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临床试验/NCT04886570
NCT04886570Unknown不适用

Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study

Taipei Veterans General Hospital, Taiwan0 个研究点目标入组 260 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
主要终点
Visual Analogue Scale

研究概览

简要总结

This longitudinal follow-up study aims to analyze how surgical and patient characteristics affect clinical outcomes in the subjects received total hip arthroplasty (THA) or hemiarthroplasty (HA).

详细描述

Clinical assessments in this research include visual analogue scale (VAS), Harris Hip Score (HHS), Oxford Hip Score (OHS), forgotten joint score (FJS-12) and X-ray imaging applied to examine the stability of implants. Through analyzing surgical information, functional measures and self-reported questionnaires, this study intends to gain insights into the correlations between various clinical aspects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • 20 years old at least.
  • Osteoarthritis (OA)
  • Avascular necrosis
  • Rheumatoid arthritis (RA)
  • Previous failure of hemiarthroplasty
  • Femoral head or neck or trochanteric fractures
  • Developmental dysplasia of the hip

排除标准

  • Being unable or unwilling to participate in
  • Subjects having cognitive impairment cannot fill out survey
  • Other complication causing severe deficiency in function and motion

结局指标

主要结局

Visual Analogue Scale

时间窗: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

Visual Analogue Scale (VAS) is a patient-reported outcome measure. Scale from 0 to 10 stands for no pain to extreme pain.

Harris Hip Score

时间窗: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

Harris Hip Score (HHS) assesses the results of hip replacement. the domains cover pain, function, absence of deformity and range of motion. The maximum score of HHS is 100, and the higher score participants get, the less dysfunction they have.

Oxford Hip Score

时间窗: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

Oxford Hip Score (OHS) 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.

Forgotten Joint Score (FJS-12)

时间窗: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

Forgotten Joint Score (FJS-12) is a patient-reported questionnaire with 12 questions, assessing the ability of the patient to forget the affected joints during daily activities. The higher the scores, the better the outcome.

Radiographic analysis

时间窗: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

X-ray imaging will be applied to examine the stability of implants, such as radiolucent line and loosening. The width of radiolucent line around implant suggest the possibility of implant loosening; generally, the wider the width is, the higher risk of loosening.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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