The Validity and Reliability of the OMERACT in the Turkish Population

March 23, 2026 updated by: Kadir Songur, Izmir Democracy University

The Validity, Reliability, and Clinical Correlation Study of the OMERACT Knee Osteoarthritis Ultrasound Scoring System in the Turkish Population

Knee osteoarthritis is a chronic disease common in middle-aged and older adults, characterized by functional impairment and reduced quality of life due to pain. While physical examination and radiographic Kellgren-Lawrence grading are frequently used in clinical evaluation, the severity of pain does not always correlate with the degree of structural degeneration. Ultrasonography is gaining prominence in osteoarthritis research due to its advantage of simultaneously evaluating both inflammatory and structural components, such as synovial hypertrophy, effusion, power Doppler signal, and osteophytes. The Outcome Measures in Rheumatology (OMERACT) working group has developed a standardized, multidimensional ultrasound scoring system for knee osteoarthritis, and this method is frequently used in the literature. This method consists of a diagnostic ultrasound examination lasting approximately 8-10 minutes. The examination evaluates the anatomical structures of the knee and also includes soft tissue examinations such as synovial hypertrophy. With this method, a diagnostic ultrasound examination lasting approximately 8-10 minutes is performed. The examination evaluates the anatomical structures of the knee and also includes soft tissue examinations such as synovial hypertrophy. Considering the differences between societies in cultural, genetic, biomechanical, body mass index distribution, and healthcare system practices, direct validity, clinical interpretability, and inter-study comparability are of significant importance. The validity, reliability, and applicability of the OMERACT osteoarthritis ultrasound scoring system have been reported in a study conducted on the Egyptian population. However, there is no data on the validity and reliability of OMERACT ultrasound scoring in the Turkish population. This study is the first prospective validation study aimed at establishing standardization for use in clinical practice in Turkey.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
100

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.

Study Locations

  • Turkey (Türkiye)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye), 35570
        • Recruiting
        • Izmir Democracy University
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

This study will include patients aged 45 years and older who have been diagnosed with knee osteoarthritis based on clinical and radiological evaluation and who have applied to the Physical Medicine and Rehabilitation Outpatient Clinic at İzmir Democracy University Buca Seyfi Demirsoy Education and Research Hospital.

Description

Inclusion Criteria:

  • Adults aged 45 years and older
  • Patients diagnosed with knee osteoarthritis clinically or radiographically
  • Being in a clinical condition that allows tolerance of ultrasound evaluation of both knees
  • Being able to provide written informed consent for participation in the study
  • Having sufficient cognitive ability to understand Turkish forms and scales

Exclusion Criteria:

  • Diagnosis of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, gout, CPPD, etc.)
  • Intra-articular injection into the knee joint within the last 6 months (corticosteroid, hyaluronic acid, PRP, etc.)
  • Previous major knee surgery (total knee replacement, major ligament reconstruction, etc.)
  • Acute pathology that has developed within the last 6 weeks, such as acute trauma/fracture/ligament injury
  • Severe deformity or severe movement restriction that technically prevents ultrasound examination
  • Active infection/systemic febrile condition
  • Neurological disease causing motor or sensory deficit in the lower extremities
  • Use of Gabapentinoid/SNRI/SSRI due to fibromyalgia or psychiatric illness
  • Severe cognitive impairment or communication problems that would prevent participation in the study
  • Pregnancy
  • Subjects who have been informed about the study and refuse to participate

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.
knee osteoarthritis

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
Western Ontario and McMaster Universities (WOMAC) score
Time Frame: Day 1
The WOMAC Osteoarthritis Index questionnaire, consisting of 5 questions using a Likert scale, is provided in the attached case report form to assess pain, stiffness, and daily living functions. The WOMAC Osteoarthritis Index consists of 24 questions covering three subscales: pain (5 questions), stiffness (2 questions), and function (17 questions). The scoring system consists of the WOMAC pain score, WOMAC stiffness score, WOMAC function score, and WOMAC total score. A Turkish validity and reliability study has been conducted.
Day 1
Outcome Measures in Rheumatology knee osteoarthritis scale
Time Frame: Day 1
Participants' Outcome Measures in Rheumatology knee ultrasound parameters will be evaluated (The necessary permission to use the OMERACT ultrasound protocol in the study has been obtained from Dr. George Bruyn). Ultrasound evaluations will be performed on patients' bilateral knees by two blinded evaluators (the first investigator with 8 years of experience in musculoskeletal ultrasonography and the second investigator with 1 year of experience) using a Philips HD11XE device and a 4-8 MHz linear probe. Synovitis, synovial hypertrophy, effusion, power Doppler signal, cartilage damage, meniscal pathology, and osteophyte scores in the Outcome Measures in Rheumatology knee osteoarthritis scoring system will be evaluated according to Outcome Measures in Rheumatology definitions. A higher Outcome Measures in Rheumatology knee ultrasound score indicates a worse outcome.
Day 1

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
Visual analog scale
Time Frame: Day 1
Visual analog scale measures pain as it is subjectively perceived. It uses a 0-10 cm scale, the most commonly used tool for quantitatively determining pain intensity, with one end representing no pain and the other end representing the most severe pain possible. '0' indicates no pain, while '10' indicates the most severe pain. The individual is asked to select the numerical value that best represents their condition. This marked value is used as numerical data to determine the level of pain perception. A higher score indicates a higher level of pain.
Day 1
Joint Range of Motion measurement
Time Frame: Day 1
Knee flexion and extension will be measured bilaterally using universal goniometry to assess patients' joint range of motion, and the angles will be recorded.
Day 1
Kellgren-Lawrence Classification
Time Frame: Day 1
The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.
Day 1

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.
Izmir Democracy 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 (Actual)

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.
February 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.
March 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.
September 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).
February 9, 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.
February 14, 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.
February 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.
March 27, 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.
March 23, 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.
March 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 2025 548

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 because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.

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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