The Validity and Reliability of the OMERACT in the Turkish Population

NCT07416357 | Recruiting DMC

• 1 other identifier: 2025 548
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthristis

Keywords

ostheoarthritis; ultrasonography; knee

Outcome Measures

Primary Outcomes (2)

• Western Ontario and McMaster Universities (WOMAC) score

  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

  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 Outcomes (3)

• Visual analog scale

  Day 1

• Joint Range of Motion measurement

  Day 1

• Kellgren-Lawrence Classification

  Day 1

Study Arms (1)

knee osteoarthritis

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, İzmir, 35570, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Kadir Songür, Assoc. Prof.

CONTACT

+905054529231; kadir.93@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lecturer

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 18, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)