Hip ArthropathyNCT04886570
Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study
An observational study of Hip Arthropathy and Hip Replacement, run by Taipei Veterans General Hospital, Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hip Arthropathy, Hip Replacement
- What is being tested?
- hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: Subjects receiving hip arthroplasty in Taipei Veterans General Hospital meet the inclusion criteria can be considered to recruit
Who may be able to join
- 20 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
Who cannot join
- Being unable or unwilling to participate in
- Subjects having cognitive impairment cannot fill out survey
- Other complication causing severe deficiency in function and motion
Trial locations and contacts
No sites are listed yet.
About this 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).
Read the 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.
- Conditions
- Hip Arthropathy, Hip Replacement
- Being tested
- hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroplastyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chieh-Szu Yang, Principal investigator, Department of orthopedics, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886570
- Sponsor's protocol ID
- 2021-05-017BC
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study
- ClinicalTrials.gov ID
- NCT04886570
- Acronym / sponsor ID
- 2021-05-017BC
- Conditions
- Hip Arthropathy, Hip Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects receiving hip arthroplasty in Taipei Veterans General Hospital meet the inclusion criteria can be considered to recruit
Key inclusion criteria (7 listed)
- 20 years old at least.
- Osteoarthritis (OA)
- Avascular necrosis
- Rheumatoid arthritis (RA)
- Previous failure of hemiarthroplasty
Key exclusion criteria (3 listed)
- Being unable or unwilling to participate in
- Subjects having cognitive impairment cannot fill out survey
- Other complication causing severe deficiency in function and motion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hip arthroplastyHip 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. | Device | – |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chieh-Szu Yang principal investigator
Department of orthopedics, Taipei Veterans General Hospital, Taipei, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy and Hip Replacement, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chieh-Szu Yang ((02) 2875-7557 ext. 112, jeffyang80@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.