First Vienna Pediatric Medical Center, Donau-City-Straße 1, 1220, Vienna, Austria.
Sigmund Freud Private University, Vienna, Austria.
BMC Pediatr. 2019 Jan 10;19(1):14. doi: 10.1186/s12887-019-1392-z.
In Middle Europe ultrasonography is the standard method used to screen for developmental dysplasia of the hip in infants. Our aim was to determine whether manual fixation of the child is equivalent to Graf's technique regarding image quality.
This randomized trial was conducted at a free-standing general pediatric outpatient clinic in Vienna, Austria. Healthy infants in the 1st and between the 6th and 8th week of life with no hip malalignment were included. After randomization, Group 1 was examined using Graf's fixation device and participants in Group 2 were fixated on the examination couch by their parents. In a second step, all images underwent a blinded evaluation.
A total of 117 babies (Group 1: n = 62, Group 2: n = 54, excluded: n = 1) were examined and 230 images (Group 1: n = 122, Group 2: n = 108) were evaluated, of which 225 were sonographically normal. Two images, showing a type IIa right hip and a type IIa + left hip respectively, were excluded. One participant had to be excluded as the respective images showed two pathologic hip joints. Two images in Group 1 and three in Group 2 were not evaluable. No statistical association between image quality (11 quality criteria and overall evaluability) and fixation technique (0.12 ≤ p ≤ 1.0 or constant) was found.
Considering sonographically normal hip joints, we found no evidence that manual fixation differed from Graf's technique regarding image quality. In future studies, hip pathologies should be included and discomfort of infants and parents during the examination should be addressed.
German Clinical Trials Register, ID: DRKS00015694 ), registered retrospectively on October 7th, 2018.
在中欧,超声检查是用于筛查婴儿发育性髋关节发育不良的标准方法。我们的目的是确定在图像质量方面,手动固定儿童与 Graf 技术是否等效。
这项随机试验在奥地利维也纳的一家独立的普通儿科门诊进行。纳入了无髋关节畸形的第 1 周和第 6-8 周龄健康婴儿。随机分组后,Graf 固定装置用于检查第 1 组,而第 2 组由父母将婴儿固定在检查台上。然后,所有图像均进行盲法评估。
共检查了 117 名婴儿(第 1 组:n = 62,第 2 组:n = 54,排除:n = 1),共评估了 230 张图像(第 1 组:n = 122,第 2 组:n = 108),其中 225 张图像正常。排除了 2 张图像,分别显示右侧髋关节为 IIa 型和左侧髋关节为 IIa+型。由于相应的图像显示两个病理性髋关节,1 名参与者被排除。第 1 组中有 2 张图像和第 2 组中有 3 张图像无法评估。未发现图像质量(11 个质量标准和整体可评估性)与固定技术(0.12≤p≤1.0 或恒定)之间存在统计学关联。
考虑到正常的髋关节,我们没有发现手动固定在图像质量方面与 Graf 技术有差异的证据。在未来的研究中,应包括髋关节疾病,并应解决婴儿和父母在检查过程中的不适。
德国临床试验注册处,编号:DRKS00015694),于 2018 年 10 月 7 日回顾性注册。