An observational study in Bilateral Condylar Fracture of the Mandible, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 21 sites in 14 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by AO Clinical Investigation and Publishing Documentation · Observational
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's enrollment of 227 is above the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 50 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients sustaining a bilateral condylar fracture of the mandible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Non-surgical · Procedure: Non-surgical / Surgical · Procedure: Surgical
Non-surgical treatment in both condylar fractures
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
Surgical treatment in both condylar fractures
Mandibular movements (mobility index)
* 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
Time frame: 3 months
Mandible dysfunction (Helkimo Index)
Time frame: 6 weeks / 3 months
Clinical evaluation of the occlusion status
* 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)
Time frame: 6 weeks / 3 months
Pain (numeric rating scale)
Time frame: 6 weeks / 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Mar 2023, 74 months.
Of 66 non-industry observational studies under Fractures, Bone, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 88. This study's 74 months is above that.
Counting every sponsor, half of 86 studies reached it within 46 months; a quarter within 20 and three quarters within 124.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation