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Completed

NCT Number: NCT02884765

Bilateral Condylar Fractures Registry

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).

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Key information

Conditions

Bilateral Condylar Fracture of the Mandible Fractures, Bone Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Surgical

Procedure

Non-surgical treatment in both condylar fractures

Non-surgical / Surgical

Procedure

Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture

Surgical

Procedure

Surgical treatment in both condylar fractures

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • AOCMF

Registry information

Official study title

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

Acronym: BCFx

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2016
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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