Bilateral Condylar Fracture of the MandibleBCFxNCT02884765
Bilateral Condylar Fractures Registry
An observational study of Bilateral Condylar Fracture of the Mandible, run by AO Clinical Investigation and Publishing Documentation at 21 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bilateral Condylar Fracture of the Mandible
- What is being tested?
- Non-surgical, Non-surgical / Surgical and Surgical
- Type of treatment
- Surgery or procedure
- How many people
- 227 participants
- Where
- 21 sitesin 14 countries
- Study dates
- Jan 2017to Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients sustaining a bilateral condylar fracture of the mandible.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 14 countries.
21 sites in 14 countries
United States3 sites
University of Kentucky Chandler Medical Center
Lexington, Kentucky
University of Louisville
Louisville, Kentucky
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Spain3 sites
Hospital Vall d' Hebron
Barcelona, Catalonia
12 de Octubre University Hospital
Madrid
University Hospital La Paz de Madrid
Madrid
Germany2 sites
Universitaetsklinikum Eppendorf
Hamburg
LMU - Klinikum der Universität München
Munich
Mexico2 sites
Hospital General de Especialidades
Campeche
Hospital Trauma y Ortopedia Lomas Verdes
Mexico City
Switzerland2 sites
Universitätsspital Basel
Basel
Universitätsspital Zürich
Zurich
About this study
Official title: 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).
Read the 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.
- Being tested
- Non-surgical, Non-surgical / Surgical, Surgical
- Keywords
- mandibular condyle, subcondylar, mandible, fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgicalProcedure or surgery
Non-surgical treatment in both condylar fractures
Non-surgical / SurgicalProcedure or surgery
Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
SurgicalProcedure or surgery
Surgical treatment in both condylar fractures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Non-surgical; Procedure: Non-surgical / Surgical; Procedure: Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Condylar Fracture of the MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- AOCMF
- Responsible party
- Sponsor
- Investigators
- Edward Ellis 3rd, DDS MS, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884765
- Sponsor's protocol ID
- RP_BCFx_1.0
- Acronym
- BCFx
- Status last verified
- Jul 2024
- First submitted
- 22 Aug 2016
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible
- ClinicalTrials.gov ID
- NCT02884765
- Acronym / sponsor ID
- BCFx / RP_BCFx_1.0
- Keywords
- mandibular condyle, subcondylar, mandible, fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- AOCMF
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bicondylar Fracture | – | Procedure: Non-surgical, Procedure: Non-surgical / Surgical, Procedure: SurgicalPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients sustaining a bilateral condylar fracture of the mandible.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgicalNon-surgical treatment in both condylar fractures | Procedure or surgery | Bicondylar Fracture |
| Non-surgical / SurgicalNon-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture | Procedure or surgery | Bicondylar Fracture |
| SurgicalSurgical treatment in both condylar fractures | Procedure or surgery | Bicondylar Fracture |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Ellis 3rd, DDS MS principal investigator
University of Texas
21 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Condylar Fracture of the Mandible, run by AO Clinical Investigation and Publishing Documentation at 21 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Spain, Germany, Mexico, Switzerland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular movements (mobility index) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.