NCT00545428

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

October 16, 2007

Last Update Submit

February 3, 2009

Conditions

Nose Deformities, Acquired

Keywords

Nasal acquired diseasesNasal congenital diseasesRhinoplastyGrafts

Outcome Measures

Primary Outcomes (1)

  • Patient's satisfaction

    1 year

Secondary Outcomes (1)

  • Observer's satisfaction

    1 year

Study Arms (1)

1

EXPERIMENTAL

Rhinoplasty

Procedure: Rhinoplasty

Interventions

RhinoplastyPROCEDURE

Mastoid bone autograft for dorsal nasal augmentation

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Previous otologic surgery/disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlandia, Department of ENT/H&N

Uberlândia, Minas Gerais, 38400-368, Brazil

Location

Related 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. doi: 10.1017/s0022215100118109.

    PMID: 1787353BACKGROUND

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

    PMID: 1780628BACKGROUND

  • 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.

    PMID: 17350737BACKGROUND

  • 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.

    PMID: 17116787BACKGROUND

  • 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.

    PMID: 17143420BACKGROUND

MeSH Terms

Conditions

Nose Deformities, Acquired

Interventions

Rhinoplasty

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsNasal Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Lucas G Patrocinio, MD

    Federal University of Uberlandia, Department of ENT/H&N

    PRINCIPAL INVESTIGATOR

  • Jose A Patrocinio, MD, PhD

    Federal University of Uberlandia, Department of ENT/H&N

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Study Start

April 1, 2006

Primary Completion

July 1, 2008

Study Completion

December 1, 2008

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

BR(1)