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

May 12, 2021 updated by: Taipei Veterans General Hospital, Taiwan
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
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.
Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
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.
Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
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.
Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
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.
Pre-operation, 6 weeks, 12 weeks and 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chieh-Szu Yang, Department of orthopedics, Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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