Bilateral Condylar Fractures Registry



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 90
Updated:1/20/2019
Start Date:January 2017
End Date:December 2020
Contact:Víctor Díaz, PhD
Email:victor.diaz@aofoundation.org
Phone:0041814142507

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

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).

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.

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
We found this trial at
4
sites
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Edward Ellis III, Prof.
Phone: 210-567-3470
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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