Mastoid Bone Autograft for Dorsal Nasal Augmentation

Nose Deformities, Acquired Clinical Trial

Official title:

Mastoid Bone Autograft for Dorsal Nasal Augmentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545428
• Other study ID #: 1-Patrocinio
• Status: Completed
• Phase: N/A
• First received: October 16, 2007
• Last updated: February 3, 2009
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous otologic surgery/disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nose Deformities, Acquired

Intervention

Procedure:
• Rhinoplasty
Mastoid bone autograft for dorsal nasal augmentation

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia, Department of ENT/H&N	Uberlandia	MG

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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

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

Patrocínio LG, Carvalho PM, de Souza HM, Couto HG, Patrocínio JA. Surgical maneuvers performed on rhinoplasty procedures carried out at an otorhinolaryngology residency program. Braz J Otorhinolaryngol. 2006 Jul-Aug;72(4):439-42. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's satisfaction		1 year	No
Secondary	Observer's satisfaction		1 year	No