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Mastoid Bone Autograft for Dorsal Nasal Augmentation

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ClinicalTrials.gov Identifier: NCT00545428
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Nose Deformities, Acquired Procedure: Rhinoplasty

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mastoid Bone Autograft for Dorsal Nasal Augmentation
Study Start Date : April 2006
Primary Completion Date : July 2008
Study Completion Date : December 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Rhinoplasty
Procedure: Rhinoplasty
Mastoid bone autograft for dorsal nasal augmentation


Outcome Measures

Primary Outcome Measures :
  1. Patient's satisfaction [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Observer's satisfaction [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous otologic surgery/disease
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): NCT00545428


Locations
Brazil
Federal University of Uberlandia, Department of ENT/H&N
Uberlandia, MG, Brazil, 38400-368
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
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
More Information