CTRI/2022/07/043920尚未招募不适用
‘‘Comparative study to evaluate the occurrence of nonunion/malunion in the double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation – Randomized controlled trialâ€
KISHORE M S1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Non-union
研究概览
简要总结
This is a clinical trial to compare and evaluate the occurrence of nonunion and malunion in double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation. The primary outcome measure will be occurrence of nonunion at the time of followup.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with double mandibular fracture.
排除标准
- •Edentulous patients with atrophic mandible, Patients with condyle, coronoid or ramus fracture, Patients having fracture with bone loss who need bone graft, Infected mandibular fractures, Comminuted mandibular fractures,Patients with old mandibular fractures who requires surgery for residual deformities >8 wecks from time of trauma ).
- •Pan facial trauma/associated maxillary fracture requiring postoperative I.
结局指标
主要结局
Non-union
时间窗: non-union will be assessed after 10 weeks of placement
次要结局
- Pain and infection(after 10 weeks of placement of the plates)
研究者
研究点 (1)
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