NCT03849898

Patients 60 Years and Older Suffering From Mandibular Fractures Registry

International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: —

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.

Conditions

• Mandibular Fractures

Interventions

Type	Name	Description
PROCEDURE	Surgery	Surgical fracture treatment
OTHER	Non-Surgical fracture treatment	Non-Surgical fracture treatment

Timeline

• Start date: 2019-10-14
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2019-02-21
• Last updated: 2024-07-16

Locations

24 sites across 15 countries: United States, Finland, Germany, Malaysia, Mexico, Netherlands, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Uruguay