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Assessment of Digital Radiograph Measurements of Hip,Spine and Lower Limbs

2008年10月29日 更新者:Tel-Aviv Sourasky Medical Center

Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population: Using PACS Integrated Computer Software (TraumaCad From OrthoCrat)

Research Protocol Assessment of Hip, Spine and Lower Limbs Digital Radiograph Measurements in Pediatric Population: using PACS integrated Computer Software (TraumaCad from OrthoCrat ™).

Introduction The integration of the PACS system into many medical institutions created a plethora of digital measurements to assess anatomic and deformity parameters for torso and limbs.

A number of commercial digital software is being offered to supply the medical practioner with tools to assess normal and pathological bony architecture land marks.

The relevant architecture of the pelvis (hip joint), spine and the length and alignment of lower limbs may be measured using these digital software's.

The validity and accuracy of digital work in comparison to conventional radiographs has been studied recently, mainly with lower extremity axial alignment, the digital length and anatomical angles measurements were found to be more reliable in terms of intra observer reliability than conventional radiographs (1, 2).

Study purposes

  1. To compare the, accuracy and reliability of specifically designed digital software (TraumaCad from OrthoCrat ™) measurements using wizard guidance, to those produced by using the tool bar (ruler and angle guide tools) of the DICOM folder.
  2. To assess intra and inter observer reliability of the TraumaCad software for different pediatric orthopaedics conditions.

    Methods *Twenty hip joins radiographs (AP views) of patients who suffer from Cerebral Palsy (10) and Developmental Dysplasia of the Hip (10) will be measured using the TraumaCad software hip joint wizard, and than again using basic tools of the DICOM folder.

    **Twenty spinal scoliosis radiographs (AP and Lat views) will be measured using the TraumaCad software templates.

    ***Ten digital radiographs of long leg standing (AP views) from normal and from patients with deformities will ne analyzed for length and angular differences using the LLD wizard.

    The following parameters will be measured *Hip joint radiographs: Acetabular Angle, Central Edge Angle, and Reimer's Index **Spinal radiographs: Cobe Angle (AP views), Coronal Balance, Sagital Balance. ***Long standing views: length of Femur and Tibia, mLDFA, mMPTA, mLDTA, JLCA, (the "Baltimore numbers").

    All measurements will be taken by 4 senior orthopaedic surgeons after consensus conference for the technique.

    Intra observer reliability will be tested by repeating the same set of measurements on 2 different dates, after all radiographs are randomly mixed and done at least 2 days apart. High resolution single computer will be used for all measurements by all participating surgeons.

    The intra and inter observer reliability for the hip joint measurements will be calculate to compared between TraumaCad software wizard and the DICOM measurements tools.

    All measurements using TraumaCad software will be analyzed for intra and inter observer reliability using accepted statistical tools.

    The study will be supervised by the department of statistics of TAU for maximum statistical significance.

1) Sailer J, Scharitzer M, Peloschek P, Giurea A, Imhof H, Grampp S.

Quantification of axial alignment of the lower extremity on conventional and digital total leg radiographs.

Eur Radiol. 2005 Jan; 15(1):170-3. Epub 2004 Aug 5.

2) Hankemeier S, Gosling T, Richter M, Hufner T, Hochhausen C, Krettek C.

Computer-assisted analysis of lower limb geometry: higher intraobserver reliability compared to conventional method.

Comput Aided Surg. 2006 Mar; 11(2):81-6

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

50

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2个月 至 30年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Digital X-rays from PACS system

描述

Inclusion Criteria:

  • hip, long leg & spine digital X-rays

Exclusion Criteria:

  • inadequate X-rays

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
1
Hip X-rays DDH
2
Hip X-rays, CP
3
Long standing lower Limb X-rays
4
Scoliosis, AP X-rays
5
Scoliosis Lateral X-rays

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年7月1日

初级完成 (预期的)

2008年12月1日

研究注册日期

首次提交

2008年10月29日

首先提交符合 QC 标准的

2008年10月29日

首次发布 (估计)

2008年10月31日

研究记录更新

最后更新发布 (估计)

2008年10月31日

上次提交的符合 QC 标准的更新

2008年10月29日

最后验证

2008年10月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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