An International, Multicenter, Focused Registry to Collect Clinical Data on the MatrixWAVE Mandibulo-Maxillary Fixation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Time of application
研究概览
简要总结
The goal of this registry is to evaluate the performance of the MatrixWAVE(TM) MMF system in patients suffering from non-condylar and/or condylar fractures. The evaluation will focus on the clinical performance in terms of :
- surgical technique
- application time
- intra- and postoperative complications
- short term patient-reported outcomes
详细描述
Following standard of care (routine) procedures, a total number of 50 patients suffering from non-condylar and/or condylar fractures of the mandible requiring MMF for a minimum of two weeks during or subsequent to open reduction internal fixation (ORIF) will be prospectively enrolled in this registry.
Data on the classification of the injury (AO CMF fracture classification system) and the time needed for application of the MatrixWAVE(TM) MMF system will be collected.
Follow-up (FU) visits will be performed between 2 to 6 weeks and at 3 months according to standard of care to evaluate the mandible function impairment, pain and local complications (anticipated procedure-related adverse events) related to the MatrixWAVE(TM) MMF system.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older at the time of the surgery
- •Diagnosis of a mandibular fracture requiring ORIF and use of MMF during or subsequent to surgical intervention for a minimum of two weeks
- •Informed consent obtained, i.e.:
- •Ability to understand the content of the patient information/ICF
- •Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
- •Signed and dated EC/IRB approved written informed consent
排除标准
- •Pre-traumatic non-occlusion due to hypodontia, edentulousness or severe malalignment of dental arches (e.g. complete crossbite)
- •Concomitant maxillary fracture (e.g. Le Fort)
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the registry period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
- •Intra-operative decision of the surgeon to use other MMF systems than the MatrixWAVE MMF system
结局指标
主要结局
Time of application
时间窗: Intraoperative
Time required by the surgeons to apply the MatrixWAVE MMF system
次要结局
- Patient-reported outcome (Likert scale)(6 weeks)