Comparative Evaluation of Clinical and Radiological Outcomes of Open Reduction & Internal Fixation of Unilateral Subcondylar Fracture With and Without Use of Virtual Surgical Planning and Surgical Template –A Randomised Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To evaluate and compare the clinical outcomes such as
研究概览
简要总结
Mandibular Condylar fractures are relatively common accounting for 29% to 52% of all Mandibular fractures. There are various classification systems describing Mandibular Condylar fractures based on the anatomical position of fracture, degree of displacement and/ or dislocation. There are two principal treatment modalities for these fractures. Traditionally conservative management was most preferred but in recent years Open reduction & Internal fixation (ORIF) has become the method of choice because it can provide better functional and morphological outcomes in terms of mouth opening, occlusal status and facilitates anatomic reduction of Condyle. The challenges most often faced during ORIF include difficulty in controlling the small proximal fragment and achieving good stability. The struggle to achieve good reduction and fixation often prolongs the intraoperative time. Advent of Computed tomography and 3D modelling have enabled better understanding of the level of fracture, degree of comminution, obliquity along the fracture line and hence better treatment planning. Virtual surgical planning has been recently introduced which has enabled surgeons to perform the repositioning of the fragment virtually andpresumably select and precontour the appropriate fixation device thus reducing the intraoperative time and increasing the accuracy of reduction and fixation. This idea has been adopted following its proven efficacy in treatment planning in reconstructive surgeries with Bone grafting and free tissue transfers. A surgical template can made with the help of virtual surgical planning which can aid in holding the proximal fragment in position and help in precise reduction, better control of the proximal fragment and ensure placement of plates in the preplanned position and overall reduce the intraoperative time.The aim of the study is to evaluate whether the use of virtual surgical planning and surgical template can provide an anatomic reduction, require less intraoperative time and ensure enhanced clinical andradiological outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants in the age group of 18 – 60 years.
- •Participants with Unilateral Subcondylar fractures with more than 2 mm overlap and/or >10 degree angulation at the lower end of the condylar fragment.
- •Participants with other concomitant fractures of Mandible which will be treated by Open reduction and internal fixation
- •Participants who have sustained fracture in the past two weeks.
- •Participants with a dentition complete enough to apply a stable Erich arch bar.
- •Participants willing to participate in the study.
排除标准
- •Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology.
- •Intracapsular Condylar fracture
- •Undisplaced condylar fracture.
- •Participants with history of previous Mandibular fractures or Osteotomies.
- •Subjects with bilateral condylar fracture.
- •Pregnant participants.
结局指标
主要结局
To evaluate and compare the clinical outcomes such as
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
occlusion,inter incisal mouth opening, lateral excursion on
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
the contralateral side, lateral excursion on the fractured
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
site, protrusion, pain, edema and radiological
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
outcomes such as the degree of displacement, direction
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
of displacement, ramus height and the degree of
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
approximation of the fractured fragment.
时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks
次要结局
- To evaluate and compare the intra operative time taken(for the completion of Open Reduction Internal Fixation of)
