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Bilateral Condylar Fractures Registry (BCFx)

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ClinicalTrials.gov Identifier: NCT02884765
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
AOCMF
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Study Description
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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).

Condition or disease Intervention/treatment
Bilateral Condylar Fracture of the Mandible Procedure: Non-surgical Procedure: Non-surgical / Surgical Procedure: Surgical

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.


Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Procedure: Non-surgical
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

Procedure: Surgical
Surgical treatment in both condylar fractures


Outcome Measures
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Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Mandible dysfunction (Helkimo Index) [ Time Frame: 6 weeks / 3 months ]
  2. 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)

  3. Pain (numeric rating scale) [ Time Frame: 6 weeks / 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients sustaining a bilateral condylar fracture of the mandible.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Víctor Díaz, PhD 0041814142507 victor.diaz@aofoundation.org

  Show 21 Study Locations
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOCMF
Investigators
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Principal Investigator: Edward Ellis 3rd, DDS MS University of Texas
More Information
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Additional Information:

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02884765     History of Changes
Other Study ID Numbers: RP_BCFx_1.0
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AO Clinical Investigation and Documentation:
mandibular condyle
subcondylar
mandible
fracture
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries