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临床试验/NCT06365112
NCT06365112招募中早期 1 期

The Endoscopic Surgical Technique of the Acetabulum: A Minimally Invasive Operative Technique for the Extraperitoneal Fixation of Acetabulum Fractures

Tampere University Hospital2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年4月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
招募中
入组人数
13
试验地点
2
主要终点
Operation time

研究概览

简要总结

Try to develop an endoscopic surgical technique to treat acetabulum fractures

详细描述

Endoscopically assisted acetabular fracture treatment

Introduction Acetabular fractures are uncommon trauma in Finnish population (1). The trauma mechanism usually in elderly population is fall in same level and in younger population high energy trauma such as motor vehicle accidents and fall from hights (1). Acetabular fractures are classified according the Letournel classification in which the fractures are divided in three main gategories: posterior column, both columns and anterior column (2).

These fractures are further divided into posterior column, posterior wall and posterior wall plus posterior column fractures. These posterior only fractures are usually operated through posterior approach. Both column fractures are further divided into six different types: transverse, transverse plus posterior wall, both column, T-shaped (posterior column and anterior hemitransverse), anterior column plus posterior hemitransverse; anterior wall plus posterior hemitransverse. Anterior approach is used usually to these fractures sometimes combined with posterior approach. The third fracture type is likewise divided into anterior column, anterior wall and anterior wall plus anterior column fractures, which are usually operated using anterior approach. (2)

Operative treatment is the golden standard in displaced high energy acetabulum fractures and technique has traditionally been open reduction and internal fixation (ORIF). Approach, which has been used to operate the anterior part of the acetabulum fractures, has been modified Stoppa in which the acetabulum is exposed through low midline incision in extraperitoneal region (3).

The problem with this approach is the visualization of the highest proportion of the pelvic brim and usually fractures highest point, because of the anatomical reasons, peritoneum and the arteria and vena femoralis goes nearby and sometimes prevent making the approach, reduction and plating of the fracture safely. Some patients have also post operative problems with the incision, they have pain in the anterior part of the pelvis. Also the dissection and sometimes detachment of the rectus abdominis muscles may cause serious problems post operatively.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acetabulum fracture

排除标准

  • <18years
  • Previous lower abdominal operation

结局指标

主要结局

Operation time

时间窗: Intraoperative

Patient satisfaction using EQ5D

时间窗: through study completion, an average of 1 year

Number of patients with minor complications

时间窗: At three months

Number of patients with major complications

时间窗: At three months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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