Bilateral Condylar Fractures Registry

Overview

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).

Full Title of Study: “International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2021

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AO Clinical Investigation and Publishing Documentation
  • Collaborator
    • AOCMF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edward Ellis 3rd, DDS MS, Principal Investigator, University of Texas
  • Overall Contact(s)
    • Víctor Díaz, PhD, 0041814142507, victor.diaz@aofoundation.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.