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

• Conditions: Hip Arthropathy; Hip Replacement

• Registration Number: NCT04886570
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-14
• Last Update Posted: 2021-05-14
• Study Start: 2021-06-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. 20 years old at least.
2. Osteoarthritis (OA)
3. Avascular necrosis
4. Rheumatoid arthritis (RA)
5. Previous failure of hemiarthroplasty
6. Femoral head or neck or trochanteric fractures
7. Developmental dysplasia of the hip

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	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	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	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)	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	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.