Validity and reliability of the OMERACT knee ultrasound score in Turkish adults with knee osteoarthritis
The Validity, Reliability, and Clinical Correlation Study of the OMERACT Knee Osteoarthritis Ultrasound Scoring System in the Turkish Population
This project will test whether the OMERACT ultrasound scoring system works well for Turkish adults aged 45 and older who have knee osteoarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Izmir Democracy University Academic / other |
| Locations | 1 site (Izmir, İzmir) |
| Trial ID | NCT07416357 on ClinicalTrials.gov |
What this trial studies
This is an observational validation project at a single center that applies the OMERACT standardized ultrasound protocol to people with knee osteoarthritis. Each participant undergoes a diagnostic ultrasound of both knees (about 8–10 minutes) to record synovial hypertrophy, effusion, power Doppler signal, and osteophytes. The study will compare ultrasound scores with clinical and radiographic findings and measure inter- and intra-rater reliability of the Turkish implementation. Common exclusions include inflammatory arthritis, recent intra-articular injections, prior major knee surgery, acute knee injury, and severe deformity that prevents ultrasound.
Who should consider this trial
Good fit: Ideal candidates are Turkish-speaking adults aged 45 or older with a clinical or radiographic diagnosis of knee osteoarthritis who can tolerate bilateral knee ultrasound and provide informed consent.
Not a fit: Patients with inflammatory arthritis, recent intra-articular injections, major previous knee surgery, acute knee trauma, severe deformity preventing ultrasound, active infection, or significant cognitive impairment are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could give clinicians in Turkey a reliable, standardized ultrasound tool to better describe knee inflammation and structural changes and to track disease over time.
How similar studies have performed: OMERACT ultrasound scoring has been used internationally and prior validations in other populations have generally shown good reliability, but formal validation in a Turkish population has been limited.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Izmir, İzmir
- Izmir Democracy University — Izmir, İzmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Kadir Songür, Assoc. Prof.
- Email: kadir.93@gmail.com
- Phone: +905054529231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.