Bilateral Condylar Fractures Registry

NCT02884765 | Completed

• 1 other identifier: RP_BCFx_1.0
• Study Type: observational
• Target: 227
• Locations: 14 countries
• Sites: 21

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).

Conditions

Bilateral Condylar Fracture of the Mandible

Keywords

mandibular condyle; subcondylar; mandible; fracture

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (3)

• Mandible dysfunction (Helkimo Index)

  6 weeks / 3 months

• Clinical evaluation of the occlusion status

  6 weeks / 3 months

• Pain (numeric rating scale)

  6 weeks / 3 months

Study Arms (1)

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; Procedure: Non-surgical / Surgical; Procedure: Surgical

Interventions

Non-surgical PROCEDURE

Non-surgical treatment in both condylar fractures

Bicondylar Fracture

Non-surgical / Surgical PROCEDURE

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

Bicondylar Fracture

Surgical PROCEDURE

Surgical treatment in both condylar fractures

Bicondylar Fracture

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients sustaining a bilateral condylar fracture of the mandible.

You may qualify if:

• 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

You may not qualify if:

• Unilateral condylar fracture
• Additional maxillary fracture(s)
• Polytrauma (i.e. life threatening condition)
• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead
• AOCMF: collaborator

Study Sites (21)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Location

University of Louisville

Louisville, Kentucky, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Universitaetsklinikum Eppendorf

Hamburg, Germany

Location

LMU - Klinikum der Universität München

Munich, Germany

Location

Hospital Sungai Buloh

Sungai Buloh, Malaysia

Location

Hospital General de Especialidades

Campeche, Mexico

Location

Hospital Trauma y Ortopedia Lomas Verdes

Mexico City, Mexico

Location

Eramus MC

Rotterdam, Netherlands

Location

Mayo Hospital Lahore

Lahore, Pakistan

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

King Edward VIII Hospital

Durban, South Africa

Location

Hospital Vall d' Hebron

Barcelona, Catalonia, Spain

Location

12 de Octubre University Hospital

Madrid, Spain

Location

University Hospital La Paz de Madrid

Madrid, Spain

Location

Universitätsspital Basel

Basel, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Lviv Regional Clinical Hospital

Lviv, Ukraine

Location

Hospital Maciel de Montevideo

Montevideo, Uruguay

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Edward Ellis 3rd, DDS MS

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 31, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); ES (3); TW (1); DE (2); CH (2); US (3); ME (2); NL (1); MY (1); UA (1); PA (1); FI (1); SL (1); UR (1)