NCT07416357 The Validity and Reliability of the OMERACT in the Turkish Population
| NCT ID | NCT07416357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Izmir Democracy University |
| Condition | Knee Osteoarthristis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-02-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07416357 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Knee Osteoarthristis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07416357 currently recruiting?
Yes, NCT07416357 is actively recruiting participants. Contact the research team at kadir.93@gmail.com for enrollment information.
Where is the NCT07416357 trial being conducted?
This trial is being conducted at Izmir, Turkey (Türkiye).
Who is sponsoring the NCT07416357 clinical trial?
NCT07416357 is sponsored by Izmir Democracy University. The trial plans to enroll 100 participants.