Serum COMP and MMP-3 in Knee Osteoarthritis (KOACOMP)

April 7, 2026 updated by: Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital

Evaluation of the Relationship Between Serum COMP (Cartilage Oligomeric Matrix Protein) and MMP-3 (Matrix Metalloproteinase-3) Levels and Clinical and Radiological Severity in Patients With Knee Osteoarthritis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal disorders and a leading cause of pain, disability, and reduced quality of life worldwide. The pathophysiology of OA involves not only mechanical degeneration but also complex biological processes including cartilage degradation, synovial inflammation, and extracellular matrix remodeling. In recent years, there has been growing interest in identifying biochemical markers that can reflect disease severity and progression.

Cartilage oligomeric matrix protein (COMP) is a non-collagenous extracellular matrix protein predominantly found in cartilage, and its serum levels are considered to reflect cartilage turnover and degradation. Matrix metalloproteinase-3 (MMP-3) is an important proteolytic enzyme involved in the breakdown of extracellular matrix components and plays a key role in cartilage destruction in osteoarthritis. Elevated levels of these biomarkers have been reported in patients with OA and may be associated with disease severity.

This cross-sectional observational study is designed to investigate the relationship between serum COMP and MMP-3 levels and clinical and radiological severity in patients with knee osteoarthritis. A total of 60 participants will be included, consisting of 30 patients diagnosed with knee osteoarthritis and 30 healthy controls with similar demographic characteristics.

Clinical assessment will include pain severity measured by the Visual Analog Scale (VAS) and functional status assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Functional performance will be evaluated using the 5 Times Sit-to-Stand Test. Radiological severity will be determined according to the Kellgren-Lawrence classification based on standard knee radiographs.

Venous blood samples will be collected under aseptic conditions. Serum samples will be separated by centrifugation and stored under appropriate conditions until analysis. Serum COMP and MMP-3 levels will be measured using validated enzyme-linked immunosorbent assay (ELISA) kits in an accredited laboratory. All samples will be analyzed according to the manufacturer's instructions.

The primary objective of the study is to evaluate the association between serum COMP and MMP-3 levels and clinical and radiological severity parameters in knee osteoarthritis. Secondary objectives include comparing biomarker levels between patients and healthy controls and exploring the independent predictive value of these biomarkers after adjusting for potential confounding factors such as age, sex, and body mass index.

It is hypothesized that serum COMP and MMP-3 levels will be significantly higher in patients with knee osteoarthritis compared to healthy controls and will show a positive correlation with pain severity, functional impairment, and radiological grade. The findings of this study may contribute to a better understanding of the role of biochemical markers in osteoarthritis and support their potential use in clinical assessment and disease monitoring.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Knee Osteoarthritis
Patients diagnosed with knee osteoarthritis
Other: Observational Study
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
Age- and sex-matched healthy individuals without knee osteoarthritis
Other: Observational Study
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum COMP and MMP-3 Levels
Time Frame: At baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KOA-COMP-MMP3-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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