Knee OsteoarthristisNCT07416357
The Validity and Reliability of the OMERACT in the Turkish Population
An observational study of Knee Osteoarthristis, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthristis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Democracy University
Izmir, İzmir, 35570
Kadir Songür, 05054529231, kadir.93@gmail.com
About this study
Official title: The Validity, Reliability, and Clinical Correlation Study of the OMERACT Knee Osteoarthritis Ultrasound Scoring System in the Turkish Population
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| knee osteoarthritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (3)
Visual analog scale
Visual analog scale measures pain as it is subjectively perceived. It uses a 0-10 cm scale, the most commonly used tool for quantitatively determining pain intensity, with one end representing no pain and the other end representing the most severe pain possible. '0' indicates no pain, while '10' indicates the most severe pain. The individual is asked to select the numerical value that best represents their condition. This marked value is used as numerical data to determine the level of pain perception. A higher score indicates a higher level of pain.
Measured: Day 1
Joint Range of Motion measurement
Knee flexion and extension will be measured bilaterally using universal goniometry to assess patients' joint range of motion, and the angles will be recorded.
Measured: Day 1
Kellgren-Lawrence Classification
The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Songur, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416357
- Sponsor's protocol ID
- 2025 548
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity, Reliability, and Clinical Correlation Study of the OMERACT Knee Osteoarthritis Ultrasound Scoring System in the Turkish Population
- ClinicalTrials.gov ID
- NCT07416357
- Acronym / sponsor ID
- 2025 548
- Conditions
- Knee Osteoarthristis
- Keywords
- ostheoarthritis, ultrasonography, knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis | – | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Western Ontario and McMaster Universities (WOMAC) score
Time frame: Day 1
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.
Outcome Measures in Rheumatology knee osteoarthritis scale
Time frame: Day 1
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.
3 secondary outcomes
Visual analog scale
Time frame: Day 1
Joint Range of Motion measurement
Time frame: Day 1
Kellgren-Lawrence Classification
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.
Related trials for Knee Osteoarthristis
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Study NRPT Feasibility in Knee Osteoarthritis
Knee Osteoarthristis
Not yet recruitingEarly Phase 1
Medication vs. Meditation for Chronic Knee Osteoarthritis
Knee Osteoarthristis
Not yet recruiting
Wearable Device Guided Exercise for Patients on Total Knee Arthroplasty Wait-list
Knee Osteoarthristis
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthristis, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kadir Songür, Assoc. Prof. (+905054529231, kadir.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities (WOMAC) score (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.