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Mastoid Bone Autograft for Dorsal Nasal Augmentation

This study has been completed.
Sponsor:
Information provided by:
Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT00545428
First received: October 16, 2007
Last updated: February 3, 2009
Last verified: February 2009

October 16, 2007
February 3, 2009
April 2006
July 2008   (final data collection date for primary outcome measure)
Patient's satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Patient's satisfaction [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00545428 on ClinicalTrials.gov Archive Site
Observer's satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Observer's satisfaction [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Mastoid Bone Autograft for Dorsal Nasal Augmentation
Mastoid Bone Autograft for Dorsal Nasal Augmentation

The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.

INTRODUCTION: Several grafts and/or implants have been used for dorsal augmentation. In some cases, especially the traumatic, non-caucasian, and multi-operated ones, the amount of augmentation is higher than the usually available from septal and auricular conchal autografts.

OBJECTIVE: To evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.

DESIGN: A prospective study of 15 consecutive patients submitted to dorsal nasal augmentation with mastoid bone, during a 2-year period.

SETTING: One major academic medical center.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Nose Deformities, Acquired
Procedure: Rhinoplasty
Mastoid bone autograft for dorsal nasal augmentation
Experimental: 1
Rhinoplasty
Intervention: Procedure: Rhinoplasty

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Nasal acquired or congenital deformity of the dorsum that requires augmentation of more than 5 mm

Exclusion Criteria:

  • Previous otologic surgery/disease
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00545428
1-Patrocinio
No
Lucas Gomes Patrocinio, Federal University of Uberlandia
Federal University of Uberlandia
Not Provided
Principal Investigator: Lucas G Patrocinio, MD Federal University of Uberlandia, Department of ENT/H&N
Study Chair: Jose A Patrocinio, MD, PhD Federal University of Uberlandia, Department of ENT/H&N
Federal University of Uberlandia
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP