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Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results

2014年2月22日 更新者:David Eliya Rothem、Ziv Hospital

Total knee replacement is one of the most commonly performed orthopedic procedures. As of 2010, about 600,000 total knee replacements were being performed annually in the United States and these numbers are rising. The normal knee joint functions as a complex hinge allowing primarily flexion and extension, rotation and gliding. The knee joint is made up of three compartments, the lateral, medial and anterior (patellofemoral). Damage to the cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or post-traumatic), inflammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis, tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties.

A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. Incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems.

The common techniques for Total knee replacement are:

  1. Conventional method TKR
  2. CT/MRI-based preoperative navigated TKR
  3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment.

We aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively.

Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

70

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

      • Safed、以色列
        • ZIV Medical Center

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 至 90年 (成人、年长者)

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

patients undergoing navigated total knee replacement

描述

Inclusion Criteria:

  • age over 18
  • severe osteoarthrosis of the knee
  • failure of conservative treatment.

Exclusion Criteria:

  • patients with severe vascular disease
  • secondary knee deformation due to muscular atrophy or disease
  • active infection
  • morbid obesity
  • neuropathic knee and osteomyelitis.

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
Navigation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
limb axis measurement
大体时间:An average, 1 week preoperatively up to 3 days postoperatively.

surview CT images pre-( 1 week before the operation) and post-operatively(the day of operation) will be analyzed using the Traumacad software for limb axis.

The navigation system results pre- and post-operatively will be given by the computer as an output at the Operation Theater.

The results will be recorded for Varus/Valgus and degrees of deformity.

An average, 1 week preoperatively up to 3 days postoperatively.

次要结果测量

结果测量
措施说明
大体时间
Clinical outcome and function
大体时间:up to 6 months postoperatively
the clinical evaluation of the patient will be based on the knee society scoring system: Range of movement(degrees), pain level(1-lowest,10-highest), anterior-posterior stability(mm), mediolateral stability(degrees), function test based on walking,climbing stairs, use of walking aids. The results will be summed up and give a numerical score.
up to 6 months postoperatively

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。

赞助

调查人员

  • 首席研究员:David E Rothem, MD、Head of joint repalcement unit, Orthopedic department, Ziv medical center, Safed, Israel

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2013年7月1日

初级完成 (实际的)

2014年1月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2014年2月18日

首先提交符合 QC 标准的

2014年2月22日

首次发布 (估计)

2014年2月26日

研究记录更新

最后更新发布 (估计)

2014年2月26日

上次提交的符合 QC 标准的更新

2014年2月22日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • ZIV-0041-13

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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