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Bilateral Condylar Fractures Registry

Completed
Conditions
Bilateral Condylar Fracture of the Mandible
Registration Number
NCT02884765
Lead Sponsor
AO Clinical Investigation and Publishing Documentation
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
227
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (21)

University of Kentucky Chandler Medical Center

🇺🇸

Lexington, Kentucky, United States

University of Louisville

🇺🇸

Louisville, Kentucky, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

Helsinki University Hospital

🇫🇮

Helsinki, Finland

Universitaetsklinikum Eppendorf

🇩🇪

Hamburg, Germany

LMU - Klinikum der Universität München

🇩🇪

Munich, Germany

Hospital Sungai Buloh

🇲🇾

Sungai Buloh, Malaysia

Hospital General de Especialidades

🇲🇽

Campeche, Mexico

Hospital Trauma y Ortopedia Lomas Verdes

🇲🇽

Mexico City, Mexico

Eramus MC

🇳🇱

Rotterdam, Netherlands

Scroll for more (11 remaining)
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States

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