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CT Analysis of Structural Buttresses in the Traumatised Nose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136616
First Posted: June 3, 2010
Last Update Posted: April 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National University Hospital, Singapore
  Purpose

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.

Condition Phase
Fractures Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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.


Enrollment: 67
Study Start Date: May 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136616


Locations
Singapore
National University Hospital, Singapore
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Shu Jin Lee, MD National University Hospital, Singapore
  More Information

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01136616     History of Changes
Other Study ID Numbers: NUHS/SUR-PRAS/2010/3
D / 09 / 383 ( Registry Identifier: DSRB - D / 09 / 383 )
First Submitted: June 2, 2010
First Posted: June 3, 2010
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by National University Hospital, Singapore:
Nasal fracture
Nasal buttresses
Septal deviation
Nasal morphology
CT Scan