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Hip OsteoarthritisNCT07770971

Turkish Validation of the HOOS-12

An observational study of Hip Osteoarthritis, run by Hacettepe University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) is a short patient-reported outcome measure developed to assess pain, function, and hip-related quality of life in individuals with hip osteoarthritis. Although widely used internationally, a validated Turkish version is currently unavailable. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Osteoarthritis
What is being tested?
Patient-Reported Outcome Assessment
How many people
150 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 1 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Adult, Older adult

Study population: The study population will consist of Turkish-speaking adults diagnosed with primary hip osteoarthritis who are scheduled to undergo primary total hip arthroplasty at the Department of Orthopedics and Traumatology. Eligible participants will be recruited consecutively during routine preoperative outpatient visits. Participants will complete the Turkish version of the Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) and the Short Form-12 Health Survey (SF-12) before surgery. A subgroup of clinically stable participants will complete the HOOS-12 again seven days after the initial assessment to evaluate test-retest reliability. All participants will be reassessed three months after surgery to evaluate the responsiveness of the Turkish HOOS-12.

Who may be able to join

  • Age 18 years or older.
  • Native Turkish speaker or able to read and understand Turkish fluently.
  • Diagnosed with primary hip osteoarthritis based on clinical and radiographic evaluation.
  • Scheduled to undergo primary total hip arthroplasty.
  • Able to complete the study questionnaires independently or with standardized assistance.
  • Clinically stable during the test-retest period.
  • Willing to participate in the study and provide written informed consent.

Who cannot join

  • Previous total hip arthroplasty on the affected side.
  • Scheduled for revision hip arthroplasty.
  • Hip arthroplasty indicated for conditions other than primary hip osteoarthritis, including hip fracture, inflammatory arthritis, avascular necrosis, congenital hip disorders, or malignancy.
  • History of major lower-extremity surgery within the previous six months.
  • Neurological or neuromuscular disorders that may substantially affect mobility or lower-extremity function.
  • Severe cognitive impairment, psychiatric disorder, or communication difficulty that prevents reliable questionnaire completion.
Show all 10Show fewer
  • Severe visual or hearing impairment that prevents completion of the assessment procedures.
  • Presence of another acute musculoskeletal condition that substantially affects pain or physical function.
  • Any therapeutic intervention, significant change in medication, acute clinical deterioration, or surgery occurring between the baseline and test-retest assessments.
  • Incomplete questionnaire data or inability to complete the planned follow-up assessments.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nazli Cigercioglu Assoc. Prof. contact

+90 541 290 32 93

nazlicigercioglu@gmail.com

About this study

Official title: Turkish Cross-cultural Adaptation, Validity, Reliability, and Responsiveness of the Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) in Patients With Hip Osteoarthritis

The Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) is a short patient-reported outcome measure developed to assess pain, function, and hip-related quality of life in individuals with hip osteoarthritis. Although widely used internationally, a validated Turkish version is currently unavailable. This study aims to translate and culturally adapt the HOOS-12 into Turkish and evaluate its psychometric properties, including internal consistency, test-retest reliability, construct validity, structural validity, responsiveness, and measurement error, in Turkish-speaking patients with hip osteoarthritis.

Read the detailed description

## Detailed Description

Hip osteoarthritis (HOA) is one of the leading causes of pain, disability, and reduced health-related quality of life among older adults worldwide. Patient-reported outcome measures (PROMs) are essential for evaluating symptoms, functional limitations, treatment effectiveness, and patient-centered outcomes in both clinical practice and research. The Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) is a concise, multidimensional PROM developed to assess pain, physical function, and hip-related quality of life while substantially reducing respondent burden compared with the original HOOS questionnaire.

Although the HOOS-12 has been validated in several languages and populations, no culturally adapted and psychometrically validated Turkish version is currently available. The absence of a validated Turkish HOOS-12 limits its use in clinical practice, multicenter studies, and international research involving Turkish-speaking patients with hip osteoarthritis. Therefore, a rigorous cross-cultural adaptation and psychometric evaluation is required before the instrument can be recommended for clinical and research applications in Türkiye.

The primary objective of this study is to translate and culturally adapt the HOOS-12 into Turkish and to evaluate its psychometric properties in patients with hip osteoarthritis who are scheduled to undergo primary total hip arthroplasty. The translation and cross-cultural adaptation process will be conducted in accordance with internationally accepted guidelines for patient-reported outcome measures, including forward translation, synthesis, backward translation, expert committee review, and pilot testing to ensure semantic, idiomatic, experiential, and conceptual equivalence between the original and Turkish versions.

Following the adaptation process, the psychometric performance of the Turkish HOOS-12 will be evaluated according to the COSMIN recommendations. Internal consistency will be assessed using Cronbach's alpha, while test-retest reliability will be examined using the intraclass correlation coefficient (ICC) in clinically stable participants who complete the questionnaire twice before surgery without any therapeutic intervention between assessments. Measurement error will be determined by calculating the standard error of measurement (SEM) and the minimal detectable change (MDC). Structural validity will be evaluated using confirmatory factor analysis (CFA). Construct validity will be examined by testing predefined hypotheses regarding the relationships between the Turkish HOOS-12 and the Short Form-12 Health Survey (SF-12). Floor and ceiling effects will also be investigated.

To determine responsiveness, participants will complete the Turkish HOOS-12 and SF-12 before surgery and again three months after primary total hip arthroplasty. Changes in questionnaire scores over time will be analyzed to evaluate the instrument's ability to detect clinically meaningful improvement following surgical treatment.

The results of this study are expected to provide a reliable, valid, and responsive Turkish version of the HOOS-12 for evaluating patient-reported outcomes in individuals with hip osteoarthritis. The availability of this instrument will facilitate standardized outcome assessment in routine clinical practice, clinical trials, and multicenter research involving Turkish-speaking populations.

Being tested
Patient-Reported Outcome Assessment
Keywords
Hip Osteoarthritis, validity, Turkish, Reliability
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-Reported Outcome AssessmentOther

    Participants will complete the Turkish version of the Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) and the Short Form-12 Health Survey (SF-12) at predefined assessment time points. No therapeutic intervention will be assigned or administered as part of this observational study. Primary total hip arthroplasty will be performed as part of routine clinical care and will not be assigned by the investigators.

Study groups in NCT07770971
Study groupRoleWhat they receive
Patients with Hip OsteoarthritisAdults with clinically and/or radiographically diagnosed hip osteoarthritis who are scheduled to undergo primary total hip arthroplasty. Participants will complete the Turkish version of the Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) and the Short Form-12 Health Survey (SF-12) before surgery. A subset of clinically stable participants will complete the HOOS-12 again after 7 days for test-retest reliability assessment. Participants will also complete the HOOS-12 and SF-12 three months after surgery to evaluate responsiveness.
Receives: Other: Patient-Reported Outcome Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Internal Consistency of the Turkish HOOS-12

    Internal consistency of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be assessed using Cronbach's alpha coefficient. The HOOS-12 is a 12-item patient-reported outcome measure assessing hip-related pain, physical function, and hip-related quality of life. The HOOS-12 summary score ranges from 0 to 100, where 0 represents the worst possible hip-related health and 100 represents the best possible hip-related health. Higher scores indicate better hip-related health. Internal consistency will be evaluated using baseline data.

    Measured: Baseline

  2. Test-Retest Reliability

    Test-retest reliability of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be assessed in clinically stable participants who complete the questionnaire at baseline and again on Day 7. The HOOS-12 summary score ranges from 0 to 100, where 0 represents the worst possible hip-related health and 100 represents the best possible hip-related health. Higher scores indicate better hip-related health. Test-retest reliability will be evaluated using the intraclass correlation coefficient (ICC). Participants with a substantial therapeutic intervention or clinically relevant change in their condition between the two assessments will not be included in the test-retest reliability analysis.

    Measured: Baseline and Day 7

  3. Construct Validity With SF-12 Physical Component Summary

    Construct validity of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be evaluated by examining the correlation between the HOOS-12 summary score and the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12), according to a predefined hypothesis. Higher scores on both measures indicate better health status.

    Measured: Baseline

  4. Construct Validity With SF-12 Mental Component Summary

    Construct validity of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be evaluated by examining the correlation between the HOOS-12 summary score and the Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12), according to a predefined hypothesis. Higher scores on both measures indicate better health status.

    Measured: Baseline

  5. Structural Validity

    Structural validity of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be evaluated using confirmatory factor analysis (CFA). The HOOS-12 consists of 12 items assessing hip-related pain, physical function, and quality of life. The HOOS-12 summary score ranges from 0 to 100, where 0 represents the worst possible hip-related health and 100 represents the best possible hip-related health. Higher scores indicate better hip-related health. Model fit will be evaluated using the Comparative Fit Index (CFI), Tucker-Lewis Index (TLI), Root Mean Square Error of Approximation (RMSEA), and Standardized Root Mean Square Residual (SRMR). CFI, TLI, RMSEA, and SRMR will be interpreted jointly as complementary model-fit indices to evaluate the overall fit of the prespecified measurement model rather than as separate outcome measures.

    Measured: Baseline

  6. Responsiveness

    Responsiveness will be evaluated in participants who undergo primary total hip arthroplasty within 12 months after baseline assessment. The Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be administered before surgery and again 3 months after surgery. The HOOS-12 summary score ranges from 0 to 100, with higher scores indicating better hip-related health. Changes in scores will be used to evaluate the ability of the Turkish HOOS-12 to detect clinically meaningful change.

    Measured: From baseline until primary total hip arthroplasty, assessed up to 12 months; responsiveness assessed 3 months after surgery.

Secondary outcomes (6)
  1. Standard Error of Measurement of the Turkish HOOS-12

    Measurement error of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be quantified using the Standard Error of Measurement (SEM), based on scores obtained from clinically stable participants at baseline and Day 7.

    Measured: Baseline and Day 7

  2. Minimal Detectable Change of the Turkish HOOS-12

    The Minimal Detectable Change at the 95% confidence level (MDC95) of the Turkish Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) will be calculated using scores obtained from clinically stable participants at baseline and Day 7.

    Measured: Baseline and Day 7

  3. Floor Effect of the Turkish HOOS-12

    The floor effect will be determined as the percentage of participants achieving the minimum possible HOOS-12 summary score of 0 at baseline.

    Measured: Baseline

  4. Ceiling Effect of the Turkish HOOS-12

    The ceiling effect will be determined as the percentage of participants achieving the maximum possible HOOS-12 summary score of 100 at baseline.

    Measured: Baseline

  5. Physical Health-Related Quality of Life

    Physical health-related quality of life will be assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12). Higher PCS scores indicate better physical health-related quality of life.

    Measured: Baseline and Month 3

  6. Mental Health-Related Quality of Life

    Mental health-related quality of life will be assessed using the Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12). Higher MCS scores indicate better mental health-related quality of life.

    Measured: Baseline and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770971
Sponsor's protocol ID
HOOS-12 Turkish
Other IDs
Selcuk University
Status last verified
Aug 2026
First submitted
31 Jul 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) will not be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Osteoarthritis, run by Hacettepe University.

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 10 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: opening soon, as of the sponsor's last update on 18 Aug 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nazli Cigercioglu Assoc. Prof. (+90 541 290 32 93, nazlicigercioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Internal Consistency of the Turkish HOOS-12 (time frame: Baseline). The study lists 6 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 18 Aug 2026.

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