Patients 60 Years and Older Suffering From Mandibular Fractures Registry

AO Clinical Investigation and Publishing Documentation

Status: Terminated

Conditions: Mandibular Fractures

Treatments: Procedure: Surgery; Other: Non-Surgical fracture treatment

Study type: Observational

Funder types: Other

Identifiers

NCT03849898

MFx 60+_RP_v.1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Mandibular Fracture

Description:

Elderly patients of \> 60 years who present a mandibular fracture Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice

Treatment:

Other: Non-Surgical fracture treatment

Procedure: Surgery