NCT01136616

Brief Summary

Hypothesis: There are 5 support buttresses in the complex osteocartilaginous architecture of the nose.

  1. 1.The membranous septum;
  2. 2.The Right nasal bone;
  3. 3.The Left nasal bone;
  4. 4.The perpendicular plate of the ethmoid;
  5. 5.The vomer, vomerine groove and anterior nasal spine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

4 years

First QC Date

June 2, 2010

Last Update Submit

April 1, 2014

Conditions

Keywords

Nasal fractureNasal buttressesSeptal deviationNasal morphologyCT Scan

Outcome Measures

Primary Outcomes (1)

  • Normal architecture of the nasal buttresses

    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.

    1 year

Study Arms (1)

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

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age 21 - 80 years old
  • Both Male, Female
  • All patients with nasal fracture and are able to give informed consent

You may not qualify if:

  • \- Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Shu Jin Lee, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

May 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations