Serum Fetuin-A and COMP Levels in Knee Osteoarthritis

NCT07706569 | Recruiting

• 1 other identifier: 2026-108
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Fetuin-A; Cartilage Oligomeric Matrix Protein; Biological Biomarkers; Systemic Inflammation Response Index; Cross-Sectional Studies

Outcome Measures

Primary Outcomes (1)

• Serum Fetuin-A Levels

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

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

Secondary Outcomes (7)

• Serum COMP (Cartilage Oligomeric Matrix Protein) Levels

  Baseline

• Radiographic Severity via Kellgren-Lawrence (K-L) Classification

  Baseline

• Clinical Severity and Functional Status via WOMAC Index

  Baseline

• Systemic Inflammation Response Index (SIRI)

  Baseline

• Pain Severity via Visual Analog Scale (VAS)

  Baseline

Study Arms (2)

Knee Osteoarthritis Group

120 patients diagnosed with primary knee osteoarthritis (Grade 2-4 according to Kellgren-Lawrence classification, 40 patients from each grade).

Healthy Control Group

60 age- and sex-matched healthy volunteers without any knee pain, history of joint disease, or systemic inflammatory conditions.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of two main groups: a patient group and a healthy control group. The patient group included individuals who presented to the Physical Medicine and Rehabilitation Outpatient Clinics of SBÜ Antalya Training and Research Hospital and were diagnosed with primary knee osteoarthritis (Stage 2-4 according to the Kellgren-Lawrence classification system). The control group consisted of healthy volunteers of similar age and gender who did not have a known joint disorder, a history of knee pain, or a systemic inflammatory disease. All participants were selected using a single-center, hospital-based convenience sampling method during the specified study period.

You may qualify if:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

S.B.U. Antalya Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Antalya, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples isolated from fasting venous blood to analyze Fetuin-A and COMP levels via ELISA.

MeSH Terms

Conditions

Osteoarthritis, Knee; Pseudoachondroplasia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Burak Karaman, MD

CONTACT

+905079130762; burak2498@gmail.com

Meral Bilgilisoy Filiz, Assoc. Prof.

CONTACT

mbilgilisoy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

TU (1)