The effect of Sequencing the condylar fracture fixation on its operative time for effective fixation amongst the patients with multifocal fractures of Mandible – A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Operative Time for fracture reduction and fixation
研究概览
简要总结
Maxillofacial injuries are common in polytrauma patients, and the spectrum can be minor to life-threatening injuries. Maxillofacial injuries can be due to various causes, including road traffic accidents, assault and falls from height, industrial injuries, animal bites, sports injuries, burns, and war injuries. Mandibular fractures are more common, accounting for about 66% of total jaw fractures in a study conducted on the Indian population in 2014. Most of these fractures are solitary, but 22% and 52% involve two or more sites in the mandible. Fractures of the condylar process as the highest and contribute to 37% of total mandibular fractures, and the prevalence of Angle fracture, Para symphysis fracture, and body fractures are 27%, 17% and 15%, respectively. Amongst all mandibular fractures, multifocal fractures – the fractures occurring in multiple sites of the mandible accounts for 56%. While treating these multifocal mandibular fractures the reduction and fixation of the mandibular condylar fracture poses a difficulty to the surgeons. Establishing proper anatomical posterior ramal height and post operative occlusion is the expected end outcome of all these fractures. But due to the complexity causes by the presence of multiple fractures and ease of manipulation due to the presence of body or symphyseal fractures, surgeons differ in the opinion regarding the sequence of fixation of these fractures. If condyle fixed first the freely movable fractures aid in early reduction of the condylar segment, but on the contrary if the dentate segments are fixed earlier it aids in early occlusal reestablishment . There are few case series and opinions regarding the sequence of fixation of multifocal fractures, however a strong evidence favouring either of these is not available in the literature.Due to the paucity of the evidence suggesting the proper sequence in fixation of these multifocal fractures of the mandible, and the requirement of early and effective surgical technique to ensure faster returning to normalcy of these patients. We intend to study the effect of the sequencing of the reduction and fixation of these fractures of mandible on the operative time required for good outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with multiple fracture sites in the mandible involving condyle and any other sites like symphysis, Parasymphysis, body, and angle of the mandible.
排除标准
- •Patients below 12 years of age.
- •Neff A classification of condylar fractures.
- •Patients with condylar fractures involving medial cranial fossa and those who requires neurological intervention.
- •Only Patients who refuse to give consent.
- •Undisplaced fracture of mandible vi.
- •Patients unfit for Surgery.
结局指标
主要结局
Operative Time for fracture reduction and fixation
时间窗: At the time of Surgery only once
次要结局
- Facial asymmetry if any(7 Day)
- Surgeons Difficulty Index as per the Likert Scale(O Days (Operative Day))
- Post operative Occlusion(7 Day)
- Posterior Ramal Height Measurment in Ipsilateral and contralateral site(1 Day)
- Condylar and gonial angle flaring if any(1 Day)