Serum COMP and MMP-3 in Knee Osteoarthritis

NCT07528872 | Not Yet Recruiting

• 1 other identifier: KOA-COMP-MMP3-2026-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Knee osteoarthritis is a common degenerative joint disease characterized by pain, stiffness, and functional limitation, significantly affecting quality of life. In addition to mechanical factors, cartilage degradation and extracellular matrix remodeling play a key role in disease progression. Therefore, identifying reliable biomarkers reflecting disease severity has become an important research focus. Cartilage oligomeric matrix protein (COMP) is a structural component of cartilage associated with cartilage turnover, while matrix metalloproteinase-3 (MMP-3) is a proteolytic enzyme involved in extracellular matrix degradation. Both biomarkers have been suggested to be elevated in osteoarthritis and may reflect disease severity. The aim of this cross-sectional observational study is to evaluate the relationship between serum COMP and MMP-3 levels and clinical and radiological severity in patients with knee osteoarthritis. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and radiological severity with the Kellgren-Lawrence classification. Functional performance will also be evaluated using the 5 Times Sit-to-Stand Test. Additionally, serum COMP and MMP-3 levels will be compared between patients with knee osteoarthritis and healthy controls. The findings of this study are expected to contribute to a better understanding of the relationship between biochemical markers and clinical severity in osteoarthritis and may provide insight into their potential diagnostic and prognostic value.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Serum COMP and MMP-3 Levels

  Serum levels of cartilage oligomeric matrix protein (COMP) and matrix metalloproteinase-3 (MMP-3) will be measured using ELISA. The association between biomarker levels and clinical (VAS, WOMAC), functional (5 Times Sit-to-Stand Test), and radiological (Kellgren-Lawrence grade) severity parameters will be evaluated.

  At baseline

Study Arms (2)

Knee Osteoarthritis

Patients diagnosed with knee osteoarthritis

Other: Observational Study

Healthy Control

Age- and sex-matched healthy individuals without knee osteoarthritis

Other: Observational Study

Interventions

Observational Study OTHER

This is an observational study with no intervention. Participants will undergo clinical, radiological, and laboratory assessments, including serum biomarker analysis, without any therapeutic or experimental intervention.

Healthy Control; Knee Osteoarthritis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult participants aged 40-75 years recruited from the outpatient clinic of Physical Medicine and Rehabilitation. The patient group will include individuals with clinically and radiologically confirmed knee osteoarthritis, while the control group will consist of age- and sex-matched healthy volunteers without knee pain or radiographic evidence of osteoarthritis. All participants will be able to comply with study procedures and will provide written informed consent prior to enrollment.

You may qualify if:

• Age between 40 and 75 years Male and female participants For patient group: clinically and radiologically confirmed diagnosis of knee osteoarthritis Kellgren-Lawrence grade 2-3 (or 2-4 if you decide to include advanced stages) Ability to understand and comply with study procedures Willingness to participate and provision of written informed consent For control group: absence of knee pain and no radiographic evidence of knee osteoarthritis

You may not qualify if:

• Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis) History of acute knee trauma Previous knee surgery (e.g., arthroplasty or arthroscopy) History of septic arthritis or active infection History of malignancy Severe systemic diseases (e.g., advanced cardiac, renal, or hepatic failure) Neuromuscular disorders affecting lower extremity function Intra-articular injection (e.g., corticosteroids, PRP) within the last 3 months Other conditions that may cause knee pain apart from osteoarthritis Cognitive or psychiatric conditions preventing compliance with study procedures Refusal to provide informed consent

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected from all participants under aseptic conditions. Blood samples will be centrifuged to obtain serum, which will be aliquoted and stored at appropriate temperatures until analysis. Serum samples will be used to measure cartilage oligomeric matrix protein (COMP) and matrix metalloproteinase-3 (MMP-3) levels using validated enzyme-linked immunosorbent assay (ELISA) kits. No DNA analysis will be performed.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Zeynep Karakuzu Güngör, M.D

CONTACT

905077750375; zeynepkarakuzu@hotmail.com.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion: May 15, 2026
• Study Completion: June 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04