Bilateral Condylar Fractures Registry (BCFx)
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|ClinicalTrials.gov Identifier: NCT02884765|
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : August 13, 2020
|Condition or disease||Intervention/treatment|
|Bilateral Condylar Fracture of the Mandible||Procedure: Non-surgical Procedure: Non-surgical / Surgical Procedure: Surgical|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
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.
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
Surgical treatment in both condylar fractures
- Mandibular movements (mobility index) [ Time Frame: 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
- Mandible dysfunction (Helkimo Index) [ Time Frame: 6 weeks / 3 months ]
- Clinical evaluation of the occlusion status [ Time Frame: 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) [ Time Frame: 6 weeks / 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884765
|Contact: Víctor Díaz, PhDfirstname.lastname@example.org|
|Principal Investigator:||Edward Ellis 3rd, DDS MS||University of Texas|