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
  Purpose

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


Condition Intervention
Nose Deformities, Acquired
Procedure: Rhinoplasty

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mastoid Bone Autograft for Dorsal Nasal Augmentation

Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • Patient's satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Observer's satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rhinoplasty
Procedure: Rhinoplasty
Mastoid bone autograft for dorsal nasal augmentation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: Lucas Gomes Patrocinio, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT00545428     History of Changes
Other Study ID Numbers: 1-Patrocinio
Study First Received: October 16, 2007
Last Updated: February 3, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
Nasal acquired diseases
Nasal congenital diseases
Rhinoplasty
Grafts

Additional relevant MeSH terms:
Congenital Abnormalities
Nose Deformities, Acquired
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014