NCT02884765

Bilateral Condylar Fractures Registry

International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 227 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Bilateral Condylar Fracture of the Mandible

Interventions

Type	Name	Description
PROCEDURE	Non-surgical	Non-surgical treatment in both condylar fractures
PROCEDURE	Non-surgical / Surgical	Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
PROCEDURE	Surgical	Surgical treatment in both condylar fractures

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-03-01
• Completion: 2023-12-01
• First posted: 2016-08-31
• Last updated: 2024-07-16

Locations

21 sites across 14 countries: United States, Finland, Germany, Malaysia, Mexico, Netherlands, Pakistan, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, Uruguay