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临床试验/CTRI/2025/03/083337
CTRI/2025/03/083337尚未招募4 期

Assessment of outcomes with Y modification of transconjunctival approach for zygomatic complex fractures with Orbital floor discontinuity

Jagadguru Sri Shivarathreeshwara Dental College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年10月3日最近更新:

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
Patient and surgeon satisfaction analysis with Y modification of transconjunctival incision

研究概览

简要总结

The transconjunctival approach for zygomaticomaxillary complex (ZMC) fractures has become a popular technique due to its minimal invasiveness and favorable aesthetic outcomes. However, the traditional transconjunctival approach has limitations in providing adequate visualization and reduction of complex ZMC fractures, leading to suboptimal results and complications.

 Therefore, we hypothesize that modification of the transconjunctival approach by incorporating Y technique (e.g. endoscope-assisted, intraoral incision, etc.) can improve visualization and reduction of complex ZMC fractures, resulting in better functional and aesthetic outcomes, and reduced complications

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with orbito-zygomatico-maxillary complex fractures (class III to VII according to Rowe and Killey’s classification 1968) requiring surgical access by trans-conjunctival approach with Y -modification, reduction & fixation at both infraorbital margins and fronto-zygomatic suture.
  • 2.Patients without existing laceration in the periorbital region.
  • 3.Patients who consent to be part of the study.

排除标准

  • 1.Patients medically contraindicated for surgery.
  • 2.Patients with infected fracture of the orbito-zygomatico-maxillary complex region.
  • 3.Patients with undisplaced fracture not warranted for surgical intervention.
  • 4.Comminuted ZMC fractures.
  • 5.Patients with eye injury or with impaired visual acquity.

结局指标

主要结局

Patient and surgeon satisfaction analysis with Y modification of transconjunctival incision

时间窗: Follow up period for one month and third month

次要结局

  • Complications associated with Y modification of transconjunctival incision(At 3 months & 6 months interval)

研究者

发起方
Jagadguru Sri Shivarathreeshwara Dental College
申办方类型
Other [Dental College]

研究点 (1)

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