Nose Deformities, AcquiredNCT00545428
Mastoid Bone Autograft for Dorsal Nasal Augmentation
A study testing Rhinoplasty in people with Nose Deformities, Acquired, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nose Deformities, Acquired
- What is being tested?
- Rhinoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nasal acquired or congenital deformity of the dorsum that requires augmentation of more than 5 mm
Who cannot join
- Previous otologic surgery/disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia, Department of ENT/H&N
Uberlândia, Minas Gerais, 38400-368
About this study
The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.
Read the 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.
- Conditions
- Nose Deformities, Acquired
- Being tested
- Rhinoplasty
- Keywords
- Nasal acquired diseases, Nasal congenital diseases, Rhinoplasty, Grafts
- Medical subject headings
- Nose Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinoplastyProcedure or surgery
Mastoid bone autograft for dorsal nasal augmentation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rhinoplasty Receives: Procedure: Rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction
Measured: 1 year
Secondary outcomes (1)
Observer's satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startApr 2006
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nose Deformities, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Investigators
- Lucas G Patrocinio, MD, Principal investigator, Federal University of Uberlandia, Department of ENT/H&NJose A Patrocinio, MD, PhD, Study chair, Federal University of Uberlandia, Department of ENT/H&N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545428
- Sponsor's protocol ID
- 1-Patrocinio
- Status last verified
- Feb 2009
- First submitted
- 16 Oct 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 1787353Jovanovic S, Berghaus A. Autogenous auricular concha cartilage transplant in corrective rhinoplasty. Practical hints and critical remarks. Rhinology. 1991 Dec;29(4):273-9.
PubMed 1780628Patrocinio 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.
PubMed 17350737Pedroza 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.
PubMed 17116787Patrocinio 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.
PubMed 17143420
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastoid Bone Autograft for Dorsal Nasal Augmentation
- ClinicalTrials.gov ID
- NCT00545428
- Acronym / sponsor ID
- 1-Patrocinio
- Conditions
- Nose Deformities, Acquired
- Keywords
- Nasal acquired diseases, Nasal congenital diseases, Rhinoplasty, Grafts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: RhinoplastyRhinoplasty |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nasal acquired or congenital deformity of the dorsum that requires augmentation of more than 5 mm
Key exclusion criteria (1 listed)
- Previous otologic surgery/disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhinoplastyMastoid bone autograft for dorsal nasal augmentation | Procedure or surgery | 1 |
Primary outcome
Patient's satisfaction
Time frame: 1 year
1 secondary outcome
Observer's satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Background: PubMed 1787353Baser 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.
- Background: PubMed 1780628Jovanovic S, Berghaus A. Autogenous auricular concha cartilage transplant in corrective rhinoplasty. Practical hints and critical remarks. Rhinology. 1991 Dec;29(4):273-9.
- Background: PubMed 17350737Patrocinio 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.
- Background: PubMed 17116787Pedroza 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.
- Background: PubMed 17143420Patrocinio 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas G Patrocinio, MD principal investigator
Federal University of Uberlandia, Department of ENT/H&N
Jose A Patrocinio, MD, PhD study chair
Federal University of Uberlandia, Department of ENT/H&N
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinoplasty in people with Nose Deformities, Acquired, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's satisfaction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545428, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.