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Clinical Trials/NCT04886570
NCT04886570
Unknown
N/A

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

Taipei Veterans General Hospital, Taiwan0 sites260 target enrollmentJune 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Arthropathy
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
260
Primary Endpoint
Visual Analogue Scale
Last Updated
4 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
May 31, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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.

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