Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 9:14 PM
Study NCT ID:
NCT07416357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Validity and Reliability of the OMERACT in the Turkish Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities (WOMAC) score', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Outcome Measures in Rheumatology knee osteoarthritis scale', 'timeFrame': 'Day 1', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'Day 1', 'description': "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."}, {'measure': 'Joint Range of Motion measurement', 'timeFrame': 'Day 1', 'description': "Knee flexion and extension will be measured bilaterally using universal goniometry to assess patients' joint range of motion, and the angles will be recorded."}, {'measure': 'Kellgren-Lawrence Classification', 'timeFrame': 'Day 1', 'description': 'The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ostheoarthritis', 'ultrasonography', 'knee'], 'conditions': ['Knee Osteoarthristis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 45 years and older\n* Patients diagnosed with knee osteoarthritis clinically or radiographically\n* Being in a clinical condition that allows tolerance of ultrasound evaluation of both knees\n* Being able to provide written informed consent for participation in the study\n* Having sufficient cognitive ability to understand Turkish forms and scales\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, gout, CPPD, etc.)\n* Intra-articular injection into the knee joint within the last 6 months (corticosteroid, hyaluronic acid, PRP, etc.)\n* Previous major knee surgery (total knee replacement, major ligament reconstruction, etc.)\n* Acute pathology that has developed within the last 6 weeks, such as acute trauma/fracture/ligament injury\n* Severe deformity or severe movement restriction that technically prevents ultrasound examination\n* Active infection/systemic febrile condition\n* Neurological disease causing motor or sensory deficit in the lower extremities\n* Use of Gabapentinoid/SNRI/SSRI due to fibromyalgia or psychiatric illness\n* Severe cognitive impairment or communication problems that would prevent participation in the study\n* Pregnancy\n* Subjects who have been informed about the study and refuse to participate'}, 'identificationModule': {'nctId': 'NCT07416357', 'briefTitle': 'The Validity and Reliability of the OMERACT in the Turkish Population', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Democracy University'}, 'officialTitle': 'The Validity, Reliability, and Clinical Correlation Study of the OMERACT Knee Osteoarthritis Ultrasound Scoring System in the Turkish Population', 'orgStudyIdInfo': {'id': '2025 548'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'knee osteoarthritis'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kadir Songür, Assoc. Prof.', 'role': 'CONTACT', 'email': 'kadir.93@gmail.com', 'phone': '+905054529231'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Democracy University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Lecturer', 'investigatorFullName': 'Kadir Songur', 'investigatorAffiliation': 'Izmir Democracy University'}}}}