Arthroplasty ComplicationsNCT05211310
Validity and Reliability of High-Activity Arthroplasty Score
An observational study of Arthroplasty Complications, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- High-Activity Arthroplasty Score (HAAS), Western Ontario and McMaster Universities osteoarthritis score (WOMAC) and The Knee injury and Osteoarthritis Outcome Score (KOOS)
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have undergone primary total knee arthroplasty surgery at least 6 months ago in the Orthopedics and Traumatology Outpatient Clinic will be included. Participants will be contacted via telephone.
Who may be able to join
- To have undergone primary total knee arthroplasty for osteoarthritis at least 6 months ago,
- To be between the ages of 18-65.
Who cannot join
- Having orthopedic, neurological, cardiovascular, or cognitive problems that may affect physical performance,
- Presence of previous lower extremity surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Afyonkarahisar Health Science University
Afyonkarahisar, 03030
EMEL TAŞVURAN HORATA, 05547759663, ethorata@gmail.com
- Recruiting
Emel Taşvuran Horata
Afyonkarahisar, 03030
EMEL TAŞVURAN HORATA, PhD, 05547759663, ethorata@gmail.com
Emel TAŞVURAN HORATA
About this study
Official title: Turkish Validity and Reliability of High Activity Arthroplasty Score After Total Knee Arthroplasty
Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score (HAAS) into Turkish and to conduct a validity and reliability study of the Turkish version.
Read the detailed description
Studies show that TKA practice has increased in the young population in recent years. Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score into Turkish and to conduct a validity and reliability study of the Turkish version. The adaptation of the questionnaire to Turkish in the study will be made according to the COSMIN and Reliability and Agreement Studies Reporting Guide. The construct validity, concurrent validity, reliability, and floor and ceiling effects of the questionnaire will be evaluated.
- Conditions
- Arthroplasty Complications
- Being tested
- High-Activity Arthroplasty Score (HAAS), Western Ontario and McMaster Universities osteoarthritis score (WOMAC), The Knee injury and Osteoarthritis Outcome Score (KOOS), The Forgotten Joint Score-12 (FJS-12), EQ-5D-5L
- Keywords
- Knee Arthroplasty, Total, Validation Study, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Activity Arthroplasty Score (HAAS)Other
The questionnaire developed by Talbot et al. in 2010 consists of 4 sub-dimensions. 0-18 points can be obtained from the survey. High scores are associated with higher functional ability.
Western Ontario and McMaster Universities osteoarthritis score (WOMAC)Other
It is used to evaluate disability in patients with hip and knee osteoarthritis. Each sub-dimension is standardized within the range of 0-100 points, with high scores indicating poor health.
The Knee injury and Osteoarthritis Outcome Score (KOOS)Other
It is calculated between 0 and 100 points. 0 points indicate severe knee problem, 100 points no knee problem
The Forgotten Joint Score-12 (FJS-12)Other
It evaluates how much an individual can forget an artificial joint during activities of daily living. A total of 100 points can be obtained. A high score is associated with the ability to forget.
EQ-5D-5LOther
It is a questionnaire evaluating the quality of life. The higher the total score, the higher the quality of life.
Numerical pain scale (NPS)Other
It is the numerical expression of perceived pain intensity. It is rated from 0-10 points. 10 points indicate the highest pain intensity, 0 points the absence of pain.
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Activity Arthroplasty Score (HAAS)
It consists of 4 sub-dimensions (walking, running, climbing stairs and activity level). 0 (min. score) -18 points (max. score) can be obtained from the survey. Higher score is associated with more functional ability
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 May 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, PhD, Principal investigator, AFSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211310
- Sponsor's protocol ID
- 2022/2
- Status last verified
- Dec 2023
- First submitted
- 23 Jan 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of High Activity Arthroplasty Score After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05211310
- Acronym / sponsor ID
- 2022/2
- Conditions
- Arthroplasty Complications
- Keywords
- Knee Arthroplasty, Total, Validation Study, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jan 2022 (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.
Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score (HAAS) into Turkish and to conduct a validity and reliability study of the Turkish version.
Detailed description
Studies show that TKA practice has increased in the young population in recent years. Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score into Turkish and to conduct a validity and reliability study of the Turkish version. The adaptation of the questionnaire to Turkish in the study will be made according to the COSMIN and Reliability and Agreement Studies Reporting Guide. The construct validity, concurrent validity, reliability, and floor and ceiling effects of the questionnaire will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have undergone primary total knee arthroplasty surgery at least 6 months ago in the Orthopedics and Traumatology Outpatient Clinic will be included. Participants will be contacted via telephone.
Key inclusion criteria (2 listed)
- To have undergone primary total knee arthroplasty for osteoarthritis at least 6 months ago,
- To be between the ages of 18-65.
Key exclusion criteria (2 listed)
- Having orthopedic, neurological, cardiovascular, or cognitive problems that may affect physical performance,
- Presence of previous lower extremity surgery
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 |
|---|---|---|
| High-Activity Arthroplasty Score (HAAS)The questionnaire developed by Talbot et al. in 2010 consists of 4 sub-dimensions. 0-18 points can be obtained from the survey. High scores are associated with higher functional ability. | Other | – |
| Western Ontario and McMaster Universities osteoarthritis score (WOMAC)It is used to evaluate disability in patients with hip and knee osteoarthritis. Each sub-dimension is standardized within the range of 0-100 points, with high scores indicating poor health. | Other | – |
| The Knee injury and Osteoarthritis Outcome Score (KOOS)It is calculated between 0 and 100 points. 0 points indicate severe knee problem, 100 points no knee problem | Other | – |
| The Forgotten Joint Score-12 (FJS-12)It evaluates how much an individual can forget an artificial joint during activities of daily living. A total of 100 points can be obtained. A high score is associated with the ability to forget. | Other | – |
| EQ-5D-5LIt is a questionnaire evaluating the quality of life. The higher the total score, the higher the quality of life. | Other | – |
| Numerical pain scale (NPS)It is the numerical expression of perceived pain intensity. It is rated from 0-10 points. 10 points indicate the highest pain intensity, 0 points the absence of pain. | Other | – |
Primary outcome
High-Activity Arthroplasty Score (HAAS)
Time frame: 10 minutes
It consists of 4 sub-dimensions (walking, running, climbing stairs and activity level). 0 (min. score) -18 points (max. score) can be obtained from the survey. Higher score is associated with more functional ability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Arthroplasty Complications
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis
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Posterior Pericapsular Deep-gluteal Block
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Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication
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.
EMEL TAŞVURAN HORATA, PhD principal investigator
AFSU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
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 2 inclusion and 2 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 EMEL TAŞVURAN HORATA, PhD (+905547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Activity Arthroplasty Score (HAAS) (time frame: 10 minutes). 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 27 Dec 2023.