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| Name | Class |
|---|---|
| AOCMF | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical | Procedure | Non-surgical treatment in both condylar fractures |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mandibular movements (mobility index) |
Depending on the score, the mobility index will be calculated as follow:
| 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Mandible dysfunction (Helkimo Index) | 6 weeks / 3 months | |
| Clinical evaluation of the occlusion status |
|
Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients sustaining a bilateral condylar fracture of the mandible.
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| Name | Affiliation | Role |
|---|---|---|
| Edward Ellis 3rd, DDS MS | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | |||
| University of Louisville |
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| Non-surgical / Surgical |
| Procedure |
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture |
|
| Surgical | Procedure | Surgical treatment in both condylar fractures |
|
| 6 weeks / 3 months |
| Pain (numeric rating scale) | 6 weeks / 3 months |
| Louisville |
| Kentucky |
| United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Helsinki University Hospital | Helsinki | 00029 | 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 |
| Mayo Hospital Lahore | Lahore | Pakistan |
| University Medical Centre Ljubljana | Ljubljana | Slovenia |
| King Edward VIII Hospital | Durban | South Africa |
| Hospital Vall d' Hebron | Barcelona | Catalonia | Spain |
| 12 de Octubre University Hospital | Madrid | Spain |
| University Hospital La Paz de Madrid | Madrid | Spain |
| Universitätsspital Basel | Basel | Switzerland |
| Universitätsspital Zürich | Zurich | Switzerland |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Lviv Regional Clinical Hospital | Lviv | Ukraine |
| Hospital Maciel de Montevideo | Montevideo | Uruguay |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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