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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Replacement; Hip Arthropathy
• Intervention / Treatment: Device: hip arthroplasty

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 Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: Chieh-Szu Yang; Phone Number: 112 (02) 2875-7557; Email: jeffyang80@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects receiving hip arthroplasty in Taipei Veterans General Hospital meet the inclusion criteria can be considered to recruit

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Visual Analogue Scale (VAS) is a patient-reported outcome measure. Scale from 0 to 10 stands for no pain to extreme pain.	Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
Harris Hip Score	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.	Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
Oxford Hip Score	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.	Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
Forgotten Joint Score (FJS-12)	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.	Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
Radiographic analysis	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.	Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Chieh-Szu Yang, Department of orthopedics, Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2021-05-017BC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No