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

NCT04886570 | Unknown

• 1 other identifier: 2021-05-017BC
• Study Type: observational
• Target: 260
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hip Arthropathy; Hip Replacement

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

hip arthroplasty DEVICE

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Chieh-Szu Yang

  Department of orthopedics, Taipei Veterans General Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh-Szu Yang

CONTACT

(02) 2875-7557; jeffyang80@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 14, 2021

Record last verified: 2021-05