Patients 60 Years and Older Suffering From Mandibular Fractures Registry

NCT ID: NCT03849898

Last Updated: 2024-07-16

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2023-03-29

Brief Summary

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Approximately 200 of patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

Detailed Description

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Patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated (surgical or non-surgical) and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

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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Mandibular Fractures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type PROCEDURE

Surgical fracture treatment

Non-Surgical fracture treatment

Intervention Type OTHER

Non-Surgical fracture treatment

Interventions

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Surgery

Surgical fracture treatment

Intervention Type PROCEDURE

Non-Surgical fracture treatment

Non-Surgical fracture treatment

Intervention Type OTHER

Other Intervention Names

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Operative

Eligibility Criteria

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Inclusion Criteria

* Age \> 60 years at the time of the injury
* 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

* Patients with previous history of mandibular fractures or mandibular defects treated surgically
* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

University Hospital Freiburg

Freiburg im Breisgau, , Germany

Site Status

Medical Center Hamburg Eppendorf

Hamburg, , Germany

Site Status

Universitatsklinikum Marburg

Marburg, , Germany

Site Status

LMU - Klinikum der Universität München

München, , Germany

Site Status

Bundeswehrkrankenhauses Ulm

Ulm, , Germany

Site Status

Hospital Sungai Buloh

Sungai Buloh, , Malaysia

Site Status

Hospital General de Especialidades

Campeche, , Mexico

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Spitalul Clinic Judeţean de Urgenţă "Sf. Apostol Andrei" Constanţa

Constanța, , Romania

Site Status

Clinic for Maxillofacial Surgery, University of Belgrade

Belgrade, , Serbia

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

King Edward VIII Hospital

Durban, , South Africa

Site Status

Hospital Vall d' Hebron

Barcelona, , Spain

Site Status

Hospital Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Universitaetsspital Basel

Basel, , Switzerland

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Hospital Maciel de Montevideo

Montevideo, , Uruguay

Site Status

Countries

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United States Finland Germany Malaysia Mexico Netherlands Romania Serbia Slovenia South Africa Spain Sweden Switzerland Taiwan Uruguay

Other Identifiers

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MFx 60+_RP_v.1.0

Identifier Type: -

Identifier Source: org_study_id

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