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临床试验/NCT05354531
NCT05354531已完成不适用

Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions

Assiut University4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Majeed score

研究概览

简要总结

With a prospective case series study of 15 patients The aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( B&C ) after treatment with (INFIX)

详细描述

Unstable pelvic ring fractures are usually associated with high energy trauma. They account for about 1.5-3.9% of all fractures, but they have a high rate of morbidity and mortality. Although the posterior pelvic ring provides the main stability (60%), the anterior ring still account for 40% of stability fracture pelvis B &C according to tiles classification require fixation of the anterior ring or anterior-posterior ring simultaneously.

The external fixator is the most widely used treatment for initial and temporary stabilization of anterior pelvic ring injury, especially in emergency situations. It can be quickly placed and can easily stabilize the disrupted pelvic ring and decrease pelvic cavity haemorrhage. However, many clinical complications associated with the external fixator have been reported, including wound infection, loosening of the fixator, and impingement on the skin.

Moreover, the anterior pelvic external fixator limits patients' daily activities, such as sitting, lying in the lateral position, rolling over, and sexual intercourse

Recently, anterior subcutaneous internal fixator (INFIX) was proposed by several scholars to treat anterior pelvic ring injury.

INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

盲法说明

Those previously mentioned cases should be assessed clinically and radiologically

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • skeletally mature patient.
  • type B2 / B3 & C1 pelvic fracture.
  • open book B1 fracture with urogenital disruption.
  • Patient with fatty tissue that cover pubic bones enable insertion of the rod.
  • if there is a contraindication to Anterior symphyseal plating.

排除标准

  • associated comorbidities preventing surgery.
  • pelvic fracture associated with iliac bones fracture
  • combined pelvis and acetabulum fracture.

结局指标

主要结局

Majeed score

时间窗: After 3 months

Majeed rating scale will be used to evaluate the functional outcome. Patients will be followed up by phone or at the clinic. functional recovery will be scored by asking the rating scale questions. These questions including the subjective feelings of pain, return to the work, the feelings of sitting, sexual intercourse, standing, walking distance, and the condition of gait. The aggregate score will be classified as excellent (\>85), good (70-84), fair (55-69), or poor (\<55).

次要结局

  • Time to surgery(Within the first week)
  • Radiology dose(Within the first week)
  • Procedure time(Within the first week)
  • Incidence and rate of adverse events(After 6 months)

研究者

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

Kyrillos Talaat saadallah abdelshahid

Professor Doctor Osama Farouk Head of trauma unit in department of orthopedic surgery Assiut university

Assiut University

研究点 (4)

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