Menu
Recruiting NCT07416357

The Validity and Reliability of the OMERACT in the Turkish Population

Observational Knee Osteoarthristis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Western Ontario and McMaster Universities (WOMAC) score [Time frame: Day 1]
  • Outcome Measures in Rheumatology knee osteoarthritis scale [Time frame: Day 1]
Secondary outcome measures (3)
  • Visual analog scale [Time frame: Day 1]
  • Joint Range of Motion measurement [Time frame: Day 1]
  • Kellgren-Lawrence Classification [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Izmir Democracy University — Izmir

Identifiers

NCT: NCT07416357 · 2025 548

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗