Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
227 participants
OBSERVATIONAL
2017-01-31
2023-12-31
Brief Summary
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Detailed Description
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The treatment of condylar fractures, and in particular of bilateral condylar fractures (BCFx), is complex due to many different fracture patterns, surgeon's preferences, local constraints of the health care system and patient characteristics. Briefly, BCFx can be treated using either closed treatment (CTx) (e.g. intermaxillary fixation \[IMF\] and/or functional therapy) or surgical treatment (i.e. open reduction and internal fixation \[ORIF\]) in both fractures, or a combination of closed treatment and ORIF. The relationship of these treatments with the final outcome remains elusive, since the available literature does not report specific data for patients sustaining BCFx and has ignored or inadequately reported patient-reported outcomes. Consequently there is a lack of clinical evidence to assist the decision-making process.
Therefore, the purpose of this registry is to collect data in a standardized manner regarding the treatment, the clinical and the patient-oriented outcomes, and the complications of BCFx.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Bicondylar Fracture
Patients presenting a bilateral condylar fracture of the mandible with or without additional symphyseal fracture. Bilateral condylar fractures will be treated non-surgical, surgical or combining both.
Non-surgical
Non-surgical treatment in both condylar fractures
Non-surgical / Surgical
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
Surgical
Surgical treatment in both condylar fractures
Interventions
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Non-surgical
Non-surgical treatment in both condylar fractures
Non-surgical / Surgical
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
Surgical
Surgical treatment in both condylar fractures
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of bilateral condylar fracture of the mandible with or without a concomitant fracture of the symphysis
* Dentition: Patients must have enough maxillary and mandibular teeth present to identify proper occlusion
Exclusion Criteria
* Additional maxillary fracture(s)
* Polytrauma (i.e. life threatening condition)
* Patients being treated with antiresorptive drugs at the time of inclusion or during their participation in the registry
* Pregnancy
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
18 Years
90 Years
ALL
No
Sponsors
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AOCMF
OTHER
AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Edward Ellis 3rd, DDS MS
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Helsinki University Hospital
Helsinki, , Finland
Universitaetsklinikum Eppendorf
Hamburg, , Germany
LMU - Klinikum der Universität München
Munich, , Germany
Hospital Sungai Buloh
Sungai Buloh, , Malaysia
Hospital General de Especialidades
Campeche, , Mexico
Hospital Trauma y Ortopedia Lomas Verdes
Mexico City, , Mexico
Eramus MC
Rotterdam, , Netherlands
Mayo Hospital Lahore
Lahore, , Pakistan
University Medical Centre Ljubljana
Ljubljana, , Slovenia
King Edward VIII Hospital
Durban, , South Africa
Hospital Vall d' Hebron
Barcelona, Catalonia, Spain
12 de Octubre University Hospital
Madrid, , Spain
University Hospital La Paz de Madrid
Madrid, , Spain
Universitätsspital Basel
Basel, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
National Cheng Kung University Hospital
Tainan City, , Taiwan
Lviv Regional Clinical Hospital
Lviv, , Ukraine
Hospital Maciel de Montevideo
Montevideo, , Uruguay
Countries
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Other Identifiers
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RP_BCFx_1.0
Identifier Type: -
Identifier Source: org_study_id
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