- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136616
CT Analysis of Structural Buttresses in the Traumatised Nose
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.
Study Overview
Status
Conditions
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,
1. 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 119074
- National University Hospital, Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 21 - 80 years old
- Both Male, Female
- All patients with nasal fracture and are able to give informed consent
Exclusion Criteria:
- Patient refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shu Jin Lee, MD, National University Hospital, Singapore
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUHS/SUR-PRAS/2010/3
- D / 09 / 383 (Registry Identifier: DSRB - D / 09 / 383)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fractures
-
University Hospital, GhentCompletedWounds and Injuries | Ankle Fractures | Wrist Fractures | Elbow Fractures | Forearm Fractures | Foot FracturesBelgium
-
Oslo University HospitalUniversity of Oslo; University Hospital of North Norway; Norwegian University... and other collaboratorsCompletedHip Fractures | Ankle Fractures | Osteoporotic Fractures | Humeral Fractures, Proximal | Vertebral Compression Fractures | Wrist FracturesNorway
-
University of Kansas Medical CenterNot yet recruitingFemoral Neck Fractures | Distal Radius Fractures | Femoral Shaft Fracture | Intertrochanteric Fractures | Patella Fracture | Lisfranc Injuries | Distal Femur Fracture | Calcaneus Fractures | Clavicle Fractures | Proximal Humerus Fractures | Tibial Shaft Fracture With or Without Associated Fibula Fracture | Ankle... and other conditionsUnited States
-
Herlev and Gentofte HospitalRecruitingIntra-Articular Fractures | Distal Humerus Fracture | Comminuted FractureDenmark
-
AO Innovation Translation CenterRecruitingHip Fractures | Tibial Fractures | Distal Radius Fracture | Ankle Fractures | Humeral Fracture, ProximalUnited States, Colombia, Germany, Austria, United Kingdom
-
AO Clinical Investigation and Publishing DocumentationCompletedReverse Oblique Intertrochanteric Fractures | Reverse Oblique Subtrochanteric FracturesAustralia, Switzerland
-
Peking University Third HospitalBeijing Yanqing HospitalRecruitingFemoral Intertrochanteric FracturesChina
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedFracturesFrance, Germany, Canada, United States, Australia, Mexico, Brazil, Finland, Norway, Romania, Sweden
-
AO Clinical Investigation and Publishing DocumentationSynthes Inc.CompletedUnstable Trochanteric FracturesSpain
-
AO Clinical Investigation and Publishing DocumentationSynthes Inc.CompletedHumerus Fracture | Femur Fracture | Tibia FractureAustria, Germany