The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- accessibility to the fracture site
研究概览
简要总结
The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.
详细描述
The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:
Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ZMC fractures requiring open reduction and internal fixation.
- •Adult patients aged between 20 and 50 years with no gender predilection.
排除标准
- •An existing laceration in the inferior and lateral periorbital site.
- •Infection at the fracture line.
- •Comminuted fracture with bone loss.
- •Acute and chronic conjunctival diseases.
结局指标
主要结局
accessibility to the fracture site
时间窗: intraoperative
Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No
esthetic appearance and scarring
时间窗: 6 weeks postoperative
Postoperative scarring was recorded as noticeable or unnoticeable
radiographic verification of adequacy of fracture reduction
时间窗: immediate postoperative
computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No
次要结局
- The duration for exposure of the fracture site(intraoperative)
- postoperative pain(at 24 hours and 1 week)
- sensory nerve function(3 months postoperative)
研究者
Lydia Nabil
Associate Professor of Oral and Maxillofacial Surgery
University of Alexandria