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Total Hip Replacement With Ceramic on Ceramic Bearing- Clinical Follow-up Study

2020年2月3日更新者：National Taiwan University Hospital

The pain and severe wear of hip joints caused by osteoarthritis, rheumatoid arthritis, avascular necrosis and trauma can be subjected to total hip replacement (THR). A hip implant consists of 4 components: acetabular cup, femoral stem, articular liner and femoral head. As an ideal material for THR, ceramic possesses excellent biocompatibility and stability in the human bodies. Moreover, ceramic-on-ceramic interface is highly wear-resistant, preventing generation of wear particles. With the development of latest fourth-generation ceramic Delta, larger femoral heads can be manufactured to conform to the size of native femoral heads. The rate of some of the complications after THR, such as dislocation, can be significantly reduced. The purpose of the present study is to carry out a clinical follow up for each patient who has received the ceramic-on-ceramic THR in order to understand the clinical outcome. Furthermore, the possible complications, such as dislocation and squeaking, can be determined.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

160

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

台湾
- - Douliu、台湾
    - 招聘中
    - Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch
    - 接触：
      
      Yang-Chen Chou
      
      电话号码：5886 886-5-5323911
      
      邮箱：ycchou00058@gmail.com

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

20年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013 at National Taiwan University Hospital Yunlin Branch.

描述

Inclusion criteria:

Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013.

Exclusion criteria:

Patients who are unable or unwilling to return for follow-up
Patients who have deep periprosthetic joint infection
Patients who are diagnosed skeletal dysplasia
Patients who suffer from mental disorders

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

观测模型：队列
时间观点：预期

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
Visual Analogue Scale- Change from baseline at 1 year 大体时间：Change from baseline at 1 year	Visual Analogue Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain.	Change from baseline at 1 year
Harris Hip Score- Change from baseline at 1 year 大体时间：Change from baseline at 1 year	Harris Hip Score includes 4 sections that evaluate pain, function, deformity, and range of motion. Total scores is from 0 to 100, higher scores represent a better outcome.	Change from baseline at 1 year
Oxford Hip Score- Change from baseline at 1 year 大体时间：Change from baseline at 1 year	Oxford Hip Score is a patient-reported outcome measure with 12 questions related to the condition of function and pain. Total scores is from 0 to 48, higher scores represent a better outcome.	Change from baseline at 1 year
Radiologic analysis- Change from baseline at 1 year 大体时间：Change from baseline at 1 year	Radiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs.	Change from baseline at 1 year

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

National Taiwan University Hospital

调查人员

学习椅：Yang-Chen Chou、National Taiwan University Hospital Yunlin Branch
研究主任：Chen-Chiang Lin、National Taiwan University Hospital Yunlin Branch

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 (实际的)

2018年8月1日

初级完成 (预期的)

2021年7月31日

研究完成 (预期的)

2021年7月31日

研究注册日期

首次提交

2020年1月30日

首先提交符合 QC 标准的

2020年2月3日

首次发布 (实际的)

2020年2月5日

研究记录更新

最后更新发布 (实际的)