Bilateral Condylar Fractures Registry (BCFx)

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Bilateral Condylar Fracture of the Mandible

Treatments: Procedure: Non-surgical / Surgical; Procedure: Surgical; Procedure: Non-surgical

Study type: Observational

Funder types: Other

Identifiers

NCT02884765

RP_BCFx_1.0

Details and patient eligibility

About

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).

Full description

Fractures of the condyles occur in around one third of patients sustaining a mandibular fracture. Bilateral fractures are reported in around one fifth to one third of all fractures of the mandibular condyles and are often combined with other fractures of the mandible or facial skeleton.

The treatment of condylar fractures, and in particular of bilateral condylar fractures (BCFx), is complex due to many different fracture patterns, surgeon's preferences, local constraints of the health care system and patient characteristics. Briefly, BCFx can be treated using either closed treatment (CTx) (e.g. intermaxillary fixation [IMF] and/or functional therapy) or surgical treatment (i.e. open reduction and internal fixation [ORIF]) in both fractures, or a combination of closed treatment and ORIF. The relationship of these treatments with the final outcome remains elusive, since the available literature does not report specific data for patients sustaining BCFx and has ignored or inadequately reported patient-reported outcomes. Consequently there is a lack of clinical evidence to assist the decision-making process.

Therefore, the purpose of this registry is to collect data in a standardized manner regarding the treatment, the clinical and the patient-oriented outcomes, and the complications of BCFx.

Enrollment: 227 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

227 participants in 1 patient group

Bicondylar Fracture

Description:

Patients presenting a bilateral condylar fracture of the mandible with or without additional symphyseal fracture. Bilateral condylar fractures will be treated non-surgical, surgical or combining both.

Treatment:

Procedure: Non-surgical

Procedure: Surgical

Procedure: Non-surgical / Surgical