Clinical trial NCT03849898: Patients 60 Years and Older Suffering From Mandibular Fractures Registry
Official title: International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mandibular Fractures
Keywords: Fracture fixation
Surgical treatment
Non-Surgical treatment
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported outcome
timeFrame: Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months
Secondary outcomes:
Other outcomes:
measure: Occlusal Status
timeFrame: 2 weeks / 6 weeks / 3 months / 6 months
measure: Degree of malocclusion (if present)
timeFrame: 2 weeks / 6 weeks / 3 months / 6 months
measure: Mandibular dysfunction (Helkimo index)
timeFrame: 2 weeks / 6 weeks / 3 months / 6 months
measure: Mandibular Movements (mobility index)
timeFrame: 2 weeks / 6 weeks / 3 months / 6 months
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
city: Baltimore
country: United States
facility: R Adams Cowley Shock Trauma Center
state: Maryland
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Hamburg
country: Germany
facility: Medical Center Hamburg Eppendorf
city: Marburg
country: Germany
facility: Universitatsklinikum Marburg
city: München
country: Germany
facility: LMU - Klinikum der Universität München
city: Ulm
country: Germany
facility: Bundeswehrkrankenhauses Ulm
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
city: Campeche
country: Mexico
facility: Hospital General de Especialidades
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Constanţa
country: Romania
facility: Spitalul Clinic Judeţean de Urgenţă "Sf. Apostol Andrei" Constanţa
city: Belgrade
country: Serbia
facility: Clinic for Maxillofacial Surgery, University of Belgrade
city: Lubiana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Durban
country: South Africa
facility: King Edward VIII Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d' Hebron
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Montevideo
country: Uruguay
facility: Hospital Maciel de Montevideo
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, Helsinki University Hospital
name: Risto Kontio, Prof.
role: PRINCIPAL_INVESTIGATOR
References: