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The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement

2011年4月27日 更新者:Hadassah Medical Organization

Goal of the research

  1. To check the viability of "Operating Table Position Simulating Radiographs", while positioned on the contralateral side.
  2. To determine whether knowledge about the angles displayed on this radiograph (pelvic tilt) influences the accurate positioning of the acetabular cup during the Total Hip Replacement procedure.

研究概览

地位

完全的

干预/治疗

详细说明

Type of research:

A prospective study.

Population:

A power study has been calculated in order to define the sample size. The results indicated that the following sample size will suffice:

  • Study group: 50 consecutive patients undergoing a primary total hip replacement procedure
  • Control group: 50 consecutive patients undergoing a primary total hip replacement procedure

Inclusion criteria:

  1. Age>18
  2. Candidate for primary total hip replacement
  3. Agrees to participate in the study

Exclusion criteria:

1. Patient doesn't agree to participate in the study

Protocol:

Patients included in the research group and in the control group will undergo an "Operating Table Position Simulating " radiograph of the pelvis. The radiograph will be done in the following manner: the patient will be potisioned on the non-operated side in such way that his pelvis is perpendicular to the table. The legs are flexed in 30 degrees at the hip joints and 30 degrees at the knees. The plate with a grid will be placed behind the pelvis in a device with notches (which can be used to measure the angles later). After the total hip replacement the patients will undergo an A-P radiograph of the hip joints while lying on the back with the hip joints bent to 30 degrees to overcome the forward tilt of the pelvis. All of the radiographs will be performed in the presence of an orthopedic surgeon.

The control group will be the first group of patients. Their radiographs will be stored in a standalone file with controlled access rather than the general PACS system. The file will be opened only when the study is over. The radiologist will control the file and be responsible for this stage.

The study group will be the next group of patients. In this group the radiographs will be saved in the general PACS system. The radiographs with measurement of the lateral inclination of the pelvis, while lying in an "Operating Table Position" will be shown to the chief surgeon on the day of surgery or one day prior to it.

Both chief surgeons will not know about the study until the end of it. At the end of the study, a comparison of both groups' acetabular cup angles will be done. The angles will be measured twice. The first measurement will be done by a senior orthopedic surgeon specializing in joint replacement operations. The second one will be done by a senior radiologist specialized in skeletal radiology. If a difference of 5 degrees or more is found between the two measurements, a third measurement will be done by a third examiner.

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Jerusalem、以色列
        • Hadassah Medical Organization

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age>18
  2. Candidate for primary total hip replacement
  3. Agrees to participate in the study

Exclusion Criteria:

  1. Patient doesn't agree to participate in the study
  2. Dysplastic hip, Crowe>1
  3. After previous hip surgery

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:Surgeon doesn't see
The surgeon doesn't see the radiograph prior to surgery
实验性的:Surgeon does see
The surgeon can see the radiograph prior to surgery
One radiograph with the patient lying on his contralateral side

研究衡量的是什么?

主要结果指标

结果测量
大体时间
acetabular cup angle
大体时间:3 days
3 days

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

2009年1月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2008年11月9日

首先提交符合 QC 标准的

2008年11月10日

首次发布 (估计)

2008年11月11日

研究记录更新

最后更新发布 (估计)

2011年4月28日

上次提交的符合 QC 标准的更新

2011年4月27日

最后验证

2008年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • cupangle-HMO-CTIL

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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