Bilateral Condylar Fracture of the Mandible
Conditions
Keywords
mandibular condyle, subcondylar, mandible, fracture
Brief 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.
Interventions
PROCEDURENon-surgical
Non-surgical treatment in both condylar fractures
PROCEDURENon-surgical / Surgical
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
PROCEDURESurgical
Surgical treatment in both condylar fractures
Sponsors
AOCMF
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mandibular movements (mobility index) | 3 months | * Interincisal opening/maximal opening is defined as distance in millimeters between the edges of the incisors of the mandibular and the maxillary bone. * Lateral movements: With the mandible slightly open, it is defined as the distance in millimeters from the labioincisal embrasure between the central incisors to the labioincisal embrasure of the mandibular incisors * Protrusive movement: With the mandible slightly open, it is defined as the distance in millimeters between the incisal edges of the maxillary central incisor to the mandibular central incisor. Depending on the score, the mobility index will be calculated as follow: * 0 points: normal mandibular mobility * 1 - 4 points: slightly impaired mobility * 5 - 20 points: severely impaired mobility |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mandible dysfunction (Helkimo Index) | 6 weeks / 3 months | — |
| Clinical evaluation of the occlusion status | 6 weeks / 3 months | * Normal for the patient * Abnormal for the patient (anterior open bite / crossbite / lateral open bite in the premolar area / lateral open bite in the mola area) |
| Pain (numeric rating scale) | 6 weeks / 3 months | — |
Countries
Finland, Germany, Malaysia, Mexico, Netherlands, Pakistan, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United States, Uruguay
Outcome results
None listed