Bilateral Condylar Fractures Registry (BCFx)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02884765 |
|
Recruitment Status :
Recruiting
First Posted : August 31, 2016
Last Update Posted : August 13, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Bilateral Condylar Fracture of the Mandible | Procedure: Non-surgical Procedure: Non-surgical / Surgical Procedure: Surgical |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 250 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Months |
| Official Title: | International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible |
| Actual Study Start Date : | January 2017 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | December 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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 |
- 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
- Mandible dysfunction (Helkimo Index) [ Time Frame: 6 weeks / 3 months ]
- 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)
- Pain (numeric rating scale) [ Time Frame: 6 weeks / 3 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884765
| Contact: Víctor Díaz, PhD | 0041814142507 | victor.diaz@aofoundation.org |
Show 21 study locations
| Principal Investigator: | Edward Ellis 3rd, DDS MS | University of Texas |
| Responsible Party: | AO Clinical Investigation and Publishing Documentation |
| ClinicalTrials.gov Identifier: | NCT02884765 |
| Other Study ID Numbers: |
RP_BCFx_1.0 |
| First Posted: | August 31, 2016 Key Record Dates |
| Last Update Posted: | August 13, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
mandibular condyle subcondylar mandible fracture |
|
Fractures, Bone Wounds and Injuries |