Clinical trial NCT02884765: Bilateral Condylar Fractures Registry
Official title: International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bilateral Condylar Fracture of the Mandible
Keywords: mandibular condyle
subcondylar
mandible
fracture
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AOCMF
First posted: 2016-08-31
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients sustaining a bilateral condylar fracture of the mandible.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mandibular movements (mobility index)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Mandible dysfunction (Helkimo Index)
timeFrame: 6 weeks / 3 months
measure: Clinical evaluation of the occlusion status
timeFrame: 6 weeks / 3 months
measure: Pain (numeric rating scale)
timeFrame: 6 weeks / 3 months
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Hamburg
country: Germany
facility: Universitaetsklinikum Eppendorf
city: Munich
country: Germany
facility: LMU - Klinikum der Universität München
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
city: Campeche
country: Mexico
facility: Hospital General de Especialidades
city: Mexico City
country: Mexico
facility: Hospital Trauma y Ortopedia Lomas Verdes
city: Rotterdam
country: Netherlands
facility: Eramus MC
city: Lahore
country: Pakistan
facility: Mayo Hospital Lahore
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Durban
country: South Africa
facility: King Edward VIII Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d' Hebron
state: Catalonia
city: Madrid
country: Spain
facility: 12 de Octubre University Hospital
city: Madrid
country: Spain
facility: University Hospital La Paz de Madrid
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Montevideo
country: Uruguay
facility: Hospital Maciel de Montevideo
Study officials:
affiliation: University of Texas
name: Edward Ellis 3rd, DDS MS
role: PRINCIPAL_INVESTIGATOR
References: