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CT Analysis of Structural Buttresses in the Traumatised Nose

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01136616
First received: June 2, 2010
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  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:

MedlinePlus related topics: CT Scans Fractures
U.S. FDA Resources

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

Primary Outcome Measures:
  • Normal architecture of the nasal buttresses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 67
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated 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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136616

Contacts
Contact: Shu Jin Lee, MD 65-67722022 surv14@nus.edu.sg
Contact: Eileen Hing 65-67722276 surhch@nus.edu.sg

Locations
Singapore
National University Hospital, Singapore Recruiting
Singapore, Singapore, 119074
Contact: Shu Jin Lee, MD     65-67722022     surv14@nus.edu.sg    
Contact: Eileen Hing     65-67722276     surhch@nus.edu.sg    
Principal Investigator: Shu Jin Lee, MD            
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Shu Jin Lee, MD National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Dr. Lee Shu Jin, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01136616     History of Changes
Other Study ID Numbers: NUHS/SUR-PRAS/2010/3, D / 09 / 383
Study First Received: June 2, 2010
Last Updated: June 9, 2010
Health Authority: Singapore: Domain Specific Review Boards

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013