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Recruiting NCT07416357

The Validity and Reliability of the OMERACT in the Turkish Population

Trial Parameters

Condition Knee Osteoarthristis
Sponsor Izmir Democracy University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 45 Years
Max Age N/A
Start Date 2026-02-01
Completion 2027-03-01

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.

Eligibility Criteria

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

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