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NCT Number: NCT07706569

Serum Fetuin-A and COMP Levels in Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Pseudoachondroplasia Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Serum Fetuin-A Levels

    Time frame: Baseline (At the time of enrollment / single time point measurement)

    Measurement of serum Fetuin-A concentration using a human-specific ELISA kit to evaluate its relationship with radiographic and clinical severity.

Secondary outcomes

  1. Serum COMP (Cartilage Oligomeric Matrix Protein) Levels

    Time frame: Baseline

  2. Radiographic Severity via Kellgren-Lawrence (K-L) Classification

    Time frame: Baseline

  3. Clinical Severity and Functional Status via WOMAC Index

    Time frame: Baseline

  4. Systemic Inflammation Response Index (SIRI)

    Time frame: Baseline

    (Neutrophil x Monocyte) / Lymphocyte

  5. Pain Severity via Visual Analog Scale (VAS)

    Time frame: Baseline

  6. Functional Mobility via 10-Meter Walk Test (10MWT)

    Time frame: Baseline

  7. Lower Extremity Muscle Strength via 5-Times Sit-to-Stand Test (5x STS)

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Karaman, MD

CONTACT

[email protected]

+905079130762

Meral Bilgilisoy Filiz, Assoc. Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Official study title

The Relationship Between Clinical and Radiographic Severity of Knee Osteoarthritis and Serum Fetuin-A and COMP Levels: A Controlled Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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