Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures. A Randomized Clinical Trial
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
- Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
研究概览
简要总结
Orbito-Zygomaticomaxillary-complex fractures is a form of a complex orbital floor fracture, with affection of the inferior orbital rim and the orbital walls. According to published research, between 67 - 84 % of periorbital bone fractures are orbital floor fractures.
Evaluation of 3D-Modified Anatomic Mesh in the management of OZM- complex fractures with orbital floor defect, and compare it with the conventional fixation configuration.
详细描述
Patients suffering from OZM- complex fractures was treated using 3D-Modified Anatomical Mesh for orbital floor reconstruction and orbital rim fixation. Patients was randomly allocated into study and control groups, where it is managed with the conventional 2.0-miniplate and stock mesh. A standardized surgical protocol was followed in both groups. Patients was clinically evaluated for pain, wound healing, nerve sensation, ocular motility and diplopia, and tarsal plate morphology. Moreover, radiographic survey was performed post operatively to assess the proper positioning of the implant, to confirm proper fracture reduction, and radiographic enophthalmos analysis
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
- Single (Participant)
盲法说明
Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16).
- •Fractures that are indicated for open reduction and internal fixation.
- •Patients suffering from ocular complications:
- •Monocular diplopia.
- •Enophthalmos above 2 mm.
- •Restricted ocular motility.
- •Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus.
- •Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period.
排除标准
- •Patients with isolated orbital floor defects and blowout fractures.
- •Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects.
- •Patients with bilateral orbital defects.
- •Patients with Infected wounds in periorbital region.
- •Medically compromised patients rendering them inoperable.
- •Patients with ruptured globe or blindness.
研究组 & 干预措施
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh
干预措施: 3D-Modified Anatomical-Mesh. (Device)
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini
干预措施: conventional orbital rim miniplates and orbital mesh configuration (Device)
结局指标
主要结局
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
时间窗: 1 week
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
次要结局
- Periorbital ecchymosis(6 weeks)