Bilateral Condylar Fractures Registry

Bilateral Condylar Fracture of the Mandible Clinical Trial

— BCFx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884765
• Other study ID #: RP_BCFx_1.0
• Status: Completed
• Start date: January 2017
• Est. completion date: December 2023

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Condylar Fracture of the Mandible
• Fractures, Bone

Intervention

Procedure:
• Non-surgical
Non-surgical treatment in both condylar fractures
• Non-surgical / Surgical
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
• Surgical
Surgical treatment in both condylar fractures

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation	AOCMF

Countries where clinical trial is conducted

United States,  Uruguay,  Finland,  Germany,  Malaysia,  Mexico,  Netherlands,  Pakistan,  Slovenia,  South Africa,  Spain,  Switzerland,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mandible dysfunction (Helkimo Index)		6 weeks / 3 months
Other	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)	6 weeks / 3 months
Other	Pain (numeric rating scale)		6 weeks / 3 months
Primary	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	3 months