Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Bicondylar Fracture 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.
  • 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

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229-3900
Contact:
Edward Ellis III, Prof.
210-567-3470
ELLISE3@UTHSCSA.EDU

More Details

NCT ID
NCT02884765
Status
Recruiting
Sponsor
AO Clinical Investigation and Documentation

Study Contact

Víctor Díaz, PhD
0041814142507
victor.diaz@aofoundation.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.