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临床试验/NCT04256291
NCT04256291Unknown不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Visual Analogue Scale- Change from baseline at 1 year

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Visual Analogue Scale- Change from baseline at 1 year

时间窗: 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.

Harris Hip Score- Change from baseline at 1 year

时间窗: 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.

Oxford Hip Score- Change from baseline at 1 year

时间窗: 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.

Radiologic analysis- Change from baseline at 1 year

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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