Status:
TERMINATED
Patients 60 Years and Older Suffering From Mandibular Fractures Registry
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Mandibular Fractures
Eligibility:
All Genders
60+ years
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 (ro...
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 standa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03849898
Start Date
October 14 2019
End Date
March 29 2023
Last Update
July 16 2024
Active Locations (24)
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1
UC Davis Health System
Sacramento, California, United States, 95817
2
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
3
Harborview Medical Center
Seattle, Washington, United States, 98104
4
Helsinki University Hospital
Helsinki, Finland