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Recruiting NCT07706569

Serum Fetuin-A and COMP Levels in Knee Osteoarthritis

Observational Knee Osteoarthritis Osteoarthritis, Knee

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 Osteoarthritis, Osteoarthritis, Knee. Basic parameters: No limits · 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 Relationship Between Clinical and Radiographic Severity of Knee Osteoarthritis and Serum Fetuin-A and COMP Levels: A Controlled Cross-Sectional Study

Overview

The purpose of this study is to investigate the relationship between the clinical and radiographic severity of knee osteoarthritis (OA) and the serum levels of specific biomarkers, namely Fetuin-A and Cartilage Oligomeric Matrix Protein (COMP). Osteoarthritis is a degenerative joint disease characterized by cartilage breakdown and low-grade inflammation. Investigating these biomarkers may help healthcare providers better understand the disease pathology, potentially leading to earlier diagnosis and improved tracking of disease progression. The study will compare two distinct groups: a patient group consisting of 120 individuals diagnosed with Grade 2-4 knee osteoarthritis, and a control group of 60 age- and sex-matched healthy volunteers with no history of joint disorders. Participants will undergo radiographic evaluations using the Kellgren-Lawrence classification system, alongside clinical and functional assessments, including pain severity scales, mobility metrics, and functional questionnaires. Fasting blood samples will be collected from all participants to measure serum Fetuin-A and COMP levels via laboratory analysis, and the Systemic Inflammation Response Index (SIRI) will be calculated. The collected data will be statistically analyzed to determine if biomarker levels significantly correlate with the severity of knee joint degeneration and functional impairment.

Primary outcome measures

  • Serum Fetuin-A Levels [Time frame: Baseline (At the time of enrollment / single time point measurement)]
Secondary outcome measures (7)
  • Serum COMP (Cartilage Oligomeric Matrix Protein) Levels [Time frame: Baseline]
  • Radiographic Severity via Kellgren-Lawrence (K-L) Classification [Time frame: Baseline]
  • Clinical Severity and Functional Status via WOMAC Index [Time frame: Baseline]
  • Systemic Inflammation Response Index (SIRI) [Time frame: Baseline]
  • Pain Severity via Visual Analog Scale (VAS) [Time frame: Baseline]
  • Functional Mobility via 10-Meter Walk Test (10MWT) [Time frame: Baseline]
  • Lower Extremity Muscle Strength via 5-Times Sit-to-Stand Test (5x STS) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

\- Diagnosis of knee osteoarthritis according to ACR (American College of Rheumatology) criteria. Knee osteoarthritis classified as Grade 2, 3, or 4 according to Kellgren-Lawrence (K-L) grading. Volunteering to participate and providing signed informed consent.

Exclusion criteria

  • Secondary post-traumatic knee osteoarthritis, history of major knee injury or joint infection. Signs of acute joint inflammation (swelling, heat increase, erythema). History of knee surgery (open or arthroscopic). Systemic inflammatory or autoimmune diseases. History of malignancy. Advanced renal or hepatic disease. Diagnosis of Diabetes Mellitus. Current use of systemic corticosteroids. Symptomatic osteoarthritis in other major joints (hip, hand, ankle, spine). Active systemic infection (fever ≥ 38, cough, diarrhea, dysuria, leukocytosis, or elevated CRP).

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

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • S.B.U. Antalya Training and Research Hospital, Department of Physical Medicine and Rehabil — Antalya

Identifiers

NCT: NCT07706569 · 2026-108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗