to assess the flow pattern or nasal patency of the airway after the proposed surgical corrections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Fracture | – | –67 patients admitted for facial fractures and who undergo routine CT scans of the face are to be studied. CT scans are evaluated to assess the position, comminution and displacement of the 5 said buttresses. The buttresses are graded Grade 1 Simple fracture without displacement Grade 2 Simple fracture with displacement Grade 3 Comminuted fracture without displacement Grade 4 Comminuted fracture with minimal displacement Grade 5 Comminuted fractured with displacement The septum is graded from Grade 0 Septum is straight Grade 1 Septum is deviated by less than 1 half the distance from the midline to the nasal turbinate Grade 2 Septum is deviated by more than 1 half the distance from the midline to the nasal turbinate Grade 3 Septum is almost touching the nasal turbinate |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 67 consecutive patients admitted for facial fractures and who undergo routine CT scans of the face with our protocol of axial and coronal sections taken at 0.6mm and gantry 0 are to be studied. The CT scans are evaluated to assess the position, comminution and displacement of the 5 said buttresses.
Key inclusion criteria (3 listed)
- Age 21 - 80 years old
- Both Male, Female
- All patients with nasal fracture and are able to give informed consent
Key exclusion criteria (1 listed)
- Patient refusal
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
Normal architecture of the nasal buttresses
Time frame: 1 year
To impact current clinical practice and improve the treatment outcomes by utilizing CT scans to analyze 1. Normal architecture of the nasal buttresses; 2. Fracture patterns of the buttresses associated with septal deviation and changes to the external nasal morphology; 3. Weakest buttress as seen by the highest frequency of fracture; 4. Strongest buttress as seen by the lowest frequent of fracture; 5. Assessment of nasal patency due to the changes in nasal morphology before and after the surgical correction.
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 3 Apr 2014.
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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.
Shu Jin Lee, MD principal investigator
National University Hospital, Singapore
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 Fractures, run by National University Hospital, Singapore at 1 site in Singapore.
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 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 3 Apr 2014. 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 Singapore. 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.
What does the primary outcome measure?
Normal architecture of the nasal buttresses (time frame: 1 year). 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 3 Apr 2014.