Bilateral Condylar Fractures Registry (BCFx)

March 19, 2024 updated by: AO Clinical Investigation and Publishing Documentation

International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital
  • Germany
      • Hamburg, Germany
        • Universitaetsklinikum Eppendorf
      • Munich, Germany
        • LMU - Klinikum der Universität München
  • Malaysia
      • Sungai Buloh, Malaysia
        • Hospital Sungai Buloh
  • Mexico
      • Campeche, Mexico
        • Hospital General de Especialidades
      • Mexico City, Mexico
        • Hospital Trauma y Ortopedia Lomas Verdes
  • Netherlands
      • Rotterdam, Netherlands
        • Eramus MC
  • Pakistan
      • Lahore, Pakistan
        • Mayo Hospital Lahore
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre Ljubljana
  • South Africa
      • Durban, South Africa
        • King Edward VIII Hospital
  • Spain
      • Madrid, Spain
        • 12 de Octubre University Hospital
      • Madrid, Spain
        • University Hospital La Paz de Madrid
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital Vall d' Hebron
  • Switzerland
      • Basel, Switzerland
        • Universitatsspital Basel
      • Zürich, Switzerland
        • Universitätsspital Zürich
  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
  • Ukraine
      • Lviv, Ukraine
        • Lviv Regional Clinical Hospital
  • United States
    • Kentucky
      • Lexington, Kentucky, United States
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States
        • University of Louisville
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
  • Uruguay
      • Montevideo, Uruguay
        • Hospital Maciel de Montevideo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients sustaining a bilateral condylar fracture of the mandible.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mandible dysfunction (Helkimo Index)
Time Frame: 6 weeks / 3 months
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)
6 weeks / 3 months
Pain (numeric rating scale)
Time Frame: 6 weeks / 3 months
6 weeks / 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

AOCMF

Investigators

  • Principal Investigator: Edward Ellis 3rd, DDS MS, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimated)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP_BCFx_1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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