Mastoid Bone Autograft for Dorsal Nasal Augmentation - Full Text View

Sponsored by:	Federal University of Uberlandia
Information provided by:	Federal University of Uberlandia
ClinicalTrials.gov Identifier:	NCT00545428

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
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
1: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545428

Locations

Brazil, mg
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:

Baser B, Shahani R, Khanna S, Grewal DS. Calvarial bone grafts for augmentation rhinoplasty. J Laryngol Otol. 1991 Dec;105(12):1018-20.

Jovanovic S, Berghaus A. Autogenous auricular concha cartilage transplant in corrective rhinoplasty. Practical hints and critical remarks. Rhinology. 1991 Dec;29(4):273-9.

Patrocinio LG, Patrocinio JA. Open rhinoplasty for African-American noses. Br J Oral Maxillofac Surg. 2007 Oct;45(7):561-6. Epub 2007 Mar 12.

Pedroza F, Anjos GC, Patrocinio LG, Barreto JM, Cortes J, Quessep SH. Seagull wing graft: a technique for the replacement of lower lateral cartilages. Arch Facial Plast Surg. 2006 Nov-Dec;8(6):396-403.

Patrocinio LG, Carvalho PM, de Souza HM, Couto HG, Patrocinio JA. Surgical maneuvers performed on rhinoplasty procedures carried out at an otorhinolaryngology residency program. Rev Bras Otorrinolaringol (Engl Ed). 2006 Jul-Aug;72(4):439-42.

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

Keywords provided by Federal University of Uberlandia:

Nasal acquired diseases
Nasal congenital diseases
Rhinoplasty
Grafts

Study placed in the following topic categories:

Nose Deformities, Acquired
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Nose Deformities, Acquired
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Nose Diseases

ClinicalTrials.gov processed this record on May 06, 2009