【ChiCTR1900023885】Procedural outcomes of double vs. single fluoroscopy for fixing supracondylar humerus fractures in children

查看原文

立即下载

基本信息

登记号

ChiCTR1900023885

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2019-06-15

临床申请受理号

靶点

适应症

肱骨上骨折

试验通俗题目

Procedural outcomes of double vs. single fluoroscopy for fixing supracondylar humerus fractures in children

试验专业题目

Procedural outcomes of double vs. single fluoroscopy for fixing supracondylar humerus fractures in children

申办单位信息

申请人联系人

请登录查看

申请人名称

请登录查看

联系人邮箱

请登录查看

联系人邮编

联系人通讯地址

请登录查看

临床试验信息

试验目的

The most common elbow fractures, especially in children under the age of 7 years, are supracondylar fractures. These injuries mostly caused by falling on an outstretched hand while elbow in extension or hyperextension [1]. Pediatric elbow fractures account for approximately 60% of upper extremity fractures and more than 13% of all pediatric fractures [2]. Supracondylar humerus fractures (SHF) of pediatric patients may be difficult to treat for an inexperienced specialist [3]. These types of fractures are divided into two types as extension and flexion [4]. Extension type fractures are seen in 95-98% of the patients and in 2-5% flexion type fractures are seen [4]. SHF is divided into 3 types according to the Gartland classification. Type 1 is stable and minimally displaced fracture, while type 2 and 3 are displaced fractures [5]. The treatment of SHF type 1 fractures is closed reduction and plaster application, percutaneous pinning method is preferred after either open or closed reduction in the treatment of Type 2 and Type 3 fractures [4]. Recently, double fluoroscopy method began to be used during the surgical procedures [6-8]. Double fluoroscopy was used in the nailing of intertrochanteric femoral fractures [6], Boszczyk et al. stated that using double scopy in kyphoplasty cases reduced the radiation exposure time [7]. Similarly, Peng et al. also stated that patients with pelvic trauma had less radiation exposure time in sacroiliac screw application with using double fluoroscopy [8]. There is not enough information about the usage of double fluoroscopy in the treatment of pediatric SHF. We hypothesized that radiological and functional results will be better in patients who were operated by using double fluoroscopy. In this study, we aimed to compare the functional, radiological results and also radiation exposure times of patients with SHF who were treated by double or single fluoroscopy.

试验分类

请登录查看

试验类型

横断面

试验分期

诊断试验新技术

随机化

Forty patients who underwent closed reduction and percutaneous pinning (CRPP) with the diagnosis of SHF between March 2016 and April 2018 were included in the study. In other words, every patient was included if has not any problem with inclusion criteria.

盲法

N/A

试验项目经费来源

试验范围

目标入组人数

19;21

实际入组人数

第一例入组时间

2019-03-15

试验终止时间

2019-06-15

是否属于一致性

入选标准

Type 2 and Type 3 extension type fractures were included in this study and patients who had undergone CRPP were included in this study.；

排除标准

Patients with type 1 fractures, patients with a fracture older than 2 days, patients with open fractures, patients who required open reduction, patients with flexion type, patients with additional fractures of the same extremity, patients with preoperative nerve injury and patients without adequate follow-up were excluded from the study.；

研究者信息

研究负责人姓名

请登录查看

试验机构

Sirnak State Hospital

研究负责人电话

请登录查看

研究负责人邮箱

请登录查看

研究负责人邮编

联系人通讯地址

请登录查看