International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns in Patients With Bilateral Condylar Fracture (BCFx) of the Mandible
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 21
- 主要终点
- Mandibular movements (mobility index)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
结局指标
主要结局
Mandibular movements (mobility index)
时间窗: 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
次要结局
未报告次要终点