Mastoid Bone Autograft for Dorsal Nasal Augmentation

• Sponsor: Federal University of Uberlandia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00545428
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.5

Study Details

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	Phase
Nose Deformities, Acquired	Procedure: Rhinoplasty	N/A

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
• 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: Apr 1, 2006
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Dec 1, 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 [1 year]

Secondary Outcome Measures

1. Observer's satisfaction [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.
• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00545428
• Other Study ID Numbers: 1-Patrocinio
• First Posted: Oct 17, 2007
• Last Update Posted: Feb 4, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Nasal acquired diseases; Nasal congenital diseases; Rhinoplasty; Grafts
• Additional relevant MeSH terms: Nose Deformities, Acquired

Study Results

No Results Posted as of Feb 4, 2009