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临床试验/NCT06333197
NCT06333197尚未招募不适用

A Comparative Study Between the Retromandibular Transparotid Approach and Retromandibular Retroparotid Approach for Open Reduction and Internal Fixation of Mandibular Condylar Fracture.

Assiut University0 个研究点目标入组 30 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Facial nerve injury

研究概览

简要总结

The condylar region is the most frequent anatomical site for mandibular fractures .

Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

详细描述

Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches.

The selection of the appropriate surgical approach for condylar neck fracture represents a controversy.

The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.

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

性别
All
接受健康志愿者

入选标准

  • ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.

排除标准

  • Open Laceration in the condylar region.
  • Concomitant traumatic Facial Nerve injury.
  • Previous Surgery in Retromandibular region.
  • Severe Obese patients
  • Patients Refusing Surgery.

结局指标

主要结局

Facial nerve injury

时间窗: Up to 6 months

Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )

Operative time

时间窗: Up to 3 hours

The duration of the operation

次要结局

  • Other Complication related to the Approach(Up to 6 Months)
  • Fracture stability(Up to 3 Months)
  • Mouth opening(Up to 3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Mahmoud Hussien Ahmed

Resident doctor at general surgery department

Assiut University

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