ArthropathyNCT05217264
Adaptation of High Activity Arthroplasty Score to Turkish
An observational study of Arthropathy and Surgery--Complications, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The objectives of this study were the translation, cross-cultural adaptation, and assessment of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in patients with primary TKA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthropathy, Surgery--Complications, Physical Disability
- What is being tested?
- Assesment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2022to 20 Jun 2022
- 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: The patients with a total or unicompartmental knee prosthesis.
Who may be able to join
- Primary THA/TKA due to primary osteoarthritis for >6 months,
- Age <65
- To be able to communicate in Turkish
- Agree to participate in the study
Who cannot join
- 1. who do not agree to participate in the study 2- who will undergo 2nd revision TKA 3- who have undergone lower extremity surgery and thus have sequelae 4-having cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the High Activity Arthroplasty Score
The objectives of this study were the translation, cross-cultural adaptation, and assessment of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in patients with primary TKA.
Read the detailed description
The purpose of this study is to translate and cross-culturally adapt the HAAS instrument into Turkish and investigate its psychometric properties. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of HAAS to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlations with the Turkish version of the KOOS, SF-36 and FJS-12 will determine to check the validity.
- Conditions
- Arthropathy, Surgery--Complications, Physical Disability
- Being tested
- Assesment
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssesmentOther
This is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Activity Arthroplasty Score
The HAAS questionnaire, developed in 2010, is self-reported and comprises the four items walking, running, stair climbing, and the activity level [20]. The response level for each item ranges from normal function to serious limitation. The patient selects the highest possible level of his functional ability for each item. A point system for each item is applied whereby a higher score indicates a higher functional ability. The total score ranges from 0 to 18 points. The original version provides no instruction regarding missing answers.
Measured: Baseline,
Secondary outcomes (4)
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of a knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used, and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Measured: Baseline
SF-36
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It comprises 36 questions which cover eight domains of health:
- Limitations in physical activities because of health problems.
- Limitations in social activities because of physical or emotional problems
- Limitations in usual role activities because of physical health problems
- Bodily pain
- General mental health (psychological distress and well-being)
- Limitations in usual role activities because of emotional problems
- Vitality (energy and fatigue)
- General health perceptions
Measured: Baseline
Forgotten Joint Score
The FJS-12 was developed to identify the awareness of an artificial joint (hip or knee) during activities of daily living. It uses a 5-point Likert response format (0, never; 1, almost; 2, seldom; 3, sometimes; and 4, mostly) consisting of 12 items that assess "the patient's ability to forget the artificial joint in everyday life" following activities of daily living -in bed at night; sitting in a chair (>1hr); walking (>15 min); taking bath; traveling in a car; climbing stairs; walking on uneven ground; standing up from a low sitting position; standing for long periods; doing housework or gardening; taking a walk or hiking, and involving in a sports activity. The raw scores are transformed to range from 0 to 100 points. High scores indicate a good outcome, which means a high degree of "forgetting" the joint.
Measured: Baseline
High-Activity Arthroplasty Score
The HAAS questionnaire, developed in 2010, is self-reported and comprises the four items walking, running, stair climbing, and the activity level [20]. The response level for each item ranges from normal function to serious limitation. The patient selects the highest possible level of his functional ability for each item. A point system for each item is applied whereby a higher score indicates a higher functional ability. The total score ranges from 0 to 18 points. The original version provides no instruction regarding missing answers.
Measured: Within a 3-to-5-day period after the first assessment (Second assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start3 Feb 2022
- Primary completion1 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthropathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynal Yasacı, Harran University
- Investigators
- Zeynal YASACI, MSc, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217264
- Sponsor's protocol ID
- Observational
- Status last verified
- Jul 2022
- First submitted
- 18 Jan 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yasaci Z, Altay MA, Satis S, Tiras HM. Psychometric properties of the Turkish high-activity arthroplasty score in TKA patients. BMC Musculoskelet Disord. 2026 Mar 6;27(1):310. doi: 10.1186/s12891-026-09561-y.
PubMed 41787380
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the High Activity Arthroplasty Score
- ClinicalTrials.gov ID
- NCT05217264
- Acronym / sponsor ID
- Observational
- Conditions
- Arthropathy, Surgery--Complications, Physical Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 1 Feb 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.
The objectives of this study were the translation, cross-cultural adaptation, and assessment of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in patients with primary TKA.
Detailed description
The purpose of this study is to translate and cross-culturally adapt the HAAS instrument into Turkish and investigate its psychometric properties. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of HAAS to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlations with the Turkish version of the KOOS, SF-36 and FJS-12 will determine to check the validity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with a total or unicompartmental knee prosthesis.
Key inclusion criteria (4 listed)
- Primary THA/TKA due to primary osteoarthritis for >6 months,
- Age <65
- To be able to communicate in Turkish
- Agree to participate in the study
Key exclusion criteria (1 listed)
- 1. who do not agree to participate in the study 2- who will undergo 2nd revision TKA 3- who have undergone lower extremity surgery and thus have sequelae 4-having cognitive impairment
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 |
|---|---|---|
| AssesmentThis is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist. | Other | – |
Primary outcome
High-Activity Arthroplasty Score
Time frame: Baseline,
The HAAS questionnaire, developed in 2010, is self-reported and comprises the four items walking, running, stair climbing, and the activity level [20]. The response level for each item ranges from normal function to serious limitation. The patient selects the highest possible level of his functional ability for each item. A point system for each item is applied whereby a higher score indicates a higher functional ability. The total score ranges from 0 to 18 points. The original version provides no instruction regarding missing answers.
4 secondary outcomes
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
SF-36
Time frame: Baseline
Forgotten Joint Score
Time frame: Baseline
High-Activity Arthroplasty Score
Time frame: Within a 3-to-5-day period after the first assessment (Second assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 41787380Yasaci Z, Altay MA, Satis S, Tiras HM. Psychometric properties of the Turkish high-activity arthroplasty score in TKA patients. BMC Musculoskelet Disord. 2026 Mar 6;27(1):310. doi: 10.1186/s12891-026-09561-y.
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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.
Zeynal YASACI, MSc principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy and Surgery--Complications, run by Harran University at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Activity Arthroplasty Score (time frame: Baseline,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217264, which also lists 1 linked publication.
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 Jul 2022.