Turkish Validation of the HOOS-12

August 17, 2026 updated by: Nazli Cigercioglu, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with Hip Osteoarthritis
Adults 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.
Other: Patient-Reported Outcome Assessment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Internal Consistency of the Turkish HOOS-12
Time Frame: Baseline
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.
Baseline
Test-Retest Reliability
Time Frame: Baseline and Day 7
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.
Baseline and Day 7
Construct Validity With SF-12 Physical Component Summary
Time Frame: Baseline
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.
Baseline
Construct Validity With SF-12 Mental Component Summary
Time Frame: Baseline
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.
Baseline
Structural Validity
Time Frame: Baseline
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.
Baseline
Responsiveness
Time Frame: From baseline until primary total hip arthroplasty, assessed up to 12 months; responsiveness assessed 3 months after surgery.
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.
From baseline until primary total hip arthroplasty, assessed up to 12 months; responsiveness assessed 3 months after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standard Error of Measurement of the Turkish HOOS-12
Time Frame: Baseline and Day 7
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.
Baseline and Day 7
Minimal Detectable Change of the Turkish HOOS-12
Time Frame: Baseline and Day 7
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.
Baseline and Day 7
Floor Effect of the Turkish HOOS-12
Time Frame: Baseline
The floor effect will be determined as the percentage of participants achieving the minimum possible HOOS-12 summary score of 0 at baseline.
Baseline
Ceiling Effect of the Turkish HOOS-12
Time Frame: Baseline
The ceiling effect will be determined as the percentage of participants achieving the maximum possible HOOS-12 summary score of 100 at baseline.
Baseline
Physical Health-Related Quality of Life
Time Frame: Baseline and Month 3
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.
Baseline and Month 3
Mental Health-Related Quality of Life
Time Frame: Baseline and Month 3
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.
Baseline and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HOOS-12 Turkish
  • Selcuk University (Registry Identifier: Selcuk University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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