Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 1:08 PM
Study NCT ID:
NCT00545428
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2007-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mastoid Bone Autograft for Dorsal Nasal Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009667', 'term': 'Nose Deformities, Acquired'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012225', 'term': 'Rhinoplasty'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059747', 'term': 'Nasal Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2007-10-16', 'studyFirstSubmitQcDate': '2007-10-16', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's satisfaction", 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': "Observer's satisfaction", 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nasal acquired diseases', 'Nasal congenital diseases', 'Rhinoplasty', 'Grafts'], 'conditions': ['Nose Deformities, Acquired']}, 'referencesModule': {'references': [{'pmid': '1787353', 'type': 'BACKGROUND', '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.'}, {'pmid': '1780628', 'type': 'BACKGROUND', '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.'}, {'pmid': '17350737', 'type': 'BACKGROUND', '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.'}, {'pmid': '17116787', 'type': 'BACKGROUND', '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.'}, {'pmid': '17143420', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.', 'detailedDescription': '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.\n\nOBJECTIVE: To evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal augmentation in rhinoplasty.\n\nDESIGN: A prospective study of 15 consecutive patients submitted to dorsal nasal augmentation with mastoid bone, during a 2-year period.\n\nSETTING: One major academic medical center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nasal acquired or congenital deformity of the dorsum that requires augmentation of more than 5 mm\n\nExclusion Criteria:\n\n* Previous otologic surgery/disease'}, 'identificationModule': {'nctId': 'NCT00545428', 'briefTitle': 'Mastoid Bone Autograft for Dorsal Nasal Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Uberlandia'}, 'officialTitle': 'Mastoid Bone Autograft for Dorsal Nasal Augmentation', 'orgStudyIdInfo': {'id': '1-Patrocinio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rhinoplasty', 'interventionNames': ['Procedure: Rhinoplasty']}], 'interventions': [{'name': 'Rhinoplasty', 'type': 'PROCEDURE', 'description': 'Mastoid bone autograft for dorsal nasal augmentation', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38400-368', 'city': 'Uberlândia', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Uberlandia, Department of ENT/H&N', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}], 'overallOfficials': [{'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', 'affiliation': 'Federal University of Uberlandia, Department of ENT/H&N'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Uberlandia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lucas Gomes Patrocinio', 'oldOrganization': 'Federal University of Uberlandia'}}}}