Patients 60 Years and Older Suffering From Mandibular Fractures Registry

Stopped early

Conditions studied: Mandibular Fractures

In brief

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.

Key facts

Study ID

NCT03849898

Run by

AO Clinical Investigation and Publishing Documentation

People needed

25

Starts

2019-10-14

Expected to finish

2023-03-29

Last updated by the study team

2024-07-16

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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, Taiwan
• Hospital Maciel de Montevideo — Montevideo, Uruguay

Full record on ClinicalTrials.gov

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