Mandible condylar fracture treatment: Y-shaped plate VsTrapezoidal Condylar Plate: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anatomical Reduction of fracture at day 180 postoperative
研究概览
简要总结
all the patients with mandible condylar fracture who will be fulfilling the inclusion and exclusion criteria and
giving an informed written consent for the procedure/study would be included. In all included patients, ‘fracture
deviation’ and ‘pain score’ will be assessed by Computed Tomography (CT) scan and using VAS
preoperatively respectively.
All the patients with mandible condylar fracture will be admitted and preoperative occlusion will be assessed and detailed
proforma will be filled. All the included patients will be allocated to one of the 2 groups using a table of random
numbers. Group A (Control): To be treated by using Trapezoidal condylar plate (TCP).
Group B (Case): To be treated by using Y-shaped plate.
Surgery would be done by approaching the fractured site through indicated surgical approach. Open reduction and
internal fixation(ORIF) will be proformed with intraoperative photographic documentation using Trapezoidal
Condylar Plate(TCP) and Y-shaped plate.
All the patients of both the groups (cases as well as control) will be assessed by a single observer through a well
designed proforma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group between 16-65 years
- •Patient with unilateral or bilateral condylar fractures.
- •Good physical and mental condition (ASA I , II )
- •Absence of infection or trauma prior to the surgery.
排除标准
- •Age <16 years and >65 years.
- •Patients/with life threatening cardio-respiratory co-morbidities increasing risk of complication during GA like previous MI/under treatment for CAD,COPD patients, severe hepatic and renal impairment, patients with head injury (condition that increased amount of pressure in brain).
- •Patient diagnosed with pan-facial fractures.
- •Pregnant patients.
结局指标
主要结局
Anatomical Reduction of fracture at day 180 postoperative
时间窗: Anatomical Reduction of fracture at day 180 postoperative
次要结局
- Reduction under direct vision(Time of plating (time from final reduction to last screw tightened))