Patients 60 Years and Older Suffering From Mandibular Fractures Registry
NCT ID: NCT03849898
Last Updated: 2024-07-16
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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TERMINATED
25 participants
OBSERVATIONAL
2019-10-14
2023-03-29
Brief Summary
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Detailed Description
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Data collection will include patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications). Radiographs and/or other images (e.g. CT scan) taken as per standard of care will be collected within the registry.
Primary objectives are to obtain epidemiological data and describe the most common mandibular fracture patterns in older patients, to explore the relationship(s) between the treatment of mandibular fractures and its outcome in older patients, to identify risk factors and initiating factors of elderly related to mandible fracture events and to describe concomitant fractures associated with mandibular fractures in older patients.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Mandibular Fracture
Elderly patients of \> 60 years who present a mandibular fracture
Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice
Surgery
Surgical fracture treatment
Non-Surgical fracture treatment
Non-Surgical fracture treatment
Interventions
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Surgery
Surgical fracture treatment
Non-Surgical fracture treatment
Non-Surgical fracture treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of any kind of mandibular fracture
* Informed consent obtained, i.e.:
* Ability to understand the content of the patient information/ informed consent form (ICF)
* Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
* Signed and dated EC/IRB approved written informed consent OR For patients who are not able to provide independent written informed consent: Written consent provided according to defined and IRB/EC approved procedures
Exclusion Criteria
* Participation in any other medical device or medicinal product study within the previous months that could influence bone healing and the results of the present study in the opinion of the treating physician
60 Years
ALL
No
Sponsors
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AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Risto Kontio, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Oral and Maxillofacial Surgery, Helsinki University Hospital
Locations
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UC Davis Health System
Sacramento, California, United States
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Harborview Medical Center
Seattle, Washington, United States
Helsinki University Hospital
Helsinki, , Finland
University Hospital Freiburg
Freiburg im Breisgau, , Germany
Medical Center Hamburg Eppendorf
Hamburg, , Germany
Universitatsklinikum Marburg
Marburg, , Germany
LMU - Klinikum der Universität München
München, , Germany
Bundeswehrkrankenhauses Ulm
Ulm, , Germany
Hospital Sungai Buloh
Sungai Buloh, , Malaysia
Hospital General de Especialidades
Campeche, , Mexico
Erasmus MC
Rotterdam, , Netherlands
Spitalul Clinic Judeţean de Urgenţă "Sf. Apostol Andrei" Constanţa
Constanța, , Romania
Clinic for Maxillofacial Surgery, University of Belgrade
Belgrade, , Serbia
University Medical Centre Ljubljana
Ljubljana, , Slovenia
King Edward VIII Hospital
Durban, , South Africa
Hospital Vall d' Hebron
Barcelona, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Karolinska University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Universitaetsspital Basel
Basel, , Switzerland
National Cheng Kung University Hospital
Tainan City, , Taiwan
Hospital Maciel de Montevideo
Montevideo, , Uruguay
Countries
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Other Identifiers
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MFx 60+_RP_v.1.0
Identifier Type: -
Identifier Source: org_study_id
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