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

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04886570
• Other study ID #: 2021-05-017BC
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chieh-Szu Yang
• Phone: (02) 2875-7557
• Email: jeffyang80[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Hip Replacement
• Joint Diseases

Intervention

Device:
• hip arthroplasty
Hip arthroplasty is a kind of joint reconstruction surgery, which has been successfully utilized for treatment of osteoarthritis or hip fracture for decades. In this surgery, implants is applied to reconstruct hip joint, and usually comprised of four components, including femoral stem, femoral head, acetabular cup and liner.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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