Clinical trial NCT00545428: Mastoid Bone Autograft for Dorsal Nasal Augmentation
Official title: Mastoid Bone Autograft for Dorsal Nasal Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nose Deformities, Acquired
Keywords: Nasal acquired diseases
Nasal congenital diseases
Rhinoplasty
Grafts
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Patient's satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Observer's satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Federal University of Uberlandia, Department of ENT/H&N
state: MG
Study officials:
affiliation: Federal University of Uberlandia, Department of ENT/H&N
name: Lucas G Patrocinio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Uberlandia, Department of ENT/H&N
name: Jose A Patrocinio, MD, PhD
role: STUDY_CHAIR
References:
citation: Baser B, Shahani R, Khanna S, Grewal DS. Calvarial bone grafts for augmentation rhinoplasty. J Laryngol Otol. 1991 Dec;105(12):1018-20. doi: 10.1017/s0022215100118109.
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.
citation: Patrocinio LG, Patrocinio JA. Open rhinoplasty for African-American noses. Br J Oral Maxillofac Surg. 2007 Oct;45(7):561-6. doi: 10.1016/j.bjoms.2007.01.011. Epub 2007 Mar 12.
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. doi: 10.1001/archfaci.8.6.396.
citation: Patrocinio LG, Carvalho PM, de Souza HM, Couto HG, Patrocinio JA. Surgical maneuvers performed on rhinoplasty procedures carried out at an otorhinolaryngology residency program. Braz J Otorhinolaryngol. 2006 Jul-Aug;72(4):439-42. doi: 10.1016/s1808-8694(15)30986-1.