Health TrialsbyHealthPanel

Turkish Validation of the HOOS-12

ConditionHip Osteoarthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patient-Reported Outcome Assessment

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with Hip Osteoarthritis1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hacettepe University

Lead sponsor

Source ClinicalTrials.gov

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