CompletedNot Applicable

Bilateral Condylar Fractures Registry

United States, Finland, Germany227 participantsStarted 2017-01

Plain-language summary

Prospective data will be collected in approximately 250 patients sustaining BCFx with or without any additional fracture(s) of the symphysis. Patients will be followed according to the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data collection will include fracture details (i.e. classification, mechanism of injury), treatment details, functional and patient-reported outcomes, and anticipated or procedure-related adverse events (i.e. complications).

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 90 years at the time of the fracture * Diagnosis of bilateral condylar fracture of the mandible with or without a concomitant fracture of the symphysis * Dentition: Patients must have enough maxillary and mandibular teeth present to identify proper occlusion Exclusion Criteria: * Unilateral condylar fracture * Additional maxillary fracture(s) * Polytrauma (i.e. life threatening condition) * Patients being treated with antiresorptive drugs at the time of inclusion or during their participation in the registry * Pregnancy * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry

What they're measuring

Mandibular movements (mobility index)

Timeframe: 3 months

Trial details

NCT IDNCT02884765

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03

View on ClinicalTrials.gov More Bilateral Condylar Fracture of the Mandible trials